Package leaflet: Information for the user Co-cyprindiol 2000 micrograms /35 micrograms film-coated tablets

Cyproterone acetate/ethinylestradiol

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because It contains important information for you.

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

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Co-cyprindiol Tablets are and what they are used for

2.    What you need to know before you take Co-cyprindiol Tablets

3.    How to take Co-cyprindiol Tablets

4.    Possible side effects

5.    How to store Co-cyprindiol Tablets

6.    Contents of the pack and other information

1. What Co-cyprindiol Tablets are and what they are used for

Co-cyprindiol tablet contains the active substances cyproterone acetate and ethinylestradiol. It belongs to group of medicines named anti-androgen and oestrogen.

Co-cyprindiol tablet is used to treat skin conditions such as acne, very oily skin and excessive hair growth in women of reproductive age. Due to its contraceptive properties it should only be prescribed for you if your doctor considers that treatment with a hormonal contraceptive is appropriate.

You should only take Co-cyprindiol tablet if your skin condition has not improved after use of other anti-acne treatments, including topical treatments and antibiotics.

If you are taking Co-cyprindiol tablet for skin treatment, you must not take any other hormonal contraceptive at the same time.

When your skin condition has cleared up and you stop taking Co-cyprindiol tablet, you will need to go back to your original/preferred method of contraception.

Treating skin conditions

Androgens are hormones that stimulate hair growth and the grease glands in your skin. If you produce too much androgen, or if you are sensitive to the effect, the grease glands may produce too much sebum. This can block the grease glands, which can become infected and inflamed causing acne spots. Co-cyprindiol tablet stops the androgens affecting your skin and reduces the amount of androgens produced.

Contraception

Co-cyprindiol tablet is a 21-day Pill - you take one each day for 21 days, followed by 7 days when you take no pills.

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

Co-cyprindiol tablet needs to be taken as directed to prevent pregnancy.

2. What you need to know before you take Co-cyprindiol Tablets

Do not take Co-cyprindiol Tablets if you:

•    are allergic to ethinylestradiol or cyproterone acetate or any other ingredients of this medicine (listed in section 6).

•    are(or think you are) pregnant or breast feeding

•    or any close family member (parent, brother or sister) have or have previously had a thrombosis, a condition in which a blood clot forms in the veins of the legs ( a deep vein thrombosis), in the lungs (a pulmonary embolism), the heart (a heart attack), the brain (a stroke), or other parts of the body

•    or any close family member have any medical condition which makes you more at risk of a thrombosis (see Oral contraceptives and blood clots (thrombosis))

•    suffers from sickle cell anaemia (abnormal red blood cells)

•    have cancer of the breast or of the lining of the womb (mammary or endometrial carcinoma) or a history of these conditions

•    suffer from abnormal vaginal bleeding of unknown cause

•    have certain types of jaundice (Dubin-Johnson or Rotor syndromes)

•    have liver tumors or have ever had these

•    have any other short or long term liver disease

•    have had any of the following conditions whilst pregnant:

-    itching of your whole body (pruritus of pregnancy).

-    a blister-like rash, often on the soles of your feet or palms of your hands.

-    a hearing problem.

-    jaundice which was not caused by infection (jaundice of pregnancy)

If you suffer from any of these for the first time while taking Co-cyprindiol Tablets, the medicine should be stopped and you should get medical advice IMMEDIATELY.

Tell your doctor if any of the following conditions applies to you before starting to use Co-cyprindol tablets. Your doctor may then advise you to use a different treatment:

•    if you are using another hormonal contraceptive

•    if you have (or have ever had) a blood clot in your leg (thrombosis), lung (pulmonary embolism) or other part of your body

•    if you have (or have ever had) a disease that may be an indicator of a heart attack in the future (eg angina pectoris which cases severe pain in the chest) or 'mini-stroke' (transient ischaemic attack)

•    if you have (or have ever had) a heart attack or stroke

•    if you have a condition that may increase the risk of a blood clot in your arteries.

