Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
RISEDRONATE SODIUM
Profind Wholesale Ltd.
35 Milligram
Film Coated Tablet
2009-06-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Actonel Once a Week 35mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 35mg risedronate sodium (equivalent to 32.5mg risedronic acid). Excipients: Each film-coated tablet contains lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet _Product imported from the UK and Italy:_ Oval light-orange film-coated tablet with RSN on one side and 35mg on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures (see section 5.1). Treatment of osteoporosis in men at high risk of fractures (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose in adults is one 35 mg tablet orally once a week. The tablet should be taken on the same day each week. The absorption of risedronate sodium is affected by food, thus to ensure adequate absorption patients should take Actonel Once a Week 35 mg: Before breakfast: At least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day. Patients should be instructed that if a dose is missed, one Actonel Once a Week 35 mg tablet should be taken on the day that the tablet is remembered. Patients should then return to taking one tablet once a week on the day the tablet is normally taken. Two tablets should not be taken on the same day. The tablet must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach Actonel Once a Week 35 mg is to be taken while in an upright position with a glass of plain w Lire le document complet