Country: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
ETHINYLESTRADIOL; GESTODENE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
G03CA01
TABLETS
GESTODENE 0.075 MG; ETHINYLESTRADIOL 0.030 MG
PER OS
Required
PFIZER IRELAND PHARMACEUTICALS
ETHINYLESTRADIOL
ETHINYLESTRADIOL
Contraception.
2015-10-31
Minulet PIL CC 260723 Technical change 1 2023-0087005 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only MINULET ® COATED TABLETS Each coated tablet contains: Ethinylestradiol 0.03 mg Gestodene 0.075 mg INACTIVE INGREDIENTS AND ALLERGENS IN THIS MEDICINE: see section 6. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to a doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Minulet is intended for birth control and belongs to a group of medicines called “contraceptive pills”. Each tablet contains two female hormones, estrogen (ethinylestradiol) and progestogen (gestoden). THERAPEUTIC GROUP: combined oral contraceptive pills, an estrogen and progestogen combination. A FEW IMPORTANT THINGS TO KNOW ABOUT COMBINED PILLS: • When used correctly, they are one of the most reliable reversible methods of contraception. • They slightly increase the risk of having a thrombosis (blood clots) in the veins and arteries, especially in the first year or when restarting after a break of 4 or more weeks. • Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Minulet and thrombosis (blood clots)”). • Like other contraceptive pills, Minulet does not protect you against HIV infection (AIDS) or other sexually transmitted diseases. If you think you are at risk, you should use a condom as well as the Pill. 2. BEFORE USING THE MEDICINE Before you start taking Minulet 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 “Minulet and thrombosis (blood clots)”). DO NOT USE THE Aqra d-dokument sħiħ
Minulet LPD CC 020423 PAGE 1 OF 17 2022-0075978, 2022-0081366 MINULET ® SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Minulet ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 75 micrograms gestodene and 30 micrograms ethinylestradiol. Excipients with known effect: Also includes lactose monohydrate 37.43 mg and sucrose 19.66 mg per tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablets. White, round, biconvex, sugar-coated tablets, with a shiny surface. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. The decision to prescribe Minulet should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Minulet compares with other CHCs (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology HOW TO TAKE MINULET Regular daily intake of tablets for 21 consecutive days is important for the preservation of contraceptive efficacy. Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. One tablet is to be taken daily for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free interval during which time a withdrawal bleed occurs. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started. HOW TO START MINULET No hormonal contraceptive use within the preceding month The user should begin taking Minulet on Day 1 of her natural menstrual cycle (i.e. the first day of menstrual bleeding). Beginning Minulet use on days 2-7 of the menstrual cycle is allowed; however a non-hormonal back-up method of birth control [e.g. condoms and spermicide] is recommended during the first 7 days of Minulet use. _Switching from another combined hormonal contraceptive (CHC) _ _ _ Minulet LPD CC 020423 PAGE 2 OF 17 2022-0075978, 2022-0081366 Minulet use should begin preferably on the day after t Aqra d-dokument sħiħ