Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LEVONORGESTREL, ETHINYLESTRADIOL, LEVONORGESTREL, ETHINYLESTRADIOL, LEVONORGESTREL, ETHINYLESTRADIOL
Clear Pharma Limited
G03AB03
LEVONORGESTREL, ETHINYLESTRADIOL, LEVONORGESTREL, ETHINYLESTRADIOL, LEVONORGESTREL, ETHINYLESTRADIOL
Coated Tablets
Product subject to prescription which may be renewed (B)
Progestogens and estrogens, sequential preparations
Authorised
2014-03-14
PACKAGE LEAFLET: INFORMATION FOR THE USER LOGYNON® TABLETS levonorgestrel and ethinylestradiol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, even if their symptoms are the same as yours. • 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 Logynon is and what it is used for 2. Before you take Logynon 3. How to take Logynon 4. Possible side effects 5. How to store Logynon 6. Further information 1. WHAT LOGYNON IS AND WHAT IT IS USED FOR • Logynon is a contraceptive pill and is 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 ‘combined’ pills. 2. BEFORE YOU TAKE LOGYNON GENERAL NOTES Before you can begin taking Logynon, your doctor will ask you some questions about your personal health history 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 for example a breast exam or cervical screen as appropriate. In this leaflet, several situations are described where you should stop using Logynon, or where the reliability of Logynon may be decreased. In such situations you should either not have sex or you should take extra non-hormonal contraceptive precautions, e.g., use a condom or another barrier method. Do not use rhythm or temperature methods. These Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Logynon Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EACH LIGHT BROWN TABLET CONTAINS: Ethinylestradiol 30 micrograms Levonorgestrel 50 micrograms EACH WHITE TABLET CONTAINS: Ethinylestradiol 40 micrograms Levonorgestrel 75 micrograms EACH OCHRE-COLOURED TABLET CONTAINS: Ethinylestradiol 30 micrograms Levonorgestrel 125 micrograms Excipients: Each tablet also contains lactose and sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablet. _Product imported from the UK:_ Each calendar-blister contains 6 light brown sugar-coated tablets, 5 white sugar-coated tablets and 10 ochre-coloured sugar-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _METHOD OF ADMINISTRATION_ Oral use _DOSAGE REGIMEN_ _How to take Logynon_ 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. The memo-pack contains 21 tablets. Tablet-taking is always started from the section marked “Start” and then continued daily in the direction of the arrows. Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/03/2014_ _CRN 2135495_ _page number: 1_ 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 Read the complete document