Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
LEVONORGESTREL ETHINYLESTRADIOL
Pfizer Healthcare Ireland
LEVONORGESTREL ETHINYLESTRADIOL
100, 20 Microgram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
Page 1 of 10 Pfleet No.: 2013-0003758 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ALESSE ® 100 MICROGRAMS/20 MICROGRAMS FILM-COATED TABLETS levonorgestrel/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 ALESSE is and what it is used for 2. What you need to know before you take ALESSE 3. How to take ALESSE 4. Possible side effects 5. How to store ALESSE 6. Contents of the pack and other information 1. WHAT ALESSE IS AND WHAT IT IS USED FOR ALESSE is a combined oral contraceptive pill for the prevention of pregnancy. It contains two different female hormones, levonorgestrel and ethinylestradiol. Each of the 21 round pink tablets contains 100 micrograms of levonorgestrel and 20 micrograms ethinylestradiol. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALESSE Before you can start taking ALESSE your doctor will ask you some questions around your personal health history and that of your close relatives. Your doctor will also measure your blood pressure and may also carry out some other tests. In this leaflet some situations are described where you should stop using ALESSE or where the reliability of ALESSE may be decreased and there is a higher risk of pregnancy. In such situations you should either not have se Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alesse film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 microgram levonorgestrel and 20 microgram ethinylestradiol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablets. Round pink biconvex film coated tablets with “W” embossed on one side and “912” embossed on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _How to take Alesse_ 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 days 2-3 after the last tablet and may not have finished before the next pack is started. _How to start Alesse_ _No preceding hormonal contraceptive use [in the past month]_ Tablet-taking should start on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding). Starting on days 2-7 is allowed, but during the first cycle a back-up method of birth control [such as condoms and spermicide] is recommended in addition for the first 7 days of tablet-taking. _Changing from another combined oral contraceptive (COC)_ The woman should start Alesse preferably on the day after the last active tablet of her previous COC, but at the latest on the day following the usual tablet-free or inactive tablet interval of her previous COC. _Changing from a progestin-only method (progest Aqra d-dokument sħiħ