Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
PENICILLAMINE
Alliance Pharmaceuticals Ltd.
PENICILLAMINE
250 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-08-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Distamine 250 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250mg penicillamine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet. A white, film-coated tablet with a diameter of 10mm, marked 'DM' on one face and '250' on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS a) Severe active rheumatoid arthritis, including juvenile forms b) Wilson’s disease (hepatolenticular degeneration) c) Cystinuria – dissolution and prevention of cystine stones d) Lead poisoning e) Chronic active hepatitis 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration If possible, Distamine should be taken at least half an hour before meals, or on retiring. A) RHEUMATOID ARTHRITIS _Adults:_ 125 to 250mg daily for the first month. Increase by the same amount every four to 12 weeks until remission occurs. The minimum maintenance dose to achieve suppression of symptoms should be used and treatment should be discontinued if no benefit is obtained within 12 months. Improvement may not occur for some months. The usual maintenance dose is 500 to 750mg daily. Up to 1500mg daily may be required. If remission is established and has been sustained for six months, gradual reduction by 125 to 250mg amounts every 12 weeks may be attempted. _The elderly:_ Increased toxicity has been observed in this patient population regardless of renal function. Initial dose should not exceed 125mg daily for the first month, increasing by a similar increment every four to 12 weeks until the minimum maintenance dose to suppress symptoms is reached. Daily dosage should not exceed 1000mg. _Children:_ 15 to 20mg/kg/day is considered appropriate in the majority Perskaitykite visą dokumentą