Acid Reflux & GORD

/Acid Reflux & GORD
Acid Reflux & GORD 2020-12-01T17:36:40+00:00

Acid Reflux / GORD

About Acid Reflux / GORD
FAQs
Learn more about digestion & bowel health

Welcome to Qoctor’s online doctor service which provides assessment & treatment for GORD. Answer some simple questions, then book a video consultation. If treatment is advised, you can have your prescription emailed direct to your local pharmacy (or posted to you), OR you can get medication delivered.

  • It costs $24.99 for a consultation, which also covers any prescription(s) issued.
  • If you request to have medication delivered to you, the cost of medication will be added.
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About Acid Reflux & GORD

  • Gastro-oesophageal reflux disease (also known as GORD or acid reflux) is a common condition caused by acid rising from the stomach into the oesophagus (food pipe). This can cause symptoms such as heartburn, nausea, bloating, indigestion, belching, a taste of acid in the mouth,  and sometimes a dry cough.
  • It can be triggered by various things, such as acidic or rich foods, large meals, alcohol, being overweight, and smoking.
  • If you’ve had reflux for a few days, a short course of antacid medication may get rid of the symptoms.  If this does not work, it’s essential you see a doctor for a check up, as there can be a more serious underlying condition.
  • Some people suffer from reflux on an ongoing basis and need to take antacids every day. Anyone who needs long term antacids should have a camera test (gastroscopy) to make sure there is nothing more serious going on, and should also have a check up with their doctor every 6 to 12 months.
Acid Reflux or GORD
GET TREATMENT

Common Questions and Answers

What is Acid Reflux / GORD? 2017-10-19T23:14:51+00:00

Gastro-oesophageal reflux disease (GORD) is a general term which encompasses acid reflux, heartburn, indigestion and oesophagitis. It may include one or more of these conditions. It is caused by irritation of the stomach or food pipe (oesophagus) by stomach acid.

Why does Acid Reflux / GORD happen? 2017-10-19T23:14:08+00:00

The stomach naturally makes acid as part of the normal digestion process. Usually the sphincter at the bottom of the oesophagus acts as a valve and keeps this acid in the stomach. Acid reflux can happen if this sphincter is weak, if there is too much acid made in the stomach, if the stomach is not emptying properly, or if there is increased pressure in the stomach, forcing acid back up into the oesophagus.

What are the triggers of Acid Reflux / GORD? 2017-10-19T23:15:33+00:00

Many things can trigger Acid Reflux / GORD including:

  • Smoking
  • Caffeine
  • Alcohol
  • Hiatus Hernia
  • Helicobacter Pylori ( a common infection of the stomach)
  • Acidic or spicy food and drink
  • Large fatty meals
  • Obesity
  • Stress
  • Pregnancy
  • Medications (including anti-inflammatories, certain blood pressure medications, sleeping tablets and painkillers)
What are the symptoms of GORD? 2017-10-19T23:12:29+00:00

The main symptom of GORD is heartburn. This is a discomfort or burning sensation which rises from the upper tummy or lower chest up towards the neck. Other common symptoms include:

  • Nausea
  • Belching
  • Indigestion
  • An acid-like taste in the mouth
  • Persistent dry cough
  • A feeling of a lump in the throat
  • A burning pain when you swallow hot drinks

Symptoms tend to be worse after or with meals.

What symptoms may mean something more serious is going on? 2018-02-09T19:54:43+00:00

If you get any of the following symptoms you should seek immediate medical attention. They may indicate a more serious underlying condition:

  • Chest pain or upper tummy pain worse on exertion
  • Difficulty swallowing foods or liquids
  • Persistent pain on swallowing
  • Persistent vomiting
  • Vomiting blood or dark brown vomit
  • Unexplained weight loss
  • Altered bowel habit (diarrhoea or constipation) for more than 6 weeks
  • Altered stool (dark or black poo)
  • Lump in the abdomen (tummy)
  • Unexplained anaemia
  • Jaundice
  • New GORD symptoms in someone aged 55 years or over
  • GORD symptoms with any of the following:
    • Family history of stomach or oesophageal cancer in more than two first degree relatives
    • Barrett’s oesophagus
    • Pernicious anaemia
    • Previous stomach ulcer surgery
    • Pernicious anaemia
    • A previous diagnosis of the following stomach conditions: dysplasia, atrophic gastritis or intestinal metaplasia
Do I need any tests to confirm the diagnosis? 2017-10-19T23:10:52+00:00

Most people are diagnosed with GORD by their GP on the basis of their typical symptoms and their response to treatment. Further tests may be needed if:

  • Symptoms are severe
  • Do not improve with treatment
  • Are not typical of GORD
  • There are any red flag symptoms

If further investigation is required a gastroscopy is usually the next step. This is where a thin, flexible telescope is passed down the oesophagus into the stomach. A normal test helps to rule out more serious causes of reflux symptoms, particularly stomach cancer.

What is the treatment for acid reflux? 2018-02-09T19:58:50+00:00

Obviously, it makes sense to make some lifestyle changes, and avoid the triggers listed above- for example avoiding smoking, alcohol and weight gain.  There are over the counter medications which help to neutralise acid, as well as other medications which may be prescribed by doctors.

What are the possible complications of Acid Reflux / GORD? 2017-10-19T23:09:48+00:00

Oesophageal stricture– Acid Reflux / GORD can cause scarring and narrowing of the food pipe called an oesophageal stricture if left untreated. This can lead to difficulty swallowing, and problems eating and drinking.

Barrett’s oesophagus – this is a complication of long standing, untreated Acid Reflux / GORD. The excess acid causes a permanent change in the cells that line the oesophagus. It increases the risk of developing cancer of the oesophagus, and thus needs to be managed and monitored.

But most people with Acid Reflux / GORD do not develop any of these complications. If you have any concerns then you should discuss them with your doctor.

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A CMI leaflet is a Consumer Medication Information Leaflet. It is designed to inform the public about prescription and over-the-counter pharmacy medication. The information is written by pharmaceutical companies, and must adhere to strict government guidelines to ensure it is accurate, thorough and understandable.

ESOMEPRAZOLE GXP®

Contains the active ingredient Esomeprazole (as magnesium)

Consumer Medicine Information

 

What is in this leaflet

This leaflet answers some of the common questions people ask about Esomeprazole GxP. It does not contain all the information that is known about Esomeprazole GxP.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor will have weighed the risks of you taking Esomeprazole GxP against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Esomeprazole GxP is used for

Reflux Oesophagitis

Esomeprazole GxP is taken to treat reflux oesophagitis. This can be caused by “washing back” (reflux) of food and acid from the stomach into the food pipe (oesophagus). Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn. Esomeprazole GxP is also taken to help stop reflux oesophagitis coming back or relapsing. Upper gastrointestinal symptoms associated with non-steroidal antiinflammatory drugs (NSAIDs) therapy Esomeprazole GxP is taken to treat the symptoms of pain or discomfort, in the stomach caused by NSAIDs, a type of medicine for pain or inflammation. Esomeprazole GxP is also taken to help heal and prevent ulcers caused by NSAIDs Peptic Ulcers Associated with Helicobacter pylori Infection Most people who have a peptic (gastric and duodenal) ulcer also have a bacterium called Helicobacter pylori in their stomach. Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out from the stomach. If you have a peptic ulcer, your doctor will prescribe Esomeprazole GxP with antibiotics. When Esomeprazole GxP and antibiotics are taken together, they work to kill the bacterium and let your ulcer heal. You may need further treatment with antibiotics.

Zollinger-Ellison Syndrome

Esomeprazole GxP is also used to treat a rare condition called Zollinger-Ellison syndrome, where the stomach produces large amounts of acid, much more than in ulcers or reflux disease.

How Esomeprazole GxP works

Esomeprazole GxP is a type of medicine called a proton-pump inhibitor. It works by decreasing the amount of acid made by the stomach, to give relief of symptoms and allow healing to take place. This does not stop food being digested in the normal way.

Follow all directions given to you by your doctor carefully.

They may differ from the information contained in this leaflet Ask your doctor if you want more information.

Your doctor may have prescribed Esomeprazole GxP for another reason.

There is no evidence that Esomeprazole GxP is addictive. This medicine is only available with a prescription.

Before you take Esomeprazole GxP

When you must not take it

Do not take Esomeprazole GxP if you have allergies to:

  • esomeprazole or any ingredient listed at the end of this leaflet 
  • any medicines containing a proton-pump inhibitor.

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Do not take Esomeprazole GxP if you are also taking atazanavir or cilostazol.

Please check with your doctor or pharmacist if you are taking these medicines. These medicines will be affected by Esomeprazole GxP

Esomeprazole GxP is not approved for use in children younger than 12 years of age.

There is no specific information about use in children younger than 12 years of age, so Esomeprazole GxP is not recommended in these patients.

Do not take Esomeprazole GxP after the use by (expiry) date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

Before you start to take it

You must tell your doctor if you have:

  • allergies to any other medicines, foods, dyes or preservatives. 
  • any problems with your liver 
  • severe kidney problems 
  • any other medical conditions

Do not take Esomeprazole GxP if you are pregnant or breastfeeding unless your doctor says so. Ask your doctor about the risks and benefits involved.

It is not known if it is safe for you to take Esomeprazole GxP while you are pregnant. It may affect your baby.

It is not known if your baby can take in Esomeprazole GxP from breast milk if you are breastfeeding.

Taking other medicines

Do not take Esomeprazole GxP if you are taking the following medicines:

  • atazanavir, a medicine used to treat Human Immunodeficiency Virus (HIV) 
  • cilostazol, a medicine used to treat intermittent claudication

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Esomeprazole GxP. These include: 

  • medicines used to treat fungal infections such as ketoconazole, itraconazole and voriconazole  cisapride 
  • diazepam, a medicine used to treat anxiety and some other conditions 
  • phenytoin, a medicine used to treat epilepsy 
  • medicines used to treat depression such as citalopram, clomipramine or imipramine 
  • St John’s wort, a herbal remedy used to treat mood disorders 
  • medicines used to treat bacterial infections such as clarithromycin and rifampicin 
  • warfarin, a medicine used to prevent blood clots 
  • medicines for HIV treatment such as atazanavir and nelfinavir 
  • digoxin, a medicine used to treat heart conditions 
  • methotrexate – a medicine used to treat arthritis and some types of cancer 
  • tacrolimus – a medicine used to assist in organ transplants 
  • erlotinib or related medicines used to treat cancer

These medicines may be affected by Esomeprazole GxP or may affect how well it works. You may need different amounts of your medicine or you may need to take different medicines.

Your doctor can tell you what to do if you are taking any other medicines Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Esomeprazole GxP.

