Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
RISEDRONATE SODIUM (HEMIPENTAHYDRATE)
Pfizer Healthcare Ireland
RISEDRONATE SODIUM (HEMIPENTAHYDRATE)
30 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2012-04-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Risedronate sodium Pfizer 30mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 30 mg risedronate sodium (as risedronate sodium hemipentahydrate), equivalent to 27.8 mg risedronic acid. Excipients: Each film-coated tablet contains 147.6 mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off-white colored, circular shaped film coated biconvex tablets debossed with ‘L’ on one side and ‘30’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of Paget’s disease of the bone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended daily dose in adults is one 30 mg tablet orally for 2 months. If re-treatment is considered necessary (at least two months post-treatment), a new treatment with the same dose and duration of therapy could be given. The absorption of Risedronate sodium is affected by food, thus to ensure adequate absorption patients should take Risedronate Sodium: Before breakfast: At least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day. In the particular instance that before breakfast dosing is not practical, Risedronate sodium can be taken between meals or in the evening at the same time everyday, with strict adherence to the following instructions, to ensure Risedronate sodium is taken on an empty stomach: Between meals: Risedronate sodium should be taken at least 2 hours before and at least 2 hours after any food, medicinal product or drink (other than plain water). In the evening: Risedronate sodium should be taken at least 2 hours after the last food, medicinal product or drink (ot Přečtěte si celý dokument