Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Levonorgestrel; Ethinylestradiol; Ethinylestradiol; Levonorgestrel; Levonorgestrel
PCO Manufacturing Ltd.
G03AB; G03AB03
Levonorgestrel; Ethinylestradiol; Ethinylestradiol; Levonorgestrel; Levonorgestrel
milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Progestogens and estrogens, sequential preparations; levonorgestrel and ethinylestradiol
Authorised
2013-07-19
_ _ _ _ _ _ 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. 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. 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. 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 you some questions about your personal health history and that of your close relatives. The doctor will also measure yo Perskaitykite visą dokumentą
Health Products Regulatory Authority 03 October 2019 CRN00977H Page 1 of 2 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 Excipient(s) with known effect: Each tablet contains lactose and sucrose. _For the full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Coated tablet _Product imported from the UK_: Calendar pack containing 6 round light brown sugar-coated tablets, 5 round white sugar-coated tablets and 10 round ochre-coloured sugar-coated tablets. 4 CLINICAL PARTICULARS As per PA1410/005/001 5 PHARMACOLOGICAL PROPERTIES As per PA1410/005/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Tablet core: Lactose Maize Starch Povidone Magnesium stearate (E572) Talc Tablet coating: Sucrose Polyethylene glycol 6000 Calcium carbonate (E170) Talc Montan glycol wax Glycerin (E422) Health Products Regulatory Authority 03 October 2019 CRN00977H Page 2 of 2 Titanium dioxide (E171) Ferric oxide pigment (red and yellow) (E172) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the container and outer package of the product in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30 °C. 6.5 NATURE AND CONTENTS OF CONTAINER Logynon tablets are contained in blister packs. Each calendar-blister contains 6 light brown sugar-coated tablets, 5 white sugar-coated tablets and 10 ochre-coloured sugar-coated tablets. Presentation Carton containing 1 x 21 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDE Perskaitykite visą dokumentą