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1. NAME of the MEDICINAL PRODUCT Ethinylestradiol 0,035 Mg/ Cyproteronacetate 2 Mg, Coated Tablets

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1. NAME of the MEDICINAL PRODUCT Ethinylestradiol 0,035 Mg/ Cyproteronacetate 2 Mg, Coated Tablets Summary of Product Characteristics MRP NL/H/623/01 1. NAME OF THE MEDICINAL PRODUCT Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg, coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains 0.035 mg of ethinylestradiol and 2 mg of cyproterone acetate. Excipients: 31.115 mg lactose monohydrate and 19.637 mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablet. White, round, biconvexe coated tablet. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Ethinylestradiol 0.035 mg/ Cyproteronacetate 2 mg is indicated for the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age. For the treatment of acne, Ethinylestradiol 0.035 mg/ Cyproteronacetate 2 mg should only be used after topical therapy or systemic antibiotic treatments have failed. Since Ethinylestradiol 0.035 mg/ Cyproteronacetate 2 mg is also a hormonal contraceptive, it should not be used in combination with other hormonal contraceptives (see section 4.3). 4.2 Posology and method of administration Method of administration Oral use Posology Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg inhibits ovulation and thereby prevents conception. Patients who are using Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg should not therefore use an additional hormonal contraceptive, as this will expose the patient to an excessive dose of hormones and is not necessary for effective contraception. How to use Ethinylestradiol 0,035 mg / Cyproteronacetate 2 mg Tablets should be taken daily at approximately the same time, with some fluid, in the sequence on the blister. During 21 days, one tablet should be taken daily, followed by 7 tablet-free days. Withdrawal bleeding usually occurs by day 2 or 3 after the last tablet and does not necessarily have to be finished when the next blister of tablets is started. How to start with Ethinylestradiol 0,035 mg / Cyproteronacetate 2 mg No hormonal contraceptive in previous month 07784 Ethinylestradiol 0,035 mg / Cyproteronacetaat 2 mg 1/18 Summary of Product Characteristics MRP NL/H/623/01 First tablet should be taken on the first day of the menstrual cycle (the first day of menstruation counting as Day 1). Starting on day 2 up to day 5 is also possible, but then the use of additional (barrier) contraceptive precautions are required during the first 7 days of the first cycle. Changing from another combined oral contraceptive (COC), vaginal ring or contraceptive patch Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg should be started preferably on the day after taking the last active tablet from the previous COC, but at the latest on the day after the usual tablet-free period (or latest placebo tablet) of the previous COC. If a vaginal ring or a contraceptive patch is used, the woman should start using Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg -35 preferably on the day of removal but no later than on the day on which a new ring was to be inserted or a new patch put on. Changing from a progestagen method (oral contraceptive with only a progestagen, an injection drug, implant) or a progestagen-releasing intrauterine system (IUS) The woman can change from minipill whenever preferred; from an implant or intrauterine system releasing progesterone (IUS) on the day of removal; and from an injection on the day on which the next injection was planned. During the first 7 days additional contraceptive (barrier) precautions are required. Post-abortum use (1st trimester): The use may be started immediately in which case no additional contraceptive precautions are required. Post-partum and post-abortum use (2nd trimester) For breastfeeding women: see section 4.6. In non-lactating women, it is recommended to start between day 21 and day 28 post-partum. When starting after day 28, it is recommended to use additional contraceptive (barrier) precautions for the first 7 days of pill taking. If in this situation the patient has had intercourse, then pregnancy should be excluded or the first bleeding should be awaited, before the start of the COC, since the first post-partum ovulation may precede the first bleeding. What if tablets are forgotten? If a tablet is taken not more than 12 hours late, contraceptive protection is maintained. A delayed tablet should be taken as soon as possible and the use of the remaining tablets should be continued on the usual time. If a tablet is taken more than 12 hours late, contraception efficacy can be diminished. Measures to be taken follow the basic rules: 1. Tablet intake should never be interrupted for more than 7 subsequent days. 2. Tablets should be taken 7 days without interruption to suppress hypophyse-ovarium