البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
SODIUM ALENDRONATE
Milpharm Limited
SODIUM ALENDRONATE
10 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alendronic Acid Aurobindo 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg alendronic acid (as sodium alendronate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off-white, round, biconvex, uncoated tablets debossed with ‘F’ on one side and ‘18’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In post-menopausal women with osteoporosis, Alendronic Acid Aurobindo is indicated for the treatment of osteoporosis to prevent fractures, including those of the hip and spine (vertebral compression fractures). Alendronic Acid Aurobindo is indicated for the treatment of osteoporosis in men to prevent fractures. Alendronic Acid Aurobindo is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women. In post-menopausal women who are at risk of developing osteoporosis Alendronic Acid Aurobindo is indicated for the prevention of osteoporosis to reduce the risk of future fracture. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Treatment of osteoporosis in postmenopausal women_ The recommended dose is 10 mg once a day. _Treatment of osteoporosis in men_ The recommended dose is 10 mg once a day. _Treatment and prevention of glucocorticoid-induced osteoporosis_ For post-menopausal women not receiving harmone replacement therapy (HRT) with an oestrogen, the recommended dosage is 10 mg once a day. For other patients (i.e. men, pre-menopausal women and post-menopausal women receiving HRT with an oestrogen), the recommended dosage is 5 mg once a day. _Prevention of osteoporosis in post-menopausal women: _The recommended dosage is 5 mg once a day. _To permit adequate absorption of alendronic acid:_ Alendro اقرأ الوثيقة كاملة