Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
RISEDRONATE SODIUM
Warner Chilcott UK Limited
M05BA07
RISEDRONATE SODIUM
5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Bisphosphonates
Authorised
2010-04-30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 is and what it is used for 2. What you need to know before you take Actonel 3. How to take Actonel 4. Possible side effects 5. How to store Actonel 6. Contents of the pack and other information 1. WHAT ACTONEL IS AND WHAT IT IS USED FOR WHAT ACTONEL IS Actonel 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 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 osteoporosis have no symptoms and you may not even have known that you had it. WHAT ACTONEL IS USED FOR The treatment of osteoporosis • in postmenopausal women The prevention of osteoporosis • in women with an increased risk of osteoporosis (including low bone mass, early menopause or a family history of osteo Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Actonel 5 mg film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg risedronate sodium (equivalent to 4.64 mg risedronic acid). Excipient with known effect: Each film-coated tablet contains lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Oval yellow film-coated tablet with RSN on one side and 5 mg 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. Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis (see section 5.1) To maintain or increase bone mass in postmenopausal women undergoing long - term (more than 3 months), systemic corticosteroid treatment at doses 7.5 mg/day prednisone or equivalent. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended daily dose in adults is one 5 mg tablet orally. 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. _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 Actonel is affected by food, thus to ensure adequate absorption patients should take Actonel: - Before breakfast: At least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day. In the particular instance that before breakf Lugege kogu dokumenti