mibe GmbH Arzneimittel DE/H/2745/002/DC 0014 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT [XXX] 20 micrograms/150 micrograms film-coated tablets [XXX] 30 micrograms/150 micrograms film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION For [XXX] 20 micrograms/150 micrograms film-coated tablets Each film-coated tablet contains 20 mcg ethinylestradiol and 150 mcg desogestrel. For [XXX] 30 micrograms/150 micrograms film-coated tablets Each film-coated tablet contains 30 mcg ethinylestradiol and 150 mcg desogestrel. Excipients with known effect: For [XXX] 20 micrograms/150 micrograms film-coated tablets lactose monohydrate 47.24 mg (see section 4.4). For [XXX] 30 micrograms/150 micrograms film-coated tablets lactose monohydrate 47.23 mg (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, biconvex, round film-coated tablets with embossing. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Oral contraception. The decision to prescribe [XXX] should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with [XXX] compares with other CHCs (see sections 4.3 and 4.4). 4.2 Posology and method of administration How to take [XXX] The tablets are to be taken every day, where possible at the same time of day, with sufficient liquid in the order indicated on the blister pack. One tablet is to be taken daily on 21 consecutive days. Before every additional blister pack a 7-day administration-free interval is to be observed in which withdrawal bleeding usually occurs. This normally begins 2 to 3 days after the last tablet dose and may persist while the next blister pack is already being started. 052015 1/15 mibe GmbH Arzneimittel DE/H/2745/002/DC 0014 How to start [XXX] Women who have not taken hormonal contraceptives in the last month Tablet administration is to begin on the first day of the normal menstrual cycle (i.e. on the first day of the period). Administration may be started as from day 2 to 5, with the additional use of a mechanical contraceptive being recommended during the first 7 days of tablet administration in the first cycle. Switching from a combined hormonal contraceptive (combined oral contraceptive [COC], vaginal ring or transdermal patch) Administration of [XXX] is preferably to be started the day after last administration of the last tablet containing active substance of the combined oral contraceptive taken previously, but at the latest the day after the usual administration-free interval or the placebo phase of the previous combined oral contraceptive. If a vaginal ring or a transdermal patch has been used to date, administration of [XXX] should preferably be started on the day of removal, but at the latest when the next use would be due. Switching from a gestagen monopreparation (minipill, injection, implant) or a gestagen-releasing intrauterine system (IUS) Switching from the minipill may take place on any day, from an implant or an IUS on the day of removal and from an injection preparation when the next injection would be due. A mechanical contraceptive is to be used for the first 7 days of tablet administration in all these cases. After an abortion in the first trimester Administration of [XXX] may be started immediately. Additional contraceptive measures are not necessary in this case. After delivery or an abortion in the second trimester For breast-feeding, see section 4.6. The use of [XXX] should be started between day 21 and 28 after delivery or second-trimester-abortion in the second trimester. If started later, a mechanical contraceptive is also to be used for the first 7 days of tablet administration. If sexual intercourse has taken place in the meantime, pregnancy is to be ruled out before the beginning of administration or the first period should be awaited. Missed tablets If, within 12 hours after the usual administration time, it is noticed that a tablet has been missed, the tablet should be taken immediately. All subsequent tablets are then to be taken at the usual time of day. Contraceptive protection is then not impaired. If tablets have been missed for more than 12 hours after the usual time of administration, full contraceptive protection may no longer exist. The following two basic rules apply to the procedure for missed tablets: 1. Administration must not be interrupted for more than 7 days. 2. Regular administration for at least 7 days is required to suppress the hypothalamic-pituitary- ovarian axis effectively. The following procedure may be recommended in daily practice: Week 1 The missed tablet should be taken immediately as soon as the missed dose is noticed – even if this means that 2 tablets are to be taken at the same time. The following tablets should be taken at the usual time. Mechanical contraception, e.g. a condom, is also to be used for the next 7 days. If intercourse has already taken place in the previous 7 days, the possibility of a pregnancy must be taken into account. The more tablets have been missed and the closer to the regular administration-free interval, the greater the risk of pregnancy. 