Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pyridostigmine bromide
CST Pharma Ltd
N07AA02
Pyridostigmine bromide
60mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10020100; GTIN: 5055946801575
• Suffer from a condition called vagotonia (this is a condition where overactivity of the vagus nerve causes symptoms such as slow heart rate, low blood pressure, constipation, sweating and painful muscle spasms). • Have an overactive thyroid gland • Have had an operation to remove your thymus gland. There is no evidence to suggest that Mestinon has any special effects on elderly patients. TAKING OTHER MEDICINES Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. THIS IS EXTREMELY IMPORTANT, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines. In particular, tell your doctor if you are taking any of the following medicines: • Medicines known as steroids or other immunosuppressant medicines. • Medicines known as antimuscarinics (e.g. atropine, hyoscine). • Medicines containing methylcellulose • Antibiotics • Medicines to treat an irregular heart beat • Other medicines that interfere with transmission between nerves and muscles IF YOU ARE GOING TO HAVE SURGERY Tell your doctor that you are taking Mestinon. Mestinon can stop the effect of some medicines used to relax muscles during surgery (e.g. pancuronium, vencuronium). Mestinon can also prolong the effect of other muscle relaxants (e.g. suxamethonium). PREGNANCY AND BREAST-FEEDING Tell your doctor before you start treatment if you: • Are pregnant, if you think you are pregnant, or if you intend to become pregnant. • Are breast-feeding, as Mestinon passes into breast milk in small amounts. Your doctor will then decide if you can take this medicine. DRIVING AND USING MACHINES Mestinon may reduce the sharpness of your eyesight and therefore your ability to drive or use machines. Do not drive or operate machines if this medicine affects your ability to see clearly. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF MESTINON TABLETS M estinon Tablets contain lactose. Therefore, if you have been Les hele dokumentet
_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. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet for oral administration. 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. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Myasthenia gravis, paralytic ileus and post-operative urinary retention. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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. Paediatric population 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 to 30 – 360mg. Other Indications (paralytic ileus, post-operative urinary retention) Adults The usual dose is 1 to 4 tablets (60 – 240mg) per day. Paediatric population The usual dose is 15 – 60mg per day. The frequency of these doses may be varied according to the needs of the patient. Special populations Elderly There are no specific dosage recommendations for Mestinon in elderly patients. Renal impairment Mestinon 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. Hepatic impairment There a Les hele dokumentet