Страна: Израел
Език: английски
Източник: Ministry of Health
DESOGESTREL; ETHINYLESTRADIOL
ORGANON PHARMA ISRAEL LTD., ISRAEL
G03AC09
TABLETS
DESOGESTREL 150 MCG; ETHINYLESTRADIOL 20 MCG
PER OS
Required
ORGANON LLC, USA
DESOGESTREL
DESOGESTREL
Oral contraception
2021-11-30
[Organon] Proprietary PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 THIS MEDICINE IS MARKETED UPON DOCTOR'S PRESCRIPTION ONLY MERCILON ® Tablets COMPOSITION: EACH TABLET CONTAINS: Desogestrel 0.15 mg Ethinyl estradiol 0.02 mg For a list of inactive ingredients see section 6.1 "WHAT MERCILON CONTAINS". IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES (CHCS): • They are one of the most reliable reversible methods of contraception if used correctly. • They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following 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, “BLOOD CLOTS”). • Some women should not take the Pill because of current medical problems or illnesses. Please read this leaflet to make sure MERCILON is right for you. • To prevent pregnancy it is important to take MERCILON as instructed and to start each pack on time. Please make sure that you understand what to do if you miss a pill or if you think you are pregnant. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • This leaflet contains concise information about MERCILON. If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their medical condition seems similar to yours. • Keep this leaflet. You may need to read it again. • If you have any further questions or need more advice, ask your doctor, or pharmacist. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. 1. WHAT MERCILON IS AND WHAT IT IS USED FOR? 1.1 WHAT IS MERCILON? THERAPEUTIC GROUP: Estrogen-progestogen combination contraceptive. 1.2 WHAT I Прочетете целия документ
[Organon] Proprietary 1. NAME OF THE MEDICINAL PRODUCT MERCILON ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: desogestrel (a progestagen) 0.15 mg ethinylestradiol (an estrogen) 0.02 mg Excipient with known effect: lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. The tablets are white, round, biconvex and 6 mm in diameter. They are coded on one side “Organon*” and on the reverse side “TR” above “4”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. The decision to prescribe Mercilon should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Mercilon compares with other CHCs (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 4.2.1 HOW TO TAKE MERCILON 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 usually occurs. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started. 4.2.2 HOW TO START MERCILON _No preceding hormonal contraceptive use [in the past month]: _ It is preferable that tablet intake from the first pack is started on the first day of menstruation in which case no extra contraceptive precautions are necessary. If menstruation has already begun, (that is 2, 3, or 4 days previously), tablet taking should commence on day 5 of the menstrual period. In this case additional contraceptive precautions must be taken for the first 7 days of tablet taking. If menstruation began more than 5 days previously then the patient should be advised to wait until her next menstrual period before starting to take Mercilon. _Changing from a 21 day pill or another 22 day pill to Mercilon:_ [Organon] Proprietary All tablets in the Прочетете целия документ