Madeline

This leaflet answers some common questions about desogestrel and ethinylestradiol. 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.

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.

The name of your medicine is Madeline. It contains the active ingredients desogestrel and ethinylestradiol.

It is a combined oral contraceptive, commonly known as a "birth control pill" or "the Pill".

It is used to prevent pregnancy. You may also experience the following benefits:

There is also evidence that some medical conditions such as benign breast disease, ovarian cysts, pelvic inflammatory disease (pelvic infections), ectopic pregnancy (pregnancy in which the embryo implants outside of the womb) and cancer of the endometrium (lining of the womb) and ovaries may be less common in women using combined oral contraceptives containing 50 micrograms of ethinylestradiol (high-dose Pills). This may also be the case for low-dose Pills but so far this has only been confirmed for endometrial and ovarian cancer.

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.

When taken correctly, this medicine prevents pregnancy in two ways:

There is no evidence that this medicine is addictive.

In the meantime use non-hormonal contraceptive measures. See also 'General Notes' in the next section.

In this leaflet, several situations are described where you should stop taking the Pill, or where the reliability of the Pill may be decreased. In such situations you should not have sex or you should take extra non-hormonal contraceptive precautions, e.g. use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because the Pill alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle.

This medicine will not protect you from HIV (AIDS) or any other sexually transmitted infections. To help protect yourself from STIs, you need to use a barrier contraceptive such as a condom, but even barrier contraceptives may not protect you against human papilloma virus (HPV).

Some medicines and herbal products may interact with desogestrel and/or ethinylestradiol. These include:

If you are taking any of these you may need a different dose or you may need to take different medicines.

You may also need to use an additional barrier method of contraception (such as a condom or a diaphragm) while you are taking any of these medicines and for some time after stopping them. Your doctor will be able to advise how long you will need to use additional barrier contraceptive methods.

Do not use the Pill if you have Hepatitis C and are taking the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir as this may cause increases in liver function blood test results (increase in ALT liver enzyme). The Pill can be restarted approximately 2 weeks after completion of treatment with the combination drug regimen. (See "When you must not take it").

Other medicines not listed above may also interact with desogestrel and ethinylestradiol.

Your doctor has more information on medicines that you need to be careful with or avoid while taking this medicine.

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

The pack contains 28 tablets: 21 white tablets with active substances and 7 green placebo tablets that contain inactive substances.

Take one tablet daily.

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

Swallow each tablet whole with a glass of water.

On the blister, each tablet is marked with the day of the week on which it is to be taken.

Take one tablet daily in the order directed on the blister, at about the same time every day. This will help you remember when to take it. It does not matter if you take this medicine before or after food.

You must take this medicine every day even if you do not have sex very often.

A period should begin during the 7 days that you use the inactive tablets (the withdrawal bleed). Usually it will start on day 2-3 after the last white active tablet.

Start with a tablet from the blue zone marked with that day of week.

Start on the first day of your period (i.e. the first day of menstrual bleeding). Take a tablet from the blue zone marked with that day of the week. For example, if your period starts on a Wednesday, then take a tablet marked Wednesday. Then follow the days in order.

If your period starts on a Thursday or Friday, make sure you also use an additional barrier method of contraception (e.g. condom) for the first 7 days of white active tablet taking, as the Thursday and Friday tablets in the blue zone are green placebo (inactive) tablets.

Start the day after taking the last active tablet in your previous Pill pack (or at the latest on the day following the last placebo tablet or tablet free interval of your previous Pill pack), taking a tablet from the blue zone marked with that day of the week.

Ask your doctor or pharmacist if you are not sure which the active tablets were in your previous Pill pack. Your previous Pill pack may have had different colour tablets to those of this medicine.

If a vaginal ring or transdermal patch has been used, start on the day of removal (but at the latest when the next application would have been due), taking a tablet from the blue zone marked with that day of the week.

You may change any day, taking a tablet from the blue zone marked with that day of the week, but make sure you also use an additional barrier method of contraception (e.g. condom) for the first 7 days of white active tablet taking.

Change on the day of its removal, taking a tablet from the blue zone marked with that day of the week, and make sure you also use an additional barrier method of contraception (e.g. condom) for the first 7 days of white active tablet taking.

Change when the next injection would be due, taking a tablet from the blue zone marked with that day of the week, and make sure you also use an additional barrier method of contraception (e.g. condom) for the first 7 days of white active tablet taking.

Your doctor will advise you. Please note that there is an increased risk of thrombosis (venous thrombosis embolism, VTE) during the postpartum period and this risk should be considered when restarting this medicine.

Daily tablet taking should be continuous. One tablet is taken daily for 28 consecutive days in the order directed on the blister.

Start a new blister pack on the day after the last green placebo (inactive) tablet of the previous pack.

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

Missed green placebo (inactive) tablets should be discarded to avoid accidentally extending the placebo tablet phase. Take the next tablet at the usual time. You are still protected against pregnancy because the green placebo (inactive) tablets do not contain any active ingredients.

For this medicine to be most effective, white active tablets need to be taken every day without interruption for 7 days.

If you missed a white active tablet and take the missed tablet within 12 hours, you will be protected against pregnancy and should continue taking the tablets as normal.

If you missed a white active tablet (or several white active tablets - in which case also speak to your doctor for advice) and are more than 12 hours late, take the last missed white active tablet immediately, even if it means taking two tablets in one day. Make sure you also use an additional barrier method of contraception (e.g. condom) for the next 7 days and complete the pack as normal.

