Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Ethinyloestradiol; Gestodene
Pfizer Healthcare Ireland
G03AA; G03AA10
Ethinyloestradiol; Gestodene
75 mcg/30 microgram(s)
Coated tablet
Product subject to prescription which may be renewed (B)
Progestogens and estrogens, fixed combinations; gestodene and ethinylestradiol
Marketed
1988-03-25
Page 1 of 15 2022-0081366 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MINULET ® 75 MICROGRAMS/30 MICROGRAMS COATED TABLETS gestodene and ethinylestradiol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT MINULET IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MINULET 3. HOW TO TAKE MINULET 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE MINULET 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT MINULET IS AND WHAT IT IS USED FOR Minulet is an oral contraceptive. The name of your medicine is Minulet 75 micrograms/30 micrograms coated tablets. 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”). HOW THE FEMALE REPRODUCTIVE SYSTEM WORKS: Once a month, an egg (or ovum) is released from one of the ovaries and passes along the Fallopian tube to the womb. Fertilisation (the joining together of the male's sperm with the female's egg) usually takes place while the egg is still in the Fallopian tube. The fertilised egg embeds itself in the wall of the womb, which has been specially prepared to receive it, and it grows into a baby. If fertil Lees het volledige document
Health Products Regulatory Authority 12 January 2023 CRN00D7R6 Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Minulet 75 micrograms/30 micrograms coated tablets 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 use should begin preferably on the day after the last active tablet of the Lees het volledige document