Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Exemestane
LTT Pharma Limited
L02BG; L02BG06
Exemestane
25 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Aromatase inhibitors; exemestane
Authorised
2016-10-07
OTHER MEDICINES AND EXEMESTANE TABLETS Please tell your doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without prescription. Exemestane tablets should not be given at the same time as hormone replacement therapy (HRT). Tell your doctor if you are taking any of the following medicines: * rifampicin (an antibiotic), * drugs used to treat epilepsy (carbamazepine or phenytoin), * the herbal remedy St Johns Wort, (Hypericum perforatum), or preparations containing it. EXEMESTANE TABLETS WITH FOOD, DRINK AND ALCOHOL Exemestane Tablets should be taken after meal at approximately the same time each day. PREGNANCY, BREAST-FEEDING AND FERTILITY Do not take Exemestane tablets if you are pregnant or breastfeeding. If you are pregnant or think you might be, tell your doctor. Discuss contraception with your doctor if there is any possibility that you may become pregnant. Ask your doctor or pharmacist for advice before taking any medicine. DRIVING AND USING MACHINES If you feel drowsy, dizzy or weak whilst taking Exemestane tablets, you should not attempt to drive or operate machinery. HOW TO TAKE EXEMESTANE TABLETS Adults and the elderly Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Exemestane tablets should be taken by mouth after meal at approximately the same time each day. Your doctor will tell you how to take Exemestane and for how long. The recommended dose is one 25 mg tablet daily. If you need to go to the hospital whilst taking Exemestane tablets, let the medical staff know what medication you are taking. USE IN CHILDREN Exemestane tablets is not suitable for use in children. IF YOU TAKE MORE EXEMESTANE TABLETS THAN YOU SHOULD If too many tablets are taken by accident, contact your doctor at once or go straight to the nearest hospital casualty department. Show them the pack of Exemestane tablets. IF YOU FORGET TO TAKE EXEMESTANE TABLETS Do not take a double dose to make up for a forgotten tablet Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Exemestane 25 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 25 mg exemestane Excipients with known effect: Each film-coated tablet contains mannitol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablets. Product imported from the United Kingdom. White to off white, round, biconvex film-coated Tablet with ‘E25’ on one side and plain on the other_._ 4 CLINICAL PARTICULARS As per PA1390/026/001 5 PHARMACOLOGICAL PROPERTIES As per PA1390/026/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS TABLET CORE Mannitol Cellulose Microcrystalline Crospovidone Sodium Starch Glycolate (Type A) Hypromellose E5 Polysorbate 80 Colloidal anhydrous silica Magnesium Stearate TABLET COATING Hypromellose 6cp (E464) Titanium dioxide (E171) Macrogol 400 6.2 INCOMPATIBILITIES Not applicable. 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_ _ _ _1_ _1_ _/_ _1_ _0_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _0_ _5_ _9_ _5_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the blister and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE This product does not require any special storage conditions. 6.5 NATURE AND CONTENTS OF CONTAINER Packs contain 30 Film-coated Tablets in White opaque blister packs Pročitajte cijeli dokument