Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Risedronate sodium
Teva Pharma B.V.
M05BA; M05BA07
Risedronate sodium
35 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Bisphosphonates; risedronic acid
Marketed
2008-12-12
RISONATE ONCE WEEKLY 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 sign 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. 1. What Risonate Once Weekly is and what it is used for 2. What you need to know before you take Risonate Once Weekly 3. How to take Risonate Once Weekly 4. Possible side effects 5. How to store Risonate Once Weekly 6. Contents of the pack and other information WHAT RISONATE ONCE WEEKLY IS AND WHAT IT IS USED FOR WHAT RISONATE ONCE WEEKLY IS Risonate Once Weekly 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 RISONATE ONCE WEEKLY IS USED FOR The treatment of osteoporosis • in postmenopausal women, even if osteoporosis is severe. It reduces the risk of spinal an Läs hela dokumentet
Health Products Regulatory Authority 18 November 2020 CRN009ZH2 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Risonate Once Weekly 35 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Film-coated Tablet contains 35 mg risedronate sodium (equivalent to 32.5 mg risedronic acid). Excipients with known effect: Each Film-coated Tablet contains 140 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet. Orange, round, Film-coated Tablet, debossed with “R35”on one side and plain on the other. 4 CLINICAL PARTICULARS 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 Posology 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. Patients should be instructed that if a dose is missed, one 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 tablet is normally taken. Two tablets should not be taken on the same day. Supplemental calcium and vitamin D should be considered if the dietary intake is inadequate. 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 sodium on an individual patient basis, particularly after 5 or more years of use. _Elderly_ No dosage adjustment is necessary since bioavailability, distribution and elimination were similar in elderly (>60 years of age) compared to younger subjects. This has also been shown in the very elderly, 75 years old and above postmenopausal population. Läs hela dokumentet