Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
risedronate sodium
Arrow Pharma Pty Ltd
Risedronate sodium
Registered
RISEDRO ONCE A WEEK- Consumer Medicine Information Page 1 of 4 RISEDRO ONCE A WEEK risedronate sodium CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about RISEDRO ONCE A WEEK. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking RISEDRO ONCE A WEEK against the benefits they expect it will have for you. TALK TO YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT RISEDRO ONCE A WEEK IS USED FOR RISEDRO ONCE A WEEK is used to treat bone disease and belongs to a group of medicines called bisphosphonates. It works directly on your bones to make them stronger and therefore less likely to break or fracture. The tablets are used to treat: • osteoporosis (brittle or fragile bones that may easily fracture) • osteoporosis caused by taking steroids. Osteoporosis is caused by changes in the way bone is normally maintained. UNDERSTANDING BONE Bone is living, growing tissue consisting of calcium and other minerals. Throughout life, our bodies are breaking down old bone and rebuilding new bone in a continuous cycle. Until our late 20s, while bones are still developing, we gain bone by building more than we lose. From then until about age 35 the process is usually in balance, so that the amount of bone lost is about equal to the amount that is replaced. After about age 35 this balance is disturbed, with bone loss occurring at a slightly faster rate than it can be replaced. In women, after menopause, hormonal changes cause bone loss at an even faster rate. When bone loss is excessive, bones can become thinner and weaker, and therefore are more likely to break. OSTEOPOROSIS "Osteo" means bone, and "porosis" means something that has holes in it, like a sponge. Therefore, osteoporosis is a disease which causes bones to become Leggi il documento completo
1 AUSTRALIAN PRODUCT INFORMATION – RISEDRO ONCE A WEEK (RISEDRONATE SODIUM) UNCOATED TABLETS 1 NAME OF THE MEDICINE Risedronate sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Risedro Once A Week tablets contain 35 mg of risedronate sodium. For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM White to off-white capsule shaped Uncoated tablet, embossed with RE 35 on one side and plain on the other 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Risedro Once A Week 35 mg tablets are indicated for the: • Treatment of osteoporosis. • Treatment of glucocorticoid-induced osteoporosis. • Preservation of bone mineral density in patients on long-term corticosteroid therapy. 4.2 D OSE AND METHOD OF ADMINISTRATION Risedro Once A Week must only be taken with plain water. Please note that some mineral waters or water from regional areas may have a higher concentration of calcium and therefore should not be used. Risedro Once A Week must be taken 30 minutes before the first food or drink other than water. To facilitate delivery to the stomach, it should be taken in an upright position and the patient should avoid lying down for 30 minutes. