Erectile Dysfunction

/Erectile Dysfunction
Erectile Dysfunction 2020-12-01T17:28:21+00:00

Erectile Dysfunction

About Erectile Dysfunction
FAQs
Learn More

Welcome to Qoctor’s online doctor service which provides assessment & treatment for Erectile Dysfunction. First, you’ll need to answer some simple health questions. If treatment is appropriate, you can have your prescription emailed direct to your local pharmacy (or posted to you), OR you can get medication delivered.

  • It costs $22.99 for the online assessment, which also covers any prescription(s) issued.
  • If you request to have medication delivered to you, the cost of medication will be added.
Get treatment

About Erectile Dysfunction (E.D)

  • E.D affects most men at some time in their lives.
  • It’s when you can’t get or keep an erection firm enough for sexual intercourse.
  • Many men experience the problem now and then- for example if they are under stress. However, for some, it can be more ongoing and troublesome.
  • E.D can be caused by a variety of potentially serious health conditions. It’s also a side effect of various medications, or a symptom of stress, depression or relationship problems.
  • It’s important  to see a doctor in person to discuss these issues.
treatment for Erectile Dysfunction , also known as E.D, buy Viagra online, buy Cialis online, or Levitra online
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FAQs

What is Erectile Dysfunction? 2018-02-08T12:14:35+00:00

Erectile Dysfunction (ED) or impotence is the inability to get or keep an erection which is firm enough for sexual intercourse. Many men experience this issue now and then- for example if they are under stress. However, for some, it can be a more ongoing and troublesome problem, and if this is the case, it’s important to make sure there are no underlying causes.

What causes Erectile Dysfunction? 2017-10-04T21:59:08+00:00

A variety of issues can lead to erectile dysfunction:

  • Reduced blood flow to the penis

This is the most common cause of erectile dysfunction in men over 40 years. The arteries which take blood to the penis can become narrowed and the blood flow may be insufficient to cause an erection. Smoking, raised cholesterol and obesity can be contributing factors to this.

  • Damage to nerves supplying the penis

This may be due to a neurological condition, such as multiple sclerosis or stroke, or spinal injury/surgery

  • Diabetes

Diabetes is another common cause of ED and can affect the blood flow and the nerves to the penis. If you are concerned about diabetes you should see your doctor for a blood test.

  • Alcohol

In the short term alcohol can reduce blood flow to the penis, and in the long term it can reduce testosterone levels and reduce sex drive. Excessive drinking (more than 14 units per week) can have a number of other negative effects on your health.

  • Psychological causes

Stress, anxiety and depression are very common, and can cause or contribute to erectile dysfunction.  If you feel you may be suffering from any of these problems, you should speak to your GP.

Could it mean something serious is wrong? 2018-02-08T12:17:56+00:00

Erectile Dysfunction can be caused by a variety of medical and psychological issues. If you wish to access treatment for Erectile Dysfunction online it is very important to see a doctor first for a proper check-up and physical examination, to rule out any underlying conditions.

Could Erectile Dysfunction be a side effect of a medicine I’m taking? 2017-10-29T10:05:12+00:00

Yes, several types of medication can lead to erectile dysfunction- so if you develop problems with getting or sustaining an erection soon after starting a new medication you should speak to your doctor ( it’s usually advisable not to stop any medication suddenly). Common culprits include:

  • Beta-blockers (eg propranolol, bisoprolol or carvedilol)- often used to treat blood pressure or other heart conditions
  • Diuretics- also known as “water tablets” (eg furosemide, indapamide), often used to treat heart conditions
  • Antidepressants (eg citalopram, fluoxetine) used to treat depression or anxiety
  • Antihistamines (eg promethazine/phenergan, diphenhydramine) used to treat allergies
  • H2 blockers (e.g. cimetidine, ranitidine) used to treat acid reflux and heartburn.

Before you get treatment for erectile dysfunction, Qoctor advises you discuss your health and any medications you’re taking with your doctor.

What is the Treatment for Erectile Dysfunction? 2018-03-22T11:53:56+00:00

Phosphodiesterase Inhibitors:

A group of drugs known as phosphodiesterase inhibitors are commonly used as treatment for erectile dysfunction. They work by increasing blood flow to the penis.  However, it’s important to speak to a doctor and get checked out for underlying causes first.

Health Library- assessment, diagnosis and treatment of E.D

E.D (impotence) affects a lot of men, but it may be an embarrassing subject to broach with a doctor.  A lot of men may wish to access treatment for E.D online, however, it’s important to get your symptoms properly checked out by a doctor first, as in some situations E.D can be a symptom of other underlying health problems , such as Diabetes, circulation problems or conditions affecting the nerves. It may also be a side effect of several commonly prescribed medications– such as antidepressants, blood pressure tablets and other medications commonly prescribed for heart disease. Anxiety, depression or relationship difficulties may also be a contributing factor- if you think this may apply to you, you can find out more at Beyond Blue. In the articles below we explore symptoms, causes and treatment of E.D.

Phimosis- causes and treatment of a tight foreskin

What is Phimosis? What is Phimosis?  Phimosis is the medical word that describes a tight foreskin that cannot be pulled back past the head of the penis (glans). This is normal in babies and infants (physiologic phimosis), as almost all boys under 2 years of age have a tight foreskin at birth that cannot be pulled back to expose the head. Through repeated erections and developmental changes, the foreskin generally loosens through the ages of 3-16 so that by the age of 16-18, only 1% of boys will still have phimosis (pathologic phimosis). How to get a medical certificate online What causes Phimosis? One cause of pathologic phimosis is overzealous and forceful pulling back of the foreskin in young children, which can cause adhesions and scarring that leads to the tightness. The foreskin should never be forcibly pulled [...]

By | February 23rd, 2021|Categories: Phimosis, Tight Foreskin|

How to see a GP online with Qoctor

How to see a GP online with Qoctor We can do practically everything online these days - from banking, to ordering groceries or booking plane tickets. But healthcare has lagged behind. And whilst there are certain health issues that still require a visit to the doctor in person, there are many others that just need a discussion, advice or some paperwork to be completed. That’s where an online doctor service fits in. Here's how to see a GP online with Qoctor: Click here to get an online medical certificate How to see a GP online for a medical certificate When you go to www.qoctor.com.au you’ll see several options on the home page. The first lets you book an appointment to get a medical certificate. This is useful if you’ve missed work or uni due to a minor illness like a head cold, sore throat or gastro [...]

By | July 31st, 2017|Categories: Erectile Dysfunction, Online doctor|

How does Chlamydia affect men?

