Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Levonorgestrel micronized; Levonorgestrel micronized; Levonorgestrel micronized; Ethinylestradiol micronized; Ethinylestradiol micronized
Bayer Limited
G03AB; G03AB03
Levonorgestrel micronized; Levonorgestrel micronized; Levonorgestrel micronized; Ethinylestradiol micronized; Ethinylestradiol micronized
percent volume/volume
Coated tablet
Product subject to prescription which may be renewed (B)
Progestogens and estrogens, sequential preparations; levonorgestrel and ethinylestradiol
Marketed
1981-08-26
BP22046_REC30885 PACKAGE LEAFLET: INFORMATION FOR THE USER LOGYNON ® 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 Logynon is and what it is used for 2. What you need to know before you take Logynon 3. How to take Logynon 4. Possible side effects 5. How to store Logynon 6. Contents of the pack and other information 1. WHAT LOGYNON IS AND WHAT IT IS USED FOR • Logynon contains a small amount of two different female hormones, namely levonorgestrel, a progestogen, and ethinylestradiol, an estrogen. • Logynon is a contraceptive pill and is used to prevent pregnancy. • Contraceptive pills that contain two hormones are called ‘combined’ pills. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOGYNON GENERAL NOTES Before you start using Logynon you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot – see Section 2 “Blood clots”. Before you can begin taking Logynon, your doctor will ask Baca dokumen lengkap
Health Products Regulatory Authority 21 November 2022 CRN00D8K3 Page 1 of 16 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 with known effect: Each tablet contains 33 mg lactose monohydrate. Each tablet contains 19 mg sucrose. Please see section 4.4 for further information. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablet. 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 The decision to prescribe Logynon should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Logynon 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 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 inthe direction of the arrows. Health Products Regulatory Authority 21 November 2022 CRN00D8K3 Page 2 of 16 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 Baca dokumen lengkap