PATIENT INFORMATION LEAFLET Co-Cyprindiol 2000/35 Tablets

(cyproterone acetate and ethinylestradiol)

The name of the medicine is Co-cyprindiol 2000/35 Tablets which will be called Co-cyprindiol Tablets throughout this leaflet

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 further questions, ask your doctor or pharmacist.

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

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2.    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.    Further information

1. WHAT CO-CYPRINDIOL TABLETS ARE AND WHAT THEY ARE USED FOR

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.

2. BEFORE YOU TAKE CO-CYPRINDIOL TABLETS

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Do not take Co-cyprindiol Tablets if you :

•    are allergic (hypersensitive) to ethinylestradiol or cyproterone acetate or any other ingredients of Co-cyprindiol Tablets

•    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 (e.g 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 (e.g. protein C deficiency)

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

Take special care with Co-cyprindiol Tablets

Before you start taking Co-cyprindiol Tablets, your doctor will have given you a check up to see if it is suitable for you to take. Your doctor should also ask you to return for regular check-ups whilst you are taking the product.

A number of medical conditions need watching carefully while you are taking Co-cyprindiol Tablets. Tell your doctor if you have any of the following conditions now, or have had them in the past.

□    depression, or have suffered from depression in the past

□    varicose veins or inflamed veins (phlebitis)

□    diabetes

□    high blood pressure (hypertension)

□    fits (epilepsy)

□    an inherited form of deafness known as otosclerosis

□    a disease of the nervous system called multiple sclerosis

□    an inherited metabolic disease called porphyria

□    cramps caused by calcium deficiency (tetany)

□    a movement disorder called Sydenham's chorea

□    breast problems, past or present or if anyone in your immediate family has had breast cancer

□    any heart or circulation problems or if anyone in your family has had illness caused by blood clots, or a heart attack or stroke at a young age

□    kidney diseases

□    problems with the way your liver works

□    you are overweight (obese)

□    an intolerance to contact lenses

□    systemic lupus erythematosus (inflammation of connective tissue)

□    asthma

□    uterine fibroids(benign tumour of the womb)

□    gallstones

□    migraine

□    brown patches on the face and body (chloasma)

□    any disease that is likely to worsen during pregnancy

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)'.

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.

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 age;

•    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 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

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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).

Symptoms of blood clots:

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

•    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.

The worsening of first appearance of any of these conditions may mean that treatment with Co-cyprindiol Tablets should be stopped. You should contact your doctor for further advice.

SUNBEDS/SUN-RAY LAMPS (ULTRA VIOLET)

Ultraviolet lamps are used by some women for acne as well as to tan the skin. These lamps and prolonged sunbathing should be avoided if you are taking Co-cyprindiol Tablets as their use increases the chance of chloasma, a patchy discoloration of the skin.

ORAL CONTRACEPTIVES AND BLOOD CLOTS (THROMBOSIS)

Co-cyprindiol has many properties in common with combined oral contraceptive pills (combinations of two hormones). The use of these medicines or co-cyprindiol increases the risk of developing a thrombosis.

A thrombosis is the blockage of a vein (venous thrombosis) or an artery (arterial thrombosis) by a blood clot. Rarely a blood clot can form in the deep veins of the legs (deep vein thrombosis). If this clot breaks off from where it forms in the vein, it can travel in the blood back to the heart and into the arteries of the lungs where it may cause a blockage leading to chest pain, breathlessness, collapse or even death. This is called pulmonary embolism and is very rare. Also very rarely, blood clots can form in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). In extremely rare cases blood clots can develop in other places such as the liver, gut, kidney or eye.

A blood clot can develop whether or not you are taking the pill, and also if you become pregnant. The risk is greater if you are on the pill than if you are not (especially in the first year of taking the pill), but is still less than the risk of getting a clot during the pregnancy.

In healthy, non- pregnant women who are not on the pill, there are about 5 to 10 cases of thrombosis per 100,000 women each year. In women on the pill with a low oestrogen content (less than 50 pg) there are up to 40 cases per 100,000 women each year. In pregnant women, there are about 60 cases of thrombosis per 100,000 pregnancies per year.

There is evidence that the risk of thrombosis is greater with co-cyprindiol than with other combined pills with low oestrogen content.

