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PACKAGE LEAFLET: INFORMATION FOR THE USER Marvelon® Tablets

(desogestrel/eth inylestrad iol)

This product will be referred to as Marvelon throughout the remainder of this leaflet.

Five important things to know about the Pill.

•    The Pill is a reliable contraceptive and may reduce your risk of cancer of the ovary and womb if used in the long term.

•    The Pill will not protect you against sexually transmitted diseases.

•    This medicine can increase your risk of problems such as blood clots and breast cancer.

•    Some women should not take the Pill because of current medical problems or illnesses. Please read this leaflet to make sure Marvelon is right for you.

•    To prevent pregnancy it is important to take Marvelon as instructed and to start each pack on time. Please make sure that you understand what to do if you miss a pill or if you think you are pregnant.

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any questions or need more advice, ask your doctor, family planning nurse or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them.

•    If any of the side effects gets severe, or if you notice any not listed in this leaflet, please tell your doctor, family planning nurse or pharmacist.

In this leaflet:

1.    What Marvelon does

2.    Make sure Marvelon is OK for you

3.    Taking Marvelon

3.3 A missed Pill

4.    Possible side effects

5.    How to store Marvelon

6.    What is in Marvelon and who makes it

1.    What Marvelon does

Ma^elon is a combined oral contraceptive pill (‘the Pill’). You take it to stop you getting pregnant.

This low-dose contraceptive contains two types of female sex hormones, oestrogen and progestogen. These hormones prevent an egg being released from your ovaries so you can’t get pregnant. Marvelon also makes the fluid (mucus) in your cervix thicker which makes it more difficult for sperm to enter the womb.

Marvelon is a 21-day pill - you take one each day for 21 days, followed by 7 days when you take no pills.

The benefits of taking the Pill include:

•    it is one of the most reliable reversible methods of contraception if used correctly

•    it doesn’t interrupt sex

•    it usually makes your periods regular, lighter and less painful

•    it may help with pre-menstrual symptoms.

Marvelon will not protect you against sexually transmitted infections, such as Chlamydia or HIV. Only condoms can help to do this.

Marvelon needs to be taken as directed to prevent pregnancy.

2.    Make sure Marvelon is OK for you

It’s important that you understand the benefits and risks of taking the Pill before you start taking it, or when deciding whether to carry on taking it. Although the Pill is suitable for most healthy women it isn’t suitable for everyone.

^ Tell your doctor if you have any of the illnesses or risk factors mentioned in this leaflet.

Before you start taking the Pill

•    Your doctor will ask about you and your family’s medical problems and check your blood pressure. You may also need other checks, such as a breast examination.

While you’re on the Pill

•    You will need regular check-ups with your doctor or family planning nurse, usually when you need another prescription of the Pill.

•    You should go for regular cervical smear tests.

•    Check your breasts and nipples every month for changes - tell your doctor if you can see or feel anything odd, such as lumps or dimpling of the skin.

•    If you need a blood test tell your doctor that you are taking the Pill, because the Pill can affect the results of some tests.

•    If you’re going to have an operation, make sure your doctor knows about it. You may need to stop taking the Pill about 4-6 weeks before the operation. This is to reduce the risk of a blood clot (see section 2.1). Your doctor will tell you when you can start taking the Pill again.

2.1    The Pill and blood clots

The Pill may slightly increase your risk of having a blood clot (calleda thrombosis) especially in the first year of taking it.

A clot in a leg vein - a deep vein thrombosis (or DVT) - is not always serious. However, if it moves up the veins to the lungs, it can cause chest pain, breathlessness, collapse or even death. This is called a pulmonary embolism and is very rare.

Your chances of having a blood clot are only increased slightly by taking the Pill.

•    Of 100,000 women who are not on the Pill and not pregnant, about 5 will have a blood clot in a year.

• Of 100,000 women taking a Pill such as Marvelon, about 25 will have a blood clot in a year.

• Of 100,000 women who are pregnant, around 60 will have a blood clot in a year.

You are more at risk of having a blood clot in your veins:

•    as you get older

•    if you are seriously overweight

•    if you have a heart valve problem

•    if you or any of your close family have had blood clots

•    if you have any blood clotting problem that needs treatment with a medicine such as warfarin

•    if you have certain rare medical conditions such as systemic lupus erythematosus (SLE) or Crohn’s disease

•    if you’re off your feet for a long time because of major surgery, injury or illness

•    if you have recently had a baby.

^ Tell your doctor if any of these apply to you.

Taking the Pill may add to this risk so Marvelon may not be suitable for you.

Signs of a blood clot include:

•    painful swelling in your leg

•    sudden chest pain

•    difficulty breathing

^ See a doctor as soon as possible. Do not take any more Marvelon until your doctor says you can. Use another method of contraception, such as condoms, in the meantime.

