Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Risedronate sodium
IMED Healthcare Ltd.
M05BA07
Risedronate sodium
35 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
risedronic acid
Authorised
2009-07-03
PACKAGE LEAFLET: INFORMATION FOR THE USER ACTONEL® ONCE A WEEK 35MG FILM-COATED TABLETS RISEDRONATE SODIUM READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Actonel® Once a Week is and what it is used for 2. Before you take Actonel® Once a Week 3. How to take Actonel® Once a Week 4. Possible side effects 5. How to store Actonel® Once a Week 6. Further information 1. WHAT ACTONEL® ONCE A WEEK IS AND WHAT IT IS USED FOR WHAT ACTONEL® ONCE A WEEK IS Actonel® Once a Week 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 ACTONEL® ONCE A WEEK IS USED FOR The treatment of osteoporosis • in postmenopausal women, even if osteoporosis is severe. It reduces the risk of spinal and hip fractures. • in men. 2. BEFORE YOU TAKE Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Actonel Once a Week 35mg 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: Each film-coated tablet contains Lactose For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from the UK and Italy:_ Oval light-orange film-coated tablet with ‘RSN’ on one side and ‘35mg’ 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. Method of administration The absorption of risedronate sodium is affected by food, thus to ensure adequate absorption patients should take Actonel Once-a-Week 35 mg: • Before breakfast: At least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day. Patients should be instructed that if a dose is missed, one Actonel Once-a-Week 35 mg 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. The tablet must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach Actonel Once-a-Week 35 mg is to be taken while in an upright position with a glass of plain water ( 120 ml). Patients should not lie down for 30 minutes after taking the tablet (see section 4.4). Supplemental calcium and vitamin D should be considered if the dietary intake is inadequate. The optimal duration Lesen Sie das vollständige Dokument