However, if these next 7 days include the taking of green placebo (inactive) tablets, the white active tablets of the next pack should be started as soon as the white active tablets from the current pack are finished.

If you missed one or more of the first 7 white active tablets and sexual intercourse has taken place, there is a possibility you may be pregnant. See your doctor for advice.

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

Tell your doctor that you are taking this medicine if:

When you are taking the Pill, your doctor will tell you to return for regular check-ups, including getting a pap smear test. Your doctor will advise how often you need a pap smear test. A pap smear test can detect abnormal cells lining the cervix. Sometimes abnormal cells can progress to cancer.

The risk of having deep venous thrombosis is temporarily increased as a result of an operation or immobilisation (for example, when you have your leg or legs in plaster or splints). In women who take the Pill, the risk may be higher.

The excess risk of thrombosis is highest during the first year a woman takes a combined oral contraceptive. Your doctor may tell you to stop taking the Pill several weeks before surgery, or at the time of immobilisation, and when you can start taking the Pill again. If you notice possible signs of a thrombosis (see Possible side effects), stop taking the Pill and consult your doctor immediately.

When taking these tablets for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods. You may need to use sanitary protection, but continue to take your tablets as normal. Irregular vaginal bleeding usually stops once your body has adjusted to the Pill, usually after about 3 months.

This medicine will not protect you from HIV-AIDS or any other Sexually Transmitted Diseases (STDs), such as chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, human papilloma virus and syphilis.

In this leaflet, several situations are described where you should stop taking the Pill, or where the reliability of the Pill may be decreased. In such situations you should not have sex or you should take extra non-hormonal contraceptive precautions, e.g. use a condom or another barrier method.

Do not use rhythm or temperature methods. These methods can be unreliable because the Pill alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle.

Do not:

Tell your doctor as soon as possible if you do not feel well while taking this medicine.

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:

These are very serious side effects and you may need urgent medical attention or hospitalisation.

See 'Thrombosis and the Pill'. Possible signs of a blood clot, heart attack or a stroke can include:

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

When you are using the Pill, your doctor will tell you to return for regular check-ups. You should have a check-up at least once a year.

Thrombosis is the formation of a blood clot that may block a blood vessel.

Thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis (DVT)). If a blood clot breaks away from the veins where it has formed, it may reach and block the arteries of the lungs, causing pulmonary embolism (PE).

Deep venous thrombosis is a rare occurrence. It can develop whether or not you are taking the Pill. The risk is higher in Pill-users than in non-users. The chance of getting a thrombosis is highest after you started using the Pill for the very first time. The risk is also higher if you restart using the Pill (the same product or a different product) after a break of 4 weeks or more. Thrombosis can also occur during pregnancy

The risk of getting a blood clot in the deep veins of the legs for women using Pills with desogestrel (in Madeline) may be slightly higher than for women using Pills with levonorgestrel, norgestimate or norethisterone. The absolute numbers remain very small. If 10,000 women use a Pill with levonorgestrel for one year, 2 women would get a thrombosis. If 10,000 women use a Pill with desogestrel for a year approximately 3 to 4 women would get a thrombosis. For comparison, if 10,000 women get pregnant, approximately 6 would get a thrombosis. These findings are based on the results of some studies. Other studies did not find a higher risk for Pills with desogestrel.

Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). Extremely rarely blood clots can occur in the liver, gut, kidney or eye.

Very occasionally thrombosis may cause serious permanent disabilities or may even be fatal.

If you develop high blood pressure while using the Pill, you may be told to stop using it.

The risk of having deep venous thrombosis is temporarily increased as a result of an operation or immobilisation (for example when you have your leg or legs in plaster or splints). In women who use the Pill, the risk may be yet higher. Tell your doctor you are using the Pill well in advance of any expected hospitalisation or surgery. Your doctor may tell you to stop taking the Pill several weeks before surgery or at the time of immobilisation. Your doctor will also tell you when you can start taking the Pill again after you are back on your feet.

Breast cancer has been diagnosed slightly more often in women who take the Pill than in women of the same age who do not take the Pill. This slight increase in the numbers of breast cancer diagnoses gradually disappears during the course of the 10 years after women stop taking the Pill.

It is not known whether the difference is caused by the Pill. It may be that these women were examined more often, so that the breast cancer was noticed earlier.

In rare cases benign liver tumours and, even more rarely, malignant liver tumours have been reported in users of the Pill. These tumours may lead to internal bleeding.

Chronic infection with Human Papilloma Virus (HPV) is the single most important risk factor for cervical cancer. HPV is a sexually transmitted infection. In women who use combined oral contraceptives for a long time the chance of getting cervical cancer may be slightly higher. This finding may not be caused by the Pill, but may be related to sexual behaviour and other factors.

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

Keep your medicine in its original packaging until it is time to take it.

If you take your medicine out of its original packaging it may not keep well.

Do not store your medicine, 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.

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

If your doctor tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

21 active tablets: round, biconvex, white, film-coated tablet with "MI" debossed on one side and "7" debossed on the other.

7 placebo tablets: round, biconvex, green, film-coated tablet with no markings.

Each white active tablet contains 150 micrograms of desogestrel and 30 micrograms of ethinylestradiol as the active ingredients. It also contains the following inactive ingredients:

Each green placebo tablet contains the following inactive ingredients:

This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.