Very rarely, blood clots can also form in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). In healthy young women the chance of having a heart attack or stroke is extremely small.

You are more at risk of having a heart attack or stroke:

•    as you get older

•    if you have high blood pressure

•    if you smoke cigarettes (or other tobacco)

•    if you drink too much alcohol

•    if you have an irregular heartbeat (atrial fibrillation)

•    if you or someone in your close family has had a heart attack or stroke at a young age

•    if you have migraines

•    if you have diabetes.

^ Tell your doctor if any of these apply to you. Taking the Pill may add to this risk so Marvelon may not be suitable for you.

Signs of a heart attack or stroke include:

•    sudden sharp pains in your chest which may reach your left arm or sharp pains in your stomach

•    sudden weakness or numbness in one side or part of your body

•    having a migraine for the first time or any migraine that is worse than normal

•    slurred speech or any other difficulties affecting your speech

•    any sudden changes to your eyesight (such as loss of vision or blurred vision)

•    dizziness, fainting, collapse or seizures.

^ See a doctor as soon as possible. Do not take any more Marvelon until your doctor says you can. Use another method of contraception, such as condoms, in the meantime.

2.2    The Pill and cancer

The Pill reduces your risk of cancer of the ovary and womb if used in the long term. However, it also seems to slightly increase your risk of cancer of the cervix - although this may be due to having sex without a condom rather than the Pill itself. All women should have regular smear tests.

If you have breast cancer, of have had it in the past, you should not take the Pill. The Pill slightly increases your risk of breast cancer. This risk goes up the longer you’re on the Pill, but returns to normal within about 10 years of stopping it. Because breast cancer is rare in women under the age of 40 the extra number of cases of breast cancer in current and recent users of the Pill is small.

For example:

•    Of 10,000 women who have never taken the Pill, about 16 will have breast cancer by the time they are 35 years.

•    Of 10,000 women who take the Pill for 5 years in their early twenties, about 17-18 will have breast cancer by the time they are 35 years.

•    Of 10,000 women who have never taken the Pill, about 100 will have breast cancer by the time they are 45 years old.

•    Of 10,000 women who take the Pill for 5 years in their early thirties, about 110 will have breast cancer by the time they are 45 years old.

Your risk of breast cancer is higher:

•    if you have a close relative (mother, sister or grandmother) who has had breast cancer

•    if you are seriously overweight

^ See a doctor as soon as possible if you notice any changes in your breasts, such as dimpling of the skin, changes in the nipple or any lumps you can see or feel.

Taking the Pill has also been linked to liver diseases, such as jaundice and non-cancer liver tumours, but this is rare. Very rarely, the Pill has also been linked with some forms of liver cancer in women who have taken it for a long time.

See a doctor as soon as possible if you get severe pain in your stomach, or yellow skin or eyes

(jaundice). You may need to stop taking Marvelon.

2.3    Marvelon should not be taken by some women

^ Tell your doctor or family planning nurse if you have any medical problems or illnesses.

Do not take Marvelon if any of the following apply to you. Taking Marvelon would put your health at risk:

•    If you are pregnant or might be pregnant, or if you are breast-feeding

•    If you have cancer affected by sex hormones - such as some cancers of the breast, womb lining or ovary

•    If you have vaginal bleeding that has not been explained by your doctor

•    If you have excessive thickening of the womb lining

•    If you have ever had a severe liver disease

•    If you are allergic (hypersensitive) to any of the ingredients in Marvelon

•    If you or anyone in your close family has ever had a problem with their blood circulation. This includes a blood clot (thrombosis) in the legs (deep vein thrombosis), lungs (pulmonary embolism), heart (heart attack), brain (stroke) or any other parts of the body

•    If you have any condition which makes you more at risk of a blood clot (thrombosis - see section 2.1, The Pill and blood clots)

•    If you have moderate or severe high blood pressure (hypertension)

•    If you have high fat levels in your blood (high cholesterol or triglyceride levels)

•    If you have gall stones

•    If you have had any of the following problems while pregnant or while using steroids:

-    itching of the whole body (pruritus)

-    jaundice which was not caused by infection

-    a blister-like rash, called pemphigoid gestationis

-    a hearing problem called otosclerosis

•    If you have ever had the disease systemic lupus erythematosus

^ If you suffer from any of these, or get them for the first time while taking Marvelon, contact your doctor as soon as possible. Do not take Marvelon.

2.4    Marvelon can make some illnesses worse

Some of the conditions listed below can be made worse by taking the Pill. Or they may mean it is less suitable for you. You may still be able to take Marvelon but you need to take special care and have checkups more often.

•    If you have ever had problems with your heart, circulation or blood clotting, such as sickle cell disease

•    If you have diabetes

•    If you have any gynaecological problems, such as fibroids or endometriosis

•    If you have ever had kidney or liver problems, or have had gall stones in the past

•    If you have ever had severe depression

•    If you have ever had epilepsy or migraines

•    If you have brown patches on your face or body (chloasma).

