Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Risedronate sodium
Accord Healthcare Limited
M05BA; M05BA07
Risedronate sodium
30 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Bisphosphonates; risedronic acid
Not marketed
2000-03-20
Health Products Regulatory Authority 31 January 2019 CRN008J10 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Actonel 30 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 30 mg risedronate sodium (equivalent to 27.8 mg risedronic acid). Excipients: Each film-coated tablet contains lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Oval white film-coated tablet with RSN on one side and 30 mg on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of Paget’s disease of the bone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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. Special populations Elderly No dosage adjustment is necessary since bioavailability, distribution and elimination were similar in elderly (>60 years of age) compared to younger subjects. _Renal Impairment_ No dosage adjustment is required for those patients with mild to moderate renal impairment. The use of risedronate sodium is contraindicated in patients with severe renal impairment (creatinine clearance lower than 30 ml/min) (see sections 4.3 and 5.2). _Paediatric population_ Health Products Regulatory Authority 31 January 2019 CRN008J10 Page 2 of 10 Risedronate sodium is not recommended for use in children below age 18 due to insufficient data on safety and efficacy (see section 5.1). Method of administration The absorption of Actonel is affected by food, thus to ensure adequate absorption patients should take Actonel: - 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, Actonel can be taken between meals or in the evening at the same time everyday, with stric Baca dokumen lengkapnya