If you have not told your doctor about any of these things, tell them before you take Esomeprazole GxP.

How to take Esomeprazole GxP

Follow all directions given to you by your doctor and pharmacist carefully.

These instructions may differ from the information contained in this leaflet

If you do not understand the directions on the label, ask your doctor or pharmacist for help.

How to take it:

Esomeprazole GxP is available as enteric capsules or tablets.

Esomeprazole GxP Enteric capsules

Take one Esomeprazole GxP capsule each day, unless your doctor has told you otherwise.

The dose of Esomeprazole GxP enteric capsules is usually 20 mg or 40 mg a day depending on what condition you are being treated for and how severe it is.

Swallow Esomeprazole GxP enteric capsules whole with a glass of water.

Esomeprazole GxP Tablets

Take one Esomeprazole GxP Tablet each day, unless your doctor has told you otherwise.

The dose of Esomeprazole GxP tablets is usually 20 mg or 40 mg a day depending on what condition you are being treated for and how severe it is.

Swallow Esomeprazole GxP tablets whole with a glass of water. Do not crush or chew the tablets

If the tablets are chewed or crushed they will not work properly

If you have difficulty swallowing the tablets:

  1. Place the tablet in half a glass of non-carbonated water. Mineral water or other liquids are not suitable
  2. Gently mix the tablet and water by stirring, taking care not to crush the tablet
  3. Stir until the tablet dissolves into little pellets
  4. Drink the liquid with the pellets immediately or within 30 minutes. Do not chew the pellets
  5. Rinse the glass with half a glass of water and drink

If you cannot swallow at all, follow steps 1-3 above to disperse the tablets and administer the liquid and pellets through a gastric tube.

Take Esomeprazole GxP at about the same time each day.

Keeping a regular time for taking Esomeprazole GxP will help to remind you to take it.

Keep taking Esomeprazole GxP for as long as your doctor recommends.

In most patients, Esomeprazole GxP relieves symptoms rapidly and healing is usually complete within 4 weeks. Continue taking Esomeprazole GxP for as long as your doctor tells you to.

Esomeprazole GxP can be taken with food or on an empty stomach.

If you forget to take it

If you forget to take a dose, take it as soon as you remember, and then go back to taking it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

Taking too much (overdose)

Telephone your doctor or the Poisons Information Centre (13 11 26) or go to Accident and Emergency at your nearest hospital immediately if you think that you or anyone else may have taken too many Esomeprazole GxP. Do this even if there are no signs of discomfort or poisoning.

While you are taking Esomeprazole GxP

Things you must do

Take Esomeprazole GxP exactly as your doctor has prescribed.

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking Esomeprazole GxP.

Tell all doctors, dentists and pharmacists who are treating you that you are taking Esomeprazole GxP.

Tell your doctor if you become pregnant while you are taking Esomeprazole GxP

Tell your doctor if your symptoms return.

Although Esomeprazole GxP can heal ulcers successfully, it may not prevent them recurring at a later date If you need to have any medical tests while you are taking Esomeprazole GxP, tell your doctor.

It may affect the results of some tests.

Things you must not do

Do not use it to treat any other conditions unless your doctor tells you to.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Esomeprazole GxP.

Esomeprazole GxP helps most people with peptic ulcers or reflux disease, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • nausea or vomiting 
  • constipation 
  • diarrhoea 
  • headache 
  • wind 
  • stomach pain 
  • skin rash 
  • itchy skin 
  • dizziness 
  • dry mouth

These side effects are usually mild.

Tell you doctor immediately if you notice any of the following:

  • Blurred vision 
  • mood changes, confusion or depression 
  • muscle pain or weakness, joint pain 
  • increase in breast size (males) 
  • increased sweating 
  • changes in sleep patterns 
  • fever 
  • increased bruising 
  • “pins and needles” 
  • hair loss 
  • tremor 
  • blood in the urine
  • signs of liver inflammation including yellowing of the skin or eyes, feeling generally unwell, nausea, vomiting, loss of appetite

These are all rare or very rare side effects. These side effects may require medical attention.

If you notice any of the following happen, tell your doctor immediately or go to Accident and Emergency at the nearest hospital:

  • shortness of breath, wheezing or difficulty breathing 
  • swelling of the face, lips, tongue or other parts of the body 
  • severe skin reaction which may include rash, itching, redness, blistering or peeling of the skin

These are very serious side effects.

You may need urgent medical treatment or hospitalisation. These side effects are rare.

Tell your doctor if you think you have any of these effects or notice anything else that is making you feel unwell.

Some people may get other side effects while taking Esomeprazole GxP.

Other problems are more likely to arise from the condition itself rather than the treatment.

For this reason, contact your doctor immediately if you notice any of the following: 

  • pain or indigestion during treatment with Esomeprazole GxP 
  • you begin to vomit blood or food 
  • you pass black (blood-stained) motions.

After taking Esomeprazole GxP

Storage

Keep Esomeprazole GxP where children cannot reach it.

A locked cupboard at least one-anda-half metres above the ground is a good place to store medicines.

Keep your Esomeprazole GxP in the blister pack until it is time to take them.

Keep your Esomeprazole GxP in the bottle, with the lid firmly closed, until it is time to take them.

If you take Esomeprazole GxP out of the blister or bottle, it may not keep well.

Keep it in a cool, dry place where the temperature stays below 25 degrees C.

Protect from moisture.

Do not keep Esomeprazole GxP or any other medicine in the bathroom or near a sink.

Do not leave Esomeprazole GxP in the car or on window sills.

Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking Esomeprazole GxP or the tablets or enteric capsules have passed their expiry date, ask your pharmacist what to do with any enteric capsules you have left over.

 

 

Product description

What Esomeprazole GxP looks like:

Esomeprazole GxP 20 mg are light pink, oblong, biconvex, film coated tablets de bossed with ’20’ on one side and ‘CE’ on the other side. Esomeprazole GxP 40 mg are pink, oblong, biconvex, film coated tablets debossed ’40’ on one side and ‘CE’ on the other side.

Ingredients:

Each Esomeprazole GxP tablet contains esomeprazole magnesium as the active ingredient equivalent to esomeprazole 20mg or 40mg; plus, 

  • Sugar spheres (Non-pareil seeds 40-50, ARTG 108808) 
  • Hydroxypropylcellulose 
  • Crospovidone 
  • Confectioner’s sugar (sucrose and maize starch) 
  • Magnesium oxide light 
  • Purified talc 
  • Macrogol 6000 
  • Methacrylic acid ethyl acrylate 
  • copolymer 
  • Glyceryl monostearate 
  • Macrogol 400 
  • Polysorbate 80 
  • Hypromellose phthalate 
  • Acetone 
  • Microcrystalline cellulose 
  • Iron oxide red 
  • Povidone 
  • Pregelatinised maize starch 
  • Silicon dioxide 
  • Lactose 
  • Opadry Pink 03B848893 (ARTG  108603) (20mg) 
  • Opadry Pink 03B54193 (ARTG I 08604) ( 40mg)

Sponsor

Esomeprazole GxP is supplied in Australia by:

Alphapharm Pty Limited

(ABN 93 002 359 739) Level 1, 30 The Bond 30-34 Hickson Road Millers Point NSW 2000

Phone: (02) 9298 3999

www.alphapharm.com.au

Australian registration numbers:

Esomeprazole GxP Tabs 20 mg

Tablets (blister)- AUST R 205831

Esomeprazole GxP Tabs 40 mg

Tablets (blister)- AUST R 205845

Esomeprazole GxP Tabs 20 mg

Tablets (bottle)- AUST R 236440

Esomeprazole GxP Tabs 40 mg

Tablets (bottle) Tablets- AUST R 236441

This leaflet was prepared on 30/07/2015.

Esomeprazole GxP_cmi\Jul 15\01

NEXIUM®

Esomeprazole magnesium trihydrate

Consumer Medicine Information

 

What is in this leaflet

This leaflet answers some of the common questions people ask about NEXIUM. It does not contain all the information that is known about NEXIUM.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor will have weighed the risks of you taking NEXIUM against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What NEXIUM is used for

Reflux Oesophagitis

NEXIUM is taken to treat reflux oesophagitis. This can be caused by “washing back” (reflux) of food and acid from the stomach into the food pipe (oesophagus).

Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn.

NEXIUM is also taken to help stop reflux oesophagitis coming back or relapsing.

Upper gastrointestinal symptoms associated with non-steroidal antiinflammatory drugs (NSAIDs) therapy

NEXIUM is taken to treat the symptoms of pain or discomfort, in the stomach caused by NSAIDs, a type of medicine for pain or inflammation.

NEXIUM is also taken to help heal and prevent ulcers caused by NSAIDs.

Peptic Ulcers Associated with Helicobacter pylori Infection

Most people who have a peptic (gastric and duodenal) ulcer also have a bacterium called Helicobacter pylori in their stomach.

Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out from the stomach.

If you have a peptic ulcer, your doctor will prescribe NEXIUM with antibiotics. When NEXIUM and antibiotics are taken together, they work to kill the bacterium and let your ulcer heal. You may need further treatment with antibiotics.

Zollinger-Ellison Syndrome

NEXIUM is also used to treat a rare condition called Zollinger-Ellison syndrome, where the stomach produces large amounts of acid, much more than in ulcers or reflux disease.

Bleeding Peptic Ulcers

When peptic ulcers become severe enough, they start to bleed. You may receive treatment injected into your veins initially. This treatment may be followed with NEXIUM tablets or granules prescribed by your doctor for a longer period of time. This is to help your ulcer/s to heal.

How NEXIUM works

NEXIUM is a type of medicine called a proton-pump inhibitor. It works by decreasing the amount of acid made by the stomach, to give relief of symptoms and allow healing to take place. This does not stop food being digested in the normal way.

Follow all directions given to you by your doctor carefully.

They may differ from the information contained in this leaflet.

Ask your doctor if you want more information.

Your doctor may have prescribed NEXIUM for another reason.

There is no evidence that NEXIUM is addictive.

Before you take NEXIUM

When you must not take it

Do not take NEXIUM if you have allergies to:

  • esomeprazole or any ingredient listed at the end of this leaflet
  • any medicines containing a proton-pump inhibitor

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Do not take NEXIUM if you are also taking atazanavir or cilostazol.

Please check with your doctor or pharmacist if you are taking these medicines. These medicines will be affected by NEXIUM.

NEXIUM is not approved for use in children younger than 1 year of age.

There is no specific information about use in children younger than 1 year of age, so NEXIUM is not recommended in these patients.

