Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ALENDRONIC ACID
Pliva Pharma Limited
10 Milligram
Tablets
2006-12-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fosalen 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg alendronic acid (as sodium alendronate trihydrate). Excipients: Each tablet contains 103.95 mg of lactose monohydrate. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off-white, capsule-shaped tablet, embossed "AN 10" on one side and "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 only. The recommended dosage is 10 mg once daily. _To obtain satisfactory absorption of alendronate_ Fosalen tablets must be taken on an empty stomach immediately on rising in the morning, with plain water only, at least 30 minutes before the first food, drink or other medication of the day. Other drinks (including mineral water), food and some medicines are likely to reduce the absorption of alendronate (see section 4.5). _To assist delivery to the stomach and thus reduce the risk of irritation/side effects locally and in the oesophagus (see_ _section 4.4)_ • Fosalen tablets should only be swallowed on arising for the day with a whole glass of water (not less than 200 ml or 7 fl. oz). • Fosalen tablets should be swallowed whole. The tablets should not be crushed, chewed, or allowed to dissolve in the mouth on account of the risk of oropharyngeal ulceration. • Patients should not lie down until after the first meal of the day, which must be at least 30 minutes after taking the tablet. • Patients should not lie down within 30 minutes of taking Fosalen 10 mg tablets. • Fosalen 10 mg tablets should not Read the complete document