ACNOCIN 2000/35 TABLETS

Package Leaflet: Information for the user

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Acnocin
Co-cyprindiol 2000/35 Tablets Active substances: Cyproterone acetate/Ethinylestradiol
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 Acnocin is and what it is used for 2. Before you take Acnocin 3. How to take Acnocin 4. Possible side effects 5. How to store Acnocin 6. Further information

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What Acnocin is and what it is used for

Acnocin Tablets are used to treat women with: severe acne which shows no improvement following continuous antibiotic use excessive hair growth on the face and body Cyproterone acetate stops the effects male hormones, which also occur in women, have on the skin. It can block the grease-glands and reduce infections and inflammations which cause acne spots. This medicine additionally reduces hair growth caused by too many male hormones. The contraceptive effect Acnocin is also an effective contraceptive so taking other contraceptive pills is not necessary. This medicine should however not be exclusively used for contraception. Acnocin is a combination of the two female hormones oestrogen and progestogen.

obesity an intolerance to contact lenses immune defence disease effecting skin and internal organs, called lupus erythematosus asthma benign tumour of the womb or lining of the womb a condition known as endometriosis, where cells that line the womb are found in other parts of the body gallstones migraine brown patches on the face and body any disease likely to worsen during pregnancy, such as diabetes. If any of these conditions gets worse or you have them for the first time you should stop taking this medicine. Avoid ultraviolet lamps, sunbeds or prolonged sunbathing when taking Acnocin as these can increase possible patchy skin discolouration. Additional special warning information: Blood Clots Although parts of the following information refer to oral contraceptives they also apply to Acnocin. Studies illustrate women using medicines like this risk developing various blood-circulation diseases compared to non-users. This can lead to blood clots which may block blood vessels, known as thrombosis. Most of the clots can be treated without long-term danger. However, serious permanent disabilities are possible and in very rare cases death. Blood clots in veins, such as those in the leg, can travel into lung arteries causing a blockage. Blood clots can very rarely occur in heart or brain blood vessels causing a heart attack or stroke. In extremely rare cases, blood clots can possibly occur in other places such as the liver, gut, kidney or eyes. Blood clots can form whether you take the pill or not. Risk of a blood clot is higher for pill users than non-users however, lower than the risk during pregnancy. A thrombosis is most likely to occur in the first year of combined pill use. Around 510 thrombosis cases occur each year per 100,000 healthy women who are neither pregnant nor pill users. There are up to 40 thrombosis cases per 100,000 women using pills such as this one each year. Around 60 thrombosis cases per 100,000 pregnancies occur each year in pregnant women.

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Before you take Acnocin

Following conditions increase the risk of thrombosis: age The risk increases as you get older. smoking Heavy smoking and increasing age further increases the risk. Stop Inform your doctor if any of the above applies to you. smoking when using the pill especially if you are more than 35 years old. being very overweight (body mass index > 30 kg/m2) Stop taking Acnocin and contact your doctor immediately if you experience some diseases of the heart valves, heart rhythm and blood vessel any of the following: diseases migraine for the first time, or migraine more often than usual diabetes unusually bad headaches or more frequently occurring headaches migraine sudden changes in your eyesight, hearing, speech, sense of smell, taste or after an operation or having less movement than usual touch members of your immediate family have/had an illness caused by blood dizziness or fainting clots, heart attack, or a stroke symptoms of blood clot formation or inflammation of veins, such as varicose veins - unusual pains or swellings in your legs or arms high blood pressure - sharp pains in your chest disorders of blood fat metabolism and other blood disorders - sudden shortness of breath - crushing pains or feelings of heaviness in your chest Skin problems treated with Acnocin may also be caused by conditions which - coughing for no apparent reason increase the risk of heart and blood vessel diseases. - sudden weakness or numbness on one side of your body skin becomes yellow or the whole body starts itching The oral contraceptive and cancer an increase in the number of epileptic seizures Breast cancer increase in blood pressure - Every woman risks developing breast cancer whether she takes oral severe depression contraceptives or not. severe upper stomach pain or unusual swelling in the stomach However, breast cancer is found slightly more often in women using definite deterioration in present conditions compared to similar previous oral contraceptives than in non-users. After 10 years without oral experiences during pregnancy or when taking the pill contraceptive use the risk of breast cancer is the same as in non-users. had surgery and/or cannot move around - Breast cancer seems less likely to spread in women using oral Stop this medicine six weeks before: contraceptives than in non-users. - a planned major operation such as stomach or leg surgery - or medical treatment for varicose veins It is not certain whether or not oral contraceptives cause the increased risk of Stop treatment also if you cannot move around for some weeks, for breast cancer. Particularly as oral contraceptive users may undergo more example in the following cases: examinations resulting in higher breast cancer detection rates. Increased risks - bed rest following an accident or operation of breast cancer depend on the age when oral contraceptive use is stopped, - a broken leg in plaster cast not the duration of use. Your doctor will advise you when to start taking Acnocin again. movement disorders which may be the first sign of a stroke, such as partial Other forms of cancer paralysis. The use of oral contraceptives can lead to: - in rare cases, liver diseases such as jaundice and non aggressive liver Read the information at the end of section 3 If you stop using Acnocin. tumours - very rarely, forms of aggressive liver tumours in long-term users. Take special care with Acnocin Liver tumours may lead to life-threatening stomach bleeds. See also Do not Before you start taking this medicine your doctor will check: take in the beginning of section 2. your medical history and that of your family members too your blood pressure The oral contraceptives protect against cancers of the ovary and the lining of your breasts, stomach and pelvic organs the womb. An increased risk of cervical cancer in long term users of oral if you are pregnant or not contraceptives has been reported in some studies. It is uncertain whether this the cells in your cervix, from a smear test increased risk is caused by the pill. Inform your doctor before you start treatment if any of the following apply: depression, past or present you are over 30 years old and smoke during the last six weeks you - could not move around - had major surgery such as a leg operation - had a major trauma such as a sock or life threatening situation you have suffered from enlarged ovaries anyone in your family has/had breast cancer you are over 40 years of age. Inform your doctor if you develop any of the following conditions during treatment: varicose veins diabetes or a tendency towards diabetes high blood pressure epileptic fits a form of deafness multiple sclerosis, a disease of the nervous system a disease related to the blood substance, haemoglobin called porphyria calcium deficiency with cramps the movement disorder called Sydenham's chorea breast problems, including cysts diseases of the heart and blood vessels kidney diseases Stomach upsets Vomiting or very bad diarrhoea may stop this medicine from working properly. For precautions see section 3 In case of vomiting or severe diarrhoea. Children This medicine is not recommended for children. Taking other medicines Please 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 reduce the effects of Acnocin are: antibiotics, such as ampicillin, rifampicin, doxycycline, tetracycline, minocycline If you take an antibiotic and Acnocin to treat acne and intend using this medicine also as contraception, inform your doctor. Antibiotic medicines applied to the skin will not reduce the contraceptive reliability. griseofulvin, a medicine to treat fungal infections phenylbutazone, a medicine to reduce pain or inflammation phenytoin, primidone, phenobarbitone and some other medicines to treat people with epilepsy barbiturates, sleeping agents and sedatives carbamazepine, a medicine to treat epilepsy or other illnesses
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Do not take Acnocin Tablets or stop the therapy immediately if you are or have any of the following cases: allergic (hypersensitive) to cyproterone acetate, ethinylestradiol or any of the other ingredients of Acnocin Tablets pregnant or think you might be pregnant breast-feeding or your natural parents, brothers and sisters have or ever had - blood clots - a heart attack - a stroke or - any condition that makes you more at risk of developing blood clots abnormal red blood cells (sickle cell anaemia) disorders of blood fat metabolism such as cholesterol in the blood cancer, suspected cancer or have had cancer of the - breast - lining of the womb abnormal bleeding from your vagina of unkown cause certain type of jaundice (Dublin-Johnson or Rotor syndromes) severe diabetes with circulatory problems have, or ever had liver tumours have any liver disease a certain type of migraine which causes you to see bright spots had any of these conditions during pregnancy - itching all over your body - the rash known as herpes gestationis - worsening of inherited deafness - jaundice

