Co-Cyprindiol 2000/35 Coated Tablets
180 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
Co - Cyprindiol 2000/35 Coated Tablets
(cyproterone acetate / ethinylestradiol)
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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.
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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.
• 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 gets 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 - Cyprindol is and what it is used for
2. Before you take Co - Cyprindiol
3. How to take Co - Cyprindiol
4. Possible side effects
5. How to store Co - Cyprindiol
6. Further information.
1. WHAT CO - CYPRINDIOL IS AND WHAT IT IS USED FOR
Co - Cyprindiol 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 if your skin condition has not improved after use of other anti-acne treatments, including topical treatments and antibiotics.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CO-CYPRINDIOL
Do not take Co - Cyprindiol if:
• You are pregnant or think you may be pregnant
• You are breast feeding.
• You are allergic (hypersensitive) to cyproterone acetate, ethinylestradiol or any of the other ingredients in this medicine.
Tell your doctor if any of the following conditions applies to you before starting to use Co - Cyprindiol 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 causes 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:
o diabetes affecting your blood vessels
o very high blood pressure
o 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
• if you have ever had a severe liver disease, and you have been told by
your doctor that your liver test results are not yet back to normal
• If you have ever had liver tumours
Or If you have had any of these conditions when you were pregnant:
• Itching of your whole body (pruritus of pregnacy)
• The rash known as herpes gestations
• Worsening of inherited deafness (otosclerosis)
• Yellowing of the skin (jaundice)
• Take special care with Co-Cyprindiol
Warnings and precautions
When should you contact your doctor
Stop taking 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 Ithrombosis)
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 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.
Tell you doctor before taking Co - Cyprindiol if:
• Anyone in your family has had any illness caused by blood clots, a heart attack, or a stroke at a young age.
• You have had inflamed veins (phlebitis)
• Anyone in your family has had breast cancer
• You have been told by your doctor that you have an intolerance to some sugars
Tell your doctor if you develop any of the following conditions while you are taking Co - Cyprindiol
• depression, past or present
• varicose veins
• diabetes (diabetes mellitus) or a tendency towards diabetes
• high blood pressure (hypertension)
• fits (epilepsy)
• the inherited form of deafness known as otosclerosis
• the disease of the nervous system called multiple sclerosis
• the inherited disease called porphyria
• calcium deficiency with cramps (tetany)
• the movement disorder called Sydenham’s chorea
• breast problems, past or present
• disease of the heart and blood vessels (cardiovascular diseases).
• kidney disease
• disturbed liver function
• you are overweight (obese)
• an intolerance to contact lenses
• inflammation of connective tissue (systemic lupus erythematosus - SLE)
• asthma
• benign tumour of the womb (uterine fibroids)
• gallstones
• migraine
• brown patches on the face and body (chloasma)
• any disease that is prone to worsen during pregnancy.
If any of these conditions gets worse of you have them of the first time this may be a sign that you should stop taking this medicine.
Ultraviolet (sunray) lamps or sunbeds and prolonged sunbathing should be avoided if you are taking Co - Cyprindiol as this increases the chance of a patchy discoloration of the skin called chloasma.
When you stop taking this medicine it may take some time for your regular periods to return.
Before treatment with Co - Cyprindiol your doctor should ask you about your medical history and also about other members of your family. Your doctor should ask you these questions on a regular basis, for example, when you come back to see your doctor for more pills. Your doctor will take your blood pressure and may check your breasts, abdomen and pelvic organs. You may need to have a cervical smear test and your doctor will also want to make sure you are not pregnant.
Reasons for stopping Co - Cyprindiol immediately
You should stop taking Co - Cyprindiol and contact your doctor
immediately if you experience any of these following serious side effects.
In the meantime you should use another method of contraception such as a condom.
• migraine for the first time, or if existing migraine occurs more often than usual
• unusually bad headaches or if you have headaches more often than before
• sudden changes to your eyesight, hearing, speech, sense of smell, taste or touch
• dizziness or fainting
• unusual pains in your leg or unusual swelling of your arms or legs, sharp pains in your chest or sudden shortness of breath, crushing pains or feelings of heaviness in your chest, coughing for no apparent reason or if one side of your body suddenly becomes very weak or numb. These may be symptoms of blood clot formation or symptoms of an inflammation of veins combine with the formation of blood clots.
• your skin becomes yellow (jaundice), you develop hepatitis (inflammation of the liver) or if your whole body starts itching
• an increase in the number of fits (epileptic seizures)
• a large increase in your blood pressure
• severe depression
• severe upper abdominal pains or unusual swelling of your abdomen
• definite worsening of conditions when compared to similar conditions experienced during a previous pregnancy or whilst taking the pil in the past.
• pregnancy
• surgery or immobilization. You must stop Co - Cyprindiol six weeks before a planned major operation (e.g. stomach surgery), if you are having any surgery to the legs, or medical treatment for varicose veins. Also if you are immobilized for a long time (e.g. you are in bed after an accident or operation or you have plaster cast on a broken leg). Your doctor will advise you when to start taking Co - Cyprindiol again.
Blood Clots (Thrombosis)
Signs and symptoms of blood clots are given in the section “Should I stop taking Co - Cyprindiol for any reason?'
Apart from its strong action against androgens, Co - Cyprindiol has many properties in common with combined pills (combinations of two hormones), which must not be taken during treatment with Co - Cyprindiol.
Although the following statements refer to combined oral contraceptives, they should, for practical purposes be taken to apply to Co - Cyprindiol as well. It has been suggested, on the basis of statistical evidence, that the risk of developing various disorders of the circulation of the blood is slightly greater in women who take the combined Pill than in those who do not. This can lead to, for example, deep vein thrombosis (blood clot in the leg), strokes (blood clots and haemorrhages from the blood vessels of the brain), heart attacks or pulmonary embolism (blood clots blocking the arteries of the lungs). People do not always fully recover from these disorders, and, very rarely, they are fatal. Studies suggest that these disorders occur less often with modern low-dose oral contraceptives than with older pills.
Certain conditions increase the risk of thrombosis. They include:
• disorders of blood fat (lipid) metabolism, or other very rare blood disorders that may increase the risk of thrombosis
• high blood pressure
• heart valve disorder or a certain rhythm disorder
• giving birth recently (an increased risk of thrombosis up to 6 weeks after giving birth)
• systemic lupus erythematosus
• haemolytic uraemic syndrome
• Crohn’s disease or ulcerative colitis
• sickle cell disease
• subarachnoid haemorrhage in the past
• smoking (the risk increases further with heavy smoking and increasing age). When using oral contraceptives stop smoking, especially if you are over 35 years old.
• age (the risk of having a heart attack or stroke increases as you get older)
• obesity
• some diseases of the heart and blood vessels
• diabetes
• migraine
• a major operation or period of immobilisation (e.g. you are in bed after an accident or operation or you have a plaster cast on a broken leg)
• if any members of your family have suffered from thromboembolic diseases (e.g. deep vein thrombosis, stroke or heart attack) at a young age
• varicose veins.
If any of these conditions apply to you, you must discuss them with your
doctor before you decide to take Co - Cyprindiol while you are taking it.
Oral contraceptives and cancer
The Pill does give a substantial degree of protection again cancers of the ovary and the lining of the womb.
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 women 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.
Other forms of Cancer
An increased risk of cervical cancer in long-term uses 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 the effects of sexual behavior and other factors. On rare occasions, the use of the Pill has led to liver disease such as jaundice and benign liver tumours, and, very rarely, it has been associated with some forms of malignant liver tumours (cancer) in long-term users. Liver tumours may lead to life-threatening intra abdominal hemorrhage (bleeding in the abdomen). Therefore, if you have pain in the upper abdomen that does not clear up soon, tell your doctor. Also, if your skin becomes yellow (jaundice) you must tell your doctor.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines may stop Co - Cyprindiol working properly as a contraceptive. If you are taking any other medicine while you are relying on Co - Cyprindiol for contraception, be sure to tell your doctor (or dentist).
Your doctor (or dentist) can tell you whether you should use extra contraceptive precautions and for how long.
