Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LEVONORGESTREL ETHINYLESTRADIOL
Famy Care Europe Ltd
LEVONORGESTREL ETHINYLESTRADIOL
100/20 Microgram
Coated Tablets
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LEVONORGESTREL/ETHINYLESTRADIOL FAMY CARE 100 MICROGRAMS / 20 MICROGRAMS COATED TABLETS (Levonorgestrel 100 micrograms and Ethinylestradiol 20 micrograms) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Levonorgestrel/Ethinylestradiol is and what it is used for 2. Before you take Levonorgestrel/Ethinylestradiol 3. How to take Levonorgestrel/Ethinylestradiol 4. Possible side effects 5. How to store Levonorgestrel/Ethinylestradiol 6. Further information 1. WHAT LEVONORGESTREL/ETHINYLESTRADIOL IS AND WHAT IT IS USED FOR • Levonorgestrel/Ethinylestradiol is a contraceptive pill used to prevent pregnancy. • Each tablet contains a small amount of two different female hormones, namely levonorgestrel and ethinylestradiol. • Contraceptive pills that contain two hormones are called “combination” pills. 2. BEFORE YOU USE LEVONORGESTREL/ETHINYLESTRADIOL GENERAL NOTES Before you can begin taking Levonorgestrel/Ethinylestradiol, your doctor will ask you some questions about your personal health and that of your close relatives. The doctor will also measure your blood pressure and depending upon your personal situation, may also carry out some other tests. In this leaflet, several situations are described where you should stop using Levonorgestrel/Ethinylestradiol, or where the reliability of Levonorgestrel/Ethinylestradiol may be decreased. In such situations you should either not have inte Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levonorgestrel/Ethinylestradiol Famy Care 100 micrograms/20 micrograms coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains Levonorgestrel 100 micrograms and Ethinylestradiol 20 micrograms. Excipients: 1 coated tablet contains 48 mg of lactose monohydrate and 14 mg of sucrose For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Coated tablet Round, pink, 5.60 mm coated tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION HOW TO USE LEVONORGESTREL/ETHINYLESTRADIOL FAMY CARE 100 MICROGRAMS / 20 MICROGRAMS COATED TABLETS Tablets must be taken orally in the order directed on the blister package at about the same time every day, with some liquid if necessary. 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. The bleeding usually starts within 2 to 3 days after the last tablet and may not end before the next pack is started. HOW TO START THE USE OF LEVONORGESTREL/ETHINYLESTRADIOL FAMY CARE 100 MICROGRAMS / 20 MICROGRAMS COATED TABLETS • no preceding hormonal contraceptive use (in the past month), tablet-taking is started 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 in that case an additional barrier method is recommended for the first 7 days of the first cycle • Changing from another combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, transdermal patch) The use of Levonorgestrel and Ethinylestradiol coated tablet is preferably started on the day after the last a Read the complete document