2 QUALITATIVE AND QUANTITATIVE …

1 New Zealand Datasheet 1 PRODUCT NAME GINET 2 qualitative and quantitative COMPOSITION Each tablet contains Cyproterone Acetate mg and Ethinylestradiol Tablets 35 mcg. 3 PHARMACEUTICAL FORM Each blister tray contains 21 yellow active tablets and 7 larger white inactive tablets. Each active tablet is a yellow, biconvex, film-coated tablet, containing cyproterone acetate 2 mg and ethinylestradiol 35 micrograms ( mg) with a diameter of mm. Each inactive tablet is a white, round, biconvex, tablet, plain on both sides with a diameter of mm. 4 CLINICAL PARTICULARS Therapeutic indications Androgen-dependent diseases in women are an indication for treatment with GINET.

2 These diseases may include: acne (where local treatment or oral antibiotics alone have not been successful), especially pronounced forms of acne that may be accompanied by inflammation or formation of nodes (acne nodulocystica, acne papulopustulosa), seborrhea, mild forms of hirsutism and/or androgenic alopecia. Oral contraception in women requiring treatment for these androgen-dependent diseases is an indication for treatment with GINET. However, GINET is not recommended in women solely for contraception. It should not be used in combination with other hormonal contraceptives. GINET is indicated for the relief of symptoms of polycystic ovary syndrome.

3 Dose and method of administration Any previously used hormonal contraception should be discontinued. To achieve therapeutic efficacy and the required contraceptive protection, GINET needs to be taken regularly. The dose regimen of GINET is similar to the usual regimen for most combined oral contraceptives. Thus, the same administration rules for most combined oral contraceptives (COC s) must be considered. Intermenstrual bleeding and eventual deterioration of the therapeutic and contraceptive reliability may be caused by not taking GINET regularly at about the same time each day. How to take GINET Tablets must be taken in the order directed on the blister each day at about the same time with some liquid as needed.

4 Each subsequent blister is started after a 7-day period of non-hormonal (white or inactive) tablets, during which, withdrawal bleeding usually occurs. Usually 2 to 3 days after the last tablet the bleeding starts and may not have finished before the next blister is started. One hormonal (yellow or active) tablet is to be taken daily for 21 consecutive days. How to start GINET Where no preceding hormonal contraceptive use has occurred (in the previous month) GINET should be started on the first day of bleeding, taking the tablet in the red section marked with the appropriate day of the week. As an example, if bleeding starts on Monday then take the tablet in the red section of the blister marked MON for Monday.

5 2 One small yellow hormonal tablet is to be taken daily for 21 consecutive days. The white non-hormonal tablets are then taken daily for 7 days. Withdrawal bleeding should usually occur within 2 to 4 days after taking the last small yellow hormonal tablet. In the first cycle only, an additional form of barrier method contraception must be used for the first 14 days of tablet taking. (Do not use rhythm or temperature methods as a contraceptive measure). Tablets should be taken at the same time each day. Changing from another combined oral contraceptive (COC) Start GINET in the red section of the blister on the day after the last hormonal tablet of her previous COC.

6 Changing from a progestogen only method (minipill, injection, implant) The woman may switch from the minipill (or from an injectable when the next injection would be due, or from an implant on the day of its removal) to GINET immediately, but should be advised in all cases to use additional barrier method contraception for the first 14 days of tablet taking. Following first trimester abortion The woman may start immediately and needs to take additional contraceptive measures for the first 14 days of tablet taking. Following delivery or second trimester abortion Start taking tablets at day 21 to 28 after delivery or second trimester abortion. When starting later, additional contraception (barrier methods) should be used for the first 14 days of tablet taking.

7 If intercourse has already occurred, pregnancy should be excluded first before the actual start of GINET use, or the woman should wait for her first menstrual period before starting GINET. Extra Contraceptive Precautions When you need extra contraceptive precautions, either: Do not have sex; or Use barrier contraceptive methods such as: Use a condom or; Use a cap plus spermicide. Oral contraceptives can alter the usual menstrual cycle causing alterations in temperature and cervical mucus. Do not use the rhythm, or temperature methods as these will not be reliable. Management of Missed Tablets (yellow hormonal tablets) Missed tablets while taking the non-hormonal (white) tablets contained in GINET can be ignored, however they should be discarded.

8 Less than 12 hours late: The woman will still have contraceptive protection if the tablet is taken less than 12 hours late. The tablet should be taken as soon as it is remembered, and further tablets should be taken at the usual time. Additional contraception or emergency contraception should not be required. More than 12 hours late: The woman may have reduced contraceptive protection if the tablet is taken more than 12 hours late. If tablets are missed at the beginning or end of the week of inactive tablets, there is a particularly high risk of pregnancy. If tablets are missed in the first week of taking active 3 tablets and intercourse took place in the preceding 7 days, then the possibility of pregnancy should be considered.

9 The following rules will aid in management of missed pills (these rules form the basis of the instructions to patients provided in the package insert): Tablet taking must never be discontinued for longer than 7 days. The 7 day rule: To maintain adequate suppression of the hypothalamic-pituitary-ovarian axis requires 7 days of uninterrupted tablet taking. Always continue taking your tablets at about the same time each day. Before regaining contraceptive protection from pregnancy, you will need to take your small yellow hormonal tablet daily for the next 7 days in a row. For the next 7 days while taking the next 7 small yellow hormonal tablets, use an additional contraception barrier method, such as condoms, or refrain from sexual intercourse.

10 If there are less than 7 small yellow hormonal tablets left in the current blister pack, finish the small yellow hormonal tablets and go straight on to the small yellow hormonal tablets of the next blister pack. This means that you miss out the white non-hormonal tablets if you have the 28-day pack. You may not have a period until the end of the next pack. This is not harmful. If tablets have been missed and there is no withdrawal bleed in the first normal placebo-taking, then pregnancy should be considered. Additionally If tablets are missed in week 1 (Days 1 to 7) due to the tablet free interval being extended, and if the woman has had unprotected sex in the tablet free interval or in week 1, then emergency contraception should be considered If tablets are missed in week 3 (Days 15 to 21) - to avoid extending the tablet free interval, then the woman should finish the tablets in their current pack and start a new blister calendar pack the next day, thus omitting the tablet free tablet interval.