PACKAGE LEAFLET: INFORMATION FOR THE USER. Cyproteronacetate 50 PCH 50 mg tablets Cyproteronacetate

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER Cyproteronacetate 50 PCH 50 mg tablets Cyproteronacetate Page: 1 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, please 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 CYPROTERONACETATE PCH is and what is it used for? 2. Before you take CYPROTERONACETATE PCH. 3. How to take CYPROTERONACETATE PCH. 4. Possible side effects 5. How to store CYPROTERONACETATE PCH? 6. Further information 1. WHAT CYPROTERONACETATE PCH IS AND WHAT IS IT USED FOR? Medicinal product group Cy proteronacetate is a hormone preparation. It counteracts male sexual hormones. U se for Th e man: - relief from the symptoms of prostate cancer, when there is seeding (metastases) and when treatment with LHRH-type substances or the surgical removal of the tumour appeared to be ineffective, impossible or undesired. - prevention of the symptoms of a hormone treatment (redness of the skin with LHRH-type substances in men) - the treatment of symptoms (hot flashes) that occur during a treatment with LHRH-type substances or after surgical castration in men. - Excessive sexual urges or abnormal sexual behaviour in the man

2 Page: 2 The woman: - severe symptoms of masculinity in the woman (undesired hair growth, baldness, acne). 2. BEFORE YOU TAKE CYPROTERONACETATE PCH. Do not take Cyproteronacetate PCH - if you are allergic (hypersensitive) to Cyproteronacetate or to one of the other ingredients of the tablet - with severely weakened physical health (not true for prostate cancer) - with liver diseases, for instance Dubin-Johnson syndrome, Rotor syndrome - with liver tumours (not true for metastases of prostate cancer) - if you have ever been diagnosed with a meningioma (a generally benign tumor of the tissue layer between the brain and the skull). You should ask your physician if you are in doubt. - long-term severe depression - disorders with the clotting of blood or if disorders in the clotting of blood (thrombosis) have occurred in the past - severe diabetes affecting the blood vessels - sickle cell anaemia (a certain hereditary disorder of the blood) - women who during a previous pregnancy have had jaundice, continuous itching or sweat blisters - pregnancy and breast-feeding - before the end of the puberty. Take special care with Cyproteronacetate 50 PCH Consult your doctor if one of the below mentioned warnings is applicable to you: Warnings for all users The treatment with Cyproteronacetate may cause liver toxicity, jaundice, and a reduction of the liver function after a few months. The doctor will monitor your blood, urine and liver function regularly. Patients with diabetes are checked by the doctor more frequently. The need for insulin or blood glucose reducing products may change. The use of Cyproteronacetate is not recommended in children and adults under 18 years of age. Warnings for the man The use of alcohol has a negative influence on the effect of Cyproteronacetate 50 PCH in men with excessive sexual urges. The effect of Cyproteronacetate for the treatment of excessive sexual urges sometimes already occurs after a few weeks but at other times only after a few months. Psychotherapy

3 Page: 3 and possibly other measures are not unnecessary due to the use of Cyproteronacetate 50 PCH. If you experience fertility problems the doctor will probably examine your sperm before the start of the treatment. Warnings for the woman Cyproteronacetate 50 PCH must be prescribed by a specialist experienced in hormone therapy. Before the start of the treatment the doctor will probably perform an internal (gynaecological) examination. Women with convulsions (epilepsy), multiple sclerosis, diabetes, a disease based on a disorder in the production of the blood colouring matter haemoglobin (porphyry), hereditary deafness (otosclerosis), muscle cramps (tetany) and elevated blood pressure should follow the doctor's instructions extra carefully, as they have an increased risk of side effects. Before starting the treatment patients must be certain that they are not pregnant. During the treatment you should not become pregnant. Therefore the treatment of women of child- age should be combined with a contraceptive pill (the "pill"). See "How to take bearing Cyproteronacetate". If you have to vomit and/or have diarrhoea the protection against pregnancy is not certain even if you are using the contraceptive pill ("the pill"). You must continue the treatment and as an additional protective measure use condoms during the remainder of the cycle. If you do not start the menstrual bleeding during the interruption in taking "the pill" you should not start the treatment again until it has been confirmed that you are not pregnant. If there is mild blood loss other than during the interruption in taking "the pill" the treatment should not be interrupted. If there is a lot of blood loss or frequent blood loss then you should consult your doctor. If you are using Cyproteronacetate 50 PCH in combination with "the pill" have an increased risk of disorders in the blood clotting (thrombosis). If you have to undergo surgery and when you are bedridden for the long-term your doctor may decide to discontinue the treatment. Taking other medicines Pleas e tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. N ote: The following remarks may also be applicable to the recent use of medicinal products or their use in the near future. The medicines mentioned in this section may be known to you under a different name, often the brand name. In this section only the active ingredient of the medicinal product is mentioned, not the brand name! Therefore always carefully read on the package or in the patient leaflet what the

