Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Pyridostigmine bromide
Lexon Pharmaceuticals (Ireland) Limited
N07AA; N07AA02
Pyridostigmine bromide
60 milligram(s)
Tablet
Anticholinesterases; pyridostigmine
2020-06-12
MESTINON 60 MG TABLETS pyridostigmine bromide 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, bromine, 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 respiratory diseases such as bron Läs hela dokumentet
Health Products Regulatory Authority 16 March 2022 CRN00CV8V Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mestinon 60 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Tablet contains 60 mg pyridostigmine bromide. Each Tablet contains lactose monohydrate. _For excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Tablet _ _ Product imported from Spain 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 tablet can be divided into equal halves. 4 CLINICAL PARTICULARS As per PA2010/052/001. 5 PHARMACOLOGICAL PROPERTIES As per PA2010/052/001. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose monohydrate Silicic acid Corn starch Talc Magnesium stearate Potato starch 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. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Store in the original package. Keep the bottle tightly closed. Health Products Regulatory Authority 16 March 2022 CRN00CV8V Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER Amber glass bottles with low density polyethylene caps and desiccant containing 2 x 100 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Lexon Pharmaceuticals (Ireland) Limited Block 3 Harcourt Centre Harcourt Road Dublin 2 Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA23176/028/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 th June 2020 10 DATE OF REVISION OF THE TEXT October 2021 Läs hela dokumentet