What are the symptoms of Chlamydia in men? symptoms spread prevention treatment Chlamydia is a sexually transmitted infection/disease (STI/STD) caused by a bacteria (Chlamydia Trachomatis). This means that it is spread by having sex or sexual contact with somebody who has already caught it. Chlamydia symptoms in women can include pelvic pain, discomfort when passing urine and vaginal discharge- infection can cause serious illness and severe fertility problems, as well as increasing the risk of ectopic pregnancy (which can be fatal). But what are the symptoms of Chlamydia in men? What are the symptoms of Chlamydia in men? Chlamydia symptoms in men may include: Burning when you pee Pain in the testicles (balls) Discharge from the end of the penis Rectal pain/discharge/bleeding in men who have received anal sex Long-term it can affect fertility But in many cases there may be no [...]

By | June 26th, 2017|Categories: Men's Health, Sexual health, STI, STI test, Chlamydia|

Vasectomy – Everything You Need to Know

What is a vasectomy? Sperm is made in your testicles (balls). There are 2 tubes that take sperm from your testicles to your penis - 1 tube for each testicle. A vasectomy is a minor operation to cut both those tubes. Each tube is cut at the top of the scrotum (ball sack), near to the base of the penis. Once they’re cut, no sperm comes out of your penis when you ejaculate (come). Will they put me to sleep for my vasectomy? Not normally. Vasectomy can be performed under local anaesthetic (which means they make the area numb for a while so you don’t feel any pain). Click here to get a referral letter for a vasectomy Is vasectomy 100% effective? Nearly. After the vasectomy you will need to provide some sperm samples to check that it has worked - until you’ve got those results [...]

By | June 21st, 2017|Categories: Vasectomy|

Hair loss in men- what causes it?

Hair loss in men- what causes it? Cause Symptoms Treatment Introduction Most men will experience some degree of hair loss during their lives- many have no wish to take any action, but some may opt to seek treatment. So, what causes male pattern baldness and what can be done to prevent or reverse it? What conditions can be treated by an online doctor? What causes hair loss in men? The scalp skin normally changes testosterone to another hormone called dihydrotestosterone. In balding men it seems that the hair follicles become too sensitive to this hormone and react by shrinking over time. Normally a single hair should last around 3 years, but as hair follicles shrink, the hairs become thinner and shed more often, until they get so short and thin that they no longer grow out through the skin. [...]

By | June 1st, 2017|Categories: Men's Health, Hair Loss in Men|

Premature Ejaculation- symptoms, causes & treatment

Premature Ejaculation- symptoms, causes & treatment what is it? causes treatment   What is Premature Ejaculation? Premature Ejaculation is when a man ejaculates during sexual intercourse sooner than he or his partner would like. It’s very common- many men experience it now and then. But if it’s happening frequently, and occurs very shortly after intercourse begins, it can be distressing and frustrating- a man may even tend to avoid sexual intimacy as a result of it.  But why does it happen? What conditions can be treated by our online doctors? What causes Premature Ejaculation? The cause of premature ejaculation isn't fully understood. For a long time it was thought to be purely psychological, but now we know there can be physical factors too. Psychological factors that can play a role include poor self [...]

By | February 28th, 2017|Categories: Erectile Dysfunction, Premature Ejaculation, Men's Health|

Consumer Medication Information (CMI)

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.

VIAGRA®

 sildenafil (as citrate)

Consumer Medicine Information

What is in this leaflet?

This leaflet answers some common questions about Viagra.

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 Viagra against the benefits they expect it will have for you.

It should be used only under strict medical supervision.

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 Viagra is used for

Viagra is used to treat erectile dysfunction, more commonly known as impotence, in men. This is when a man cannot get, or keep, a hard erect penis suitable for sexual activity.

Viagra belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

It works by relaxing the blood vessels in your penis when you are sexually excited. This allows blood to flow into your penis, allowing you to get an erection in the natural way.

Viagra will work only if you are sexually excited.

Viagra will not increase your sex drive.

Viagra is not for use in women.

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

Before you take Viagra

When you must not take it

YOU MUST NOT TAKE VIAGRA IF YOU ARE TAKING NITRATES OR NITRITE MEDICATIONS. IT MAY LEAD TO A SEVERE DROP IN YOUR BLOOD PRESSURE, WHICH MAY BE DIFFICULT TO TREAT.

BECAUSE SEXUAL ACTIVITY MAY PLACE A STRAIN ON YOUR HEART, YOUR DOCTOR WILL NEED TO CHECK WHETHER YOU ARE FIT ENOUGH TO TAKE VIAGRA.

Do not take Viagra if you are being treated for angina (chest pain) or other heart conditions with medicines called nitrates.

Nitrate medicines include glyceryl trinitrate (also called nitroglycerin). Common trade names for glyceryl trinitrate tablets include Anginine and Lycinate.

Common trade names for glyceryl trinitrate patches include Nitro-Dur, Transiderm-Nitro, Nitroderm TTS, and Minitran.

Common trade names for glyceryl trinitrate sprays include Nitrolingual and Glytrin.

Trade names for glyceryl trinitrate injections include Glyceryl Trinitrate Concentrate and Glyceryl Trinitrate.

Common trade names for other nitrate preparations include Imdur Durules, Monodur Durules, Sorbidin, Isordil, Imtrate, Duride, Isomonit, Ikorel and Sodium Nitroprusside.

There may be other trade names not listed here.

Do not take Viagra if you are taking guanylate cyclase stimulators (GCS), such as Adepmas (riociguat).

GCS is a type of medicine used to treat high blood pressure in the blood vessels in the lungs caused by blood clots in the lungs (chronic thromboembolic pulmonary hypertension, CTEPH) or narrowing of the vessels that carry blood from the heart to the lungs (pulmonary arterial hypertension or PAH).

Do not take Viagra if you:

  • have heart or blood vessel problems that make sexual intercourse inadvisable
  • have suffered a heart attack or stroke in the last 6 months
  • have severe liver problems
  • have blood pressure that is unusually high or low or is not effectively treated
  • have loss of vision in one or both eyes from an eye disease called non-arteritic anterior ischaemic optic neuropathy (NAION)
  • have an eye disease called retinitis pigmentosa.

Do not take Viagra if you have an allergy to sildenafil or similar medicines or any of the ingredients listed at the end of this leaflet

An allergic reaction can include:

  • hives, itching or skin rash
  • swelling of the face, lips or tongue which may lead to difficulty swallowing or breathing.

Do not take Viagra if the packaging is torn or shows signs of tampering, or does not look quite right even if the tablets may look alright.

Do not take Viagra if the expiry date on the pack has passed.

