Country: Żvezja
Lingwa: Svediż
Sors: Läkemedelsverket (Medical Products Agency)
risedronatnatrium
Theramex Ireland Limited
M05BA07
risedronate
35 mg
Filmdragerad tablett
risedronatnatrium 35 mg Aktiv substans; laktosmonohydrat Hjälpämne
Apotek
Receptbelagt
Risedronsyra
Förpacknings: Blister, 1 x 1 tablett; Blister, 1 x 2 tabletter; Blister, 1 x 4 tabletter; Blister, 1 x 10 tabletter; Blister, 1 x 12 tabletter; Blister, 1 x 16 tabletter
Godkänd
2002-07-19
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AVESTRA SEPTIMUM 35 MG FILM-COATED TABLETS risedronate sodium 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 Avestra Septimum is and what it is used for 2. What you need to know before you take Avestra Septimum 3. How to take Avestra Septimum 4. Possible side effects 5. How to store Avestra Septimum 6. Contents of the pack and other information 1. WHAT AVESTRA SEPTIMUM IS AND WHAT IT IS USED FOR WHAT AVESTRA SEPTIMUM IS Avestra Septimum belongs to a group of non-hormonal medicines called bisphosphonates which are used to treat bone diseases. It works directly on your bones to make them stronger and therefore less likely to break. Bone is a living tissue. Old bone is constantly removed from your skeleton and replaced with new bone. Postmenopausal osteoporosis is a condition occurring in women after the menopause where the bones become weaker, more fragile and more likely to break after a fall or strain. Osteoporosis can also occur in men due to a number of causes including ageing and/or a low level of the male hormone, testosterone. The spine, hip and wrist are the most likely bones to break, although this can happen to any bone in your body. Osteoporosis–related fractures can also cause back pain, height loss and a curved back. Many patients with osteoporosis have no symptoms and you may not even have known that you had it. WHAT AVESTRA SEPTIMUM IS USED FOR Treatment of osteoporosis in postmenopausal women, even if osteoporosis Aqra d-dokument sħiħ
Produktinformationen för Avestra Septimum 35 mg filmdragerad tablett, MTnr 17859, 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 THE PRODUCT CHARACTERISTICS 1 N AME OF THE M EDICINAL P RODUCT Avestra Septimum 35 mg film-coated tablets. 2 Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Each film-coated tablet contains 35 mg risedronate sodium (equivalent to 32.5 mg risedronic acid). Excipients: Each film-coated tablet contains lactose. For a full list of excipients, see section 6.1. 3 P HARMACEUTICAL F ORM Film-coated tablet. Oval light-orange film-coated tablet with RSN on one side and 35 mg on the other. 4 C LINICAL P ARTICULARS 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 Avestra Septimum 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 Avestra Septimum 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 Aqra d-dokument sħiħ