국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Risedronate sodium
Accord Healthcare Ireland Ltd.
M05BA; M05BA07
Risedronate sodium
75 milligram(s)
Film-coated tablet
Bisphosphonates; risedronic acid
Not marketed
2018-07-06
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RISEDRONATE SODIUM ACCORD 75 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. The full name of this medicine is Risedronate Sodium Accord 75 mg film-coated tablets but within this leaflet it will be referred to as Risedronate Sodium Accord. WHAT IS IN THIS LEAFLET 1. What Risedronate Sodium Accord is and what it is used for 2. What you need to know before you take Risedronate Sodium Accord 3. How to take Risedronate Sodium Accord 4. Possible side effects 5. How to store Risedronate Sodium Accord 6. Contents of the pack and other information 1. WHAT RISEDRONATE SODIUM ACCORD IS AND WHAT IT IS USED FOR WHAT RISEDRONATE SODIUM ACCORD IS Risedronate Sodium Accord 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. 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 RISEDRON 전체 문서 읽기
Health Products Regulatory Authority 13 May 2020 CRN009PQP Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Risedronate Sodium Accord 75 mg Film Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Film-coated tablet contains 75 mg risedronate sodium, (equivalent to 69.6 mg risedronic acid). For the list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Oval pink 11.7 x 5.8 mm film-coated tablet engraved with RSN on one side and 75 mg on the other. 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 75 mg tablet orally on two consecutive days a month. The first tablet should be taken on the same day each month, followed by the second tablet the next day. Special populations _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. _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 (see section 5.1). Method of administration - The absorption of risedronate sodium is affected by food and polyvalent cations (see section 4.5), thus to ensure adequate absorption patients should take Risedronate Sodium Accord 75 mg before breakfast: at least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day. Plain water is the only drink that should be taken with Risedronate 전체 문서 읽기