- If one tablet is 12 hours late or less Further contraceptive methods such as condoms are necessary during and Contraceptive protection should not be reduced if you take the late until 7 days after treatment ends, if using any of these medicines named. tablet immediately. Then take your next tablets at the usual time. If your current pack finishes during the 7 days, start the next pack the following day without a break. If two packs are used continuously you may not Losing one tablet have a period until you finish the second pack. Inform your doctor before Take the last tablet of the pack in place of the lost tablet. Then take all the starting the next pack if after the second pack you have not yet had a period. tablets on their proper days. Your cycle will be one day shorter than normal, but contraceptive protection will not be affected. If taking Acnocin together with rifampicin, use another method of After your 7 tablet-free days you will have the starting day one day earlier contraception during and up to 4 weeks after you stop treatment. than before. Should you lose a pack of tablets halfway through, ask your doctor or pharmacist what to do. other contraceptive pills These pills are not recommended if you take Acnocin. In case of vomiting or severe diarrhoea medicines to treat diabetes Being sick or bad diarrhoea within 34 hours after intake may reduce the Your doctor may alter the dose of medicine required to treat your diabetes. medicine effects. If this happens and you are relying on this medicine for medicines containing St John's Wort contraception: Do not take medicines containing St John's Wort while using Acnocin. - keep on taking the tablets and Pregnancy and breast-feeding - use a further contraceptive method such as condoms until seven days You must not take Acnocin if you are pregnant, think you might be or while after you have recovered from the stomach upset. breast feeding. If you finish the pack before the seven days, start the next pack without a break. In this case you may not have a period until the end of the Using this medicine during pregnancy can be particularly harmful to an second pack. If you do not have a period after the second pack you unborn male child as it could prevent sexual organs developing. must inform your doctor before starting the next pack. If your stomach upset carries on for some time, see your doctor who Ask your doctor or pharmacist for advice before taking any medicine. may consider another form of contraception. Driving and using machines Acnocin is unlikely to impair the ability to drive and operate machinery. Important information about some of the ingredients of Acnocin If you have been told by your doctor that you have intolerance to some sugars contact your doctor before taking this medicine (Acnocin contains small amounts of lactose and sucrose). If you want to have a baby Stop taking Acnocin and use another method of contraception until you have a true period. However, it will not be harmful if you become pregnant straight away. If you stop taking Acnocin Take this medicine regularly in order to prevent irregular periods and to prevent pregnancy. If you stop the therapy and do not want to be pregnant, use another method of contraception such as a condom. It may take some time for your regular periods to return. If you have any further questions on the use of this product, ask your doctor or pharmacist.

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How to take Acnocin

Always take Acnocin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is: 1 tablet daily Take the tablets whole with one glass of water at the same time every day, for example, after breakfast. Starting dose Take the first Acnocin tablet when you begin bleeding on the first day of your next period. Women who no longer have periods should start treatment immediately. See also instructions for other users below. For example, if your period starts on a Wednesday, take a tablet marked Wed. Follow the arrow, according to the marked day of the week until all 21 tablets have been taken. Afterwards, do not take tablets for 7 days. Bleeding should start during this interval, usually on day 2 or 3 after you have taken the last tablet. You will not become pregnant during the 7 day break, as long as you have taken the tablets correctly. Start taking tablets from the next foil strip on day 8, even if you are still bleeding. Always start with a new foil strip on the same day as the one before. Changing from another pill type If you follow the instructions given below you will have contraceptive protection at once. - 21 day oral contraceptive Finish the old pack then start taking Acnocin directly the next day. Then follow the instructions described above under the heading Starting dose. You may not have a period until you finish the first pack and you may have some bleeding on tablet taking days. - 28 day oral contraceptive Acnocin should be started directly the day after taking the last active tablet from the old contraceptive. If you are not sure which tablets contain the active substances, ask your doctor or pharmacist. Then follow the instructions as described above under Starting dose. You may not have a period until you finish the first pack and you may have some bleeding on tablet taking days. - Mini Pill (progestogen-only oral contraceptive) Take the first Acnocin tablet on day one of your period, even if you already took a Mini Pill that day. Then follow the instructions as described above under Starting dose and only use Acnocin. Starting this way will give you immediate contraceptive protection. After birth of child Your doctor may advise you to start taking Acnocin 21 days after the birth. You do not have to wait for a period. Use an additional contraception method until you start Acnocin for the first 7 days of tablet taking. Then follow the instructions as described above under "Starting dose". You must not breast-feed if you take Acnocin.

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Possible side effects

Like all medicines, Acnocin can cause side effects, although not everybody gets them. Side effects can occur with the following frequencies: rare, occurs 1 to 10 per 10,000 users unknown, cannot be estimated from the available data Serious side effects Rare cases: liver tumours, which can in rarer cases be malignant See section 2 Other forms of cancers Unknown frequency: severe depression Although, severe depression is not considered a direct side effect of Acnocin, you should stop Acnocin as a precaution, if you develop severe depression. thrombosis See section 2 Stop taking Acnocin and Blood Clots a slightly increased risk of breast cancer. See section 2 Do not take Acnocin and Breast cancer If any of the above applies to you stop taking this medicine immediately and inform your doctor. Remember you will need to use another contraception method if you want to avoid pregnancy. Mild side effects Mild adverse side effects can occur more frequently in the first few months after starting therapy. Rare cases: depressive moods headaches nausea, vomiting and stomach upsets sore or enlarged breasts loss of interest in sex changes in weight Unknown frequency: increase in epileptic fits disturbance of hearing, vision or other senses increase in blood pressure yellow brown patches on the skin (chloasma).