axis. This results in the following practical advice: First week: 07784 Ethinylestradiol 0,035 mg / Cyproteronacetaat 2 mg 2/18 Summary of Product Characteristics MRP NL/H/623/01 The woman should take the last missed tablet as soon as she remembers, even if this means taking 2 tablets at the same time. She then continues to take the next tablets at her usual time. In addition, a barrier method should be used for the next 7 days. If the woman has had sexual intercourse in the week before missing the tablet, the possibility of a pregnancy must be considered. The more tablets have been missed and the closer they are to the regular tablet-free break, the higher the risk of pregnancy. Second week: The woman should take the last missed tablet as soon as she remembers, even if this means taking 2 tablets at the same time. She then continues to take the next tablets at her usual time. Provided that the woman has taken her tablets correctly in the 7 days preceding the first missed tablet, there is no need to use extra contraceptive precautions. If she has missed more than one tablet, she should be advised to use barrier contraceptive precautions for the next 7 days. Third week: The risk of reduced contraceptive reliability is imminent because of the forthcoming tablet-free break of 7 days. However, reduced contraceptive protection can still be prevented by adjusting the dose. By adhering one of the following advices, there is no need to use extra contraceptive precautions, provided that all the tablets have been taken correctly in the 7 days preceding the first missed tablet. If this is not the case, the woman should follow the first of the two options and use extra barrier contraceptive precautions for the next 7 days as well. 1. The woman should take the last missed tablet as soon as she remembers, even if this means taking 2 tablets at the same time. She then continues to take the next tablets at her usual time. The next pack is started as soon as the current pack is finished, i.e. ther is no tablet-free break. There will probably be no withdrawal bleeding until the end of the second pack, but the woman may experience spotting or breakthrough bleeding on tablet- taking days. 2. It is also possible to stop taking tablets from the current pack. The woman must then have a tablet-free break of 7 days, including the days she missed tablets, and then continue with the next pack. If the woman misses several tablets and has no withdrawal bleed during the first normal tablet-free break, the possibility of pregnancy must be considered. 07784 Ethinylestradiol 0,035 mg / Cyproteronacetaat 2 mg 3/18 Summary of Product Characteristics MRP NL/H/623/01 What to do after vomiting or diarrhoea (gastrointestinal disturbances) In the case of vomiting or diarrhoea, the absorption may be disturbed, and additional contraceptive means should be used. If vomiting occurs within 3-4 hours after taking a tablet, a new (replacement) tablet should be taken as soon as possible. The new tablet must be taken within 12 hours after the usual time of taking the tablets if this is possible. However, if more than 12 hours have passed, the recommendation for forgotten tablets given under the heading 4.2 “What to do after forgetting tablets?” is to be followed. If the woman does not wish to change her normal plan for taking the tablets, she should take the extra tablet(s) from another strip. How to postpone the monthly bleed or change first day To postpone a monthly bleed, the woman should continue taking tablets from the next blister, without a tablet-free period. She may continue for several days or for the full blister. Breakthrough bleeding or spotting may occur during the prolonged tablet use. After the usual tablet-free period of 7 days, the usual intake of Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg is continued. If the woman prefers to change the first day of bleeding permanently, she may be advised to shorten the next tablet-free period with as many days as she prefers. The shorter the tablet- free period gets, the smaller the chance to have withdrawal bleeding and the greater the chance to have breakthrough bleeding/ spotting during the next tablet use (like postpone bleed, see above). Duration of treatment Time to relieve of symptoms is at least three months. The need to continue treatment should be evaluated periodically by the treating physician. The duration of treatment depends upon the severity of the clinical status. Therapy usually lasts for several months. It is recommended that treatment be withdrawn 3 to 4 cycles after the indicated condition(s) has/have completely resolved and that Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg is not continued solely to provide oral contraception. Special populations Children and adolescents Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg is only indicated after menarche.
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