देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Ethinyloestradiol; Gestodene; Ethinylestradiol; Gestodene; Ethinylestradiol; Gestodene
Pfizer Healthcare Ireland
G03AA; G03AA10
Ethinyloestradiol; Gestodene; Ethinylestradiol; Gestodene; Ethinylestradiol; Gestodene
percent volume/volume
Coated tablet
Product subject to prescription which may be renewed (B)
Progestogens and estrogens, fixed combinations; gestodene and ethinylestradiol
Not marketed
1988-05-18
Page 1 of 16 2022-0081366 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRI-MINULET 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 TRI-MINULET IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRI-MINULET 3. HOW TO TAKE TRI-MINULET 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE TRI-MINULET 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT TRI-MINULET IS AND WHAT IT IS USED FOR The name of your medicine is Tri-Minulet Tablets. Tri-Minulet is an oral contraceptive. 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 fertilisation does not take place, then the egg पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 21 November 2022 CRN00D7RP Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tri-Minulet Coated* Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each beige tablet contains 30 micrograms ethinylestradiol and 50 micrograms gestodene. Each dark brown tablet contains 40 micrograms ethinylestradiol and 70 micrograms gestodene. Each white tablet contains 30 micrograms ethinylestradiol and 100 micrograms gestodene. Excipients with known effect: Each beige tablet contains 37.455mg lactose monohydrate and 19.371mg sucrose. Each dark brown tablet contains 37.425mg lactose monohydrate and 19.180mg sucrose. Each white tablet contains 37.405mg lactose monohydrate and 19.660mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablets. Beige round sugar-coated tablets, dark brown round sugar-coated tablets and white round sugar-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. The decision to prescribe Tri-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 Tri-Minulet compares with other 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 TRI-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 fin पूरा दस्तावेज़ पढ़ें