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

Before you start to take it

Tell your doctor if you:

  • have any allergies to any other medicines or any other substances such as foods, preservatives or dyes.
  • have any other heart or blood vessel problems.
  • have previously had sudden loss of eyesight in one or both eyes.
  • have any of the following medical conditions:

– diabetes, especially if you also have eye problems

– kidney or liver problems

– leukaemia (cancer of the blood cells) –

multiple myeloma (a cancer of the bone marrow)

– any disease or deformity of your penis

– any bleeding disorder such as haemophilia

– stomach ulcer

– a disease of the blood called sickle cell anaemia

– colour vision problems

– previously experienced sudden decrease or loss of hearing.

  • are taking or using any other treatment for impotence
  • are taking any medicines to treat high blood pressure in the vessels of the lungs (pulmonary arterial hypertension) including Tracleer (bosentan) or Revatio which also contains sildenafil.

Tell your doctor if you have any other medical conditions.

If you have not told your doctor or pharmacist about any of the above, tell him/her before you start taking Viagra.

Taking other medicines

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

Do not take Viagra if you are taking or using nitrate medicines for angina.

Do not take Viagra if you are taking guanylate cyclase stimulators (GCS), such as Adepmas (riociguat).

Some medicines and Viagra may interfere with each other. These include:

  • cimetidine, a medicine used to treat ulcers
  • some medicines used to treat fungal infections including ketoconazole and itraconazole
  • some antibiotics including erythromycin and rifampicin
  • some protease inhibitors such as ritonavir and saquinavir for the treatment of HIV infection
  • medicines called alpha-blockers. These are used to treat high blood pressure or prostate problems
  • Tracleer (bosentan), a medicine used to treat high blood pressure in the vessels of the lungs.

You may need different amounts of your medicine or you may need to take different medicines. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines. They also have a more complete list of medicines to be careful with or avoid while taking Viagra.

Ask your doctor or pharmacist, if you are not sure if you are taking any of these medicines.

How to take Viagra

Take Viagra exactly as your doctor has prescribed.

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

They may differ from the information contained in this leaflet.

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

How much to take

Your doctor will decide the correct dose for you depending on your condition and response.

This can be one 25 mg tablet a day or one 50 mg tablet a day or one 100 mg tablet a day.

Do not take more than one dose of Viagra a day.

How to take it

Swallow the tablet whole with a full glass of water.

When to take it

Take your dose of Viagra about one hour before you intend to have sex.

The amount of time Viagra takes to start working varies from person to person, but it normally takes between half an hour and one hour.

You may find Viagra takes longer to work if you take it with a heavy meal.

Viagra will work only if you are sexually excited.

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 Viagra.

Do this even if there are no signs of discomfort or poisoning.

 

 

 

While you are taking it

Things you must do

Stop taking Viagra if you have a loss of eyesight in one or both eyes, experience loss of hearing or have an erection that persists more than 4 hours. Seek medical attention urgently.

If Viagra does not help you get an erection or if your erection does not last long enough to complete sexual intercourse, tell your doctor.

In these cases, your doctor may decide that you need a higher dose.

If you are about to start taking any new medicines, especially nitrates, or Adepmas (riociguat), tell your doctor and pharmacist that you are taking Viagra.

See “Before you take Viagra” for a list of common nitrate medications.

Tell any other doctors, dentists and pharmacists who are treating you that you are taking Viagra.

Things you must not do

Do not use drugs containing amyl nitrite (sometimes called “poppers”) while you are taking Viagra.

If you get an angina attack do not take nitrate medicines to relieve the pain but tell your doctor immediately. Make sure your doctor knows you are taking Viagra.

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

Things to be careful of

Be careful drinking alcohol while taking Viagra.

Drinking alcohol can temporarily impair the ability to get an erection.

Do not drink large amounts of alcohol before sexual activity.

If you experience changes in vision, or dizziness, when taking Viagra, you should not drive or operate machinery.

Side effects

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

While Viagra helps most people, it can cause some unwanted side effects in a few people. All medicines have side effects. If unwanted effects occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

Do not be alarmed by this list of possible side effects.

You may not get any of them.

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

  • headache
  • dizziness
  • flushing
  • hot flushes
  • indigestion
  • heart burn
  • nasal congestion
  • sinus congestion
  • swelling of your nose
  • diarrhoea
  • rash
  • dry mouth or dry throat
  • dry nose
  • dry eye
  • tightness in your throat
  • feeling hot or irritable
  • redness in your mouth or tongue.

Tell your doctor as soon as possible if you notice any of the following:

  • unusual heart beat
  • urinary tract infection (stinging or burning urine, more frequent need to pass urine)
  • blood in the urine
  • persistent headache or fainting
  • bleeding from the nose
  • pain or tingling in your hands, toes or feet
  • decreased sensitivity or numbness in your mouth
  • irritation or feeling of having something in the eye
  • swollen or puffy eye(s)
  • fatigue, pain in or around the eyes
  • “red eye” due to swollen blood vessels in the white part of the eye and in the eyelids.

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

  • signs of allergy such as shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts
  • chest pain
  • increased heart rate
  • sudden decrease or loss of hearing
  • seizures, fits or convulsions
  • your erection is increased, painful or persists for longer than usual. If your erection continues for four hours, or sooner if there is pain, you should seek medical attention urgently
  • rarely men have lost eyesight sometime after taking drugs to treat erectile dysfunction (known as impotence). If you lose eyesight in one or both eyes or experience changes in vision such as blurring, a blue colour to your vision or a greater awareness of light, seek medical attention urgently
  • changes to your normal vision such as:

– red or yellow colour tinges to your vision or colourless objects appear coloured

– you see a halo around lights, sparks or lights when your eyes are closed.

This is not a complete list of all possible side effects. Others may occur in some people and there may be side effects not yet known.

If you notice any other symptoms that worry you, check with your doctor.

Ask your doctor or pharmacist if you don’t understand anything in this list.

After taking Viagra

Storage

Keep this medicine 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 Viagra in a cool; dry place where the temperature stays below 30°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 windowsills.

Heat and dampness can destroy some medicines.

Keep the tablets in their pack until it is time to take them. If you take your tablets out of the pack they will not keep as well.

Disposal

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

Product description

What it looks like

  • 25 mg – blue, rounded-diamond shaped tablets marked VGR 25 on one side and PFIZER on the other.
  • 50 mg – blue, rounded-diamond shaped tablets marked VGR 50 on one side and PFIZER on the other.
  • 100 mg – blue, rounded-diamond shaped tablets marked VGR 100 on one side and PFIZER on the other.

