Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Ethinylestradiol; Levonorgestrel
Bayer Limited
G03AA; G03AA07
Ethinylestradiol; Levonorgestrel
100/20 microgram(s)
Tablet
Product subject to prescription which may be renewed (B)
Progestogens and estrogens, fixed combinations; levonorgestrel and ethinylestradiol
Marketed
1998-04-03
BP22055, REC30965 1 PACKAGE LEAFLET: INFORMATION FOR THE USER MICROLITE ® 100/20 MICROGRAM TABLETS levonorgestrel 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 or pharmacist. • 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. 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”) WHAT IS IN THIS LEAFLET 1. What Microlite is and what it is used for 2. What you need to know before you take Microlite 3. How to take Microlite 4. Possible side effects 5. How to store Microlite 6. Contents of the pack and other information 1. WHAT MICROLITE IS AND WHAT IT IS USED FOR • Microlite contains a small amount of two different female hormones, namely levonorgestrel, a progestogen, and ethinylestradiol, an estrogen. • Microlite is a contraceptive pill and is used to prevent pregnancy. • Contraceptive pills that contain two hormones are called 'combination' pills. Microlite is called a ‘low-dose’ contraceptive pill because it contains only a small amount of hormones. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MICROLITE GENERAL NOTES Before you start using Microlite you should read the information on blood clots in section 2. It is partic Prečítajte si celý dokument
Health Products Regulatory Authority 21 November 2022 CRN00D8K3 Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Microlite 100/20 microgram Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 micrograms Levonorgestrel and 20 micrograms Ethinylestradiol. Excipients with known effect Each tablet contains lactose monohydrate 35.19 mg and sucrose 19.374 mg. Please see section 4.4 for further information. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablet (Tablet). Pink coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. The decision to prescribe Microlite should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Microlite compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _How to take Microlite _ _ _ Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly. 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 coated tablet and may not have finished before the next pack is started. _How to start Microlite_ _ _ _No preceding hormonal contraceptive use (in the past month)_ Tablet-taking has to start on day 1 of the woman's natural cycle (i.e. the first day of her menstrual bleeding). Starting on days 2-5 is allowed but during the first cycle a barrier method is recommended in addition for the first 7 days of tablet-taking. _Changing from a combined hormonal contraceptive (combined oral contraceptive/CO Prečítajte si celý dokument