Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ALENDRONIC ACID
McDermott Laboratories Ltd t/a Gerard Laboratories
10 Milligram
Tablets
2006-10-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fostepor 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg alendronic acid, as sodium alendronate Excipient: Lactose monohydrate. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, oval shaped tablet embossed "AD10" on one side and "G" on the reverse; 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of osteoporosis in postmenopausal women. Treatment of osteoporosis in men to reduce the risk of vertebral fractures (see section 5.1) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Treatment of osteoporosis in post-menopausal women_: The recommended dosage is 10 mg once a day _Treatment of osteoporosis in men_: The recommended dosage is 10 mg once a day _Prophylaxis of glucocorticoid-induced osteoporosis_ For post-menopausal women who are not receiving oestrogen treatment the recommended dose is one 10 mg tablet daily. _To permit adequate absorption of alendronate_: Fostepor must be taken at least 30 minutes before the first food, beverage, or medicinal product of the day with plain water only. Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of alendronate (see section 4.5). To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal irritation/adverse experiences (see section 4.4): • Fostepor should only be swallowed upon arising for the day with a full glass of water (not less than 200 ml or 7 fl.oz.). • Patients should only swallow Fostepor whole. Patients should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration. • Patients should not lie down until after th Read the complete document