Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
ALENDRONATE SODIUM
Merck Sharp and Dohme Limited
70 Milligram
Tablets
2001-05-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fosamax Once Weekly 70 mg tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains the equivalent of 70 mg alendronic acid as 91.37 mg of alendronate sodium trihydrate. Excipients: Each tablet contains 113.4 mg lactose anhydrous. For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet. Oval white tablets, marked with an outline of a bone image on one side, and ‘31’ on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of postmenopausal osteoporosis. ‘Fosamax’ reduces the risk of vertebral and hip fractures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dosage is one 70 mg tablet once weekly. 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 ‘Fosamax’ on an individual patient basis, particularly after 5 or more years of use. _To permit adequate absorption of alendronate:_ ‘Fosamax’ 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)_: • ‘Fosamax’ 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 ‘Fosamax’ whole. Patients should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a Läs hela dokumentet