Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SODIUM ALENDRONATE
Arrow Generics Limited
70 Milligram
Tablets
2008-11-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alendromax Once Weekly 70mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 70mg alendronic acid (as sodium alendronate trihydrate) Excipient: Each tablet contains 142.64 mg lactose monohydrate For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white, oval tablet, embossed "AN 70" on one side and the 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. The recommended dose is one 70 mg tablet per week. 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 Once Weekly on an individual patient basis, particularly after 5 or more years of use. _To permit adequate absorption of alendronate:_ Alendromax Once Weekly 70mg Tablets 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 4.5 ‘Interaction with other medicinal products and other forms of interaction’). _To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal irritation/adverse_ _experiences (see 4.4 ‘Special warnings and precautions for use’)_: • Alendromax Once Weekly 70mg Tablets 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 on Read the complete document