SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET 1 SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT <invented name> 2 mg/0.03 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2 mg of chlormadinone acetate and 0.03 mg of ethinyl estradiol. Excipient with known effects: One coated tablet contains 75.27 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Tablets are biconvex, pink and rounded. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Hormonal contraception The decision to prescribe <invented name> should take into consideration the individual woman’s current risk factor, particularly those for venous thromboembolism (VTE), and how the risk of VTE with <invented name> compares with other CHCs (see sections 4.3 and 4.4). 4.2 Posology and method of administration Administration of the film-coated tablets One film-coated tablet should be taken daily, at the same time (preferably at night) for 21 consecutive days, followed by a 7-day tablet-free period; withdrawal bleeding, similar to menstruation, should occur two to four days after the administration of the last tablet. The tablets should be resumed after the 7-day rest period, using the following blister of <invented name>, regardless of whether the bleeding has ceased or not. The film-coated tablet should be removed from the blister, choosing the tablet marked with the correct day of the week, and swallowed whole with a little liquid, if necessary. The tablets should be taken daily, following the direction of the arrow. Starting administration of the film-coated tablets No previous administration of a hormonal contraceptive (during the last menstruation cycle): The first film-coated tablet should be taken on day one of the women’s natural cycle, i.e. on the first bleeding day of the next menstruation. If the first film-coated tablet is taken on the first day of 3 menstruation, contraception starts on the first day of administration and also continues during the seven-day medication-free interval. The first film-coated tablet can also be taken on the 2nd-5th day of menstruation, irrespective of whether bleeding has ceased or not. In this case additional mechanical contraceptive measures must be taken during the first seven days of administration. If menstruation had started more than five days earlier, then the woman should be instructed to wait until her next menstruation before starting to take <invented name>. Change from another hormonal contraceptive to <invented name>: Change from a 21 or 22-day hormonal contraceptive: All the tablets from the previous container should be finished. The first film-coated tablet of <invented name> should be taken on the following day. In this case, the administration of the tablets is not interrupted and the patient does not have to wait until her next withdrawal bleed to start. No additional contraceptive measures are required. Change from a combined daily hormonal contraceptive (28-day contraceptive): The administration of <invented name> should start after the last active tablet from the 28-day hormonal contraceptive pack (after taking 21 or 22 tablets, for example). The first film-coated tablet of <invented name> should be taken on the following day. There is no time interval between taking the tablets and the patient does not have to wait for her next withdrawal bleed to start. No additional contraceptive measures are required.” Change from a progestogen-only pill ("POP"): The first <invented name> film-coated tablet should be taken on the day after stopping the progestogen-only preparation. During the first seven days additional mechanical contraceptive measures must be used. Change from a contraceptive hormone injection or implant: Administration of <invented name> can be started on the day of removal of the implant or the day of the originally planned injection. During the first seven days additional mechanical contraceptive measures must be used. Change from a vaginal ring or transdermal patch: The use of <invented name> tablets is preferably started on the day after removal of the ring or patch, but at the latest on the day following the usual ring-free or patch-free break. After a miscarriage or an abortion in the first trimester After a miscarriage or an abortion in the first trimester administration of <invented name> can be started immediately. In this case no further contraceptive measures are necessary. After childbirth or after a miscarriage or abortion in the second trimester After childbirth women who do not breast-feed can start administration 21-28 days after delivery in which case no additional mechanical contraceptive measures are required. If administration starts more than 28 days after childbirth, additional mechanical contraceptive measures are necessary during the first seven days. If a woman has already had sexual intercourse, pregnancy must be ruled out or she must wait until her next menstruation before starting administration. Lactation (see section 4.6) <invented name> should not be taken by breast-feeding women. 4 After discontinuation of <invented name> After discontinuation of <invented name> the current cycle may be prolonged by about a week. Irregular administration of a tablet If the patient has forgotten to take a film-coated tablet but no more than 12 hours have passed since she did so, additional contraceptive measures are not required. She should continue to take the tablet as usual. If more than 12 hours have passed since she forgot to take the tablet, the contraceptive effect of the medicinal product may have diminished. She should immediately take the missed film-coated tablet. The next film-coated tablet should be taken as usual. Another contraceptive method, such as a condom, should also be used during the following seven days. If within these seven days the pack finishes, start with the next pack as soon as the previous one is finished. In other words, no time interval should be left between packs (“seven-day rule”). The normal withdrawal bleed will probably not occur until the pack is finished; however, spotting often occurs during administration of the tablets. If the next menstrual period does not occur after taking the second pack, a pregnancy test should be performed. Instructions in case of vomiting or diarrhoea If vomiting occurs within 4 hours after administration of the tablets or severe diarrhoea develops, absorption may be incomplete and reliable contraception is no longer ensured. In this case the instructions in "Irregular tablet administration" (see above) should be followed. <invented name> administration should be continued. 4.3 Contraindications Combined hormonal contraceptives (CHCs) should not be used in the following conditions: - initial or early signs of thrombosis, thrombophlebitis - loss of control of diabetes mellitus. - uncontrolled hypertension or significant rise in blood pressure (values consistently over 140/90 mm Hg) - hepatitis, jaundice, liver function disorders until liver values return to normal - generalised pruritus, cholestasis, especially during a previous pregnancy or oestrogen therapy - Dubin-Johnson syndrome, Rotor syndrome, alterations in bile flow - history or existence of benign or malignant liver tumours - severe epigastric pain, hepatomegaly or symptoms of intra-abdominal haemorrhage (see 4.8) - first case or repetition of porphyria (the three forms, particularly acquired porphyria) - presence or history of hormone-sensitive malignant tumours, such as of the breast or womb - severe lipid metabolism alterations - pancreatitis or a history of same, if associated with severe hypertriglyceridemia - first symptoms of migraine headaches or more frequent episodes of unusual severe headaches - acute sensory disturbances, such as visual or auditory disturbances - motor disturbances (particularly paresis) - increase in epileptic attacks - severe depression - otosclerosis deteriorating during previous pregnancies - amenorrhoea of unknown cause - endometrial hyperplasia - genital bleeding of unknown cause. - hypersensitivity to 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]) 5 - Known hereditary or acquired predisposition for venous thrombosis, 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 thrombosis, history of arterial thrombosis (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris) - Cerebrovascular disease – current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA) - Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipidantibodies (anticardiolipin-antibodies, lupus