Land: Nederländerna
Språk: nederländska
Källa: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
NATRIUMRISEDRONAAT 2,5-WATER 40,2 mg/stuk SAMENSTELLING overeenkomend met ; NATRIUMRISEDRONAAT 0-WATER 35 mg/stuk ; SAMENSTELLING overeenkomend met RISEDRONINEZUUR 32,5 mg/stuk
Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock D01 YE64 DUBLIN 1 (IERLAND)
M05BA07
NATRIUMRISEDRONAAT 2,5-WATER 40,2 mg/stuk SAMENSTELLING overeenkomend met ; NATRIUMRISEDRONAAT 0-WATER 35 mg/stuk ; SAMENSTELLING overeenkomend met RISEDRONINEZUUR 32,5 mg/stuk
Maagsapresistente tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; DINATRIUMEDETAAT 2-WATER ; IJZEROXIDE GEEL (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; SIMETICON ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TRIETHYLCITRAAT (E 1505), CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; DINATRIUMEDETAAT 2-WATER ; IJZEROXIDE GEEL (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; SIMETICON ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TRIETHYLCITRAAT (E 1505), CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; DINATRIUMEDETAAT 2-WATER ; IJZEROXIDE GEEL (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; SIMETICON ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TRIETHYLCITRAAT (E 1505),
Oraal gebruik
Risedronic Acid
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); DINATRIUMEDETAAT 2-WATER; IJZEROXIDE GEEL (E 172); MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POLYSORBAAT 80 (E 433); SILICIUMDIOXIDE (E 551); SIMETICON; STEARINEZUUR (E 570); TALK (E 553 B); TRIETHYLCITRAAT (E 1505);
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ACTONEL WEKELIJKS MSR 35 MG, MAAGSAPRESISTENTE TABLETTEN 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 Actonel Wekelijks is and what it is used for 2. What you need to know before you take Actonel Wekelijks 3. How to take Actonel Wekelijks 4. Possible side effects 5. How to store Actonel Wekelijks 6. Contents of the pack and other information 1. WHAT ACTONEL WEKELIJKS IS AND WHAT IT IS USED FOR WHAT ACTONEL WEKELIJKS IS Actonel Wekelijks 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. 2 WHAT ACTONEL WEKELIJKS IS USED FOR Treatment of osteoporosis in postmenopausal women, even if osteopo Läs hela dokumentet
SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Actonel Wekelijks MSR 35 mg, maagsapresistente tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 35 mg risedronate sodium (equivalent to 32.5 mg risedronic acid). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet. Oval, yellow, gastro-resistant tablet with “EC 35” engraved on one side. The dimensions of the tablet are as follows: width 13 mm, length 6 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of osteoporosis in postmenopausal women at increased risk of fractures (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose in adults is one Actonel Wekelijks 35 mg gastro-resistant tablet orally once a week. The tablet should be taken on the same day each week. 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 risedronate on an individual patient basis, particularly after 5 or more years of use. Special populations _Elderly _ Of the patients receiving risedronate 35 mg gastro-resistant tablets in postmenopausal osteoporosis studies, 59% were 65 and over, while 13 % were 75 and over. No overall differences in safety and effectiveness were observed between these patients and younger patients. _Patients with renal impairment _ No dosage adjustment is required for those patients with mild to moderate renal impairment. The use of risedronate sodium is contraindicated in patients with severe renal impairment (creatinine clearance lower than 30 ml/min) (see sections 4.3 and 5.2). _Paediatric population _ Risedronate sodium is not recommended for use in children below age 18 due to insufficient data on safety and efficacy (also see section 5.1). Method of administration Actonel Wekelijks 35 mg gastro-resistant tablets should be taken orally in the morning Läs hela dokumentet