Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ALENDRONATE SODIUM TRIHYDRATE
B & S Healthcare
70 Milligram
Tablets
2009-04-24
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: Also includes anhydrous lactose. For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from Italy:_ 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. _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 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')_: • '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 not 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 their first food of the day which should be at least 30 minutes after taking the tablet. • Patients should not lie down for at least 30 minutes after taking Read the complete document