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Package leaflet: Information for the user

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Desogestrel (150 micrograms)

Ethinyl estradiol (30 micrograms)

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Important things to know about combined hormonal

contraceptives (CHCs):

•    They are one of the most reliable reversible methods of contraception if used correctly.

•    They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks.

•    Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

•    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    What you need to know before you use Marvelon

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

2 What you need to know before you use Marvelon

General notes

Before you start using Marvelon you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot - see section 2 “Blood clots”.

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 When you should not use Marvelon

You should not use Marvelon if you have any of the conditions listed below. If you do have any of the conditions listed below, you must tell your doctor. Your doctor will discuss with you what other form of birth control would be more appropriate. See also section 2.2 ‘When to take special care with Marvelon'.

•    if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis. DVT), your lungs (pulmonary embolus. PE) or other organs:

•    if you know you have a disorder affecting your blood

clotting - for instance, protein C deficiency, protein S deficiency, antithrombin-lll deficiency. Factor V Leiden or antiphospholipid antibodies:

•    if you need an operation or if you are off your feet for a long time (see section ‘Blood clots'):

•    if you have ever had a heart attack or stroke:

•    if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack [TIA -temporary stroke symptoms]).

•    if you have any of the following diseases that may increase your risk of a clot in the arteries:

-    severe diabetes with blood vessel damage

-    very high blood pressure

-    a very high level of fat in the blood (cholesterol or triglycerides)

-    a condition known as hyperhomocysteinaemia

•    if you have (or have ever had) a type of migraine called ‘migraine with aura':

•    If you have or have recently had a severe liver disease

•    If you have ever had a liver tumour

•    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 are allergic (hypersensitive) to any of the ingredients in Marvelon. ■♦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.

•    if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease):

•    if you have systemic lupus erythematosus (SLE - a disease affecting your natural defence system):

•    if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing failure of the kidneys):

•    if you have sickle cell anaemia (an inherited disease of the red blood cells):

•    if you have elevated levels of fat in the blood (hypertriglyceridaemia) ora positive family history for this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas):

•    if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots'):

•    if you have just given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start taking Marvelon:

•    if you have an inflammation in the veins under the skin (superficial thrombophlebitis):

•    if you have varicose veins:

2.2.1. The Pill and Thrombosis

BLOOD CLOTS

Using a combined hormonal contraceptive such as Marvelon. increases your risk of developing a blood clot compared with not using one. In rare cases a blood clot can block blood vessels and cause serious problems.

Blood clots can develop

•    in veins (referred to as a ‘venous thrombosis', ‘venous thromboembolism' orVTE)

•    in the arteries (referred to as an ‘arterial thrombosis', ‘arterial thromboembolism' or ATE).

Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or. very rarely, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to Marvelon is small.

If you have missed any of the pills in a strip, and you do not bleed in the first pill-free break, you may be pregnant. Contact your doctor or family planning clinic, or do a pregnancy test yourself.

If you start a new strip of pills late, or make your “week off” longer than seven days, you may not be protected from pregnancy. If you had sex in the last seven days, ask your doctor, family planning nurse or pharmacist for advice. You may need to consider emergency contraception You should also use extra contraception, such as a condom, for seven days.

3.4    A lost pill

If you lose a p II,

Either take the last pill of the strip in place of the lost pill. Then take all the other pi Is on their proper days. Your cycle will be one day shorter than normal, but your contraceptive protection won't be affected. After your seven pill-free days you will have a new starting day, one day earlier than before.

Or if you do not want to change the starting day of your cycle, take a pill from a spare strip. Then take all the other pills from your current strip as usual. You can then keep the opened spare strip in case you lose any more pills.

3.5    If you are sick or have diarrhoea

If you are sick (vomit) or have very bad diarrhoea your body may not get its usual dose of hormones from that pill.

If you vomit within 3 to 4 hours after taking your pill, this is like missing a pill. You must follow the advice for missed pills - see section 3.3, A missed pill.

If you have severe diarrhoea for more than 12 hours after taking Marvelon follow the instructions for if you are more than 12 hours late - see section 3.3. A missed pill.

■♦Talk to your doctor if your stomach upset carries on or gets worse. He or she may recommend another form of contraception.