This applies to the following conditions:

•    diabetes affecting your blood vessels

•    very high blood pressure

•    a very high level of fat in your blood (cholesterol or triglycerides)

•    if you have problems with blood clotting (eg. protein C deficiency)

•    if you have (or have ever had) a migraine, with visual disturbances Warnings and precautions

Talk to your doctor or pharmacist before taking Co-cyprindiol Tablets

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

•    If you are currently suffering from depression or have done so in the past

•    If you or your close family have ever had problems with blood clotting

•    If you have diabetes

•    If you or your close family have ever had problems with your heart or circulation, such as high blood pressure

•    If you have the inherited disease called porphyria

•    If you are overweight (obese)

•    If you have had migraines

•    If you have inflammation of the pancreas (pancreatitis), or a history or family history of high levels of fat in your blood (hypertriglyceridemia), as you may be at risk of developing pancreatitis

•    If you have brown patches on your face or body (chloasma) (see below 'Co-cyprindiol Tablets and sun-beds or sun-lamps')

•    If you have any illness that worsened during pregnancy or previous use of the Pill or Co-cyprindiol Tablets (see section 4)

^ Tell your doctor if any apply to you. Also tell them if you get any of these for the first time while taking Co-cyprindiol Tablets, or if any get worse or come back, because you may need to stop taking it.

When should you contact your doctor?

Stop taking Co-cyprindiol Tablets and contact your doctor immediately if you notice possible signs of a blood clot. The symptoms are described in section 2 'Blood clots (Thrombosis)' and in section

Co-cyprindiol also works as an oral contraceptive. You and your doctor will have to consider all the things that would normally apply to the safe use of oral hormonal contraceptives.

Blood clots (thrombosis)

Taking Co-cyprindiol may slightly increase your risk of having a blood clot (called a thrombosis). Your chances of having a blood clot are only increased slightly by taking Co-cyprindiol compared with women who do not take Co-cyprindiol or any contraceptive pill. A full recovery is not always made and in 1-2% of cases, can be fatal.

Blood clots in a vein

A blood clot in a vein (known as a 'venous thrombosis') can block the vein. This can happen in veins of the leg, the lung (a lung embolus), or any other organ.

Using a combined pill increases a woman's risk of developing such clots compared with a woman not taking any combined pill. The risk of developing a blood clot in a vein is highest during the first year a woman uses the pill. The risk is not as high as the risk of developing a blood clot during pregnancy.

Your chances of having a blood clot are only increased slightly by taking Co-cyprindiol Tablets.

•    Of 100,000 women who are not taking Co-cyprindiol Tablets, not on the Pill and not

pregnant, about 5 to 10 will have a blood clot in a year.

•    Of 100,000 women who take Co-cyprindiol Tablets or the Pill, up to 40 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 The risk of blood clots in a vein in users of a combined pill increases further:

•    with increasing age,

•    if you smoke. When using a hormonal contraceptive like Co-cyprindiol you are strongly advised to stop smoking, especially if you are older than 35 years,

•    if one of your close relatives has had a blood clot in the leg, lung or other organ at a young

•    if you are overweight,

•    if you must have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in a plaster cast.

•    if you have polycystic ovary syndrome,

•    if you have recently had a baby,

•    if you have certain rare medical conditions such as systemic lupus erythematosus, Crohn's disease or ulcerative colitis,

•    if you have sickle cell disease.

If this applies to you, it is important to tell your doctor that you are using Co-cyprindiol, as the treatment may have to be stopped. Your doctor may tell you to stop using Co-cyprindiol several weeks before surgery or while you are less mobile. Your doctor will also tell you when you can start using Co-cyprindiol again after you are back on your feet.

Blood clots in an artery

A blood clot in an artery can cause serious problems. For example, a blood clot in an artery in the heart may cause a heart attack, or in the brain may cause a stroke.

The use of a combined pill has been connected with an increased risk of clots in the arteries. This risk increases further:

•    with increasing age,

•    if you smoke. When using a hormonal contraceptive like Co-cyprindiol you are strongly advised to stop smoking, especially if you are older than 35 years,

•    if you are overweight,

•    if you have high blood pressure,

•    if a close relative has had a heart attack or stroke at a young age,

•    if you have a high level of fat in your blood (cholesterol or triglycerides),

•    if you get migraines,

•    if you have a problem with your heart (valve disorder, disturbance of the rhythm).

•    if you have polycystic ovary syndrome,

•    if you have diabetes,

•    if you have certain rare medical conditions such as systemic lupus erythematosus,

•    if you have sickle cell disease.

Symptoms of blood clots:

Stop taking tablets and see your doctor immediately if you notice possible signs of a blood clot,

•    an unusual sudden cough,

•    severe pain in the chest which may reach the left arm,

•    breathlessness,

•    any unusual, severe, or long-lasting headache or worsening of migraine,

•    partial or complete loss of vision, or double vision,

•    slurring or speech disability,

•    sudden changes to your hearing, sense of smell, or taste,

•    dizziness or fainting,

•    weakness or numbness in any part of your body,

•    severe pain in your abdomen,

•    severe pain or swelling in either of your legs.

