Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SODIUM ALENDRONATE
Arrow Generics Limited
10 Milligram
Tablets
2008-11-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alendromax 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg alendronic acid (as sodium alendronate trihydrate). Excipient: Each tablet contains 103.95 mg lactose monohydrate For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off-white, capsule-shaped tablet, embossed "AN 10" on one side and "Arrow logo" on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of post-menopausal osteoporosis. Alendronate reduces the risk of vertebral and hip fractures. Treatment of osteoporosis in men. Alendronate reduces the risk of vertebral fractures. Treatment and prophylaxis of glucocorticoid-induced osteoporosis in post-menopausal women who are not receiving hormone replacement therapy (HRT) with an oestrogen. See 5.1 Pharmacodynamic properties. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Post-menopausal osteoporosis:_ The recommended dosage is 10 mg once daily. _Osteoporosis in men:_ The recommended dosage is 10 mg once daily. _Glucocorticoid-induced osteoporosis:_ For post-menopausal women who are not receiving oestrogen treatment the recommended dose is one 10 mg tablet daily. For other patients, preparations containing 5 mg alendronate should be used. The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Alendromax on an individual patient basis, particularly after 5 or more years of use. _To permit adequate absorption of alendronate:_ Alendromax 10 mg tablets must be taken at least 30 minutes before the first food, beverage, or medicinal product of the day with plain water only. IRISH MEDICINES BOARD ______ Read the complete document