Combined Oral Contraceptive Pill – Patient Information Leaflet

Key points every woman who takes the pill should know:

• No contraceptive option is 100% effective, though taken correctly the combined oral contraceptive pill is extremely reliable.
• Different pill brands have different pack designs-it’s important that you understand how your particular pill should be taken- carefully read the instructions contained in the pack or talk to your pharmacist if you’re not sure.
• If a woman is older than 35 and is still smoking or has smoked regularly within the past year, the pill should not be prescribed.
• Vomiting or diarrhoea when taking the pill, or a missed pill, can lead to pregnancy.
• The pill does NOT protect against sexually transmitted infections.
• The pill slightly increases a woman’s risk of getting a blood clot– this is a rare but serious side effect- so it’s important to know the risk factors and symptoms (see below)
• Smoking whilst on the pill further increases clotting risk.
• <Migraine WITH aura> (even once in your life) means you should never take the pill as there is a risk of stroke.
• You need a blood pressure check at least once a year when taking the pill
• All sexually active women are advised to have regular pap smears

How effective is the pill?

• Around 0.3% of women who use the pill perfectly will become pregnant each year
• Around 9% of  women will become pregnant if they take the pill correctly most of the time
• More than 80% of sexually active women will become pregnant within a year if they use no contraception

Who shouldn’t take the pill?

The pill should not be taken if any of the following apply to you:

• Increased risk of clotting:
  • obesity with body mass index (BMI) more than 35
  • if your parent, brother, sister or child had a blood clot before the age of 45
  • any history of blood clots in your legs (also known as DVT/deep vein thrombosis), in your lungs (pulmonary embolism) or in your eyes
  • significantly reduced mobility for any reason such as wheelchair use, illness, or recent major surgery
  • any condition (or a family history of any condition), which may put you at an increased risk of blood clots , e.g antiphospholipid syndrome, factor V Leiden, prothrombin mutation, protein S, protein C and antithrombin
    deficiencies.
• Increased risk of heart disease or stroke:
  • a history of <migraine with aura>, even if only one previous episode
  • if you have a parent, brother, sister or child who has had a stroke, heart attack or arterial disease before the age of 45
  • if you have more than one risk factor for heart disease (such as smoking, being overweight, diabetes, high blood pressure or a family history of heart disease)
  • high blood pressure (hypertension)
  • if you have ever had a heart attack, heart disease, stroke, mini-stroke/TIA, atrial fibrillation (A.F) disease of the heart valves or blood vessels
  • diabetes which has affected your blood vessels, kidneys, eyes or nerves
  • undiagnosed headaches or new onset of migraine since starting the pill
• Increased risk of breast cancer:
  • breast cancer- now OR in the past
  • an undiagnosed breast lump
  • a strong family history of breast cancer
  • if you are a carrier of a breast cancer gene such as the BRCA1 or BRCA2 mutations
• Other:
  • allergy to any of the ingredients contained in the pill (check the leaflet in your pack)
  • history of weight loss (bariatric) surgery
  • unexplained/irregular vaginal bleeding
  • breast-feeding, pregnancy, or if you suspect you may be pregnant  
  • cancer of the uterus (womb), cervix or vagina
  • liver disease, e.g. cirrhosis, hepatitis, jaundice, liver tumours
  • current gallbladder disease
  • organ transplant complicated by rejection
  • inflammation of the pancreas (pancreatitis)

Some other conditions MAY mean the pill is not suitable for you-if you have any of the following, you should consult a doctor prior to taking the pill:

• diabetes
• high cholesterol or triglycerides
• obesity with BMI between 30 and 35
• history of organ transplant NOT complicated by rejection
• history of high blood pressure in a previous pregnancy
• if you have a parent, brother, sister or child who had a blood clot after the age of 45
• migraine
• epilepsy
• rheumatic disease such as rheumatoid arthritis or lupus (SLE)
• kidney disease
• sickle cell disease
• history of organ transplant (not complicated by rejection)
• conditions causing malabsorption (i.e. the gut does not absorb food & medicines properly), such as coeliac disease or ulcerative colitis

Clotting risk and the pill

• Women who take the pill have a higher risk of developing a blood clot
• Smokers’ risk of clots is elevated still further
• In the rare event of a clot,  a blood vessel can be blocked, leading to stroke, heart attack , DVT or pulmonary embolism. These conditions may be fatal
• The risk of developing a blood clot when taking the pill is still lower than the risk of developing a clot when pregnant
• Pills containing the following ingredients have a higher clotting risk : desogestrel, drosperinone, gestodene, and norgestimate. If possible, it is safer to take a pill containing lower risk ingredients such as  levonorgestrel, norgestrel or norethisterone
• Long haul flights also increase the risk of clotting and women who take the pill should watch for symptoms of a clot in the days and weeks after a flight
• Symptoms of a clot include the following:
  • A painful/swollen leg
  • Chest pains worse on taking a deep breath, unexplained shortness of breath, coughing up blood
  • Numbness or weakness of an arm or leg, or sudden problems with speech or eyesight

The Pill and Cancer

• Taking the pill increases the risk of some types of cancer but may protect against others
• The overall risk of cancer is lower if you take the pill
• Breast cancer occurs more often in women who take the pill.  All women are advised to check their breasts regularly, and consult a doctor if they notice changes
• There may be a link between the pill and a slightly increased risk of certain cancers including cervical. It is therefore important to have regular pap smears
• The pill may reduce risk of cancer of the ovary, uterus and bowel

What are the possible risks and side effects of taking the pill?

• The pill can cause side-effects, but serious side effects are very uncommon
• For most women the benefits of taking the pill outweigh the risks
• It may cause a rise in blood pressure. You should have your blood pressure checked at least annually
• Weight-gain is not a proven side-effect of the pill
• There is no convincing evidence that the pill causes mood changes
• Common temporary side effects include breast tenderness, nausea, acne, skin pigmentation changes and headaches
• If side-effects don’t settle within 2 to 3 months you should consider trying an alternative contraceptive

Changes in bleeding pattern while taking the pill

• If I don’t have a period as expected what should I do?

• • If you do not bleed as expected while you are taking your sugar pills, but have been taking your pill correctly, it is unlikely that you are pregnant- it is quite common for there to be no bleeding between pill packs. However, if in any doubt, you should do a pregnancy test.
• What does it mean if I have unexpected bleeding while taking the active pills?
  • In the first few months after starting the pill, you may experience some vaginal bleeding whilst taking the active pills- this may vary from spotting to a light flow. Do not stop taking your pill. Whilst this usually settles after 2 or 3 months, we advise you to consult a doctor if it occurs, because it may be a sign of pregnancy, infection or other gynaecological problems
  • If you feel unwell or if you have abdominal  or pelvic pain, you should see a doctor immediately.

Breastfeeding and the pill

• If you are breast-feeding, the pill is not recommended because it can reduce the flow of milk.
• There are other more  suitable contraceptive options available on our website such as the <progesterone only pill / POP/ mini pill>

Can other medications affect my pill?

• If you take any other medication you need to be certain that it doesn’t interact with the pill. If you are in any doubt you should speak to a pharmacist
• There are a number of medications that interact with the pill. You can find a more complete list in the Consumer Medicines Information Leaflet that comes in the pack. Below is a list of the most common ones:
  • Epilepsy medications
  • HIV medications
  • St John’s Wort