Do not take NEXIUM after the use by (expiry) date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

Before you start to take it

You must tell your doctor if you have:

  • allergies to any other medicines, foods, dyes or preservatives
  • any problems with your liver
  • severe kidney problems
  • any other medical conditions
  • been diagnosed with osteoporosis

Do not take NEXIUM if you are pregnant or breastfeeding unless your doctor says so. Ask your doctor about the risks and benefits involved.

It is not known if it is safe for you to take NEXIUM while you are pregnant. It may affect your baby.

It is not known if your baby can take in NEXIUM from breast milk if you are breastfeeding.

Taking other medicines

Do not take NEXIUM if you are taking the following medicines:

  • atazanavir and nelfinavir – medicines used to treat viral infections such as HIV
  • cilostazol – a medicine used to treat intermittent claudication

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with NEXIUM. These include:

  • ketoconazole, itraconazole and voriconazole – medicines used to treat fungal infections
  • diazepam – a medicine used to treat anxiety and some other conditions
  • phenytoin – a medicine used to treat epilepsy or fits
  • citalopram, clomipramine and imipramine – medicines used to treat depression
  • St John’s wort – a herbal remedy used to treat mood disorders
  • clarithromycin and rifampicin – medicines used to treat bacterial infections
  • warfarin and clopidogrel – medicines used to prevent blood clots
  • digoxin – a medicine used to treat heart conditions
  • methotrexate – a medicine used to treat arthritis and some types of cancer
  • tacrolimus and mycophenolate mofetil – medicines used to assist in organ transplants
  • erlotinib or related medicines used to treat cancer

These medicines may be affected by NEXIUM or may affect how well it works. You may need different amounts of your medicine or you may need to take different medicines. Your doctor can tell you what to do if you are taking any other medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking NEXIUM.

If you have not told your doctor about any of these things, tell them before you take NEXIUM.

How to take NEXIUM

Follow all directions given to you by your doctor and pharmacist carefully.

These instructions may differ from the information contained in this leaflet

If you do not understand the directions on the label, ask your doctor or pharmacist for help.

How to take it

NEXIUM is available as tablets and as granules for suspension in sachets.

NEXIUM Tablets

Take one NEXIUM tablet each day, unless your doctor has told you otherwise.

The dose of NEXIUM tablets is usually 20 mg or 40 mg a day depending on what condition you are being treated for and how severe it is.

Swallow NEXIUM tablets whole with a glass of water. Do not crush or chew the tablets.

If the tablets are chewed or crushed they will not work properly.

If you have difficulty swallowing the tablets:

  1. Place the tablet in half a glass of non-carbonated water. Mineral water or other liquids are not suitable.
  2. Gently mix the tablet and water by stirring, taking care not to crush the tablet.
  3. Stir until the tablet dissolves into little pellets.
  4. Drink the liquid with the pellets immediately, or within 30 minutes. Do not chew the pellets.
  5. Rinse the glass with half a glass of water and drink.

If you cannot swallow at all, follow steps 1-3 above to disperse the tablets and administer the liquid and pellets through a gastric tube.

NEXIUM Sachets

NEXIUM sachets are usually used for children or adults who have trouble swallowing tablets. The dose of NEXIUM sachets is 10 to 20 mg a day depending on what condition is being treated and how severe it is.

The granules in NEXIUM sachets should be dispersed as follows in non-carbonated water (mineral water is not suitable) before being taken:

  1. For a 10 mg dose empty the contents of a 10 mg sachet into a glass containing 15 mL of water. For a 20 mg dose empty the contents of two 10 mg sachets into a glass containing 30 mL of water.
  2. Stir the contents and leave for a few minutes to thicken.
  3. Stir again and drink within 30 minutes.
  4. If any material remains after drinking, add more water, stir and drink immediately.

For patients who cannot swallow, NEXIUM granules for oral suspension can be administered via a large syringe through a nasogastric or gastric tube:

  1. For a 10 mg dose add the contents of a 10 mg sachet to a syringe containing 15 mL of water. For a 20 mg dose add the contents of two 10 mg sachets to a syringe containing 30 mL of water.
  2. Immediately shake the syringe and leave for a few minutes to thicken.
  3. Shake the syringe and inject through the nasogastric or gastric tube within 30 minutes.
  4. Refill the syringe with 15 mL of water, then shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.

Do not crush or chew the pellets in the suspension.

If the pellets are chewed or crushed they will not work properly.

Take NEXIUM at about the same time each day.

Keeping a regular time for taking NEXIUM will help to remind you to take it.

Keep taking NEXIUM for as long as your doctor recommends.

In most patients, NEXIUM relieves symptoms rapidly and healing is usually complete within 4 weeks. Continue taking NEXIUM for as long as your doctor tells you to.

NEXIUM can be taken with food or on an empty stomach.

If you forget to take it

If you forget to take a dose, take it as soon as you remember, and then go back to taking it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

Taking too much (overdose)

Telephone your doctor or the Poisons Information Centre (13 11 26) or go to Accident and Emergency at your nearest hospital immediately if you think that you or anyone else may have taken too many NEXIUM. Do this even if there are no signs of discomfort or poisoning.

While you are taking NEXIUM

Things you must do

Take NEXIUM exactly as your doctor has prescribed.

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking NEXIUM.

Tell all doctors, dentists and pharmacists who are treating you that you are taking NEXIUM.

Tell your doctor if you become pregnant while you are taking NEXIUM.

Tell your doctor if your symptoms return.

Although NEXIUM can heal ulcers successfully, it may not prevent them recurring at a later date.

If you need to have any medical tests while you are taking NEXIUM, tell your doctor.

It may affect the results of some tests.

Things you must not do

Do not take it to treat any other complaints unless your doctor tells you to.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking NEXIUM.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • nausea or vomiting
  • constipation
  • diarrhoea
  • headache
  • wind
  • stomach pain
  • skin rash, itchy skin
  • dizziness
  • dry mouth

These side effects are usually mild.

Tell your doctor immediately if you notice any of the following:

  • blurred vision
  • mood changes, confusion or depression
  • muscle pain or weakness, joint pain
  • increase in breast size (males)
  • increased sweating
  • changes in sleep patterns
  • fever
  • increased bruising
  • “pins and needles”
  • hair loss
  • tremor
  • blood in the urine

These side effects may require medical attention.

If you notice any of the following happen, tell your doctor immediately or go to Accident and Emergency at the nearest hospital:

  • shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • severe skin reaction which may include rash, itching, redness, blistering or peeling of the skin
  • signs of liver inflammation including yellowing of the skin or eyes, feeling generally unwell, nausea, vomiting, loss of appetite

These are very serious side effects. You may need urgent medical treatment or hospitalisation.

Occasionally, NEXIUM may be associated with changes in your liver or blood, which may require your doctor to do certain blood tests.

Tell your doctor if you think you have any of these effects or notice anything else that is making you feel unwell.

Some people may get other side effects while taking NEXIUM.

Other problems are more likely to arise from the condition itself rather than the treatment.

For this reason, contact your doctor immediately if you notice any of the following:

  • pain or indigestion during treatment with NEXIUM
  • you begin to vomit blood or food
  • you pass black (blood-stained) motions

After taking it

Storage

Keep your NEXIUM in the blister pack until it is time to take them.

If you take NEXIUM out of the blister pack it will not keep well.

Keep it in a cool, dry place where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on a window sill.

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

A locked cupboard at least one-anda-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking NEXIUM or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets you have left over.

Product description

What NEXIUM looks like

Tablets

NEXIUM 20 mg are light pink, oblong shaped tablets engraved 20 mg on one side and A / EH on the other.

NEXIUM 40 mg are pink, oblong shaped tablets engraved 40 mg on one side and A / EI on the other.

NEXIUM Granules for oral suspension

NEXIUM 10 mg granules for oral suspension are pale yellow fine granules (brownish granules may be visible) in a unit dose sachet.

Ingredients

Tablets

Each NEXIUM tablet contains esomeprazole magnesium trihydrate as the active ingredient equivalent to esomeprazole 20 mg or 40 mg. Plus the following inactive ingredients:

  • glyceryl monostearate (E 471)
  • hydroxypropyl cellulose
  • hypromellose
  • magnesium stearate (E 572)
  • methacrylic acid copolymer
  • microcrystalline cellulose (E 460)
  • paraffin synthetic
  • macrogol 6000
  • polysorbate 80 (E 433)
  • crospovidone
  • sodium stearyl fumarate
  • purified talc (E 553(b))
  • titanium dioxide (E 171)
  • triethyl citrate
  • sugar spheres (maize starch and sucrose)

The tablets are coloured with iron oxide red CI77491 and/or iron oxide yellow CI77492.

NEXIUM Granules for oral suspension

Each sachet of NEXIUM granules for oral suspension contains esomeprazole magnesium trihydrate as the active ingredient equivalent to esomeprazole 10 mg.

Plus the following inactive ingredients:

  • glyceryl monostearate
  • hydroxypropylcellulose
  • hypromellose
  • magnesium stearate
  • methacrylic acid copolymer
  • polysorbate 80
  • talc
  • triethyl citrate
  • glucose – anhydrous
  • xanthan gum
  • crospovidone
  • citric acid – anhydrous
  • iron oxide yellow
  • sugar spheres (maize starch and sucrose)

NEXIUM tablets and granules for oral suspension do not contain gluten.

NEXIUM tablets are available in blister packs of 7 or 30 tablets.

NEXIUM granules are available in packs containing 30 unit dose sachets.

Sponsor

AstraZeneca Pty Ltd

ABN 54 009 682 311

Alma Road

NORTH RYDE NSW 2113

Australian Registration Numbers:

NEXIUM 20 mg (blister) – 74133

NEXIUM 40 mg (blister) – 74134

NEXIUM 10 mg (sachet) – 135726

Non-marketed presentations

NEXIUM 20 mg (bottle) – 75726

NEXIUM 40 mg (bottle) – 75727

This leaflet was prepared in July 2015.

NEXIUM® is a registered trade mark of the AstraZeneca group of companies.

Doc ID-002261449 V6.0

LOSEC® TABLETS

Multiple Unit Pellet System

Omeprazole magnesium

Consumer Medicine Information

 

What is in this leaflet

This leaflet answers some of the common questions people ask about LOSEC. It does not contain all the information that is known about LOSEC.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor will have weighed the risks of you taking LOSEC against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What LOSEC is used for

Reflux Oesophagitis

LOSEC is used to treat the symptoms of reflux oesophagitis or reflux disease. This can be caused by “washing back” (reflux) of food and acid from the stomach into the food pipe (oesophagus).

Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn.

LOSEC is also taken to help stop reflux oesophagitis coming back or relapsing.

Peptic Ulcers

LOSEC is used to treat peptic ulcers. Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out from the stomach.