Following a blood clot, recovery is not always complete. Rarely serious permanent disabilities may occur or the blood clot may even be fatal.

Directly after giving birth, women are at an increased risk of blood clots so you should ask your doctor how soon after delivery you can start taking Co-cyprindiol.

See a doctor straight away if you also develop severe depression, a severe allergic reaction, worsening of hereditary angioedema, signs of breast cancer or cerncal cancer or signs of severe liver problems (symptoms and signs are described in section 4).

Co-cyprindiol Tablets and sun-beds or sun-lamps

Sun-lamps are used by some women for acne as well as to tan the skin. This is not a very useful treatment for acne. Do not use sun-beds or sun-lamps and avoid prolonged sunbathing if you are taking Co-cyprindiol Tablets. Their use increases the chance of chloasma, a patchy discoloration of the skin (as it does with ordinary oral contraceptives).

Co-cyprindiol and cancer

While high dose COCs reduce your risk of cancer of the ovary and womb if used in the long term, it is not clear whether lower dose oestrogen-progestogen containing Pills like Co-cyprindiol tablets also provide the same protective effects. However, it also seems that taking Co-cyprindiol tablets slightly increases your risk of cancer of the cervix - although this may be due to having sex without a condom, rather than Co-cyprindiol tablets. All women should have regular smear tests.

If you have breast cancer, or have had it in the past, you should not take Co-cyprindiol tablets or other oral contraceptives, as they slightly increase your risk of breast cancer. This risk goes up the longer you're on Co-cyprindiol tablets, 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 cases of breast cancer in current and recent Co-cyprindiol tablets users is small. For example:

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

•    Of 10,000 women who have taken the Pill or Co-cyprindiol for 5 years, whilst in their early 20's, about 17-18 will have breast cancer by the time they are 35 years old.

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

•    Of 10,000 women who have taken the Pill or Co-cyprindiol for 5 years, whilst in their early 30's, 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

— Seea doctor as soon as possible ifyou 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 Co-cyprindiol has also been linked to liver diseases, such as jaundice and non-cancer liver tumours, but this is rare. Very rarely, Co-cyprindiol has also been linked with some forms of liver cancer in women who have taken it for a long time.

^Seea doctor as soon as possible ifyou get severe pain in your stomach, oryellowskin or eyes (jaundice). You may need to stop taking Co-cyprindiol.

Other medicines and Co-cyprindiol Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

If you are taking Co-cyprindiol tablets for skin treatment, you must not take any other hormonal contraceptive at the same time.

Some medicines can have an influence on the blood levels of Co-cyprindiol tablets and can stop it from working properly - for example:

•    antibiotics to treat a bacterial infection (such as ampicillin and rifampicin),

•    tetracycline antibiotics taken by mouth,

•    griseofulvin (used to treat fungal infections),

•    medicines used to treat epilepsy such as phenytoin, primidone, phenobarbitone, barbiturates and carbamazepine(which can be used to treat epilepsy or other illnesses).

•    certain sedatives (called barbiturates)

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

•    some medicines used to treat HIV and Hepatitis C Virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors)

If you are diabetic your doctor may tell you to use more insulin or other anti-diabetic medicines.

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

Co-cyprindiol tablets can also affect how well other medicines work. Your doctor may need to adjust the dose of your other medicine.

In addition, Co-cyprindiol tablets can also interfere with the results of some blood tests, so always tell your doctor that you are taking Co-cyprindiol tablets if you have a blood test.

Co-cyprindiol tablets with food and drink

There are no special instructions about food and drink while on Co-cyprindiol tablets.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not use Co-cyprindiol tablets if you are pregnant or are breast-feeding.

Driving and using machines

Co-cyprindiol tablets has no known effect on the ability to drive or use machines.    <§

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Co-cyprindiol Tablet contains lactose

If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicine.

3. How to take Co-cyprindiol Tablets

Always take Co-cyprindiol Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor has chosen Co-cyprindiol Tablets as a treatment for your acne or excessive hair growth on your face and body. However, Co-cyprindiol Tablets also have a contraceptive effect, so it is important to follow the advice below if you are relying on Co-cyprindiol Tablets for contraception.

If you are only using Co-cyprindiol Tablets for your acne or excessive hair growth, you can still follow this advice, but ask your doctor if you are unsure.

Duration of use

Your doctor will tell you how long you need to keep taking Co-cyprindiol Tablets.