Medicines which can sometimes stop Co - Cyprindiol from working properly are:
• antibiotics (such as ampicillin and rifampicin);
• griseofulvin (which is used to treat fungal infections
• phenylbutazone (which is used as an anti-inflammatory drug to treat some types of joint disease)
• phenytoin, primidone, phenobarbitone and some other medicines used in people with epilepsy
• carbamazaepine (which can be used to treat epilepsy or other illnesses)
• barbiturates (which can be used to treat epilepsy or other illnesses).
Inform your doctor if you are relying on Co - Cyprindiol for contraception and you are taking any of these medicines, you will need to use an extra contraceptive method (e.g. condoms or cap plus spermicide) while you are taking the other medicine and for 7 days (4 weeks in the case of rifampicin) after you stop taking it. If your present pack ends before these 7 days, start the next pack the next day without a break. If you run two packs together you may not have a period until the end of two packs, but this is not harmful. If you do not have a period after the second pack, you must talk to your doctor before you start the next pack.
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Medicines applied to the skin, including antibiotics, will not affect the contraceptive reliability of Co - Cyprindiol.
If you are diabetic your doctor may alter the dose of medicine required to treat your diabetes.
The herbal remedy St John’s Wort (Hypericum perforatum) should not be taken at the same time as Co - Cyprindiol. If you are in any doubt, check with your doctor or pharmacist.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
You should not use Co - Cyprindiol if you become, or think you might be pregnant. If you think you might be pregnant, stop taking Co - Cyprindiol and consult your doctor immediately. Use another method of contraception such as a condom until you see your doctor.
Androgens (male sex hormones) are necessary for the development of the sexual organs in males, and the strong action of Co - Cyprindiol against androgens has been found to prevent the normal development of these organs during pregnancy in experimental studies. The level of risk in humans of such an effect (known as “feminisation”) is uncertain and for this reason it is absolutely essential that you should not be pregnant while taking Co -Cyprindiol.
You must not breast feed while taking Co - Cyprindiol Driving and using machines
There are no known effects of Co-cyprindiol on the ability to drive or use machines.
HOW TO TAKE CO - CYPRINDIOL
Always take Co - Cyprindiol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
If you are relying on this medicine for contraception, it is important that you follow these instructions carefully.
When to start your first pack of Co - Cyprindiol
• If you are new to Co - Cyprindiol or are starting it again after a break, take your fist tablet on the first day of bleeding of your next period. For other users, follow instructions for “Changing from another type of oral contraceptive”, “Starting Co - Cyprindiol after having a baby” or “Starting Co - Cyprindiol after a miscarriage or an abortion”.
• Start with a pill marked with the correct day of the week. For instance, if your period starts on a Wednesday, start with a pill marked “Wed”.
Taking your first pack of Co - Cyprindiol
• After taking your first pill, take one pill each day, following the directions of the arrows, until you have finished all 21 pills in the pack.
• You should try to take the pill at the same time every day, for example, after breakfast. Swallow each pill whole, with water if necessary.
• By starting in this way you will have contraceptive protection at once.
Your seven pill-free days.
After you have taken all 21 tablets, you have 7 days when you take no tablets.
A few days after you have taken the last pill from each pack, you will have a period. Your periods will be regular, probably lighter than before and almost always painless. The feelings that often make the last days before a period unpleasant (called pre-menstrual syndrome) usually disappear. You are very unlikely to become pregnant during the 7 day break from taking the pill, as long as you have taken your pills correctly, and start the next pack on time.
Taking your next pack of Co - Cyprindiol
Start taking your next pack of Co - Cyprindiol after 7 pill-free days even if you are still bleeding. Each new pack will begin on the same day of the week as the one before.
Changing from another type of oral contraceptive
If you follow the instructions given below you will have contraceptive protection at once.
21 dav pill
If you are taking a 21 day contraceptive pill, finish that pack and then start taking Co - Cyprindiol the next day. Do not leave a gap between packs. Start with a pill marked with the correct day of the week. Then follow the instructions as described before (see “Taking your first pack of Co - Cyprindiol”). You may not have a period until the end of the first Co - Cyprindiol pack or you may have some bleeding on pill-taking days, but do not worry.