These ulcers can be caused by too much acid being made in the stomach.

LOSEC is also used to help stop gastric or duodenal ulcers coming back.

Peptic Ulcers Associated with Helicobacter pylori Infection

Most people who have a peptic ulcer also have a bacterium called Helicobacter pylori in their stomach.

When LOSEC is taken with antibiotics, they work to kill the bacterium and let your ulcer heal. You may need further treatment with antibiotics.

Peptic Ulcers Associated with Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Some peptic ulcers are caused by taking medicines called non-steroidal anti-inflammatory drugs (NSAIDs), a type of medicine used to treat pain or inflammation.

LOSEC is also used to heal and prevent ulcers associated with NSAIDs.

Zollinger-Ellison Syndrome

LOSEC is also used to treat a rare condition called Zollinger-Ellison syndrome, where the stomach produces large amounts of acid, much more than in ulcers or reflux disease.

How LOSEC Works

LOSEC is a type of medicine called a proton-pump inhibitor. It works by decreasing the amount of acid made by the stomach, to give relief of symptoms and allow healing to take place. This does not stop food being digested in the normal way.

Follow all directions given to you by your doctor carefully.

They may differ from the information contained in this leaflet.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may prescribe this medicine for another reason.

There is no evidence that LOSEC is addictive.

This medicine is only available on prescription.

Before you take LOSEC

When you must not take it

Do not take LOSEC if you have an allergy to:

  • omeprazole or any ingredient listed at the end of this leaflet
  • any medicine containing a proton-pump inhibitor

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Do not take LOSEC if you are also taking cilostazol.

Please check with your doctor or pharmacist if you are taking cilostazol. This medicine will be affected by LOSEC.

Do not take LOSEC after the use by (expiry) date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should take this medicine, talk to your doctor.

 

 

Before you start to take it

You must tell your doctor if you have:

  • allergies to any other medicines, foods, dyes or preservatives
  • any problems with your liver
  • any other medical conditions
  • been diagnosed with osteoporosis

Do not take LOSEC if you are pregnant or breastfeeding unless your doctor says so. Ask your doctor about the risks and benefits involved.

It is not known if it is safe for you to take LOSEC while you are pregnant. It may affect your baby.

It is not known if your baby can take in LOSEC from breast milk if you are breastfeeding.

Taking other medicines

Do not take LOSEC if you are taking the following medicine:

  • cilostazol – a medicine used to treat intermittent claudication

Tell your doctor if you are taking any other medicines including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with LOSEC Tablets. These include:

  • phenytoin – a medicine used to treat epilepsy or fits
  • warfarin and clopidogrel – medicines used to prevent blood clots
  • digoxin – a medicine used to treat heart conditions
  • diazepam – a medicine used to treat anxiety and some other conditions
  • St John’s wort – a herbal remedy used to treat mood disorders
  • ketoconazole, itraconazole, voriconazole – medicines used to treat fungal infection
  • clarithromycin or rifampicin – medicines used to treat infections
  • atazanavir and nelfinavir – medicines used to treat viral infections such as HIV
  • tacrolimus and mycophenolate mofetil – medicines used to assist in organ transplants
  • methotrexate – a medicine used to treat arthritis and some types of cancer
  • erlotinib or related medicines used to treat cancer

These medicines may be affected by LOSEC or may affect how well it works. You may need different amounts of your medicine or you may need to take different medicines. Your doctor can tell you what to do if you are taking any other medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

If you have not told your doctor about any of these things, tell them before you take LOSEC.

How to take LOSEC

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How to take it

Take one LOSEC tablet each day, unless your doctor has told you otherwise.

Adults:

The dose of LOSEC is usually 20 mg a day. The dose may vary from 10 mg to 40 mg a day depending on what condition you are being treated for and how severe it is.

Children (1 year or older):

The dose of LOSEC is 10 mg a day for children 10 to 20 kg. This dose may be increased to 20 mg if required. For children more than 20 kg the dose is 20 mg a day. This dose may be increased to 40 mg if required.

Swallow LOSEC whole with a glass of water. Do not crush or chew the tablets.

If the tablets are chewed or crushed, they will not work properly.

If you have difficulty swallowing the tablets

  1. Place the tablet in half a glass of non-carbonated water or fruit juice. Mineral water, carbonated fruit juices, or other liquids are not suitable.
  2. Gently mix the tablet and liquid by stirring, taking care not to crush the tablet.
  3. Stir until the tablet disperses into little pellets.
  4. Drink the liquid with the pellets immediately, or within 30 minutes. Do not chew the pellets
  5. Rinse the glass with half a glass of water and drink.

When to take it

Take LOSEC at about the same time each day.

Keeping a regular time for taking LOSEC will help to remind you to take it.

LOSEC can be taken with food or on an empty stomach.

How long to take it

Keep taking LOSEC for as long as your doctor recommends.

In most patients, LOSEC relieves symptoms rapidly and healing is usually complete within 4 weeks.

Continue taking LOSEC for as long as your doctor tells you to.

If you forget to take it

If you forget to take a dose, take it as soon as you remember, and then go back to taking it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (Overdose)

Telephone your doctor or the Poisons Information Centre (13 11 26) or go to Accident and Emergency at your nearest hospital immediately if you think that you or anyone else may have taken too much LOSEC even if there are no signs of discomfort or poisoning.

While you are taking LOSEC

Things you must do

Take LOSEC exactly as your doctor has prescribed.

If you are about to start any new medicine, remind your doctor and pharmacist that you are taking LOSEC.

Tell all doctors, dentists and pharmacists who are treating you that you are taking LOSEC.

Tell your doctor if you become pregnant while you are taking LOSEC.

Tell your doctor if your symptoms return.

Although LOSEC can heal ulcers successfully, it may not prevent them recurring at a later date.

If you need to have any medical tests while you are taking LOSEC, tell your doctor.

It may affect the results of some tests.

Things you must not do

Do not take LOSEC to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or change the dosage without checking with your doctor.

If you stop taking it suddenly or change the dose, your condition may worsen or you may have unwanted side effects.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking LOSEC.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • constipation
  • nausea or vomiting
  • diarrhoea
  • headache
  • skin rash, itchy skin
  • wind
  • stomach pain
  • dizziness
  • dry or sore mouth

These side effects are usually mild.

Tell your doctor immediately if you notice any of the following:

  • muscle pain or weakness, joint pain
  • “pins and needles”
  • changes in sleep patterns
  • mood changes, confusion or depression
  • blurred vision
  • increase in breast size (males)
  • fever
  • increased bruising
  • increased sweating
  • hair loss
  • tremor

These are serious side effects that may require medical attention. Serious side effects are rare.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital.

  • swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing
  • shortness of breath or difficulty in breathing
  • skin reaction which may include rash, itching, redness, blistering or peeling of the skin
  • ulcers, blisters or bleeding of the lips, eyes, mouth, nose and genitals
  • blood in the urine
  • swelling of hands, feet or ankles
  • signs of liver inflammation including yellowing of the skin or eyes, feeling generally unwell, nausea, vomiting, loss of appetite

These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

Occasionally, LOSEC may be associated with changes in your liver or blood, which may require your doctor to do certain blood tests.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may occur in some people.

Other problems are more likely to arise from the ulcer itself rather than the treatment.

For this reason, contact your doctor immediately if you notice any of the following:

  • pain or indigestion that occurs during treatment with LOSEC
  • you begin to vomit blood or food
  • you pass black (blood-stained) motions

After using it

Storage

Keep your LOSEC in the blister pack until it is time to take them.

If you take LOSEC out of the blister pack they will not keep well.

Keep it in a cool, dry place where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

A locked cupboard at least one-anda-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking LOSEC or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets you have left over.

Product description

What LOSEC looks like

LOSEC 10 mg tablets are light pink, oblong shaped, marked with 10 mg on one side and a logo on the other side.

LOSEC 20 mg tablets are pink, oblong shaped, marked with 20 mg on one side and a logo on the other side.

Ingredients

Each LOSEC tablet contains omeprazole magnesium as the active ingredient equivalent to omeprazole 10 mg or 20 mg.

Plus the following inactive ingredients:

  • Glyceryl monostearate (E 471)
  • Hydroxypropylcellulose
  • Hypromellose
  • Magnesium stearate (E 572)
  • Methacrylic acid copolymer
  • Microcrystalline cellulose (E 460)
  • Paraffin synthetic
  • Macrogol 6000
  • Polysorbate 80 (E 433)
  • Crospovidone
  • Sodium stearylfumarate
  • Purified talc (E 553(b))
  • Titanium dioxide (E 171)
  • Triethyl citrate
  • Sodium hydroxide
  • Sugar spheres (maize starch and sucrose)

The tablets are coloured with iron oxide red CI77491 and/or iron oxide yellow CI77492.

LOSEC are available in blister packs of 30 tablets.

LOSEC tablets do not contain gluten.

 

Sponsor

AstraZeneca Pty Ltd

ABN 54 009 682 311

Alma Road

NORTH RYDE NSW 2113

Australian Registration Numbers:

LOSEC 10 mg (blister pack) – 63414

LOSEC 20 mg (blister pack) – 63416

LOSEC 40 mg (blister pack) – 63418* *non-marketed

This leaflet was prepared in July 2015. LOSEC® is a registered trade mark of the AstraZeneca group of companies.

Doc ID-001944965 V6.0

LOSEC® TABLETS

Multiple Unit Pellet System

Omeprazole magnesium

Consumer Medicine Information

 

What is in this leaflet

This leaflet answers some of the common questions people ask about LOSEC. It does not contain all the information that is known about LOSEC.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor will have weighed the risks of you taking LOSEC against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What LOSEC is used for

Reflux Oesophagitis

LOSEC is used to treat the symptoms of reflux oesophagitis or reflux disease. This can be caused by “washing back” (reflux) of food and acid from the stomach into the food pipe (oesophagus).

Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn.

LOSEC is also taken to help stop reflux oesophagitis coming back or relapsing.

Peptic Ulcers

LOSEC is used to treat peptic ulcers. Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out from the stomach.

These ulcers can be caused by too much acid being made in the stomach.

LOSEC is also used to help stop gastric or duodenal ulcers coming back.

Peptic Ulcers Associated with Helicobacter pylori Infection

Most people who have a peptic ulcer also have a bacterium called Helicobacter pylori in their stomach.

When LOSEC is taken with antibiotics, they work to kill the bacterium and let your ulcer heal. You may need further treatment with antibiotics.

Peptic Ulcers Associated with Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Some peptic ulcers are caused by taking medicines called non-steroidal anti-inflammatory drugs (NSAIDs), a type of medicine used to treat pain or inflammation.