4 Page: 4 active ingredient is of the medicines you are using. An interaction means that (medicinal) products that are used together can influence each other s effect and/ or side effect. An interaction can occur with the concomitant use of these tablets and: - Insulin or blood glucose reducing products (for instance metformin, tolbutamide, glibenclamide, gliclazide), the need for these products may change. Pregnancy and breast-feeding Pregnancy Do not use Cyproteronacetate 50 PCH if you are pregnant. Breast-feeding Do not use Cyproteronacetate 50 PCH during breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines This medicinal product can cause fatigue and listlessness, which reduces the ability to concentrate. If you experience fatigue or listlessness do not drive and/ or use machines that require your full attention. Important information about some of the ingredients of Cyproteronacetate 50 PCH This product contains lactose. Patients with certain metabolic diseases (so-called lactose insufficient galactosemia and glucose/ galactose malabsorption) should not take Cyproteronacetate 50 PCH. 3. HOW TO TAKE CYPROTERONACETATE 50 PCH. Always take Cyproteronacetate 50 PCH exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is: Men: PROSTATE CANCER: 2 tablets 2 to 3 times per day (=24 hours). Th e treatment must not be interrupted and the dose should not be reduced after improvement occurs. START OF HORMONE TREATMENT WITH LHRH-TYPE SUBSTANCES

5 Page: 5 2 tablets 3 times per day (=24 hours) for the first 5-7 days. After that start with the hormone treatment with LHRH-type substances and continue to use the Cyproteronacetate 50 PCH for 3 to 4 weeks. During the hormone treatment with LHRH-type substances the doctor can reduce the dose of Cyproteronacetate 50 PCH to 2 tablets 2 times per day. TREATMENT OF HOT FLASHES DURING THE HORMONE TREATMENT WITH LHRH-TYPE SUBSTANCES OR AFTER SURGICAL CASTRATION 2 tablets 1-2 times per day. EXCESSIVE SEXUAL URGES OR SEXUALLY ABNORMAL BEHAVIOUR: 1 tablet 2 times per day (=24 hours). If necessary the dose can be increased for a short period of tim e. After some time it sometimes is also possible to reduce the dose to ½ tablet 2 times per day. When initiating the maintenance dose or when discontinuing the treatment your doctor will gradually reduce the dose. Women: DOSE IN WOMEN OF CHILD-BREARING AGE WITH A REGULAR MENSTRUAL CYCLE The treatment is started on the first day of the menstrual bleeding. From the first through the tenth day of the cycle you take 2 tablets after the meal. Also on the first day of the menstrual bleeding you start with "the pill" for 21 days. From day 22 through day 28 of the cycle (for 7 days) there is an interruption in taking "the pill", in which usually a menstrual bleeding occurs. Exactly four weeks after the start of the first treatment (on the same day of the week) you start with the next ten-day treatment of Cyproteronacetate 50 PCH. On this day you also start with "the pill" again. If no menstrual bleeding has occurred, pregnancy must be ruled out before you start with the next treatment. When improvement occurs your doctor can reduce the dose of Cyproteronacetate 50 PCH to 1 or ½ tablet. DOSE IN WOMEN OF CHILD-BREARING AGE WITH AN IRREGULAR MENSTRUAL CYCLE OR WITHOUT A MENSTRUAL CYCLE From the first through the tenth day: 2 tablets after the meal. You also start with "the pill for 21 days on the first day on which you start the treatment with Cyproteronacetate 50 PCH. Because "the pill" does not offer complete protection from pregnancy during the first 14 days, you should take this into account by using additional contraceptive measures, for instance by using a condom. From day 22 through day 28 of the cycle (for 7 days) there is an interruption in taking "the pill", in which usually a menstrual bleeding occurs. Exactly four weeks after the start of the first treatment (on the same day of the week) you start with the next ten-day treatment of Cyproteronacetate 50 PCH. On this day you also start with "the pill" again. If no menstrual bleeding has occurred, pregnancy must be ruled out before you start with the next treatment. When improvement occurs your doctor can reduce the dose of