Every Dav( ED) combined pill (28 dav pill)
Co-Cyprindiol should be started the day after taking the last active tablet from the Every Day pill pack. If you are not sure which tablets are the active ones, ask your doctor or pharmacist.
Start with a pill marked with the correct day of the week. Return any remaining inactive tablets from your old Every Day pack to your pharmacist. Then follow the instructions as before(see" Taking your first pack of Co-Cyprindiol").You may not have a period until the end of the first Co-Cyprindiol pack or you may have some bleeding on pill-taking days, but do not worry.
Mini pill (progestogen-only pill)
The first Co - Cyprindiol should be taken on the first day of the period, even if you have already taken a mini pill on that day. Return any mini pills left in your old pack to your pharmacist. Start with a pill marked with the correct day of the week and following the instructions as before (see “Taking your first pack of Co - Cyprindiol”).
Starting Co - Cyprindiol after having a baby
If you have just had a baby, your doctor may advise you to start taking Co -Cyprindiol 21 days after delivery. You do not have to wait for a period. You will need to use another method of contraception until you start Co - Cyprindiol and for the first 7 days of pill taking. Follow the instructions as before (see “Taking your first pack of Co - Cyprindiol”). You must not breastfeed if you take Co -Cyprindiol.
Starting Co - Cyprindiol after a miscarriage or an abortion
If you have just had a miscarriage or an abortion your doctor may advise you to start using Co - Cyprindiol immediately. Follow the instructions as before (see “Taking your first pack of Co - Cyprindiol”).
When can I expect to see improvement in my skin?
Unlike treatments that are rubbed on the skin, this treatment does not so much attack existing spots as reduce the formation of new spots. It does this by working at the point at which the androgens stimulate the grease-glands to produce too much grease. The first thing that you will notice is that your skin has become much less greasy. This should be obvious in the first few weeks. After about three months you should see a definite improvement in acne. If you are taking this medicine to treat excessive hair growth on your body or face, you may have to wait a few months, possibly longer, to see a definite improvement.
How long can I take Co - Cyprindiol?
Your doctor may stop treating you with this medicine when your skin is completely clear, or the amount of body and facial hair growth has decreased. You will be able to have further courses of treatment if the problem returns.
Duration of use
Your doctor will tell you how long you need to keep taking Co-cyprindiol.
What do I do if I miss a period?
If you have no bleeding in the 7 day break, whether you have missed tablets or not, tell your doctor as soon as possible and do not start another pack until your doctor tells you to. In the meantime, you should use other forms of contraception such as condoms or a cap plus spermicide.
What if I have bleeding between periods?
A small number of women may have a breakthrough bleeding or spotting while taking this medicine, especially during the first few months. Normally, this will stop in a day or two. Keep taking the pills as usual, and the problem should disappear after the first few packs. If the bleeding keeps returning or is long lasting, talk to your doctor. Also, if you start to have breakthrough bleeding after being on this medicine for a long time, you should see your doctor.
Unexpected bleeding may also be a sign of irregular pill-taking, so try to take your pill at the same time every day.
What should I do if I lose a pill?
If you lose a pill, the easiest thing to do is to take the last pill of the pack in place of the lost pill. Then take all the pills on their proper days. Your cycle will be one day shorter than normal, but contraceptive protection will not be affected. After your 7 pill-free days you will have a new starting-day, one day earlier than before. Should you lose a pack of pills halfway through, ask your doctor or pharmacist what to do.
What should I do if I have stomach upsets?
Being sick or having bad diarrhea may stop this medicine from working properly. If this happens and you are relying on this medicine for contraception, keep on taking the tablets but also use an alternative method of contraception (e.g. condoms or cap plus spermicide) until seven days after you are recovered from the stomach upset. If you finish the pack before the seven days, start the next pack without a break. If you do continue onto the next pack you may not have a period until the end of the second pack. This is not harmful. If you do not have a period after the second pack you must talk with you doctor before starting the next pack.
If your stomach upset carries on for some time, see you doctor who may consider another form of contraception.
What if I want to have a baby?
The bleeding you have after each pack (including the last pack) is not a true period. Your doctor relies on the day of your last true period before you get pregnant to tell you when your baby will be born. So, if you stop taking Co -Cyprindiol to have a baby, use another method of contraception until you have had a true period.