How to take it

Take Co-cyprindiol Tablets every day for 21 days

Co-cyprindiol Tablets 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. Take 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 7 days when you take no pills. 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. If you are relying on this medicine to prevent pregnancy, always take this medicine as described here. You don't need to use extra contraception during the seven pill-free days-as long as you have taken your pills correctly, and start the next strip of pills on time.

Check with your doctor if you are not sure.

Start your next strip on day eight

Start taking your next strip of Co-cyprindiol Tablets after 7 pill-free days (on day eight)-even if you are still bleeding.

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. Always start the new strip on time.

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

Starting Co-cyprindiol Tablet

New users or starting Co-cyprindiol Tablet after a break

It is best to take your first Co-cyprindiol pill on the first day of your next period. By starting in this way, you will have contraceptive protection with your first pill.

Changing to Co-cyprindiol Tablet from another contraceptive pill If you are currently taking a 21-day Pill

Start Co-cyprindiol the next day after the end of the previous strip.

You will have contraceptive protection with your first pill. You will not have a bleed until after your first strip of Co-cyprindiol Tablet.

If you are taking a 28-day Pill:

Start taking Co-cyprindiol Tablet the day after your last active pill. You will have contraceptive protection with your first pill. You will not have a bleed until after your first strip of Co-cyprindiol Tablet.

If you are taking a progestogen-only Pill (POP or ‘mini Pill’)

Start Co-cyprindiol Tablet on the first day of bleeding, even if you have already taken the progestogen-only Pill for that day. You will have contraceptive cover straight away.

Starting Co-cyprindiol Tablet after a miscarriage or abortion

If you have had a miscarriage or an abortion during the first three months of pregnancy, your doctor may tell you to start taking Co-cyprindiol Tablet straight away. This means that you will have contraceptive protection with your first pill.

If you have had a miscarriage or an abortion after the third month of pregnancy, ask your doctor for advice. You may need to use extra contraception, such as condoms, for a short time. Contraception after having a baby

If you have just had a baby, your doctor may advise you that Co-cyprindiol Tablets should be started 21 days after delivery provided that you are fully mobile. You do not have to wait for a period. You will need to use another method of contraception, such as a condom, until you start Co-cyprindiol and for the first 7 days of pill taking.

Do not take Co-cyprindiol Tablets if you are breast-feeding A missed pill

1.    If you are less than 12 hours late with a pill, take it straight away. Keep taking your pills at the usual time. This may mean taking two pills in one day. Don't worry - your contraceptive protection should not be reduced.

2.    If you are more than 12 hours late with a pill, or you have missed more than one pill:

your contraceptive protection may be reduced.

•    Take the most recently missed pill as soon as you remember, even if it means taking two at once. Leave any earlier missed pills in the pack.

• Continue to take a pill every day for the next seven days at your usual time.

• If you come to the end of a strip of pills during these seven days, start the next strip without taking the usual seven day break. You probably won't have a bleed until after you finish the second strip of pills, but don't worry. If you finish the second strip of pills and don't have a bleed, do a pregnancy test before starting another strip.

•    Use extra contraception for seven days after missing a pill, such as condoms.

•    If you have missed one or more pills from the first week of your strip (days 1 to 7) and you had sex in that week, you could become pregnant. Contact your doctor or pharmacist for advice as soon as possible. They may recommend you use emergency contraception.

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 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 or pharmacist for advice. You may need to consider emergency contraception. You should also use extra contraception, such as a condom, for seven days.

A lost pill

If you lose a pill, either take the last pill of the strip in place of the lost pill. Then take all the other pills on their proper days. Your cycle will be one day shorter than normal, but contraceptive protection is not affected. After your 7 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 if you have one. 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.

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 are better within 12 hours of taking Co-cyprindiol Tablets, follow the instructions in A lostpill, which describes how to take another pill.

If you are still sick or have diarrhoea more than 12 hours after taking Co-cyprindiol Tablets

see 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.

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 doctors surgery. If you are pregnant, stop taking Co-cyprindiol Tablets and see your doctor.

When you want to get pregnant

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

If you take more Co-cyprindiol Tablets than you should

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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

associated with thoughts of ending their lives. If you develop severe depression, you should stop Co-cyprindiol tablets as a precaution, and see your doctor straight away.

Signs of a blood clot

•    an unusual sudden cough,

•    severe pain in the chest which may reach the left arm,

•    breathlessness,

•    any unusual, severe, or long-lasting headache or worsening of migraine,

•    partial or complete loss of vision, or double vision,

•    slurring or speech disability,

•    sudden changes to your hearing, sense of smell, or taste,

•    dizziness or fainting,

•    weakness or numbness in any part of your body,

•    severe pain in your abdomen,

•    severe pain or swelling in either of your legs.

