Country: Израел
Језик: Енглески
Извор: Ministry of Health
ETHINYLESTRADIOL; GESTODENE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
G03AA10
COATED TABLETS
ETHINYLESTRADIOL 0.020 MG; GESTODENE 0.075 MG
PER OS
Required
PFIZER IRELAND PHARMACEUTICALS
GESTODENE AND ESTROGEN
GESTODENE AND ESTROGEN
Contraceptive.
2021-04-30
Harmonet PIL CC Technical change 130723 2023-0086959 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only HARMONET ® COATED TABLETS Each coated tablet contains: ethinylestradiol 0.02 mg gestodene 0.075 mg 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? Harmonet is a preparation for birth control that belongs to a group of medicines called “contraceptive pills”. Each tablet contains two female hormones, estrogen (ethinylestradiol) and progestogen (gestodene). THERAPEUTIC GROUP: Combined oral contraceptive pills, a combination of estrogen and progestogen. SEVERAL IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES: • When used correctly, combined hormonal contraceptives are one of the most reliable reversible contraceptive method. • They slightly increase the risk of thrombosis (blood clots) in the veins and arteries, especially during the first year or upon resuming intake after stopping for 4 weeks or more. • Be vigilant and contact your doctor if you are concerned that you suffer from any symptoms of a blood clot (see section 2, “Harmonet and thrombosis (blood clots)”). 2. BEFORE USING THIS MEDICINE Before you start taking Harmonet, you should read the information about thrombosis (blood clots) in section 2. It is especially important to read the part about the symptoms of thrombosis (see section 2, “Harmonet and thrombosis (blood clots)”). DO NOT USE THIS MEDICINE IF: You are in Прочитајте комплетан документ
Harmonet LPD CC 220323 Page 1 of 17 2022 -0075978, 2022-0081366 HARMONET ® 1. NAME OF THE MEDICINAL PRODUCT Harmonet ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.075 mg of gestodene and 0.02 mg of ethinylestradiol Excipients with known effect : lactose and sucrose (each tablet contains 37.505 mg lactose hydrouse and 19.66 mg sucrose; see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablets White, sugar coated tablets with a shiny surface. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Oral hormonal contraception The decision to prescribe Harmonet ® should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Harmonet ® compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2. POSOLOGY AND METHOD OF ADMINISTRATION PAEDIATRIC POPULATION _ _ Paediatric data are not available. Safety and efficacy of CHCs have been established in adult women of reproductive age. GERIATRIC POPULATION _ _ CHCs are not indicated for use in postmenopausal women. HOW TO TAKE HARMONET ® 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 HARMONET ® No hormonal contraceptive use within the preceding month _ _ Harmonet LPD CC 220323 Page 2 of 17 2022 -0075978, 2022-0081366 The user should begin taking Harmonet ® on Day 1 of her natural menstrual cycle (i.e. the first day of her menstrual bleeding). Beginning Harmonet ® use on days 2-7 of the menstrual cycl Прочитајте комплетан документ