LOSEC is also used to heal and prevent ulcers associated with NSAIDs.

Zollinger-Ellison Syndrome

LOSEC is also used to treat a rare condition called Zollinger-Ellison syndrome, where the stomach produces large amounts of acid, much more than in ulcers or reflux disease.

How LOSEC Works

LOSEC is a type of medicine called a proton-pump inhibitor. It works by decreasing the amount of acid made by the stomach, to give relief of symptoms and allow healing to take place. This does not stop food being digested in the normal way.

Follow all directions given to you by your doctor carefully.

They may differ from the information contained in this leaflet.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may prescribe this medicine for another reason.

There is no evidence that LOSEC is addictive.

This medicine is only available on prescription.

Before you take LOSEC

When you must not take it

Do not take LOSEC if you have an allergy to:

  • omeprazole or any ingredient listed at the end of this leaflet
  • any medicine containing a proton-pump inhibitor

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Do not take LOSEC if you are also taking cilostazol.

Please check with your doctor or pharmacist if you are taking cilostazol. This medicine will be affected by LOSEC.

Do not take LOSEC after the use by (expiry) date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should take this medicine, talk to your doctor.

 

 

Before you start to take it

You must tell your doctor if you have:

  • allergies to any other medicines, foods, dyes or preservatives
  • any problems with your liver
  • any other medical conditions
  • been diagnosed with osteoporosis

Do not take LOSEC if you are pregnant or breastfeeding unless your doctor says so. Ask your doctor about the risks and benefits involved.

It is not known if it is safe for you to take LOSEC while you are pregnant. It may affect your baby.

It is not known if your baby can take in LOSEC from breast milk if you are breastfeeding.

Taking other medicines

Do not take LOSEC if you are taking the following medicine:

  • cilostazol – a medicine used to treat intermittent claudication

Tell your doctor if you are taking any other medicines including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with LOSEC Tablets. These include:

  • phenytoin – a medicine used to treat epilepsy or fits
  • warfarin and clopidogrel – medicines used to prevent blood clots
  • digoxin – a medicine used to treat heart conditions
  • diazepam – a medicine used to treat anxiety and some other conditions
  • St John’s wort – a herbal remedy used to treat mood disorders
  • ketoconazole, itraconazole, voriconazole – medicines used to treat fungal infection
  • clarithromycin or rifampicin – medicines used to treat infections
  • atazanavir and nelfinavir – medicines used to treat viral infections such as HIV
  • tacrolimus and mycophenolate mofetil – medicines used to assist in organ transplants
  • methotrexate – a medicine used to treat arthritis and some types of cancer
  • erlotinib or related medicines used to treat cancer

These medicines may be affected by LOSEC or may affect how well it works. You may need different amounts of your medicine or you may need to take different medicines. Your doctor can tell you what to do if you are taking any other medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

If you have not told your doctor about any of these things, tell them before you take LOSEC.

How to take LOSEC

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How to take it

Take one LOSEC tablet each day, unless your doctor has told you otherwise.

Adults:

The dose of LOSEC is usually 20 mg a day. The dose may vary from 10 mg to 40 mg a day depending on what condition you are being treated for and how severe it is.

Children (1 year or older):

The dose of LOSEC is 10 mg a day for children 10 to 20 kg. This dose may be increased to 20 mg if required. For children more than 20 kg the dose is 20 mg a day. This dose may be increased to 40 mg if required.

Swallow LOSEC whole with a glass of water. Do not crush or chew the tablets.

If the tablets are chewed or crushed, they will not work properly.

If you have difficulty swallowing the tablets

  1. Place the tablet in half a glass of non-carbonated water or fruit juice. Mineral water, carbonated fruit juices, or other liquids are not suitable.
  2. Gently mix the tablet and liquid by stirring, taking care not to crush the tablet.
  3. Stir until the tablet disperses into little pellets.
  4. Drink the liquid with the pellets immediately, or within 30 minutes. Do not chew the pellets
  5. Rinse the glass with half a glass of water and drink.

When to take it

Take LOSEC at about the same time each day.

Keeping a regular time for taking LOSEC will help to remind you to take it.

LOSEC can be taken with food or on an empty stomach.

How long to take it

Keep taking LOSEC for as long as your doctor recommends.

In most patients, LOSEC relieves symptoms rapidly and healing is usually complete within 4 weeks.

Continue taking LOSEC for as long as your doctor tells you to.

If you forget to take it

If you forget to take a dose, take it as soon as you remember, and then go back to taking it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (Overdose)

Telephone your doctor or the Poisons Information Centre (13 11 26) or go to Accident and Emergency at your nearest hospital immediately if you think that you or anyone else may have taken too much LOSEC even if there are no signs of discomfort or poisoning.

While you are taking LOSEC

Things you must do

Take LOSEC exactly as your doctor has prescribed.

If you are about to start any new medicine, remind your doctor and pharmacist that you are taking LOSEC.

Tell all doctors, dentists and pharmacists who are treating you that you are taking LOSEC.

Tell your doctor if you become pregnant while you are taking LOSEC.

Tell your doctor if your symptoms return.

Although LOSEC can heal ulcers successfully, it may not prevent them recurring at a later date.

If you need to have any medical tests while you are taking LOSEC, tell your doctor.

It may affect the results of some tests.

Things you must not do

Do not take LOSEC to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or change the dosage without checking with your doctor.

If you stop taking it suddenly or change the dose, your condition may worsen or you may have unwanted side effects.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking LOSEC.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • constipation
  • nausea or vomiting
  • diarrhoea
  • headache
  • skin rash, itchy skin
  • wind
  • stomach pain
  • dizziness
  • dry or sore mouth

These side effects are usually mild.

Tell your doctor immediately if you notice any of the following:

  • muscle pain or weakness, joint pain
  • “pins and needles”
  • changes in sleep patterns
  • mood changes, confusion or depression
  • blurred vision
  • increase in breast size (males)
  • fever
  • increased bruising
  • increased sweating
  • hair loss
  • tremor

These are serious side effects that may require medical attention. Serious side effects are rare.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital.

  • swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing
  • shortness of breath or difficulty in breathing
  • skin reaction which may include rash, itching, redness, blistering or peeling of the skin
  • ulcers, blisters or bleeding of the lips, eyes, mouth, nose and genitals
  • blood in the urine
  • swelling of hands, feet or ankles
  • signs of liver inflammation including yellowing of the skin or eyes, feeling generally unwell, nausea, vomiting, loss of appetite

These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

Occasionally, LOSEC may be associated with changes in your liver or blood, which may require your doctor to do certain blood tests.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may occur in some people.

Other problems are more likely to arise from the ulcer itself rather than the treatment.

For this reason, contact your doctor immediately if you notice any of the following:

  • pain or indigestion that occurs during treatment with LOSEC
  • you begin to vomit blood or food
  • you pass black (blood-stained) motions

After using it

Storage

Keep your LOSEC in the blister pack until it is time to take them.

If you take LOSEC out of the blister pack they will not keep well.

Keep it in a cool, dry place where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

A locked cupboard at least one-anda-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking LOSEC or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets you have left over.

Product description

What LOSEC looks like

LOSEC 10 mg tablets are light pink, oblong shaped, marked with 10 mg on one side and a logo on the other side.

LOSEC 20 mg tablets are pink, oblong shaped, marked with 20 mg on one side and a logo on the other side.

Ingredients

Each LOSEC tablet contains omeprazole magnesium as the active ingredient equivalent to omeprazole 10 mg or 20 mg.

Plus the following inactive ingredients:

  • Glyceryl monostearate (E 471)
  • Hydroxypropylcellulose
  • Hypromellose
  • Magnesium stearate (E 572)
  • Methacrylic acid copolymer
  • Microcrystalline cellulose (E 460)
  • Paraffin synthetic
  • Macrogol 6000
  • Polysorbate 80 (E 433)
  • Crospovidone
  • Sodium stearylfumarate
  • Purified talc (E 553(b))
  • Titanium dioxide (E 171)
  • Triethyl citrate
  • Sodium hydroxide
  • Sugar spheres (maize starch and sucrose)

The tablets are coloured with iron oxide red CI77491 and/or iron oxide yellow CI77492.

LOSEC are available in blister packs of 30 tablets.

LOSEC tablets do not contain gluten.

 

Sponsor

AstraZeneca Pty Ltd

ABN 54 009 682 311

Alma Road

NORTH RYDE NSW 2113

Australian Registration Numbers:

LOSEC 10 mg (blister pack) – 63414

LOSEC 20 mg (blister pack) – 63416

LOSEC 40 mg (blister pack) – 63418* *non-marketed

This leaflet was prepared in July 2015. LOSEC® is a registered trade mark of the AstraZeneca group of companies.

Doc ID-001944965 V6.0

PARIET® Tablets

Rabeprazole sodium

Consumer Medicine Information

 

What is in this leaflet

This leaflet answers some common questions about PARIET tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking PARIET against the benefits this medicine is expected to have for you.

If you have any concerns about using PARIET ask your doctor or pharmacist.

Keep this leaflet with your medicine.

You may need to read it again.

What PARIET is used for

The name of your medicine is PARIET. It contains the active ingredient rabeprazole sodium.

PARIET belongs to a group of medicines called proton pump inhibitors (PPIs). PARIET works by decreasing the amount of acid the stomach makes, to give relief from the symptoms and allow healing to take place. Your food will still be digested in the same way.

Gastro-oesophageal reflux disease:

PARIET is used to treat gastrooesophageal reflux disease (GORD), commonly known as ‘reflux’. This can be caused by food and acid from the stomach flowing the wrong way (reflux) back up the food pipe, also known as the oesophagus.

Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn. PARIET is also used to help stop gastrooesophageal reflux disease from coming back or relapsing.

Peptic Ulcers:

PARIET is used to treat peptic ulcers. Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum, which is the tube leading out of the stomach.

These ulcers can be caused by too much acid being made in the stomach.

Most people who have a peptic ulcer also have bacteria called Helicobacter pylori in their stomach. Your doctor may also prescribe a course of antibiotics (clarithromycin and amoxycillin) for you. When PARIET is taken with antibiotics, the combination therapy will kill the Helicobacter pylori and let your ulcer heal.

Chronic Gastritis:

The presence of the bacteria Helicobacter pylori may cause the stomach to become inflamed, resulting in pain, nausea and vomiting; all of which are signs of chronic gastritis.

When PARIET tablets are taken with antibiotics, they will help kill Helicobacter pylori and allow the stomach to heal.

Your doctor may have prescribed PARIET for another reason. Ask your doctor if you have any questions about why PARIET has been prescribed for you.

