देश: नीदरलैंड
भाषा: डच
स्रोत: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
NATRIUMALENDRONAAT 3-WATER SAMENSTELLING overeenkomend met ; ALENDRONINEZUUR
Basics GmbH Hemmelrather Weg 201 51377 LEVERKUSEN (DUITSLAND)
Alendronate sodium 3-WATER COMPOSITION corresponding to ; alendronic acid
Tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 0-WATER ; MAGNESIUMSTEARAAT (E 470b)
Oraal gebruik
2021-02-05
PACKAGE LEAFLET. INFORMATION FOR THE USER ALENDRONINEZUUR BASICS 10 MG, TABLETTEN alendroninezuur 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. - It is particularly important to understand the information in section 3 How to take Alendroninezuur BASICS, before taking this medicine. WHAT IS IN THIS LEAFLET: 1. What Alendroninezuur BASICS 10mg Tablets are and what they are used for 2. What you need to know before you take Alendroninezuur BASICS 10mg Tablets 3. How to take Alendroninezuur BASICS 10mg Tablets 4. Possible side effects 5. How to store Alendroninezuur BASICS 10mg Tablets 6. Contents of the pack and other information 1. WHAT ALENDRONINEZUUR BASICS 10MG TABLETS ARE AND WHAT THEY ARE USED FOR WHAT IS ALENDRONINEZUUR BASICS Alendronic Acid is a tablet containing the active substance alendronic acid (commonly called alendronate) and belongs to a group of medicines called bisphosphonates. Alendronic Acid prevents the loss of bone that occurs in women after they have been through the menopause. It can also prevent loss of bone in men or people taking steroids, such as prednisolone and methylprednisolone. It also has been shown to help rebuild bone and makes bone and reduce the risk of spine and hip fractures (broken bones) in women (after their menopause) and in men who have thinning of their bones (osteoporosis). WHAT IS ALENDRONINEZUUR BASICS USED FOR Your doctor has prescribed alendronic acid because you either have osteoporosis or you are at risk of developing this disease. WHAT IS OSTEOPOROSIS? Osteoporosis i पूरा दस्तावेज़ पढ़ें
S UMMARY OF P RODUCT C HARACTERISTICS 1. N AME OF THE M EDICINAL P RODUCT _ _ Alendroninezuur BASICS 10 mg tabletten _ _ 2. Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Each tablet contains 10mg alendronic acid (as sodium alendronate). Excipients with known effect: Each tablet contains 38.867mg lactose anhydrous. For the full list of excipients see section 6.1. 3. P HARMACEUTICAL F ORM Tablet White to off white, oval, biconvex tablet, approximately 9.00 x 4.50 mm in dimensions, debossed with “10” on one side and plain on other side. 4. C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of postmenopausal osteoporosis. Alendroninezuur BASICS 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. • Behandlung und Präventionlaxis of glucocorticoid-induced osteoporosis. Risk factors often associated with the development of osteoporosis include thin body build, family history of osteoporosis, early menopause, moderately low bone mass and long-term glucocorticoid therapy, especially with high doses (15 mg/day). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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 Alendroninezuur BASICS on an individual patient basis, particularly after 5 or more years of use. _Treatment of post-menopausal osteoporosis:_ _ _ The recommended dosage is 10 mg once daily. _Treatment of osteoporosis in men:_ _ _ The recommended dosage is 10 mg once daily. _Treatment and Prevention of 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 _Elderly_ In clin पूरा दस्तावेज़ पढ़ें