Страна: Швеция
Язык: шведский
Источник: Läkemedelsverket (Medical Products Agency)
natriumalendronattrihydrat
STADA Arzneimittel AG
M05BA04
sodium
10 mg
Tablett
natriumalendronattrihydrat 13,05 mg Aktiv substans; laktosmonohydrat Hjälpämne
Apotek
Receptbelagt
Alendronsyra
Avregistrerad
2004-12-03
PACKAGE LEAFLET: INFORMATION FOR THE USER ALENDROSTAD 10 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 Alendrostad is and what it is used for 2. What you need to know before you take Alendrostad 3. How to take Alendrostad 4. Possible side effects 5. How to store Alendrostad 6. Contents of the pack and other information 1. WHAT ALENDROSTAD IS AND WHAT IT IS USED FOR Alendronate belongs to a group of medicines called bisphosphonates. Alendronate prevents the loss of bone, and reduces the risk of spine and hip fractures. ALENDROSTAD IS USED to treat OSTEOPOROSIS. It is also used to prevent osteoporosis in people who are taking medicines called glucocorticoids (medicines which may be used to treat inflammations). Alendrostad has been shown to REDUCE THE RISK OF SPINE AND HIP FRACTURES in women and SPINE FRACTURES in men. Osteoporosis is a thinning and weakening of the bones. Early on, osteoporosis usually has no symptoms, but if left untreated it can cause fractured bones. Although these usually hurt, fractures in the spine may go unnoticed until they cause height loss. Fractures can happen during normal, everyday activity, such as lifting, or from minor injury that would not damage healthy bone. Fractures usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable problems like stooped posture (‘dowager’s hump’) and loss of mobility. As well as your treatment with Alendrostad, your doctor may suggest you make changes to your Прочитать полный документ
Produktinformationen för Alendrostad 10 mg tablett, MTnr 21347, 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 när Sverige är referensland för produkten. 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 Alendrostad 10 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg alendronic acid (as sodium alendronate trihydrate). Excipients: each tablet contains 103.95 mg 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. Treatment of osteoporosis in men at increased risk of fracture. A reduction in the incidence of vertebral, but not of non-vertebral fractures has been demonstrated. Prophylaxis of glucocorticoid-induced osteoporosis (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use only. _Post-menopausal osteoporosis:_ The recommended dosage is 10 mg once daily. _Osteoporosis in men at increased risk of fracture:_ The recommended dosage is 10 mg once daily. _Glucocorticoid-induced osteoporosis:_ For post-menopausal women who are not receiving oestrogen treatment the recommended dose is one 10 mg tablet daily. For other populations, see summary of product characteristics for preparations that contain 5 mg alendronate. _To obtain satisfactory absorption of alendronate_ Alendrostad tablets must be taken on an empty stomach immediately on rising in the morning, _ _ with Прочитать полный документ