País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Pyridostigmine bromide
LTT Pharma Limited
N07AA; N07AA02
Pyridostigmine bromide
60 milligram(s)
Tablet
Oral use
200 tablets
Product subject to prescription which may be renewed (B)
Labiana Pharmaceuticals S.L.U.
Anticholinesterases
Anticholinesterases; pyridostigmine
Myasthenia gravis, paralytic ileus and post-operative urinary retention
Authorised
2015-08-13
MESTINON 60MG TABLETS (pyridostigmine bromide) PATIENT INFORMATION LEAFLET 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. WHAT IS IN THIS LEAFLET: What Mestinon Tablets are and what they are used for What you need to know before you take Mestinon Tablets How to take Mestinon Tablets Possible side effects How to store Mestinon Tablets Contents of the pack and other information WHAT MESTINON TABLETS ARE AND WHAT THEY ARE USED FOR Mestinon tablets contain the active ingredient pyridostigmine, which belongs to a group of medicines called anticholinesterases, which improve the communication between the nerves and muscles. Mestinon tablets are used for: * Treatment of myasthenia gravis – a disease of the immune system causing muscle weakness * Paralytic ileus - a condition where the digestive tract does not work because its muscles are paralysed * Urinary retention after surgery – failure to urinate caused by an anaesthetic or certain types of surgery. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MESTINON TABLETS DO NOT TAKE MESTINON TABLETS: * If your digestive tract is twisted or blocked by an obstruction. * If you cannot pass urine because of an obstruction. * If you are allergic to pyridostigmine, brominde, or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Mestinon tablets if you have any of the following conditions: * Obstructive respi Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mestinon 60mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Tablet contains 60.0mg pyridostigmine bromide. Each Tablet contains lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from the UK_ White to off-white, round, biplanar, bevel-edged tablets imprinted with “ V ” M60 across one face and with two break marks forming a cross on the other. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS As per PA1332/034/001 5 PHARMACOLOGICAL PROPERTIES As per PA1332/034/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Colloidal hydrated silica maize starch lactose monohydrate talc magnesium stearate 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the bottle and outer package of the product on the market in the country of origin. 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_ _5_ _/_ _1_ _2_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _5_ _8_ _8_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25 ° C. Store in the original package. Keep the bottle tightly closed. 6.5 NATURE AND CONTENTS OF CONTAINER Amber glass bottles with a desiccant enclosed, containing 200 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MED Llegiu el document complet