Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Risedronate sodium
Accord Healthcare Limited
M05BA; M05BA07
Risedronate sodium
5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Bisphosphonates; risedronic acid
Marketed
2000-03-20
Health Products Regulatory Authority 31 January 2019 CRN008J10 Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Actonel 5 mg film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg risedronate sodium (equivalent to 4.64 mg risedronic acid). Excipient with known effect: Each film-coated tablet contains lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Oval yellow film-coated tablet with RSN on one side and 5 mg on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures. Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis (see section 5.1) To maintain or increase bone mass in postmenopausal women undergoing long‑term (more than 3 months), systemic corticosteroid treatment at doses ³7.5 mg/day prednisone or equivalent. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended daily dose in adults is one 5 mg tablet orally. 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_ Health Products Regulatory Authority 31 January 2019 CRN008J10 Page 2 of 14 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_ 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 l Lestu allt skjalið