3.6    Missed a period - could you be pregnant?

Occasionally, you may miss a withdrawal bleed. This could mean that you are pregnant, but that is very unlikely if you have taken your pills correctly. Start your next strip at the normal time. If you think that you might have put yourself at risk of pregnancy (for example, by missing pills or taking other medicines), or if you miss a second bleed, you should do a pregnancy test. You can buy these from the chemist or get a free test at your family planning clinic or doctors surgery. If you are pregnant, stop taking Marvelon and see your doctor.

3.7    Taking more than one pill should not cause harm

It is unlikely that taking more than one pill will do you any harm, but you may feel sick, vomit or have some vaginal bleeding. Talk to your doctor if you have any of these symptoms.

3.8    You can delay a period

If you want to delay having a period, finish the strip of pills you are taking. Start the next strip the next day without a break. Take this strip the usual way. After the second strip, leave seven pill-free days as usual, then start your next strip of pills in the normal way. When you use the second strip, you may have some unexpected bleeding or spotting on the days that you take the pill, but don't worry.

3.9    When you want to get pregnant

If you are planning a baby, it's best to use another method of contraception after stopping Marvelon until you have had a proper period. Your doctor or midwife relies on the date of your last natural period before you get pregnant to tell you when your baby is due. However, it wi I not cause you or the baby any harm if you get pregnant straight away.

4 Possible side effects

Like all medicines, Marvelon can cause side effects, although not everybody gets them. If you get any side effect, particu arly if severe and persistent, or have any change to your health that you think may be due to Marvelon, please talk to your doctor.

An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 “What you need to know before you use Marvelon”.

4.1 Serious side effects - see a doctor straight away

Signs of deep vein thrombosis include;

•    swelling of one leg or along a vein in the leg or foot especially when

•    accompanied by:

•    pain or tenderness n the leg which may be felt only when standing or walking

•    increased warmth in the affected leg

•    change in colour of the skin on the leg e.g. turning pale, red or blue Signs of a pulmonary embolism:

•    sudden unexplained breathlessness or rapid breathing;

•    sudden cough without an obvious cause, which may bring up blood;

•    sharp chest pain which may increase with deep breathing;

•    severe light headedness or dizziness;

•    rapid or irregular heartbeat;

•    severe pain in your stomach;

If you are unsure, talk to a doctor as some of these symptoms such as coughing or being short of breath may be mistaken for a milder condition such as a respiratory tract infection (e.g. a ‘common cold'). Signs of retinal vein thrombosis (blood clot in the eye):

•    Symptoms most commonly occur in one eye:

•    immediate loss of v sion or

•    painless blurring of vision which can progress to loss of vision Signs of heart attack:

•    chest pain, discomfort, pressure, heaviness:

•    sensation of squeezing or fullness in the chest, arm or below the breastbone:

•    fullness, indigestion or choking feeling:

•    upper body discomfort radiating to the back. jaw. throat, arm and stomach:

•    sweating, nausea, vomiting or dizziness:

•    extreme weakness, anxiety, or shortness of breath:

•    rapid or irregular heartbeats Signs of a stroke:

•    sudden weakness or numbness of the face, arm or leg, especially on one side of the body;

•    sudden confusion, trouble speaking or understanding;

•    sudden trouble seeing in one or both eyes;

•    sudden trouble walking, dizziness, loss of balance or coordination;

•    sudden, severe or prolonged headache with no known cau

•    loss of consciousness or fainting with or without seizure. Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.

Signs of blood clots blocking other blood vessels:

•    swelling and slight blue discolouration of an extremity;

•    severe pain in your stomach (acute abdomen)

Signs of a severe allergic reaction to Marvelon

•    swelling of the face, lips, mouth, tongue or throat.

Signs of breast cancer include:

•    dimpling of the skin

•    changes in the nipple

•    any lumps you can see or feel.

Signs of cancer of the cervix include:

•    vaginal discharge that smells and contains blood

•    Unusual vaginal bleeding

•    pelvic pain

•    painful sex.

Signs of severe liver problems include:

•    severe pain in your upper abdomen

•    yellow skin or eyes (jaundice).

■♦If you think you may have any of these, see a doctor straight away. You may need to stop taking Marvelon.

