Land: Schweden
Sprache: Schwedisch
Quelle: Läkemedelsverket (Medical Products Agency)
natriumalendronattrihydrat
ratiopharm GmbH
M05BA04
sodium
70 mg
Tablett
natriumalendronattrihydrat 91,36 mg Aktiv substans; laktosmonohydrat Hjälpämne
Apotek
Receptbelagt
Alendronsyra
Förpacknings: Blister, 2 tabletter; Blister, 4 tabletter; Blister, 12 tabletter; Blister, 8 tabletter; Blister, 40 tabletter
Avregistrerad
2004-12-03
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _ALENDRONAT RATIOPHARM VECKOTABLETT 70 MG TABLETS_ Alendronic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Alendronat ratiopharm Veckotablett is and what it is used for 2. What you need to know before you take Alendronat ratiopharm Veckotablett 3. How to take Alendronat ratiopharm Veckotablett 4. Possible side effects 5. How to store Alendronat ratiopharm Veckotablett 6. Contents of the pack and other information 1. WHAT ALENDRONAT RATIOPHARM VECKOTABLETT IS AND WHAT IT IS USED FOR WHAT ALENDRONAT RATIOPHARM VECKOTABLETT IS Alendronat ratiopharm Veckotablett belongs to a group of medicines (called bisphosphonates) that are used in the treatment of bone disorders. The medicine works directly on your bones, making them stronger and thus less likely to break. The bone is a living tissue, i.e. the body is continuously breaking down old bone tissue in the skeleton and replacing it with new tissue. In women after the menopause, bone loss (postmenopausal osteoporosis) can occur. The bones become thinner and more brittle and are more likely to break following a fall or a sprain. WHAT ALENDRONAT RATIOPHARM VECKOTABLETT IS USED FOR Alendronat ratiopharm Veckotablett is used in the treatment of bone loss (osteoporosis) in women after the menopause, in order to reduce the risk of spinal and hip fractures. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALENDRONAT RATIOPHARM VECKOTABLETT DO NOT TAKE ALENDRONAT RATIOPHARM VECKOTABLETT • if you are allergic to a Lesen Sie das vollständige Dokument
Produktinformationen för Alendronat ratiopharm Veckotablett 70 mg veckotablett MTnr 21346, gäller vid det tillfälle då läkemedlet godkändes. Informationen kommer inte att uppdateras eftersom läkemedlet inte marknadsförs i Sverige. Av samma anledning finns inte någon svensk produktinformation. Den engelska produktinformationen kommer dock att uppdateras för de produkter där Sverige är referensland. Om läkemedelsnamnet i följande produktinformation inte stämmer med namnet på dokumentet, beror det på att läkemedlet i Sverige är godkänt under ett annat namn. SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alendronat ratiopharm Veckotablett 70 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 70 mg alendronic acid (as sodium alendronate trihydrate). Excipient with known effect: 136 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white, oval tablet, embossed "AN 70" on one side and the Arrow logo on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of postmenopausal osteoporosis. Alendronate reduces the risk of vertebral and hip fractures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. Posology 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 alendronate on an individual patient basis, particularly after 5 or more years of use. Method of administration _To permit adequate absorption of alendronate_ Alendronat ratiopharm Veckotablett 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 potentia Lesen Sie das vollständige Dokument