All strengths are available in a box of 4 tablets. The 100 mg tablets are also available in a box of 12 tablets.

Ingredients

Viagra tablets contain sildenafil (as citrate) equivalent to 25 mg, 50 mg or 100 mg sildenafil.

Other ingredients

  • microcrystalline cellulose
  • calcium hydrogen phosphate
  • croscarmellose sodium
  • magnesium stearate
  • hypromellose
  • titanium dioxide (E171)
  • lactose
  • triacetin
  • indigo carmine aluminium lake (E132)
  • PF0102.

Supplier

Viagra is supplied by:

Pfizer Australia Pty Ltd

ABN 50 008 422 348

38-42 Wharf Road

West Ryde NSW 2114

Australia.

Toll Free number: 1800 675 229.

Australian Registration Numbers

25 mg – AUST R 64434.

50 mg – AUST R 64435.

100 mg – AUST R 64436.

This leaflet was prepared in July 2016.

© Pfizer Australia Pty Ltd 2016.

 

CIALIS®

 (tadalafil)

Consumer Medicine Information

What is in this leaflet?

This leaflet answers some common questions about CIALIS. 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 shown on the final page. More recent information on this medicine may be available. Make sure you speak to your pharmacist, nurse or doctor to obtain the most up to date information on this medicine. You can also download the most up to date leaflet from www.lilly.com.au. The updated leaflet may contain important information about CIALIS and its use that you should be aware of. All medicines have risks and benefits. Your doctor has weighed the risks of you taking CIALIS against the benefits they expect it will have for you.

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

Keep this leaflet with the medicine.

You may need to read it again.

What CIALIS is used for

CIALIS is used to treat:

  • erectile dysfunction, also known as impotence, in men. This is when a man cannot get, or maintain, a hard erect penis suitable for sexual activity. Following sexual stimulation, CIALIS works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. CIALIS will only treat erectile dysfunction if you are sexually aroused. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
  • urinary symptoms associated with a common condition called benign prostatic hyperplasia. This is when the prostate gland gets bigger with age. Symptoms include difficulty in starting to pass urine, a feeling of not completely emptying the bladder and a more frequent need to pass urine even at night. CIALIS improves blood flow to, and relaxes the muscles of, the prostate and bladder which may reduce symptoms of benign prostatic hyperplasia.

Your doctor may have prescribed you CIALIS to treat either, or both of these conditions.

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

Your doctor may have prescribed it for another reason. CIALIS is available only with a doctor’s prescription.

CIALIS is not intended for use by women or by children under the age of 18 years.

The active ingredient in CIALIS tablets, tadalafil, belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Before you take CIALIS

When you must not take it

Do not take CIALIS if you are currently taking any nitrates or amyl nitrite

Nitrates are medicines used for the treatment of angina (“chest pain”) or other heart conditions. CIALIS has been shown to increase the effects of these medicines.

If you are taking any form of nitrate or are unsure talk to your doctor.

  • if you have heart or blood vessel problems that make sexual intercourse inadvisable. Sexual activity carries a possible risk to patients with a heart condition because it puts extra strain on the heart
  • if you have heart problems such as angina , arrhythmias (changes in rhythm or rate of heart beat), heart failure.
  • if you have suffered a heart attack in the last 3 months
  • if you have suffered a stroke in the last 6 months
  • if your blood pressure is unusually high or low or is not effectively treated if you have vision loss in one eye because of non-arteritic interior ischaemic optic neuropathy (NAION)
  • if you use recreational drugs called “poppers” or “amyl” like amyl nitrite and butyl nitrite that are normally taken through inhalationn.
  • if you use guanylate cyclase stimulators such as riociguat, used to treat pulmonary arterial hypotension

Do not take CIALIS if you have an allergy to:

  • any of the ingredients listed at the end of this leafletI

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  this  medicine after  the  expiry  date  printed on  the  pack.

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

Do not take this medicine if the packaging is torn or if the seals over the carton ends are missing or broken. There are no seals over the carton ends of the 5mg physician sample pack.

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

If you are not sure whether you should start taking CIALIS, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

CIALIS tablets contain a small amount of lactose.

Tell your doctor if you are aged 75 years and over.

You have a higher chance of experiencing side effects like dizziness and diarrhoea.

Your doctor will assess if CIALIS is suitable for you.

Tell your doctor if you have or have had any of the following medical conditions:

liver or kidney problems

  • heart problems or if you have had a heart attack
  • blood vessel problems
  • sickle cell anaemia (an abnormality of red blood cells)
  • multiple myeloma (cancer of the bone marrow)
  • leukaemia (cancer of the blood cells)
  • any deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease)
  • loss of vision in one or both eyes

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

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 be affected by CIALIS or may affect how it works. These include:

  • Nitrates, medicine such as glyceryl trinitrate, isosorbide mononitrate and sodium nitroprusside used to treat angina and other heart conditions
  • Some antibiotic medicines such as rifampicin, erythromycin and clarithromycin
  • Some medicines used to treat seizures such as phenytoin, phenobarbitone and carbamazepine
  • Some medicines used to treat fungal infections such as ketoconazole and itraconazole
  • Protease inhibitors used to treat HIV such as ritonavir and saquinavir
  • Medicines used to treat hypertension (high blood pressure) such as metoprolol, irbesartan and enalapril
  • Alpha blockers (used to treat hypertension and some prostate problems) such as prazosin and doxazosin
  • A 5-alpha reductase inhibitor, such as finasteride (used to treat prostate and hair loss problems)
  • Warfarin, a medicine used to prevent or treat blood clots
  • High doses of alcohol
  • Grapefruit juice
  • Other PDE5 inhibitors such as sildenafil used to treat erectile dysfunction or pulmonary arterial hypertension (high blood pressure in the blood vessels in the lungs)
  • Guanylate cyclase stimulators such as riociguat, used to treat pulmonary arterial hypotension.

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

You should not take CIALIS together with any other treatments for erectile dysfunction.

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

How to take CIALIS

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

They may differ from the information contained in this leaflet.

For Erectile Dysfunction

CIALIS can be taken as either ondemand dosing or once-a-day dosing.

CIALIS on-demand (10 mg and 20 mg) is intended for use prior to anticipated sexual activity and is not for continuous daily use.

CIALIS once-a-day (5 mg) is for patients who anticipate frequent use of CIALIS (i.e. at least twice weekly). Your Doctor can advise on the appropriateness of once-a-day treatment. When taken once a day, CIALIS allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours ofthe day. Do not take once-a-day dosing and on-demand dosing concurrently.