This may happen even if you have been using Acnocin for a few months and may be reduced by avoiding too much sunlight. See section 2 Inform your doctor if you develop any of the following conditions during treatment. bleeding and spotting between your periods for the first few months. This usually stops once your body has adjusted to this medicine. See After a miscarriage or an abortion section 3 Bleeding between periods In this cases your doctor may advise you to start using Acnocin immediately. reduced menstrual flow Then follow the instructions as described above under Starting dose. missed periods or irregular bleeding See section 3 Missed bleeding in the 7 day break Improvement in the skin poor tolerance to contact lenses You may firstly notice that your skin has become much less greasy. This withdrawal effects should be obvious in the first few weeks. After about three months you will see You may experience irregular or missed periods after stopping Acnocin, a definite improvement in acne. In excessive hair growth treatment, you may especially if you had these conditions before starting treatment. The see an improvement after a few months or more. possibility of pregnancy must be excluded before the next pack is started. influence on blood test results Duration of use Always tell your doctor or the laboratory staff that you are using Acnocin. This will be decided by your doctor. He may stop treatment after your skin is completely clear or the amount of body and facial hair growth has decreased. If you notice any side effects, please inform your doctor or pharmacist. You will be able to have further courses of treatment, for as long as is necessary. How to store Acnocin

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Missed bleeding in the 7 day break Keep out of the reach and sight of children. If you have missed tablets or not, you should inform your doctor immediately and do not start another pack without your doctors permission. In the Do not use Acnocin after the expiry date which is stated on the carton or on meantime, you should use other forms of contraception such as condoms or a each blister strip. The expiry date refers to the last day of that month. cap plus spermicide. Storage: Store in the original package. Bleeding between periods Some women may have breakthrough bleeding or spotting while taking this Medicines should not be disposed of via wastewater or household waste. Ask medicine, especially during the first few months. Normally, this will stop in a your pharmacist how to dispose of medicines no longer required. These day or two. Keep taking the tablets as usual and the problem should measures will help to protect the environment. disappear after the first few packs. If the bleeding keeps returning, or is long lasting or breakthrough bleeding occurs after some months of treatment, inform your doctor. Unexpected bleeding may also be a sign of irregular tablet-taking. Therefore, take the tablets at the same time every day. If you take more Acnocin than you should Inform your doctor if this occurs. Overdosage may cause nausea, vomiting and withdrawal bleeding. If you forget to take Acnocin Missing one or more tablets - If over 12 hours have passed since you were due to take the tablet or you have missed more than one tablet: The use of additional protection, as contraceptive protection may be in sufficient. Follow the instructions for the 7-day rule: Take the most recent late tablet and continue to take your next tablets at your normal times. and Use an extra contraceptive method, such as condoms, for the next 7 days. and If your present pack ends before the 7 days, start the next pack directly the following day. Your period will not come until you have finished the next pack, this is not harmful. Do not worry if you see bleeding on tablet-taking days. If no bleeding occurs during the 7-day break see the section entitled Missed bleeding in the 7 day break.

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Further information

What Acnocin contains The active substances are: cyproterone acetate and ethinylestradiol. Each coated tablet contains 2.00 mg cyproterone acetate and 0.035 mg ethinylestradiol. The other ingredients are: Tablet core: lactose monohydrate, maize starch, povidone, talc, magnesium stearate (E572). Tablet coating: sucrose, calcium carbonate, talc, titanium dioxide (E171), povidone, macrogol, glycerol 85%, iron oxide yellow (E172), montan glycol wax. What Acnocin looks like and contents of the pack Acnocin tablets are round, biconvex, yellow sugar-coated tablets. The coated tablets are packed in plastic/aluminium blister each containing coated tablets inserted into a carton. Each carton contains either 1, 3 or 6 blister strips. Not all pack sizes may be marketed. Marketing Authorisation Holder Sandoz Ltd, 37 Woolmer Way, Bordon, Hampshire, GU35 9QE, UK. Manufacturer: Sandoz B.V., P.O. Box 10332, 1301 AH Almere, The Netherlands. This leaflet was approved in 06/2008 (to be amended after approval)
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