PARIET is only available with a doctor’s prescription.

Before you take PARIET

When you must not take it:

Do not take PARIET if you have an allergy (hypersensitivity) to:

  • rabeprazole sodium 
  • any of the ingredients listed at the end of this leaflet. 
  • other proton pump inhibitors (omeprazole, esomeprazole, lansoprazole, pantoprazole).

Symptoms of an allergic (hypersensitive) reaction may include: 

  • rash, itching or hives on the skin 
  • shortness of breath, wheezing or difficulty breathing 
  • swelling of the face, lips, tongue or other parts of the body

Do not take PARIET if:

  • the packaging is torn or shows signs of tampering. 
  • the expiry date (month and year) printed on the pack has passed. If you take PARIET after the expiry date it may not work.

PARIET should not be given to children under 18 years of age. Safety and effectiveness of PARIET in children has not been established.

Before you start to take it:

You must tell your doctor if:

  • you are pregnant or intend to become pregnant. 
  • you are breast-feeding or intend to breast-feed. It is not known if PARIET passes into breast milk.
  • you have now, or have had in the past, liver problems.

Taking other medicines:

Tell your doctor or pharmacist if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.

Do not take PARIET and tell your doctor or pharmacist if you are taking any of the following:

  • atazanavir, a medicine used (with other antiretrovirals) to treat HIV1 infection. 
  • clopidogrel, an antiplatelet medicine.

You should not take PARIET while taking these medicines.

Also tell your doctor or pharmacist if you are taking any of the following:

  • cyclosporin, a medicine used to treat several conditions including prevention of graft rejection following kidney, liver or heart transplantation; severe, active rheumatoid arthritis; severe skin diseases; kidney disease where other treatments have failed. 
  • methotrexate, a medicine used to treat some kinds of cancer. It is also used to treat psoriasis (skin disease) and rheumatoid arthritis. 
  • digoxin, a medicine used to treat heart problems. 
  • ketoconazole, a medicine used to treat fungal infections. 
  • mycophenolate mofetil, a medicine used to prevent organ rejection following kidney, liver or heart transplants. 
  • clarithromycin, a medicine used to treat infections.

These medicines may be affected by PARIET or may affect how well PARIET works. Your doctor or pharmacist can tell you what to do if you are taking any other medicines.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking PARIET.

Your doctor will advise you whether or not to take PARIET or if you need to have your dose adjusted.

How to take PARIET

Follow the directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.

How much to take:

Adults

The usual dose is one tablet, to be taken once daily, at the same time each day.

The dose of PARIET tablets is usually 20 mg, but may vary from 10 mg to 40 mg per day depending on what condition you are being treated for and how severe it is.

For treating Helicobacter pylori infections in combination with antibiotics (clarithromycin and amoxycillin), the usual dose is one 20mg tablet twice daily, morning and evening, for 7 days.

Children

PARIET should not be given to children under 18 years of age. Safety and effectiveness of PARIET in children has not been established.

How to take it:

  • PARIET should be swallowed whole, with a glass of water or other liquid. 
  • Do NOT crush or chew the tablets. They have a special coating, which protects them from the acid in your stomach. If the coating is broken by chewing, the tablets may not work. 
  • It does not matter if you take PARIET with food or on an empty stomach.

Ask your doctor or pharmacist for help if you do not understand the instructions provided with this medicine.

If you forget to take it:

If you forget to take your tablet, take it as soon as you remember and then continue to take it as you would normally.

However, if it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, check with your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you have taken too much (overdose):

If you think that you, or anyone else, may have taken too much PARIET, immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using PARIET

Things you must do:

  • Use PARIET exactly as your doctor has prescribed. 
  • Always swallow PARIET tablets whole.
  • Tell your doctor if you become pregnant while you are taking PARIET

Tell your doctor or pharmacist that you are taking PARIET if you are about to start taking a new medicine.

Things you must not do:

  • Do not use PARIET to treat any other complaint unless your doctor says to. 
  • Do not give this medicine to anyone else, even if they have the same symptoms as you. 
  • Do not crush or chew the tablets. 
  • Do not give PARIET to children.

Side Effects

PARIET is usually well tolerated but tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking PARIET.

PARIET helps most people with peptic ulcers or reflux disease, but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • headache 
  • dizziness 
  • diarrhoea 
  • nausea 
  • stomach pain 
  • wind 
  • vomiting 
  • constipation 
  • runny or blocked nose 
  • sore throat and discomfort when swallowing 
  • cough 
  • pain (including back, chest or join pain) 
  • muscle weakness, physical weakness or lack of energy 
  • rash or itchy rash accompanied by skin eruptions or blisters 
  • flu-like symptoms 
  • sleeplessness (insomnia) 
  • indigestion 
  • belching 
  • dry mouth 
  • leg cramps 
  • swelling of the arms or legs 
  • nervousness 
  • sleepiness (somnolence) 
  • loss of appetite for food (anorexia) 
  • weight gain 
  • sweating

These side effects are usually mild.

Tell your doctor immediately if you notice any of the following:

  • painful and/or frequent urination (common symptoms of a urinary tract infection) 
  • vision or taste disturbance 
  • depression 
  • feeling dizzy, faint, lightheaded or weak (hypotension) 
  • shortness of breath 
  • signs of frequent infections such as fever, chills, sore throat or mouth ulcers.

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

Tell your doctor immediately and do not take your next dose of PARIET if you experience:

  • signs of allergy such as skin rash, reddening, blisters or itching, swelling of the face, lips or other parts of the body, shortness of breath or wheezing.

If you experience symptoms such as severe (watery or bloody) diarrhoea, fever, abdominal pain or tenderness, you may have Clostridium difficile colitis (bowel inflammation).

Other problems are more likely to arise from the ulcer itself rather than the treatment.

For this reason, contact your doctor immediately if you notice any of the following:

  • pain or indigestion 
  • you begin to vomit blood or food 
  • you pass black (blood-stained) motions.

Under rare circumstances supervised by the doctor, proton pump inhibitors (PPIs) might be used for long periods of time.

Low magnesium can occur in some people who take a proton pump inhibitor. Symptoms of low magnesium can include: seizures, dizziness, spasms, cramps or muscle weakness.

People who take proton pump inhibitor medicines at high doses for a long period of time (1 year or longer) may have an increased risk of fractures of the hip, wrist, or spine.

Proton pump inhibitors may reduce the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B-12 properly. Talk with your doctor or pharmacist about the possibility of vitamin B-12 deficiency if you have been taking a proton pump inhibitor for a long time (i.e. more than 3 years).

Other side effects not listed above may also occur in some people. Tell your doctor if you notice anything making you feel unwell when you are taking, or soon after you have finished taking PARIET.

 Ask your doctor or pharmacist if you do not understand anything in this list.

After using PARIET

Storage

PARIET tablets are packaged in a double -sided aluminium blister strip.

Do not take PARIET tablets out of the blister pack until it is time to take them. If you take them out of the blister they may not keep well.

Keep PARIET tablets in a cool dry place where the temperature is below 25°C. Do not keep PARIET in the refrigerator or freezer .

Do not store PARIET, or any other medicine, in the bathroom or near a sink. Do not leave medicines in the car or on window sills. Heat and dampness can destroy some medicines.

Keep your medicines where children cannot reach them. A locked cupboard at least one -and – a -half metres (1.5 m) above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking PARIET tablets, or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.

Product Description

What PARIET tablets look like:

PARIET 10 mg tablets are pink and have “E241” in black ink on one side.

PARIET 20 mg tablets are pale yellow, and have “E243” in red ink on one side.

PARIET 10 mg tablets are supplied in blister packs of 7 and 28 tablets.

PARIET 20 mg tablets are supplied in blister packs of 5 and 30 tablets

Ingredients

Each PARIET tablet contains 10 mg or 20 mg of rabeprazole sodium as the active ingredient.

Each tablet also contains the following other ingredients: 

  • mannitol, magnesium oxide, hydroxypropylcellulose, magnesium stearate, ethylcellulose, hypromellose phthalate, diacetylated monoglycerides, purified talc, titanium dioxide and carnauba wax. 
  • the 20 mg tablets also contain yellow iron oxide (E172) and are printed with red ink (Edible Ink Red A1). 
  • the 10 mg tablets contain red iron oxide (E172) and are printed with gray ink (Edible Ink Gray F6).

The tablets do not contain lactose or gluten.

Sponsor

JANSSEN -CILAG Pty Ltd

1 -5 Khartoum Rd

Macquarie Park NSW 2113 Australia

Telephone: Toll Free 1800 226 334

Registration Numbers:

PARIET 10mg AUST R 76185

PARIET 20mg AUST R 76186

This leaflet was prepared in April 2016

PARIET ® is a trademark of Eisai Ltd.

TAZAC®

Nizatidine

Consumer Medicine Information

 

What is in this leaflet?

This leaflet is designed to provide you with answers to some common questions about this medicine. It does not contain all the available information that is known about Tazac.

It does not take the place of talking with your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Tazac against the benefits they expect it will have for you.

If you have any concerns about taking this medicine ask your doctor or pharmacist.

Keep this leaflet with this medicine.

You may need to read it again.

What TAZAC is used for

Tazac contains an active ingredient called nizatidine. It belongs to a class of medicines called H2-antagonists or H2-blockers.

Tazac is used to treat the following conditions:

Reflux oesophagitis

This can be caused by reflux or “washing back” of food and acid from the stomach into the food pipe. Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn.

Ulcers

Depending on the position of the ulcer it is either called a gastric or duodenal ulcer.

A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out of the stomach. Tazac is also used to stop duodenal ulcers from coming back.

Tazac works by reducing the amount of acid in your stomach. This helps reduce the pain and allows the ulcer and reflux disease to heal in most people.

Ask your doctor or pharmacist if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

This medicine is only available with a doctor’s prescription.

There is no evidence that it is addictive.

Before you take it

When you must not take it

Do not take Tazac if you have ever had an allergic reaction to:

  • nizatidine or other histamine H2- receptor antagonists (e.g. cimetidine, ranitidine, famotidine)
  • any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the skin.

Do not take Tazac after the expiry printed on the pack.

If you take this medicine after the expiry date has passed it may not work as well.

Do not take Tazac if the packaging is torn or shows signs of tampering.

Before you start to take it

Tell your doctor if you are allergic to any other medicines or any foods, dyes or preservatives.

Tell your doctor if you:

  • are pregnant or intend to become pregnant
  • are breast feeding or plan to breast feed
  • have kidney or liver disease.

If you have not told your doctor about any of these things, tell them before you take Tazac.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may affect the way other medicines work. Medicines such as ketoconazole and itraconazole used to treat fungal infections may be affected by Tazac. Your doctor or pharmacist will be able to tell you what to do when taking Tazac with other medicines.