052015 2/15 mibe GmbH Arzneimittel DE/H/2745/002/DC 0014 Week 2 The missed tablet should be taken immediately after the missed dose is noticed – even if this means that 2 tablets are to be taken at the same time. The following tablets should be taken at the usual time. On condition that regular administration took place on the previous 7 days, no additional use of a mechanical contraceptive is required. If this was not the case or more than 1 tablet was missed, a mechanical contraceptive is also to be used for the next 7 days. Week 3 In view of the imminent administration-free interval there is an increased risk of pregnancy which can, however, be reduced with appropriate adaptation of the method of administration. If one of the following two administration options is used, no additional contraceptive measures are required if administration took place regularly on the 7 days before the first missed tablet. Otherwise, the user must be instructed to follow the first of the two administration options and also use a mechanical contraceptive for the next 7 days. 1. The missed tablet should be taken immediately as soon as the missed dose is noticed – even if this means that 2 tablets are to be taken at the same time. The other tablets should be taken at the usual time. Administration of the tablets from the next blister pack is to be continued directly after the end of the current blister pack, i.e. without observing the administration-free interval. The usual withdrawal bleeding will probably not occur until this second blister pack is used up. Frequent breakthrough bleeding or spotting may, however, occur during tablet administration. 2. Alternatively the further administration of tablets from the current blister pack may be stopped. After an administration-free interval of up to 7 days, including any days on which administration was missed administration is continued with tablets from the next blister pack. If no withdrawal bleeding occurs after a missed dose in the next regular administration-free interval, the possibility of pregnancy should be considered. Advice in case of gastro-intestinal complaints In the case of severe gastrointestinal complaints (e.g. vomiting or diarrhoea), absorption may be incomplete. Additional contraceptive precautions are then to be taken. Where vomiting occurs within 3 to 4 hours after tablet administration a new (replacement) tablet should be taken as soon as possible. The new tablet should be taken within 12 hours of the usual time of tablet-taking if possible. If more than 12 hours elapse, the instructions under "Procedure for missed tablets", as set out in section “Missed tablets”, are to be followed. If the usual administration regime is to be followed, the additional tablet to be taken must be taken from another blister pack. Postponing or delaying the menstruation Postponing the menstruation is not an indication for this preparation. To postpone menstruation in exceptional cases the user should continue with tablet administration from the next blister pack of [XXX] directly without an administration-free interval. Withdrawal bleeding may be postponed for as long as desired until the second blister pack has been used up. Breakthrough bleeding or spotting may occur frequently during this period. Administration of [XXX] may be continued as usual after the following regular 7-day administration-free interval. The beginning of menstruation in the next cycle may be brought forward to another day of the week by shortening the administration-free interval as desired. The shorter the administration-free interval, the more unlikely it is for withdrawal bleeding to occur or the more frequently spotting or breakthrough bleeding may occur during administration of the next blister pack (as with postponement of menstruation). 4.3 Contraindications 052015 3/15 mibe GmbH Arzneimittel DE/H/2745/002/DC 0014 Combined hormonal contraceptives (CHCs) should not be used in the following conditions. Should any of the conditions appear for the first time during CHC use, the product should be stopped immediately. - Hypersensitivity to any of the active substances or to any of the excipients listed in section 6.1 - Presence or risk of venous thromboembolism (VTE) - Venous thromboembolism – current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis [DVT] or pulmonary embolism [PE]) - Known hereditary or acquired predisposition for venous thromboembolism, such as APC- resistance, (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency - Major surgery with prolonged immobilisation (see section 4.4) - A high risk of venous thromboembolism due to the presence of multiple risk factors (see section 4.4) - Presence or risk of arterial thromboembolism (ATE) - Arterial thromboembolism – current arterial thromboembolism, history of arterial thromboembolism (e.g.