Nazione: Israele
Lingua: inglese
Fonte: Ministry of Health
PYRIDOSTIGMINE BROMIDE
MEGAPHARM LTD
N07AA02
DRAGEE
PYRIDOSTIGMINE BROMIDE 60.0 MG
PER OS
Required
ICN POLFA RZESZOW S.A., POLAND
PYRIDOSTIGMINE
PYRIDOSTIGMINE
Treatment of myasthenia gravis.
2016-03-31
1 _ _ PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS - 1986_ _ This medicine is dispensed with a physician’s prescription only MESTINON DRAGEES 60 MG EACH DRAGEE CONTAINS: PYRIDOSTIGMINE BROMIDE 60 MG FOR A LIST OF INACTIVE AND ALLERGENIC INGREDIENTS, SEE SECTION 6 - “ADDITIONAL INFORMATION”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE._ _This leaflet contains concise information about the medicine._ _If you have further questions, consult your physician or pharmacist. This medicine has been prescribed for you. Do not pass it on to others._ _It may harm them even if it seems to you that their medical condition is similar._ _ 1. WHAT IS THIS MEDICINE INTENDED FOR?_ _ Treatment of myasthenia gravis. THERAPEUTIC GROUP:_ _ Cholinesterase inhibitors. MESTINON DRAGEES 60 MG contain the active ingredient Pyridostigmine bromide which acts as an inhibitor of the cholinesterase enzyme. This in turn blocks excessive breakdown of acetylcholine, a substance that transmits nerve impulses to the muscles. Patients who have myasthenia gravis feel that their muscles are weak and tire easily. In severe cases, they may even decline to muscle paralysis. 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE STARTING TREATMENT WITH MESTINON DRAGEES 60 MG, TELL YOUR PHYSICIAN IF: • You suffer from diseases of the respiratory tract such as asthma, bronchospasm or chronic obstructive pulmonary disease (COPD) • You suffer from heart diseases such as: worsening of heart failure (symptoms at rest), cardiac conduction disorders (AV block) or heart rhythm disorders such as slow heart rhythm, or you have recently had a heart attack (arrhythmia is more common in the older population) • You suffer from low blood pressure • You suffer from a stomach ulcer • You have had gastrointestinal surgery • You suffer from epilepsy • You suffer from Parkinson's disease • You are sensitive (allergic) to the active ingredient Pyri Leggi il documento completo
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT MESTINON DRAGEES 60 MG 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 coated tablet (dragee) contains 60 mg pyridostigmine bromide. Excipient(s) with known effect: Sucrose 161.6 mg/coated tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablet (dragee) for oral use Round, biconvex, orange-white or pale orange coloured sugar coated tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of myasthenia gravis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults _ Oral dosage forms: Multiple doses of 30 to 120 mg are given at intervals throughout the day. MESTINON DRAGEES 60 MG MUST NOT be divided. If available, use a tablet containing 30 mg pyridostigmine bromide for 30mg dose. The total daily dose is usually in the range of 120 – 1200 mg but doses higher than these may be needed by some patients according to dose titration. _Children _ Children under 6 years old should receive an initial dose of 30 mg of pyridostigmine bromide. MESTINON DRAGEES 60 MG MUST NOT be divided. If available, use a tablet containing 30 mg pyridostigmine bromide for 30 mg dose. Children 6 – 12 years old should receive 60 mg. Dosage should be increased gradually, in increments of 30 mg daily, until maximum improvement is obtained. Total daily requirements are usually in the range to 30 – 360 mg. Page 2 of 9 SPECIAL POPULATIONS _Elderly _ There are no specific dosage recommendations for MESTINON DRAGEES 60 MG in elderly patients. _Renal impairment _ MESTINON DRAGEES 60 MG 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 are no specific dosage recommendations for MESTINON DRAGEES 60 MG in patients with hepatic impairment. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substance, other bromides or to any of the excipients listed in section 6.1. - Leggi il documento completo