Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
ALENDRONATE MONOSODIUM TRIHYDRATE
Laboratorios Davur S.L.U.
70 Milligram
Tablets
2010-06-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alendronic Acid Once Weekly 70mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains the equivalent of 70 mg of alendronic acid (as 91.37 mg alendronate monosodium trihydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White oval flat tablets, with dimensions of 14 x 8 mm and marked on one face with “70” 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of postmenopausal osteoporosis. Sodium alendronate 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: Sodium alendronate 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'): o Sodium alendronate should only be swallowed upon arising for the day with a full glass of water (not less than 200 ml or 7 fl.oz.). o Patients should not chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration. o Patients should not lie down until after their first food of the day which should be at least 30 minutes after taking the tablet. o Patients should not lie down for at least 30 minutes after taking Sodium alendronate. o Sodium alendronate should not Læs hele dokumentet