When taking CIALIS once-a-day (5mg), it may take up to 1 week for a full effect on Erectile Dysfunction.

For urinary symptoms associated with Benign Prostate Hyperplasia

CIALIS once-a-day (5mg) is taken daily. For urinary symptoms associated with benign prostatic hyperplasia it may take up to a week to notice an improvement and 1 month for a full effect on urinary symptoms such as; urinating too frequently during the day or at night, the need to urinate being too urgent, or too soon after relieving your bladder. CIALIS must be taken daily to maintain effect.

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

How much to take

You should not take CIALIS more than once a day.

Always take CIALIS exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

ON-DEMAND DOSING FOR ERECTILE DYSFUNCTION

The maximum recommended dose of CIALIS is one 20 mg tablet taken before sexual activity.

If you have kidney disease, the recommended dose of CIALIS is one 10 mg tablet. This dose may be increased up to 20 mg. For patients with severe renal impairment 10 mg is the maximum recommended dose.

If you have liver disease, the recommended dose of CIALIS is one 10mg tablet. Patients with severe hepatic impairment should follow their doctor’s advice.

No special dosing consideration is needed for the elderly or people with diabetes.

ONCE-A-DAY DOSING FOR ERECTILE DYSFUNCTION AND/OR URINARY SYMPTOMS ASSOCIATED WITH BENIGN PROSTATE HYPERPLASIA

The recommended dose of CIALIS is one 5 mg tablet taken once per day.

Dosage adjustments are not required in patients with kidney disease, unless you have severe renal impairment. Once-a-day dosing of CIALIS is not recommended in patients with severe renal impairment.

Patients with liver disease should follow their doctor’s advice. Once-aday dosing of CIALIS is not recommended in patients with severe hepatic impairment.

No special dosing consideration is needed for the elderly or people with diabetes.

How to take it

Swallow one tablet whole with a full glass of water.

When to take it

CIALIS can be taken with or without food or alcohol. However, drinking alcohol may affect your ability to get an erection, so avoid excessive drinking.

ON-DEMAND DOSING FOR ERECTILE DYSFUNCTION

CIALIS (10 mg or 20 mg) should be taken at least 30-60 minutes prior to anticipated sexual activity.

The amount of time CIALIS takes to work varies from person to person. In some men CIALIS can work as early as 16 minutes after taking the tablet but it is recommended that you allow 1 hour the first time you take it. CIALIS has been proven to be effective for up to 36 hours. This means you can take CIALIS and it will allow you to obtain an erection when sexually stimulated, at any time during the 36 hours after taking it. Sometimes if you’re feeling anxious or nervous you may not respond to the first tablet. Don’t give up, it may take a few doses before you get the full benefit of CIALIS.

ONCE-A-DAY DOSING FOR ERECTILE DYSFUNCTION AND/OR URINARY SYMPTOMS ASSOCIATED WITH BENIGN PROSTATE HYPERPLASIA

Cialis 5 mg should be taken daily at approximately the same time of day. CIALIS must be taken daily to maintain effect.

If you have any questions about taking CIALIS, ask your doctor or pharmacist.

 

 

If you take too much (overdose)

Immediately telephone your doctor or the Australian Poisons Information Centre (telephone 13 11 26) or the New Zealand National Poisons Centre (0800 POISON or 0800 764 766), or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much CIALIS.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of an overdose may include headache, dyspepsia (indigestion), back pain, muscular aches, nasal congestion and facial flushing.

While you are taking CIALIS

Things you must do

If you have emergency treatment for any suspected heart condition tell the emergency medical or ambulance staff that you are taking CIALIS. If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking CIALIS. Tell any other doctors, dentists and pharmacists who treat you that you are taking CIALIS.

Things you must not do

Do not take CIALIS 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.

Things to be careful of

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

Side effects

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

CIALIS helps most people with erectile dysfunction or urinary symptoms associated with benign prostatic hyperplasia 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 attention if you get some of the side effects.

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

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

The following side effects are usually mild and short-lived.

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

  • facial flushing
  • indigestion
  • chest pain
  • increased heart beat
  • back pain
  • muscle aches, including pain in the arms and legs
  • stomach pain
  • diarrhoea
  • heart burn
  • allergic reactions, including skin rash, swelling of the face and hives
  • sweating
  • headache or migraine
  • nasal congestion
  • dizziness
  • fainting
  • infection
  • sore throat and discomfort when swallowing
  • red eyes, eye pain and swelling of eyelids are uncommon
  • changes in colour vision are rare
  • decreases or loss of vision are very rare
  • blurred vision
  • bleeding nose
  • prolonged erection

If you experience chest pain during or after sexual activity, stop what you are doing, sit up and sit forward.

Call an ambulance if the pain does not resolve. Do not use nitrates.

In rare instances it is possible that a prolonged and possibly painful erection may occur after taking CIALIS.

If you have an erection which lasts longer than 4 hours you should contact a doctor immediately.

When taking CIALIS with large amounts of alcohol, some men may experience dizziness.

Sudden loss or decrease in hearing which may be accompanied by ringing in the ears and dizziness, loss of vision in one or both eyes and seizures have been reported in people taking CIALIS. It is not possible to determine whether these events are related directly to CIALIS, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking CIALIS and contact a doctor immediately.

This is not a complete list of all possible side effects. Others may occur in some people and there may be side effects not yet known.

Potential withdrawal effects from daily use have not been examined. It is recommended that patients continue to be monitored by their doctor after discontinuation of CIALIS.

If you notice any symptoms that worry you, check with your doctor.

Ask your doctor or pharmacist if you don’t understand anything on this list.

After taking CIALIS

Storage

Keep your tablets in the original pack until it is time to take them.

If you take the tablets out of the pack they may not keep as well.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not store CIALIS 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 your medicine where children cannot reach.

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 this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

CIALIS 5 mg tablets are yellow, film coated, almond shaped tablets, marked “C5” on one side.

CIALIS 10 mg tablets are light yellow, film coated, almond shaped tablets, marked “C10” on one side.

CIALIS 20 mg tablets are yellow, film coated, almond shaped tablets, marked “C20” on one side.

