País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Megestrol acetate
LTT Pharma Limited
L02AB; L02AB01
Megestrol acetate
160 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Progestogens; megestrol
Authorised
2017-01-20
DRIVING AND USING MACHINES Megace Tablets do not usually affect your ability to drive. MEGACE TABLETS CONTAINS LACTOSE If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. HOW TO TAKE MEGACE TABLETS Always take Megace tablets exactly as your doctor has told you. You should check with your doctor if you are not sure. The usual dosage is 160 mg megestrol acetate per day. Tablets should be swallowed with a glass of water. This medicine is not recommended for children. Megace tablets should be taken for at least two months to see if they are effective. Some patients take them for many years. DO NOT STOP TAKING THEM, unless advised to do so by your doctor. IF YOU TAKE MORE MEGACE TABLETS THAN YOU SHOULD If you take more Megace than you should, go to your nearest hospital emergency department or contact your doctor immediately. Take the empty container and any remaining medicine with you. IF YOU FORGET TO TAKE MEGACE TABLETS If you miss a dose, do not worry. If you remember within a few hours of the missed dose take it as soon as possible, but if it is almost time for your next dose then skip the forgotten one and continue as before. Do not take a double dose to make up for the one you missed. POSSIBLE SIDE EFFECTS As with all medicines, Megace can cause side effects although not everybody gets them. If you notice any of the following, stop taking Megace and contact your doctor immediately: * swelling of the face, lips, or tongue * skin rash * difficulty breathing As these may be signs of an allergic reaction. Other side effects which may occur with Megace tablets are: Very Common (affects more than 1 in 10 people) * increase in appetite and weight gain (not associated with water retention) * shortness of breath * hot flushes, reddening of the face and neck * high blood pressure * increased blood sugar levels PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Megace 160 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Megestrol Acetate 160 mg. Excipient with known effect: Each tablet contains Lactose Monohydrate. _For the full list of excipients, see section 6.1_. 3 PHARMACEUTICAL FORM Tablet White, oval, biconvex tablets with a breakline scored on one side and engraved ‘160’ on the other side. _Product imported from Greece_ The break line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS As per PA1696/002/001 5 PHARMACOLOGICAL PROPERTIES As per PA1696/002/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS microcrystalline cellulose, lactose monohydrate, magnesium stearate, povidone, colloidal anhydrous silica, sodium starch glycolate. Purified water. 6.2 INCOMPATIBILITIES Not applicable. 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 Do not store above 25°C. Store in the original package in order to protect from moisture. 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_ _ _ _2_ _4_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _3_ _5_ _0_ _6_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER Blister packs of 30 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USE Llegiu el document complet