Land: Sverige
Sprog: svensk
Kilde: Läkemedelsverket (Medical Products Agency)
risedronatnatrium
Theramex Ireland Limited
M05BA07
risedronate
35 mg
Enterotablett
risedronatnatrium 35 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 4 tabletter; Blister, 1 tablett; Blister, 2 tabletter; Blister, 12 tabletter; Blister, 10 tabletter; Blister, 16 tabletter
Godkänd
2016-11-28
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OPTINATE SEPTIMUM 35 MG GASTRO-RESISTANT 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 Optinate Septimum is and what it is used for 2. What you need to know before you take Optinate Septimum 3. How to take Optinate Septimum 4. Possible side effects 5. How to store Optinate Septimum 6. Contents of the pack and other information 1. WHAT OPTINATE SEPTIMUM IS AND WHAT IT IS USED FOR WHAT OPTINATE SEPTIMUM IS Optinate 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. 2 WHAT OPTINATE SEPTIMUM IS USED FOR Treatment of osteoporosis in postmenopausal women, even if osteoporosis is Læs hele dokumentet
SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Optinate Septimum 35 mg gastro-resistant tablets 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 Optinate Septimum 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 Optinate Septimum 35 mg gastro-resistant tablets should be taken orally in the morning immediately Læs hele dokumentet