^ Tell your doctor or family planning nurse if any of these apply to you. Also tell them if you get

any of these for the first time while taking the Pill, or if any get worse or come back, because you may need to stop taking Marvelon.

2.5    Taking other medicines

If you ever need to take another medicine at the same time as being on the Pill, always tell your doctor, pharmacist or dentist that you’re taking Marvelon. Also check the leaflets that come with all your medicines to see if they can be taken with hormonal contraceptives.

Some medicines can stop Marvelon from working properly - for example:

•    some medicines used to treat epilepsy

•    certain antibiotics

•    certain sedatives (called barbiturates)

•    St. John’s Wort (a herbal remedy)

•    Griseofulvin (an antifungal drug)

•    certain laxatives and medical charcoal.

If you do need to take one of these medicines, Marvelon may not be suitable for you, or you may be able to take Marvelon and use extra contraception for a while. Your doctor, pharmacist or dentist can tell you if this is necessary and for how long.

Marvelon can also affect how well other medicines work. For example, if you have diabetes, you may need to take more insulin or other anti-diabetic drugs while you take Marvelon. Your doctor will tell you if this is necessary.

2.6    Taking Marvelon with food and drink

There are no special instructions about food and drink while on Marvelon.

2.7    Pregnancy and breast-feeding

Do not use Marvelon if you are pregnant. If you think you might be pregnant, do a pregnancy test to confirm that you are before you stop taking Marvelon.

^ If you are breast-feeding, you should not take Marvelon. Ask your doctor or family planning nurse about alternative contraception. Breast-feeding will not stop you getting pregnant.

2.8    Driving and using machines

Marvelon has no known effect on the ability to drive or use machines.

2.9    Marvelon contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using Marvelon.

2.10    Use in adolescents

No clinical data on efficacy and safety are available in adolescents below 18 years.

3. Taking Marvelon

3.1    How to take it

To prevent pregnancy, always take Marvelon exactly as described below. Check with your doctor or family planning nurse if you are not sure.

Take Marvelon every day for 21 days

Marvelon comes in strips of 21 pills, each marked with a day of the week.

•    Take your pill at the same time every day.

•    Start by taking a pill marked with the correct day of the week.

•    Follow the direction of the arrows on the strip. T ake one pill each day, until you have finished all 21 pills.

•    Swallow each pill whole, with water if necessary. Do not chew the pill.

Then have seven pill-free days

After you have taken all 21 pills in the strip, you have seven days when you take no pills. So if you take the last pill of one pack on a Friday, you will take the first pill of your next pack on the Saturday of the following week.

Within a few days of taking the last pill from the strip, you should have a withdrawal bleed like a period. This bleed may not have finished when it is time to start your next strip of pills. You don’t need to use extra contraception during these seven pill-free days - as long as you have taken your pills correctly and start the next strip of pills on time.

Then start your next strip

Start taking your next strip of Marvelon after the seven pill-free days - even if you are still bleeding. Always start the new strip on time.

As long as you take Marvelon correctly, you will always start each new strip on the same day of the week.

3.2    Starting Marvelon

As a new user or starting the Pill again after a break

Either take your first Marvelon pill on the first day of your next period. By starting in this way, you will have contraceptive protection with your first pill.

Or if your period has already begun start taking Marvelon on day 5 (counting the first day of your period as day 1) whether or not your bleeding has stopped. You must also use extra contraception, such as condoms, until you have taken the first seven pills correctly.

Changing to Marvelon from another contraceptive Pill

•    If you are currently on a 21-day Pill: start taking Marvelon the next day after the end of the previous strip. You will have contraceptive protection with your first pill but you will not have a bleed until after you finish your first strip of Marvelon.

•    If you are currently on a 28-day Pill: start taking Marvelon the day after your last active pill. You will have contraceptive protection with your first pill. You will not have a bleed until after you finish your first strip of Marvelon.

•    Or if you are taking a progestogen-only Pill (mini-Pill or POP): start Marvelon on the first day of bleeding, even if you have already taken the POP for that day. You will have contraceptive cover straight away. If you don’t usually have any bleeding while you are taking a progestogen-only Pill, you can stop taking it any day and start Marvelon the next day. You will need to use extra contraception, such as a condom, for seven days.

Starting Marvelon after a miscarriage or abortion

If you have had a miscarriage or an abortion, your doctor may tell you to start taking Marvelon straight away. This means that you will have contraceptive protection with your first pill.

Contraception after having a baby

If you have just had a baby, ask your doctor for advice about contraception.

If you are not breast-feeding:

•    you can start taking Marvelon three weeks after the birth or,

•    you can start taking Marvelon more than three weeks after the birth but you need to use extra contraception, such as a condom until you have taken the first seven pills correctly.