Ingredients

Active Ingredients

  • 5 mg tablet – tadalafil 5 mg
  • 10 mg tablet – tadalafil 10 mg
  • 20 mg tablet – tadalafil 20 mg

Other Ingredients

  • croscarmellose sodium
  • hydroxypropylcellulose
  • hypromellose
  • iron oxide yellow CI77492
  • lactose
  • magnesium stearate
  • cellulose – microcrystalline
  • sodium lauryl sulfate
  • talc – purified
  • titanium dioxide
  • glycerol triacetate (triacetin)

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Supplier

CIALIS is a product of:

Eli Lilly Australia Pty Limited

112 Wharf Road

West Ryde, NSW 2114

AUSTRALIA

CIALIS is distributed in New Zealand by:

Eli Lilly and Company (NZ) Limited

Level 1, 123 Ormiston Rd

Botany South, Auckland 2016

NEW ZEALAND

Australian Registration Number

CIALIS 5 mg tablet – AUST R 128496

CIALIS 10 mg tablet – AUST R 90590

CIALIS 20 mg tablet – AUST R 81137

This leaflet was revised in December 2015.

LEVITRA® 5 (La·vee·trah)

LEVITRA® 20 (La·vee·trah)

 (vardenafil)

Consumer Medicine Information (CMI)

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Levitra. 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 Levitra 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 LEVITRA IS USED FOR

This medicine is used to treat erectile dysfunction.

Erectile dysfunction, also known as impotence in adult males, is the inability to obtain and/or maintain a hard erect penis sufficient for sexual activity.

Levitra tablet contains the active ingredient vardenafil which works by relaxing the blood vessels in the penis when you are sexually aroused. This allows blood to flow into the penis, allowing you to get an erection.

Levitra will only work if you are sexually aroused. It will not increase your sex drive.

Levitra is not addictive.

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

Your doctor may have prescribed it for another reason.

BEFORE YOU TAKE LEVITRA

When you must not take it

Do not take Levitra if you have an allergy to:

  • any medicine containing vardenafil hydrochloride trihydrate
  • any of the ingredients listed at the end of this leaflet

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 Levitra if you are taking nitrate medicines which include:

  • glyceryl trinitrate (also called nitroglycerine)
  • nicorandil
  • sodium nitroprusside
  • isosorbide mononitrate
  • isosorbide dinitrate
  • amyl nitrite (also known as ‘poppers’, ‘amyl’ or ‘rush’)

Do not take Levitra if you are taking:

  • HIV protease inhibitors, medicines used to treat HIV infection. Examples of HIV protease inhibitors are indinavir or ritonavir.
  • Riociguat, used to treat a disease called pulmonary arterial hypertension.

Because sexual activity may place a strain on your heart, your doctor will need to check whether you are fit enough to have sexual intercourse.

Do not take Levitra if you have:

  • unstable angina (chest pain)
  • hypotension (low blood pressure)
  • uncontrolled hypertension (high blood pressure)
  • uncontrolled arrhythmia (irregular heart beat)
  • ever had loss of vision due to non-arteritic optic neuropathy (NAION)
  • hereditary degenerative retinal disorders (such as retinitis pigmentosa)
  • severe liver problems
  • severe kidney problems requiring dialysis
  • been diagnosed with a disease called pulmonary arterial hypertension

Do not take Levitra if you have, or have had, any of the following conditions within the previous 6 months:

  • myocardial infarction (heart attack)
  • stroke
  • cardiac ischaemia
  • serious arrhythmia (irregular heart beat)

Do not give Levitra to children, adolescents or women.

Do not take this medicine after the 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. The EXPIRY date is marked on the strip of tablets as well as on the label of the carton. For example, 11 18 refers to the eleventh month of 2018.

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

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • any heart or blood vessel problems
  • leukaemia (cancer of the blood cells)
  • multiple myeloma (a cancer of the bone marrow)
  • any disease or deformity of your penis
  • low or high blood pressure
  • sickle cell anaemia
  • bleeding disorders
  • active stomach ulcer
  • liver problems

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

Taking other medicines

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

Some medicines may be affected by Levitra or vice versa. These medicines include:

  • ketoconazole and itraconazole, used to treat fungal infections
  • erythromycin, clarithromycin and gatifloxacin, which are antibiotics
  • alpha-blockers, medicines used to treat an enlarged prostate or high blood pressure. Examples of alphablockers are terazosin, alfuzosin, tamsulosin and prazosin
  • Riociguat, a type of medicine used to treat high blood pressure in the arteries carrying blood from your heart to your lungs
  • other treatments for erectile dysfunction

You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will be able to advise you.

Talk to your doctor if you are taking certain medicines for arrhythmia, including quinidine, procainamide, amiodarone and sotalol.

Levitra should not be used with these medicines.

Levitra tablets may be used together with an alpha-blocker if you are on stable alpha-blocker therapy. If your doctor recommends this, they will start your Levitra treatment with a lower dose.

Concomitant use of Levitra with alpha-blockers may contribute to dizziness or fainting.

Your doctor or pharmacist will also have a more complete list of medicines to be careful with or avoid while taking Levitra.

Ask your doctor or pharmacist, if you are not sure if you are taking any of these medicines.

HOW TO TAKE LEVITRA

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

They may differ from the information contained in this leaflet.

Swallow the tablet whole with water. Levitra can be taken with or without food.

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

How much to take

Your doctor or pharmacist will tell you how much and how often you should take Levitra. Follow the directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

The dose ranges from 5 mg to 20 mg. Your doctor will determine the correct dose for you depending on your condition, other medicines and response.

Do not take more than one dose of Levitra a day.

When to take it

Sexual stimulation is required for a natural response to treatment with Levitra.

Take your dose of Levitra 25 to 60 minutes before you wish to have sex.

Levitra may work as soon as 15 minutes and as long as 4-5 hours after taking it. The amount of time it takes to start working varies from person to person.

If you are also taking an alphablocker other than tamsulosin or alfuzosin, allow at least 6 hours between the time you take it and the time you take your Levitra tablet (see Taking other medicines). Tamsulosin can be taken at the same time as Levitra or separately as you prefer.

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

If you take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone in Australia 13 11 26, in New Zealand 0800 POISON or 0800 764 766), or go to the accident and emergency department at your nearest hospital, if you think you or anyone else may have taken too much Levitra. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

WHILE YOU ARE USING LEVITRA

Things you must do

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Levitra. If you are about to start taking any new medicines, especially nitrates or some medicines to treat HIV, e.g. indinavir or ritonavir, tell your doctor or pharmacist that you are taking Levitra.

Stop taking Levitra and tell your doctor if you notice a sudden decrease or loss of hearing. Ringing of the ears and dizziness may also occur.

Stop taking Levitra and tell your doctor if you notice a sudden loss in vision.

Please also be aware that you may have to take treatments like Levitra a few times before you get the best response. If you’re still not getting a response, speak to your doctor.

Things you must not do

Do not use the recreational drug amyl nitrite (sometimes called poppers, amyl or rush) while you are taking Levitra.

