Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
LEVONORGESTREL ; ETHINYLESTRADIOL ; LEVONORGESTREL ; ETHINYLESTRADIOL ; LEVONORGESTREL ; ETHINYLESTRADIOL
LTT Pharma Limited
G03AB03
LEVONORGESTREL ; ETHINYLESTRADIOL ; LEVONORGESTREL ; ETHINYLESTRADIOL ; LEVONORGESTREL ; ETHINYLESTRADIOL
Unknown
Tablets
Product subject to prescription which may be renewed (B)
levonorgestrel and ethinylestradiol
Authorised
2014-10-17
LOGYNON TABLETS WHEN TO TAKE SPECIAL CARE WITH LOGYNON TELL YOUR DOCTOR IF ANY OF THE FOLLOWING CONDITIONS APPLY TO YOU. In some situations you need to take special care while using Logynon or any other combined pill, and it may be necessary that you are regularly checked by your doctor. If the condition develops or gets worse while you are using Logynon, you should also tell your doctor. • if a close relative has had breast cancer • if you have liver or gallbladder disease • if you have diabetes • if you have depression • if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease) • if you have systemic lupus erythematosus (SLE - a disease affecting your natural defence system) • if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing failure of the kidneys) • if you have sickle cell anaemia (an inherited disease of the red blood cells) • if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas) • if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots’) • if you have just given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start taking Logynon • if you have an inflammation in the veins under the skin (superficial thrombophlebitis) • if you have varicose veins • if you have epilepsy (see “Logynon and using other medicines”) • if you have a disease that first appeared during pregnancy or with earlier use of sex hormones (for example, hearing loss, a blood disease called porphyria, skin rash with blisters during pregnancy (gestational herpes), or a nerve disease causing sudden movements of the body (Sydenham’s chorea) • if you have ever had golden brown pigment patches (chloasma), so called “pregnancy patches”, especially on t Διαβάστε το πλήρες έγγραφο
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 As per PA1410/005/001 5 PHARMACOLOGICAL PROPERTIES As per PA1410/005/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose Maize starch Povidone Magnesium stearate (E572) Sucrose Polyethylene glycol 6000 Calcium carbonate (E170) Talc Montan glycol wax Glycerin (E422) H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _1_ _/_ _0_ _3_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _7_ _4_ _1_ _2_ _4_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ Titanium dioxide (E171) Ferric oxide pigment red (E172) Ferric oxide pigment yellow (E172) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the blister and outer package of the product on the market in the country of origin Διαβάστε το πλήρες έγγραφο