国家: 马耳他
语言: 英文
来源: Medicines Authority
PYRIDOSTIGMINE BROMIDE
Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
N07AA02
PYRIDOSTIGMINE BROMIDE 60 mg
TABLET
PYRIDOSTIGMINE BROMIDE 60 mg
POM
OTHER NERVOUS SYSTEM DRUGS
Authorised
2007-04-05
PACKAGE LEAFLET: INFORMATION FOR THE USER 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: 1. What Mestinon tablets are and what they are used for 2. What you need to know before you take Mestinon tablets 3. How to take Mestinon tablets 4. Possible side effects 5. How to store Mestinon tablets 6. Contents of the pack and other information 1. 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. 2. 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 t 阅读完整的文件
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 60.75mg lactose monohydrate. _ _ _For excipients, see section 6.1. _ 3. PHARMACEUTICAL FORM Tablet 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 4.1. THERAPEUTIC INDICATIONS Myasthenia gravis, paralytic ileus and post-operative urinary retention. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _ _ _Myasthenia gravis _ _Adults_ Doses of 30 to 120mg are given at intervals throughout the day when maximum strength is needed (for example, on rising and before mealtimes). The usual duration of action of a dose is 3 to 4 hours in the daytime but a longer effect (6 hours) is often obtained with a dose taken on retiring for bed. The total daily dose is usually in the range of 5 - 20 tablets but doses higher than these may be needed by some patients. _Children_ Children under 6 years old should receive an initial dose of half a tablet (30mg) of Mestinon; children 6-12 years old should receive one tablet (60mg). Dosage should be increased gradually, in increments of 15-30mg daily, until maximum improvement is obtained. Total daily requirements are usually in the range of 30 - 360mg _Other Indications (paralytic ileus)_ _Adults_ The usual dose is 1 to 4 tablets (60 to 240mg) per day. _Children_ The usual dose is 15 to 60mg per day. The frequency of these doses may be varied according to the needs of the patient. _Special Populations _ _Elderly patients_ There are no specific dosage recommendations for Mestinon in elderly patients. _ _ _Renal impairment _ Pyridostigmine bromide is mainly excreted unchanged by the kidney, therefore lower doses may be required in patients with renal disease and treatment should be based on titration of drug dosage to effect. _ 阅读完整的文件