Signs of a severe allergic reaction or worsening of hereditary angioedema

•    swelling of the hands, face, lips, mouth, tongue or throat. A swollen tongue/throat may lead to difficulty swallowing and breathing

•    a red bumpy rash (hives') and itching.

Signs of breast cancer include

•    dimpling of the skin

•    changes in the nipple

•    any lumps you can see or feel.

Signs of cancer ofthe cervix include:

•    vaginal discharge that smells and/or contains blood

•    unusual vaginal bleeding

•    pelvic pain

•    painful sex.

Signs of severe liver problems include:

•    severe pain in your stomach

•    yellow skin or eyes (jaundice)

•    inflammation of the liver (hepatitis)

•    your whole body starts itching.

Other side effects

Common side effects (may affect up to 1 in 10 people)

•    feeling sick

•    -stomach ache

•    -putting on weight

•    headaches

•    -depressive mood or mood swings

•    sore or painful breasts

Uncommon side effects (may affect up to 1 in 100 people)

•    fluid retention

•    migraine

•    loss of interest in sex

•    breast enlargement

•    skin rash, which may itchy

Rare side effects (may affect up to 1 in 1000 people)

•    venous blood clot

•    poor tolerance of contact lenses

•    losing weight

•    increase of interest in sex

•    vaginal or breast discharge

Not known (frequency cannot be estimated from the available data)

•    bleeding and spotting between your periods can sometimes occur for the first few months but this usually stops once your body has adjusted to Co-cyprindiol tablets. If it continues, becomes heavy or starts again, contact your doctor

•    chloasma (yellow brown patches on the skin). This may happen even if you have been using Co-cyprindiol tablets for a number of months. Chloasma may be reduced by avoiding too much sunlight and/or UV lamps

•    increase in blood pressure

•    occurence or deterioration of the movement disorder chorea

•    Crohn’s disease or ulcerative colitis

•    conditions that may worsen during pregnancy or previous use of the Pill:

-    yellowing of the skin (jaundice)

-    persistent itching (pruritus)

-    kidney or liver problems

-    gall stones

-    certain rare medical conditions such as systemic lupus erythematosus

-    blister-like rash (herpes gestationis) whilst pregnant

-    an inherited form of deafness ( otosclerosis)

-    a personal or family history or a form of sickle cell disease

-    swelling of body parts (hereditary angioedema)

-    an inherited disease called porphyria

-    cancer of the cernx

Tell your doctor or pharmacist if you are worried about any side effects which you think may be due to Co-cyprindiol tablets. Also tell them if any existing conditions get worse while you are taking Co-cyprindiol tablets.

Bleeding between periods should not last long

A few women have a little unexpected bleeding or spotting while they are taking Co-cyprindiol tablets, especially during the first few months. Normally, this bleeding is nothing to worry about and will stop after a day or two. Keep taking Co-cyprindiol tablets 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 Co-cyprindiol tablets for a while

-    carries on even after you've stopped taking Co-cyprindiol tablets.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Co-cyprindiol Tablets

Keep this medicine out of the sight and reach of children.

Do not take this medicine after the expiry date which is stated on the carton and blister strips after "EXP". The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Co-cyprindiol Tablet contains:

The active substances are cyproterone acetate and ethinylestradiol. Each film-coated tablet contains cyproterone acetate 2000 micrograms and ethinylestradiol 35 micrograms.

The other ingredients are lactose monohydrate, maize starch, povidone, purified talc, magnesium stearate, hypromellose, propylene glycol, titanium dioxide (E171), quinoline yellow (E104).

What Co-cyprindiol Tablets look like and the contents of the pack:

Co-cyprindiol Tablets are yellow, round film coated tablets.

Your medicine is available in polyvinylchloride (PVCyaluminium blister strips containing 21 tablets. Each carton contains 1 or 3 blister strip packs.

Not all pack sizes may be marketed Marketing Authorisation Holder:

Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom. Manufacturer:

Cipla (EU) Limited, 4^lh Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom This leaflet was last revised in 10/2016

4. Possible side effects

Like all medicines, Co-cyprindiol Tablets can cause some side effects, although not everybody gets them.

If you experience any of the following symptoms, STOP taking the tablets and tell your doctor IMMEDIATELY.

Severe depression

Although, it is not considered a direct side effect of Co-cyprindiol tablets, some women have reported feeling depressed whilst taking Co-cyprindiol tablets. In very rare cases this has been

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