How to take it

How much to take

Depending on your condition, your doctor will tell you how much Tazac to take each day.

When to take it

The 150 mg capsule is usually taken in the morning and in the evening before you go to bed.

The 300 mg capsule is usually taken once daily, at bedtime.

 

How to take it

Swallow the capsule whole with a glass of water or another liquid.

How long do I take it

Do not stop taking the capsules just because you feel better.

Your doctor will tell you how long you should continue taking Tazac. If you stop taking your capsules too early then your condition may not have been properly treated.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking Tazac as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not take a double dose to make up for the dose that you missed.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital if you think that you or anyone else may have taken too much Tazac. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

While you are taking it

Things you must do

Tell your doctor or pharmacist if you start any new medicine while you are taking Tazac.

If you are taking it for an ulcer, you should go to your doctor regularly for checkups to make sure that Tazac has healed your ulcer.

Tell your doctor immediately if you become pregnant while taking Tazac.

Things you must not do

Do not give this medicine to anyone else even if their symptoms seem similar to yours.

Your doctor has prescribed it for you and your condition.

Do not take Tazac to treat any other complaints unless your doctor tells you to.

Things to be careful of

Be careful driving or operating machinery until you know how Tazac affects you.

This medicine may cause dizziness or lightheadedness in some people. Make sure you know how you react to it before you drive a car or operate any machinery.

Your doctor may advise you to limit your alcohol intake while you are being treated for your condition.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Tazac.

Tazac helps most people who take it but it may have unwanted side effects in some people. All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following common side effects and they worry you:

  • sweating
  • itchy skin or rash
  • tiredness, headaches, being short of breath when exercising, dizziness and looking pale.

Incidences of abnormal liver function, accompanied by jaundice (yellow skin) have been rarely reported by patients taking this medicine. This side effect has been reversed when Tazac is stopped.

Tell your doctor if you notice anything unusual or if you are concerned about any aspect of your health, even if you think the problems are not connected with this medicine and are not referred to in this leaflet.

After taking it

Storage

Keep your capsules in the blister pack until it is time to take them. If you take your capsules out of the blister pack, they may not keep as well.

Keep your capsules in a cool dry place where the temperature stays below 25 degrees Celsius.

Keep it where young children cannot reach it.

A locked cupboard at least one-anda-half metres above ground is a good place to store medicines.

Disposal

Dispose of the medicine where children cannot reach it. If your doctor tells you to stop taking Tazac or you find that the expiry date has passed, ask your pharmacist what to do with any capsules you have left over.

Product Description

What it looks like

150 mg: Light and dark yellow capsule printed with “N150”. Packs of 60 capsules.

300 mg: Light yellow and brown capsule printed with “N300”. Packs of 30 capsules.

Ingredients

Tazac capsules contain 150 mg or 300 mg of nizatidine as the active ingredient.

The 150 mg capsule also contains the following inactive ingredients:

  • starch-maize
  • starch-pregelatinised maize
  • dimeticone 350
  • magnesium stearate
  • iron oxide yellow
  • titanium dioxide
  • gelatin
  • colorcon black ink S-1-8100.

The 300 mg capsule also contains the following inactive ingredients:

  • starch-maize
  • starch-pregelatinised maize
  • povidone
  • carmellose
  • dimeticone 350
  • talc-purified
  • iron oxide red
  • iron oxide yellow
  • titanium dioxide
  • gelatin
  • colorcon black ink S – 1 -8100.

Tazac does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Distributor

Arrow Pharma Pty Ltd 15 -17 Chapel Street Cremorne VIC 3121

Australian Registration Numbers:

TAZAC 150 mg – AUST R 49325

TAZAC 300 mg – AUST R 49326

This leaflet was prepared in June 2016.

ZANTAC® tablets

Ranitidine hydrochloride

Consumer Medicine Information

 

About your Zantac Tablets

Read all of this leaflet carefully before you take your medicine.

This leaflet does not have the complete information available about your medicine. If you have any questions about your medicine, you should ask your doctor or pharmacist (also known as chemist).

All medicines have some risks. Sometimes new risks are found even when a medicine has been used for many years.

If there is anything you do not understand, ask your doctor or pharmacist. If you want more information, ask your doctor or pharmacist.

What is in my Zantac?

The medicine in your Zantac tablets is called ranitidine (as hydrochloride). This belongs to a group of medicines called H2- antagonists.

What does my Zantac do?

Zantac is mostly used to:

  • treat stomach and duodenal ulcer disease (also known as peptic ulcer),
  • stop these ulcers from coming back,
  • treat reflux oesophagitis (also known as reflux).

These problems are caused, in part, by too much acid in the stomach. This can lead to pain such as heartburn. Zantac works by reducing the amount of acid in the stomach. This reduces the pain and also allows the ulcer and reflux to heal.

Zantac is also used to treat:

  • Zollinger-Ellison disease,
  • scleroderma oesophagitis.

Before you take it

Do not take if:

You must not take Zantac if:

  • you have ever had an allergic (hypersensitive) reaction to ranitidine or any of the ingredients listed towards the end of this leaflet.
  • the expiry date (EXP) printed on the pack has passed
  • the packaging is torn or shows signs of tampering

Tell your doctor if:
You must tell your doctor if:

  • you are allergic to foods, dyes, preservatives or any other medicines
  • you have ever had an allergic (hypersensitive) reaction to ranitidine or any of the ingredients listed towards the end of this leaflet.
  • you are allergic to any medicine,
  • you have stomach cancer,
  • you have kidney disease,
  • you have had stomach ulcers before and you are taking NonSteroidal Anti-Inflammatory (NSAID) medicines.
  • you have a disease known as acute porphyria.
  • you are over 65 years of age.
  • you have lung disease.
  • you are diabetic.
  • you have any problems with your immune system.
  • you have to stop taking this or any other medicine for your ulcer or reflux.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, have taken any recently, or if you start new ones. This includes herbal medicines and any other medicines you have bought without a prescription.

Zantac can affect the way some other medicines work. Also other medicines can affect the way Zantac works.

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

  • warfarin, used to prevent blood clots
  • triazolam and midazolam, used as sedatives
  • ketoconazole, an anti-fungal
  • atazanavir and delaviridine, used to treat HIV
  • glipizide, used for diabetics.
  • gefitinib, used in the treatment of cancer.
  • Non-Steroidal AntiInflammatory (NSAID) medicines, for pain and inflammation
  • procainamide or nacetylprocainamide, used to treat heart problems
  • sucralfate used to treat ulcers

What if I am pregnant or breast feeding?

Tell your doctor if you are pregnant, likely to get pregnant or are breast feeding. Your doctor will tell you if you should take this medicine.

How do I take it

  • The dosage depends on the disease that you are suffering from. Your doctor or pharmacist will usually tell you how many Zantac tablets to take and how often to take them. You will also find this information on the label of your medicine.
  • The normal adult dosage is 150 to 300 milligrams per day, taken as one 150 mg tablet once or twice a day, or one 300 mg tablet at bedtime. Your doctor may prescribe a different dosage.
  • Do not take extra tablets. Do not take the tablets more often than you have been told.
  • It does not matter whether you take the tablets before or after food.
  • Zantac tablets should be swallowed whole with a glass of water.
  • Your pain or other symptoms may take a few days to go away.
  • Take all the tablets your doctor has prescribed for you, even if you feel better.
  • Even when you have completed your tablets, your doctor may decide to continue your treatment with Zantac, possibly at a different dosage, in order to prevent the problem coming back again.

Use in Children:

Zantac has not been studied fully in children. However, Zantac has been used with good results in children aged 8 to 18 years in doses up to 150 mg twice daily.

What should I do if I miss my dose?

If you forget to take your Zantac, take another as soon as possible unless it is nearly time for your next dose. Do not take a double dose to make up for the missed one.

Side effects

Like other medicines, Zantac may cause some side-effects. Most of the side-effects will be minor and temporary, but some may be serious. Your doctor will be able to answer any questions you may have.

Tell your doctor straight away and do not take any more Zantac if you have:

  • an allergic reactions, the signs may include:

− skin reactions such as rash (red spots), itching, skin lumps or hives

− swelling of the eyelids, face, lips, tongue or other parts of the body

− shortness of breath, trouble breathing, wheezing, chest pain or tightness

− unexplained fever and feeling faint, especially when standing up.

  • severe stomach pain or a change in the type of pain,
  • yellow colouring of the skin or eyes (jaundice),confusion,
  • general illness associated with weight loss,
  • fever.
  • irregular heart beat (including unusually fast or slow heart beats),
  • changes to heart beat

If you get any of the following sideeffects after taking Zantac tell your doctor, but there is no immediate reason to stop taking the tablets unless you are concerned:

  • headache,
  • joint or muscle pains,
  • dizziness,
  • depression,
  • constipation
  • feeling sick (nausea) or vomiting
  • diarrhoea
  • breast tenderness and/or breast enlargement
  • breast discharge.
  • changes in liver function tests

If you notice any symptoms that concern you or if the tablets cause any other side-effects, tell your doctor or pharmacist.

If you have taken all the tablets and still do not feel better tell your doctor as soon as possible.

Other side effects not listed above may also occur in some people.

Overdose

In the event of an overdose you should immediately telephone your doctor or Poisons Information Centre (telephone 131126) for advice, if you think you or anyone else may have taken too much Zantac, even if there ZANTAC® TABLETS 3 are no signs of discomfort or poisoning. If you are not sure what to do, contact your doctor or pharmacist.

How do I store my Zantac?

  • Keep your Zantac tablets away from heat (store below 30 degrees C). For example, you should not leave them in the car on hot days.
  • Please keep your Zantac tablets in a place where children cannot reach them.
  • You will find an “expiry” (or use by) date printed on the manufacturer’s label of the pack. Do not use the tablets after this date. Do not use the tablets if they are discoloured.
  • Keep your Zantac tablets away from moisture. Leave the tablets in the pack until you are ready to use them.

Can I let someone else use my Zantac?

Never give this medicine to someone else. The medicine is only for you. It may harm other people even if they seem to have the same symptoms that you have.

Product description

What Zantac tablets look like.

Zantac tablets come in two strengths:

  • Zantac 150 mg tablets are white, film-coated tablets engraved “RAN 150” on one face and plain on the other.
  • Zantac 300 mg tablets are white capsule-shaped, film-coated tablets engraved “RAN 300” on one face and plain on the other.
  • Pack sizes available: 150 mg – 60 tablets; 300 mg – 30 tablets. Starter packs of 2 tablets are also available from your doctor.