Do not take Levitra if you are taking HIV protease inhibitors, medicines used to treat HIV infection.

Do not take Levitra if you are taking Riociguat, used to treat pulmonary arterial hypertension.

If you get an angina attack whilst taking Levitra, do not take nitrate medicines to relieve the pain. Tell your doctor immediately or contact your nearest emergency department. Make sure that your doctor knows you are taking Levitra tablets.

Do not take more than one dose of Levitra a day. If Levitra does not help you get an erection, or if your erection does not last long enough to complete sexual intercourse, tell your doctor.

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

What to be careful of

Drinking alcohol can temporarily impair the ability to get an erection. To reduce impairment, do not drink large amounts of alcohol before sexual activity.

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

Levitra tablets may cause dizziness or faintness in some people. The ability to drive and/or operate machinery may be impaired. Dizziness or faintness may be worse if you are also taking alpha-blocker medicines.

SIDE EFFECTS

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

Levitra helps most men with erectile dysfunction, but it may have unwanted side effects. Sometimes they are serious, most of the time they are not. You may need to stop taking the tablets or have medical treatment if you get some of the serious side effects.

Tell your doctor or pharmacist if you notice any of the following and they worry you.

These are the common side effects of Levitra. They are usually mild and short-lived.

  • headache
  • dizziness or light-headedness
  • flushing
  • a stuffy or runny nose
  • dyspepsia (heartburn)
  • nausea

Very rarely, your erection may persist for longer than usual. If your erection continues for longer than four hours, or if you have a painful erection, you should seek medical attention.

In rare instances, men have lost eyesight some time after taking drugs to treat erectile dysfunction. It is not known at this time if Levitra causes this. If you experience sudden decrease or loss of vision – stop taking Levitra and seek immediate medical attention.

Sudden decrease in hearing or loss of hearing has been reported in men taking medicines to treat erectile dysfunction. It is not known at this time if Levitra causes this. If you experience sudden decrease or loss of hearing – stop taking Levitra and seek immediate medical attention.

You should tell your doctor immediately, or be reviewed in the accident and emergency department at your nearest hospital if you have any of the following:

  • angina (chest pain)
  • myocardial infarction
  • irregular heart beats or palpitations
  • loss of consciousness
  • allergic reactions such as rash, wheezing, swelling of the face, lips, tongue which may cause difficulty in swallowing or breathing

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

Other side effects not listed above may also occur in some people. Tell your doctor if you notice anything else that is making you feel unwell.

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

AFTER USING LEVITRA

Storage

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the box or the blister pack they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not leave the tablets in the car on hot days. Do not store it or any other medicine in the bathroom or near a sink. Heat and dampness can destroy some medicines.

Keep your tablets where children cannot reach them. 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 Levitra tablets or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

PRODUCT DESCRIPTION

What it looks like

Levitra 5 tablets are orange filmcoated round tablets marked with BAYER-cross on one side and “5” on the other side.

Levitra 20 tablets are orange filmcoated round tablets marked with BAYER-cross on one side and “20” on the other side.

Not all pack sizes are marketed.

Ingredients

Active ingredients:

  • Levitra 5– 5 mg vardenafil per tablet
  • Levitra 20– 20 mg vardenafil per tablet

Inactive ingredients:

  • Colloidal anhydrous silica
  • Crospovidone
  • Hypromellose
  • Iron oxide red (CI 77491-E172)
  • Iron oxide yellow (CI 77492- E172)
  • Macrogol 400
  • Magnesium stearate
  • Microcrystalline cellulose
  • Titanium dioxide (CI 77891- E171)

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

Supplier

Made in Germany for:

Bayer Australia Ltd

ABN 22 000 138 714

875 Pacific Highway

Pymble NSW 2073

Bayer New Zealand Limited

3 Argus Place, Hillcrest,

North Shore

Auckland 0627

Australian Registration Numbers

Levitra 5 – AUST R 90498

Levitra 20 – AUST R 90500

Date of preparation

3 March 2017

See TGA website (www.ebs.tga.gov.au) for latest Australian Consumer Medicine Information.

See MEDSAFE website (www.medsafe.govt.nz) for latest New Zealand Consumer Medicine Information.

® Registered trademark

© Bayer Australia Ltd

All rights reserved

 

SPEDRA®

Avanafil

Consumer Medicine Information

 

What is in this leaflet?

This leaflet answers some common questions about SPEDRA.

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 SPEDRA 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 SPEDRA is used for

SPEDRA is used to treat erectile dysfunction, more commonly known as impotence, in adult men. This is when a man cannot get, or keep, a hard erect penis suitable for sexual activity.

SPEDRA belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

SPEDRA contains the active ingredient avanafil which works by relaxing the blood vessels in your penis. This increases the blood flow into your penis, helping it stay hard and erect when you get sexually aroused. SPEDRA does not cure your condition.

It is important to note that SPEDRA only works if you are sexually aroused. SPEDRA will not increase your sex drive.

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

Before you take SPEDRA

When you must not take it

Do not take SPEDRA if you have an allergy to:

  • any medicine containing avanafil
  • any of the ingredients listed at the end of this leaflet.

Some symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
  • rash, itching or hives on the skin.

Do not take SPEDRA if you are taking nitrate medicines which include:

  • glyceryl trinitrate (also called nitroglycerin)
  • nicorandil
  • sodium nitroprusside
  • isosorbide mononitrate
  • isosorbide dinitrate
  • amyl nitrite (also known as poppers, amyl or rush).

SPEDRA has been shown to increase the effects of these medicines and severely lower your blood pressure.

Do not take SPEDRA if you are taking:

  • riociguat, a medicine used to treat high blood pressure in the lungs
  • nefazodone, a medicine used to treat depression
  • medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir
  • medicines for fungal infections such as ketoconazole, itraconazole or voriconazole
  • clarithromycin and telithromycin, antibiotics used for bacterial infections.

Because sexual activity may place a strain on your heart, your doctor will need to check whether you are fit enough to take SPEDRA.

Do not take SPEDRA if you have:

  • unstable angina (chest pain)
  • congestive heart failure
  • hypotension (low blood pressure)
  • uncontrolled hypertension (high blood pressure)
  • ever had loss of vision in one eye due to not enough blood getting to your eyes (non-arteritic ischaemic optic neuropathyNAION)
  • certain serious eye problems that run in your family (such as retinitis pigmentosa)
  • serious liver or kidney problems.

Do not take SPEDRA if you have a serious cardiac problem or you have or have had any of the following conditions within the previous 6 months:

  • myocardial infarction (heart attack)
  • stroke
  • cardiac ischaemia
  • serious arrhythmia (irregular heart beat).

