Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Risedronate sodium
Accord Healthcare Limited
M05BA; M05BA07
Risedronate sodium
75 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Bisphosphonates; risedronic acid
Not marketed
2008-10-24
Health Products Regulatory Authority 31 January 2019 CRN008J10 Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Actonel 75 mg Film Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Film-coated tablet contains 75 mg risedronate sodium, (equivalent to 69.6 mg risedronic acid). For the list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Oval pink 11.7 x 5.8 mm film-coated tablet engraved with RSN on one side and 75 mg on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of osteoporosis in postmenopausal women at increased risk of fractures (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose in adults is one 75 mg tablet orally on two consecutive days a month. The first tablet should be taken on the same day each month, followed by the second tablet the next day. 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. This has also been shown in the very elderly, 75 years old and above, postmenopausal population. _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). Health Products Regulatory Authority 31 January 2019 CRN008J10 Page 2 of 13 _Paediatric population_ 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 risedronate sodium is affected by food and polyvalent cations (see section 4.5), thus to ensure adequate absorption patients should take Optinate 75 mg before breakfast: at least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day. Plain water is the on Læs hele dokumentet