Certain conditions can increase the risk of thrombosis. These include:

•    age - the risk of having a heart attack or stroke increases as you get older.

•    smoking(heavy smoking and older age increases the risk further). Stop smoking when on the pill, especially if you are over 35 years old.

•    if any close family member has had any illness caused by blood clots, or a heart attack or stroke.

•    If you are very overweight.

And also if you have:

•    a disorder of blood fat (lipid) metabolism, or other very rare blood disorders

•    high blood pressure

•    a heart valve disorder or a certain heart rhythm disorder

•    given birth recently - the risk of thrombosis is increased for up to 6 weeks after giving birth

•    diabetes mellitus

•    systemic lupus erythematosus (SLE; a disease affecting the skin all over the body)

•    haemolytic uraemic syndrome (HUS; a disorder where blood clots make the kidneys fail)

•    Crohn's Disease or ulcerative colitis (chronic inflammatory bowel disease)

•    sickle cell disease

•    had a subarachnoid haemorrhage ( bleeding from the blood vessels of the brain)

•    an operation or cannot move around as usual. If you know you are going to have an operation, you will need to stop taking co-cyprindiol 4-6 weeks beforehand. If you have an accident and will not be able to move around as usual, you should stop taking co-cyprindiol immediately. Your doctor will advise you when you can start taking the medicine again.

Signs and symptoms of blood clots are given in Section 4, Possible side effects. Co-cyprindiol treatment should be stopped immediately and you should talk to your doctor if you experience any of these symptoms.

The skin problems that co-cyprindiol is used to treat may sometimes be caused by conditions such as polycystic ovarian syndrome, which may also increase the risk of cardiovascular disease.

ORAL CONTRACEPTIVES AND CANCER Ovarian and endometrial cancer:

The Pill does give a substantial degree of protection against cancers of the ovary and the lining of the womb (endometrium). An increased risk of cervical cancer in long- term users of the Pill has been reported in some studies. It is uncertain whether this increased risk is caused by the Pill as it could be due to other factors, such as sexual behaviour.

Breast cancer:

Every woman is at risk of breast cancer whether or not she takes the Pill. Breast cancer is rare under the age of 40 years, but the risk increases as a woman gets older.

Breast cancer has been found slightly more often in women who take the Pill than in women of the same age who do not take the Pill. If women stop taking the Pill this reduces the risk so that 10 years after stopping the Pill, the risk of finding breast cancer is the same as for women who have never taken the Pill. Breast cancer seems less likely to have spread when found in women who take the Pill than in women who do not take the Pill.

It is not certain whether the Pill causes the increased risk of breast cancer. It may be that woman taking the Pill are examined more often , so that breast cancer is noticed earlier. The risk of finding breast cancer is not affected by how long a woman takes the Pill but by the age at which she stops. This is because the risk of breast cancer strongly increases as a woman gets older.

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. 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.

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. 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 35.

You should check your breasts regularly whilst taking this medicine and tell your doctor if you notice any changes , to your breasts such as the appearance of lumps or dimpling of the skin.

Liver cancer:

In rare cases benign liver tumours and even more rarely malignant liver tumours have been reported in users of the Pill.

Taking other medicines with Co-cyprindiol Tablets

Some medicines may affect the way co-cyprindiol works as a contraceptive . Please tell your doctor, any hospital or dentist you visit that you are taking Co-cyprindiol Tablets. Also , you should tell your doctor/dentist or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Medicines which can sometimes stop Co-cyprindiol Tablets from working properly as a contraceptive are:

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

•    tetracycline antibiotics taken by mouth;

•    griseofulvin (used to treat fungal infections);

•    phenylbutazone ( used as an anti-inflammatory drug to treat some types of joint    <

diseases);

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

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PACKAGING DEVELOPMENT

NOTE TO THE PRINTER :

•    Return approved artwork alongwith the proof.

•    The proof must be verified against the approved hardcopy, should be certified and signed by an authorised QA person. The unsigned proof will not be accepted.

•    Colour scheme must be as approved by packaging development co-ordinator.

•    Any deviation must be brought to the notice of packaging development co-ordinator immediately.

•    For any clarification, please contact packaging development co-ordinator immediately.

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3. HOW TO TAKE CO-CYPRINDIOL TABLETS

4. POSSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

Cipla Inventory Code

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