Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
ETHINYLESTRADIOL; GESTODENE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
G03AA10
FILM COATED TABLETS
ETHINYLESTRADIOL 0.015 MG; GESTODENE 0.06 MG
PER OS
Required
PFIZER IRELAND PHARMACEUTICALS
GESTODENE AND ESTROGEN
GESTODENE AND ESTROGEN
Contraceptive.
2021-05-31
Minesse PIL CC 290323 1 2022-0081366 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed with a doctor’s prescription only Minesse ® Film-coated tablets Each blister pack contains 28 tablets: • 24 pale yellow active tablets, each coated tablet contains: ethinylestradiol 0.015 mg gestodene 0.060 mg • 4 white inactive tablets Inactive ingredients and allergens: See section 2 under “Important information about some of this medicine’s ingredients” and section 6 “Further information”. Read the entire leaflet carefully before using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Minesse is a preparation for birth control that belongs to a group of medicines called “contraceptive pills”. • Each of the 24 pale yellow tablets contains two female hormones: ethinylestradiol and gestodene. The 4 white tablets do not contain active ingredients. Therapeutic group: combined oral contraceptive pills, a combination of estrogen and progestogen. 2. BEFORE USING THIS MEDICINE Before you can begin taking Minesse, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure, and depending on your personal situation, may also carry out other tests. Before you start using Minesse, you should read the information on thrombosis (blood clots) in section 2. It is particularly important to read the part about symptoms of thrombosis (see section 2 “Minesse and thrombosis (blood clots)”). In this leaflet, several situations are described where you should stop using Minesse, or situations where the reliability of Minesse may be decreased. In such situations you Olvassa el a teljes dokumentumot
Page 1 of 18 2022-0081366 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT MINESSE 60 micrograms / 15 micrograms film-coated tablets 2. QUANTITATIVE AND QUALITATIVE COMPOSITION Gestodene : ...... ........... ………60 micrograms Ethinylestradiol: .......... ………15 micrograms For one pale-yellow, film-coated tablet (active tablet) Excipient with known effect: lactose The white, film-coated tablets do not contain any active ingredients (placebo). Excipient with known effect: lactose For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet. The active tablet is a pale-yellow round tablet with convex faces embossed with “60”on one side and “15”on the other. The placebo tablet is a white round tablet with convex faces. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral hormonal contraception. The decision to prescribe Minesse should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Minesse compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Take regularly and without omission, one tablet daily at the same time of the day, for 28 consecutive days (one pale-yellow, active tablet during the first 24 days, one white, inactive tablet during the 4 following days) with no free interval between each blister pack. A withdrawal bleed usually starts on day 2-3 after the last active tablet and may not have finished before the next pack is started. How to start Minesse No preceding hormonal contraceptive use in the past month: Take the first tablet on the first day of menstrual bleeding. Changing from another combined oral contraceptive (COC): Page 2 of 18 2022-0081366 The woman should start Minesse _ _ on the day after the last active tablet of her previous COC. Changing from a progestin-only method (minipill, injection, implant): The woman may switch any day Olvassa el a teljes dokumentumot