6 Cyproteronacetate 50 PCH to 1 or ½ tablet. Page: 6 D OSE IN WOMEN WHO DO NO LONGER HAVE MENSTRUAL CYCLES (POST- MENOPAUZE) The recommended dose is ½ to 1 tablet per day (=24 hours) for 21 days, followed by an interruption of 7 days. Cyproteronacetate 50 PCH can be combined with "the pill". The dose is then the same as for women of child-bearing age. DOSE IN WOMEN IN WHOM THE UTERUS HAS BEEN REMOVED The recommended dose is ½ to 1 tablet per day without interruption or ½ to 1 tablet per day for 21 days, followed by an interruption of 7 days. Children: The use of Cyproteronacetate is not recommended in children and adults under 18 years of age. Method of admin istration The tablets can best be taken after the meal with an ample amount of water (=1 glass). If you take more Cyproteronacetate 50 PCH than you should If you have taken more than the prescribed dose you should immediately contact your doctor and/ or pharmacist. If you forget to take Cyproteronacetate 50 PCH If you have missed a dose, take this dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten dose. If you are not sure consult your doctor or pharmacist. For women of child-bearing age, who are using Cyproteronacetate in combination with "the pill" it is important to contact the doctor when you have forgotten to take "the pill" and more than 36 hours has lapsed between the taking of two doses. Your doctor will then further advise you. I you stop taking Cyproteronacetate 50 PCH If you are using this product for prostate cancer you should not abruptly discontinue the treatment or interrupt the treatment. If you are using this medicine for other disorders the dose should not be stopped abruptly but should be gradually discontinued. The symptoms for which you received the treatment may return if you stop using the medicine. If you have any further questions on the use of this product, ask your doctor or pharmacist.

7 Page: 7 4. POSSIBLE SIDE EFFECTS Li ke with all medicines Cyproteronacetate 50 PCH can cause side effects, although not everybody gets them. Very common (in more than 1 of 10 patients) Co mmon (in more than 1 of 100, but in less than 1 of 10 patients) Uncommon (in more than 1 of 1,000, but in less than 1 of 100 patients) Rare (in more than 1 of 10,000, but in less than 1 of 1,000 patients) Very rare (in less than 1 of 10,000 patients), including incidental reports Not known (cannot be estimated from the available data) General information General symptoms like fatigue, depression, headache, and dizziness are very common. Other adverse reactions like stomach complaints, nausea, moments of general apathy or restlessness are also common and particularly appear in the 2nd to the 6th week of treatment. These symptoms usually disappear rapidly. 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. Metabolism and nutrition disorders. Very common: Change in body weight (both an increase and a reduction is possible). In case you experience an increase in bodyweight, it is recommended to reduce your food intake. Nervous system Very common: Headache, depression Common: Restlessness, apathy Ears Very common: dizziness (vertigo) Lungs Very rare: Shortness of breath Gastro-intestinal system Co mmon: stomach discomfort, nausea Liver Very rare: Reduced liver function, yellow skin, white of the eye and nails (jaundice) (see also the section Take special care with Cyproteronacetate 50 PCH ). This occurs rarely in older

8 Page: 8 patients with cancer who have been receiving high doses for a long period of time. Skin Common: skin reaction, changes in hair growth Muscles Rare: muscle weakness Re productive organs and the breasts In men:very common: reduced sexual drive and reduced potency, forming of breasts (in 10 to 20 % of the cases) Common:reduced ejaculation In women: Very common: pain, tension or enlargement of the breasts, irregular or not returning menstrual bleeding Common: reduced sexual drive Other Very common: fatigue Not known: The occurrence of meningiomas has been reported in association with longer term use (years) of Cyproteronacetate 50 PCH at doses of 25 mg/day and above. 5. HOW TO STORE CYPROTERONACETATE 50 PCH Keep out of the reach and sight of children. Store below 25 C Fina l expiration date Do not use Cyproteronacetate 50 PCH after the date mentioned on the package after do not use after or exp.. The first 2 numbers indicate the month the last numbers indicate the year. Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Cyproteronacetate 50 PCH contains Th e active ingredient is Cyproterone acetate: 50 mg per tablet The other ingredients (excipients) are potato starch, lactose monohydrate, crospovidone, sodium dodecyl sulphate, hydroxypropyl cellulose, talc, magnesium stearate, water-free colloidal

9 silicium dioxide. Page: 9 What Cyproteronacetate 50 PCH looks like and contents of the pack Cyproteronacetate 50 PCH tablets are white scored tablets, 9 mm in diameter with the inscription CYPROT 50. The following packagings are available: Tablets in PE and PP tablet containers of 10, 50 or 100 each. Tablets in PVC/Al blister packs of 10, 20, 30, 50 or 100 each. Tablets in EAV packing (PVC/Al) of 50 each. Marketing Authorisation Holder and Manufacturer Manufacturer Pharmachemie B.V. Swensweg 5, P.O. Box RN Haarlem, the Netherlands Marketing Authorisation Holder <to be completed nationally> This medicinal product is authorised in the Member States of the EEA under the following names: Th e Netherlands Germany Cyproteronacetaat 50 PCH, tabletten 50 mg Cyproteronacetat-GRY 50 mg Tabletten This leaflet has last been revised in July of v.NC