4.2    Possible side effects

Common (more than 1 in 100 people who take Marvelon are affected)

•    Migraine or headache (see a doctor as soon as possible if this is your first migraine or it's worse than usual, or if the headache is severe, unusual or long lasting)

•    Putting on weight or losing weight

•    Breast problems, such as painful or tender breasts: producing a milky fluid from the nipples

•    Depression or mood changes

•    Changes in sexual desire

•    Heart or circulation problems, such as increased blood pressure, swollen hands, ankles or feet- a sign of fluid retention

•    Changes in vaginal secretions

•    Irregular vaginal bleeding -see section 4.3. Bleeding between periods should not last long

•    Skin problems, such as rash: bruise-like swelling to the shins (erythema nodosom)

•    Stomach problems, such as nausea: vomiting

•    Discomfort of the eyes if you wear contact lenses

Rare (less than 1 in 1000 peop e who take Marvelon are affected)

•    Harmful blood clots in a vein or artery for example: o in a leg or foot (i.e. DVT)

o in a lung (i.e. PE) o heart attack o stroke

o mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA) o blood clots in the liver, stomach/intestine. kidneys or eye.

The chance of having a blood clot may be higher if you have any other conditions that increase this risk. (See section 2 for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot.)

•    Severe allergic reaction to Marvelon

•    Breast cancer

•    Cancer of the cervix

•    Severe liver problems

•    High blood pressure

•    Gall stones

•    Chorea (a problem with the nervous system causing jerky movements that you can't control)

•    Worsening of systemic lupus erythematosus (SLE: when your immune system attacks your body causing, for example, joint ache and tiredness)

•    Stomach and intestine problems such as pancreatitis: Crohn's disease: ulcerative colitis

•    Worsening of otosclerosis (a hearing problem)

•    Problems with blood sugar

•    Worsening of a rare condit on called porphyria

•    Worsening of skin problems, such as brown patches on your face or body (chloasma) bl ster-like rash, (herpes gestatlonls)

■♦Tell your doctor, pharmacist or family planning nurse if you

are worried about any side effects which you think may be due to Marvelon. Also tell them if any existing conditions get worse while you are taking Marvelon.

4.3    Bleeding between periods should not last long

A few women have a little unexpected bleeding or spotting while they are taking Marvelon. especially during the first few months. Normally, this bleeding is nothing to worry about and will stop after a day or two. Keep taking Marvelon as usual: the problem should disappear after the first few strips.

You may also have unexpected bleeding if you are not taking your pills regularly, so try to take your pill at the same time every day. Also, unexpected bleeding can sometimes be caused by other medicines. ■♦Make an appointment to see your doctor if you get breakthrough bleeding or spotting that:

•    carries on for more than the first few months

•    starts after you've been taking Marvelon for a while

•    carries on even after you’ve stopped taking Marvelon.

5    How to store Marvelon

Keep all medicines out of the reach and sight of children.

Store Marvelon below 25^:C but not in the fridge.

Store it in the original pack to protect it from light and moisture.

Do not use Marvelon after the expiry date shown on the packet.

The expiry date refers to the last day of that month.

Do not throw away any medicines down a drain or into a bin. Ask your pharmacist what to do with any medicines you do not want.

This will help to protect the environment.

6    What is in Marvelon and who makes it

What is in Marvelon

Each box of Marvelon contains three strips of 21 tablets.

Each strip of Marvelon contains 21 white tablets.

Each tablet is round, measures 6mm across, has TR5 marked on one side and ORGANON ' on the other side.

Each tablet contains: 150 micrograms of the progestogen desogestrel. and 30 micrograms of the oestrogen ethinyl estradiol. Marvelon also contains the inactive ingredients: dl-alpha-tocopherol. potato starch, povidone, stearic acid, aerosol and lactose.

The company that holds the product licence for Marvelon is: Merck Sharp & Dohme Limited.

Hertford Road.

Hoddesdon.

Hertfordshire. EN11 9BU. UK Marvelon is made by:

N.V. Organon. P.O. Box 20.5340 BH Oss. The Netherlands., or Organon (Ireland) Ltd.. Drynam Road. P.O. Box 2857. Swords.

Co. Dublin, Ireland

This leaflet was last updated in April 2014.

In correspondence please quote packing number.

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800198 5000 (UK Only)

Please be ready to give the following information:

Product name: Marvelon Reference Number: PL 00025/0596

This is a service provided by the Royal National Institute of Blind people.

^MSD