However, it will not be harmful if you become pregnant straight away.
If you take more Co - Cyprindiol than you should
Overdosage may cause nausea, vomiting and in women, withdrawal bleeding. You should consult your doctor who will be able to advise you what action is necessary.
If you forget to take Co - Cyprindiol
Do not take a double dose to make up for a forgotten tablet.
If you forget to take a pill and you are relying on Co - Cyprindiol for contraceptive cover:
1. If one pill is 12 hours late or less
Don’t worry. Contraceptive protection should not be affected if you take the late pill at once, and keep taking your next pills at the usual time.
2. If you are more than 12 hours late in taking a pill, or have missed more than one pill
Contraceptive protection may be lower, so you must use extra protection. Follow the instructions for the 7-day rule.
7-dav rule
Take the most recent ‘late’ pill and continue to take your next pills at your normal times and Use an extra contraceptive method (condoms or cap plus spermicide) for the next 7 days and If your present pack ends before the 7 days do, start the next pack the next day, without a break. This means taking a pill every day during your normal 7 pill-freedays. You will not have a period until you have finished the next pack, but this is not harmful. You may see some bleeding on pill-taking days, but do not worry. If no bleeding occurs in the 7-day break see the section entitled “What do I do if I miss a period”.
If you stop taking Co - Cyprindiol
If you need to stop taking Co - Cyprindiol, you should use another method of contraception such as a condom.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Co-cyprindiol can cause side effects, although not everybody gets them.
^ Tell your doctor or pharmacist if you are worried about any side effects which you think may be due to Co-cyprindiol.
4.1 Serious side effects - see a doctor straight away Severe depression:
Although, it is not considered a direct side effect of Co-cyprindiol, you should stop Co-cyprindiol as a precaution, if you develop severe depression, 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 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 of the 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.
^ If you think you may have any of these, see a doctor straight away. You may need to stop taking Co-cyprindiol.
4.2 Less serious side effects
Common side effects (between 100 and 1000 in every 10,000 users may be affected)
• feeling sick
• stomach ache
• putting on weight
• headaches
• depressive moods or mood swings
• sore or painful breasts
Uncommon side effects (between 10 and 100 in every 10,000 users may be affected)
• being sick and stomach upsets
• fluid retention
• migraine
• loss of interest in sex
• breast enlargement
• skin rash, which may be itchy
Rare side effects (between 1 and 10 in every 10,000 users may be affected)
• poor tolerance of contact lenses
• losing weight
• increase of interest in sex
• vaginal or breast discharge
• venous blood clot
Other side effects reported
• 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. 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 for a number of months. Chloasma may be reduced by avoiding too much sunlight and/or UV lamps
• 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 cervix
^ Tell your doctor or pharmacist if you are worried about any side effects which you think may be due to Co-cyprindiol. Also tell them if any existing conditions get worse while you are taking Co-cyprindiol.
HOW TO STORE CO - CYPRINDIOL
Keep out of the reach and sigh of children.
Store in the original package. Do not use Co - Cyprindiol after the expiry date which is stated on the carton and blister strip.
Medicines should not be disposed of via wasterwater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
FURTHER INFORMATION
What Co - Cyprindiol contains
The active substances are cyproterone acetate and ethinylestradiol The other ingredients are:
Tablet core: Lactose monohydrate, Maize starch, Povidone K25, Talcum, Magnesium stearate
Tablet coating: Sucrose, Calcium carbonate, Talcum, Titanium dioxie (E 171), Povidone K90, Macrogol 6000, Glycerol 85%, Iron oxide pigment, Montan glycol wax.
What Co - Cyprindiol Iooks like and contents of the pack.
Co - Cyprindiol tablets are round, yellow sugar-coated tablets. Each pack of Co - Cyprindiol contacts three blister strips each with 21 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Strandhaven Limited T/A Somex Pharma, High Road, Seven Kings, Ilford, Essex, IG 8BS, UK
Manufacturer
Haupt Pharma Muenster GmbH,
Schleebrueggenkamp 15,
48159 Muenster