Do not give SPEDRA to children, adolescents under 18 years of age, or women.

Do not take this medicine after the 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

Tell your doctor if you have any allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • any heart trouble or blood vessel problems
  • a physical condition that affects the shape of your penis (such as angulation, Peyronie’s disease or cavernosal fibrosis)
  • if you suffer from priapism, which is a persistent erection lasting 4 hours or more. This can happen in men with conditions like sickle cell disease, multiple myeloma or leukaemia
  • any bleeding disorder or active peptic ulceration
  • kidney or liver problems
  • sudden loss of eyesight in one or both eyes
  • sudden decrease or loss of hearing
  • spinal cord injury or other neurological disorders.

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

Taking other medicines

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 store.

Some medicines and SPEDRA may interfere with each other. These include:

  • some antiobiotics such as erythromycin and rifampicin
  • medicines called alpha-blockers, used for prostate problems or for lowering your high blood pressure e.g. terazosin tamsulosin and prazosin. Concomitant use of SPEDRA with alpha-blockers may contribute to dizziness or fainting
  • other antihypertensives e.g. enalapril, amlodipine
  • some medicines used to treat seizures such as phenytoin, phenobarbitone and carbamazepine
  • efavirenz, a medicine used to treat HIV
  • high doses of alcohol
  • other medicines that may reduce the breakdown of SPEDRA in the body such as amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir and verapamil
  • bosentan, a medicine used to treat pulmonary arterial hypotension
  • other treatments for erectile dysfunction.

Grapefruit juice should be avoided within 24 hours prior to taking SPEDRA.

These medicines may be affected by SPEDRA, or may affect how well it works. You may need to use different amounts of your medicine, or take different medicines.

Your doctor or pharmacist will have a more complete list of medicines to be careful with or avoid while taking SPEDRA.

Ask your doctor or pharmacist if you are not sure if you are taking any of these medicines.

How to take SPEDRA

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 in this leaflet, ask your doctor or pharmacist for help.

How much to take

Your doctor will decide the correct dose for you depending on your condition and response.

The recommended dose is a 100 mg tablet, as needed.

Do not take more than one dose of SPEDRA in a 24-hour period.

How to take it

Swallow the tablet whole with water.

SPEDRA can be taken with or without food.

If SPEDRA is taken with food, there may be a delay in how fast the medicine works compared to taking it on an empty stomach.

When to take it

You should take SPEDRA as needed, approximately 15 to 30 minutes before anticipated sexual activity. Remember that SPEDRA will only help you to get an erection if you are sexually stimulated.

 

If you take too much (overdose)

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

You may need urgent medical attention.

While you are using SPEDRA

Things you must do

Tell any other doctors, dentists and pharmacists who treat you that you are taking SPEDRA.

If you are about to be started on any new medicine, remind your doctor or pharmacist that you are taking SPEDRA.

If you have emergency treatment for any suspected heart condition, tell the emergency staff that you are taking SPEDRA.

Things you must not do

Do not use the recreational drug amyl nitrate (also known as ‘poppers’, ‘amyl’ or ‘rush’) while you are taking SPEDRA.

If you get an angina attack do not take nitrate medicines to relieve the pain but tell your doctor immediately or contact your nearest emergency department.

Make sure your doctor knows you are taking SPEDRA.

Do not take SPEDRA if you are taking certain medicines used to treat HIV infection.

Do not take more than one dose of SPEDRA per day.

If SPEDRA does not help you get an erection, or if your erection does not last long enough to complete sexual intercourse, tell your doctor.

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

Things to be careful of

Be careful when drinking alcohol while you are taking this medicine.

Substantial consumption of alcohol in combination with SPEDRA can increase the potential for symptoms such as increase in heart rate, decrease in standing blood pressure, dizziness, and headache.

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

Dizziness or faintness may be worse if you are also taking alpha-blockers.

 

 

Side effects

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

SPEDRA helps most men with erectile dysfunction, but it may have unwanted side effects in some people. All medicines have some unwanted side effects. Sometimes they are serious, but most of the time they are not. You may need medical attention if you get some of the side effects.

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

  • headache
  • flushing
  • dizziness or light-headedness
  • nasal or sinus congestion
  • feeling sleepy or very tired
  • back pain
  • indigestion, feeling or being sick in the stomach.

These side effects are usually mild and short lived.

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

  • allergic reactions such as rash, wheezing, swelling of the face, lips or tongue which may cause difficulty in breathing
  • angina (chest pain)
  • irregular heartbeats or palpitations
  • an erection that will not go away or lasts more than 4 hours (“priapism”)
  • blurred vision
  • sudden decrease or loss of vision in one or both eyes
  • sudden decrease or loss of hearing (sometimes you may also feel dizzy or have ringing in your ears).
  • nose bleeds (rare)

These are serious side effects. You may need urgent medical attention or hospitalisation. Other side effects not listed above may also occur in some people. Tell your doctor if you notice anything else that is making you feel unwell.

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

After using SPEDRA

Storage

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

If you take the tablets out of the box or the blister pack they may not keep well.

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

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

Heat and dampness can destroy some medicines.

Keep it where 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 or pharmacist tells you to stop taking this medicine, or the medicine has passed its expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

SPEDRA 50 mg tablets are pale yellow oval tablets marked ’50’ on one side. They are available in blister packs of 1, 2, 4, 8 and 12 tablets. *

SPEDRA 100 mg tablets are pale yellow oval tablets marked ‘100’ on one side. They are available in blister packs of 1, 2, 4, 8 and 12 tablets. *

SPEDRA 200 mg tablets are pale yellow oval tablets marked ‘200’ on one side. They are available in blister packs of 1, 2, 4, 8 and 12 tablets. *

* Not all pack sizes are available.

Ingredients

SPEDRA contains 50 mg, 100 mg, or 200 mg of avanafil as the active ingredient:

It also contains:

  • iron oxide yellow
  • mannitol
  • fumaric acid
  • hyprolose
  • calcium carbonate
  • magnesium stearate

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

 

Supplier

SPEDRA is supplied in Australia by: A. Menarini Australia Pty Ltd Level 8, 67 Albert Ave Chatswood NSW 2067 Medical Information: 1800 644 542 ® = Registered Trademark Australian Registration Number(s)

50 mg tablets: AUST R 228474
100 mg tablets: AUST R 228475

200 mg tablets: AUST R 228476

This leaflet was prepared in December 2018. For the most up to date version of this leaflet, please go to www.menarini.com.au/cmi [vA02-0]


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