Ingredients

Zantac contains the active ingredient ranitidine (as ranitidine hydrochloride). Each tablet contains either 150 or 300 milligrams of ranitidine.

Your tablets also contain the following inactive ingredients.

microcrystalline cellulose, magnesium stearate and opadry white OY-S-7322.

The 300 mg tablets also contain croscarmellose sodium.

Each Zantac 300 mg tablet contains 0.8 mg of sodium.

Zantac tablets are free from gluten and lactose.

Who makes my Zantac?

Your Zantac is made by:

Aspen Pharmacare Australia Pty Ltd 34-36 Chandos Street St Leonards NSW 2065 Australia.

Do not throw this leaflet away. You may need to read it again.

Zantac Tablets 150 mg AUST R 53324

Zantac Tablets 300 mg AUST R 53323

This leaflet was revised in September 2017.

©2012 Aspen Global Incorporated.

Zantac® is a registered trade mark of Aspen Global Incorporated.

APO-Lansoprazole

Contains the active ingredient, Lansoprazole

Consumer Medicine Information

 

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before taking your medicine.

This leaflet answers some common questions about lansoprazole. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.

Ask your doctor or pharmacist:

  • if there is anything you do not understand in this leaflet,
  • if you are worried about taking your medicine, or
  • to obtain the most up-to-date information.

You can also download the most up to date leaflet from www.apotex.com.au.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

Keep this leaflet with your medicine. You may want to read it again.

What this medicine is used for

The name of your medicine is APOLansoprazole. It contains the active ingredient lansoprazole.

In adults it is used to treat:

  • reflux oesophagitis
  • peptic ulcers
  • Helicobacter pylori infection in patients with peptic ulcer or chronic gastritis
  • reflux-like and/or ulcer-like symptoms associated with acidrelated dyspepsia

In children aged 1-17 years of age it is used to treat:

  • gastro-oesophageal reflux disease, including all grades of oesophagitis
  • erosive oesophagitis

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.

This medicine is available only with a doctor’s prescription.

How it works

Lansoprazole belongs to a group of medicines called proton pump inhibitors (PPIs). Lansoprazole works by decreasing the amount of acid the stomach makes, to give relief from the symptoms and allow healing to take place.

There is no evidence that this medicine is addictive.

Before you take this medicine

Do not take this medicine if:

  • You have or have had any of the following:

– severe liver disease.

  • You are taking atazanavir, a medicine used to treat HIV.
  • You are hypersensitive to, or have had an allergic reaction to, lansoprazole, other proton pump inhibitors or any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.

If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.

  • The expiry date (EXP) printed on the pack has passed.
  • The packaging is torn, shows signs of tampering or it does not look quite right.

Before you start to use it

Before you start taking this medicine, tell your doctor if:

  1. You have allergies to:
  • any other medicines
  • any other substances, such as foods, preservatives or dyes.
  1. You have or have had any medical conditions, especially the following:
  • kidney or liver problems
  • a tumour in the stomach region
  • osteoporosis
  • low magnesium levels
  • fructose intolerance, glucose galactose malabsorption or sucrose-isomaltase insufficiency.
  1. You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.
  2. You are currently breastfeeding or you plan to breast-feed. Do not take this medicine whilst breastfeeding until you and your doctor have discussed the risks and benefits involved.
  3. You are planning to have surgery or an anaesthetic.
  4. You are currently receiving or are planning to receive dental treatment.
  5. You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Some medicines may interact with lansoprazole. These include:

  • theophylline, used to treat asthma
  • carbamazepine and phenytoin used to treat seizures (fits)
  • warfarin, used to prevent blood clot
  • oral contraceptives
  • sucralfate (used to treat stomach ulcers) and antacids (used to treat heartburn). Lansoprazole should be taken at least an hour prior to taking sucralfate or an antacid
  • ampicillin esters, used in some antibiotics
  • ketoconazole, itraconazole, used to treat fungal infections
  • iron preparations
  • digoxin, used to treat heart conditions
  • tacrolimus or mycophenolate used in transplant patients to reduce organ rejection
  • methotrexate, used in rheumatoid arthritis and some cancers to control immune response
  • atazanavir and others that require an acidic pH to be effective to treat HIV
  • fluvoxamine, used to treat depression and anxiety
  • rifampicin, an antibiotic
  • St John’s wort, a herbal medicine.

If you are taking any of these you may need a different dose or you may need to take different medicines. Other medicines not listed above may also interact with lansoprazole.

How to take this medicine

Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.

How much to take

Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.

For children, this will also depend on their weight.

Do not stop taking your medicine or change your dosage without first checking with your doctor.

How to take it

The capsule should be swallowed whole with plenty of water. Do not crush or chew.

If you have difficulty swallowing this medicine, the capsule can be opened and taken as follows:

  • sprinkle the intact granules on one tablespoon of apple sauce, strained pears, cottage cheese or yoghurt and swallow immediately
  • or sprinkle the intact granules into a small volume of either apple juice, orange juice or tomato juice. Mix briefly and swallowed immediately.

To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.

Do not use other foods or liquids to swallow the granules because they have not been tested for use with this medicine.

If you have a nasogastric tube in place, this medicine may be given by a doctor or nurse by mixing the intact granules from the capsule with 40 mL of apple juice and injecting the mixture through the tube into the stomach. The tube is then flushed with more apple juice to clear it.

When to take it

Take this medicine in the morning before food.

Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

Make sure you have enough to last over weekends and holidays.

If you forget to take it

If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. Otherwise, take it as soon as you remember and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for missed doses.

This may increase the chance of you experiencing side effects.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively, go to the Accident and Emergency department at your nearest hospital. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking this medicine

Things you must do

Tell your doctor that you are taking this medicine if:

  • you are about to be started on any new medicine
  • you are pregnant or are planning to become pregnant
  • you are breastfeeding or are planning to breastfeed
  • you are about to have any blood tests
  • you are going to have surgery or an anaesthetic or are going into hospital.

Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.

Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

Things you must not do

Do not:

  • Give this medicine to anyone else, even if their symptoms seem similar to yours.
  • Take your medicine to treat any other condition unless your doctor tells you to.
  • Stop taking your medicine, or change the dosage, without first checking with your doctor.

Things to be careful of

Be careful when driving or operating machinery until you know how this medicine affects you.

Lansoprazole may cause dizziness in some people.

Possible side effects

Tell your doctor as soon as possible if you do not feel well while you are taking lansoprazole or if you have any questions or concerns.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.

Tell your doctor if you notice any of the following.

Stomach or bowel problems such as:

  • diarrhoea, constipation
  • indigestion
  • nausea (feeling sick), vomiting
  • flatulence or wind
  • abdominal or stomach pain .

Tell your doctor if you suffer from severe persistent diarrhoea and/or vomiting when taking lansoprazole.

The natural acid in your stomach helps kill bacteria. Taking medicines such as lansoprazole that reduce acid, may result in stomach infections in some people.

Difficulty in thinking or working due to:

  • headache
  • fatigue (tiredness)
  • dizziness
  • generally feeling unwell
  • joint or muscle aches or pain
  • feeling depressed, confused or having hallucinations.

Changes to your appearance such as:

  • thinning hair
  • skin rashes
  • hives or itchy skin
  • breast enlargement and impotence in men (with long-term use).

Signs of infection such as:

  • cough, cold, sore throat or sinus
  • dry or sore mouth or throat
  • frequent and painful passing of urine.

Changes in sight, hearing, taste or touch including:

  • taste disturbances
  • tingling or numbness of hands and feet
  • blurred vision
  • increased sensitivity to sunlight.

Tell your doctor as soon as possible if you notice any of the following. These may be serious side effects and you may need medical attention:

  • pain or indigestion
  • vomiting blood or food
  • passing black (blood-stained) motions.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

  • pain in the kidney region
  • bruising or bleeding more easily than usual, bleeding under the skin or red or purple flat pinhead spots under the skin
  • frequent infections such as fever, severe chills, sore throat or mouth ulcers
  • watery or severe diarrhoea with stomach and bowel problems
  • yellowing of the skin or eyes, especially if accompanied by fever, fatigue, loss of appetite, dark coloured urine or light coloured bowel movements
  • symptoms of sunburn such as redness, itching or blistering
  • cramping of the muscles in your hands or feet
  • irregular heartbeat
  • fits or seizures
  • hallucinations.

These are very serious side effects and you may need urgent medical attention or hospitalisation. Other side effects not listed above may occur in some patients.

Allergic reactions

If you think you are having an allergic reaction to lansoprazole, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

Symptoms of an allergic reaction may include some or all of the following:

  • cough, shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue, throat or other parts of the body
  • rash, itching or hives on the skin
  • fainting
  • hay fever-like symptoms.

 

Storage and disposal

Storage

Keep your medicine in its original pack until it is time to take them. If you take your medicine out of the original pack they may not keep well.

Keep your medicine in a cool, dry place where the temperature will stay below 25°C.

Do not store your medicine, or any medicine in the bathroom or near a sink. Do not leave medicines in the car or on window sills. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or it has passed its expiry date, ask your pharmacist what to do with any capsules which may be left over.

Product description

What APO-Lansoprazole looks like

APO-Lansoprazole 15 mg

Yellow cap/yellow body, self-locked hard gelatin capsules of size ‘3’ imprinted with ‘L 15’ on both cap and body, containing white to off-white pellets.

APO-Lansoprazole 30 mg

Purple cap/lavender body, selflocked hard gelatin capsules of size ‘1’ imprinted with ‘L 30’ on both cap and body, containing white to offwhite pellets.

APO-Lansoprazole 15 mg and 30 mg are available in blister packs of 28 capsules.

Ingredients

Each APO-Lansoprazole Enteric Capsules contains 15 mg or 30 mg of lansoprazole as active ingredient.

It also contains the following inactive ingredients:

  • sucrose
  • starch
  • talc
  • hypromellose
  • titanium dioxide
  • methacrylic acid-ethylacrylate copolymer
  • macrogol 300
  • colloidal anhydrous silica
  • gelatin

The 15 mg enteric capsule also contains the below colourants:

  • yellow iron oxide CI77492
  • quinoline yellow CI47005.

The 30 mg capsule contains the colourants:

  • indigo carmine CI73015
  • carmoisine CI14720.

The capsules are imprinted with the black ink Opacode S-1-277002 black.

This medicine does not contain gluten and lactose.

Australian Registration Numbers

APO-Lansoprazole 15 mg enteric capsule: AUST R 159350

APO-Lansoprazole 30 mg enteric capsule: AUST R 159345

Sponsor

Apotex Pty Ltd 16

Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered trade marks of Apotex Inc.

This leaflet was last updated in: October 2016


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