Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Risedronate sodium
Pinewood Laboratories Ltd,
M05BA; M05BA07
Risedronate sodium
35 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Bisphosphonates; risedronic acid
Marketed
2010-11-26
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RISEDRONATE PINEWOOD ONCE A WEEK 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 Risedronate Pinewood is and what it is used for 2. What you need to know before you take Risedronate Pinewood 3. How to take Risedronate Pinewood 4. Possible side effects 5. How to store Risedronate Pinewood 6. Contents of the pack and other information 1. WHAT RISEDRONATE PINEWOOD IS AND WHAT IT IS USED FOR WHAT RISEDRONATE PINEWOOD IS Risedronate Pinewood 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. Osteoporosis is more likely to occur in women who have reached the menopause early and also in patients treated long-term with steroids. 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 osteop Read the complete document
Health Products Regulatory Authority 08 March 2019 CRN008NDF Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Risedronate Pinewood Once a week 35 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 35 mg risedronate sodium which is equivalent to 32.5 mg risedronic acid. Excipients with known effect Each film-coated tablet contains 1.9 mg lactose. Each film-coated tablet contains 0.115 mmol (2.64 mg) of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White round biconvex film-coated tabletwith diameter of 11.2 mm, 5.0 mm in thickness and embossed with "35" on one side. 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. _Special populations_ _Elderly _ No dose 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 dose 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 18 years of age due to insufficient data on safety and efficacy (see also section 5.1). Method of administration The absorption of risedronate sodium is affected by food, thus to ensure adequate abso Read the complete document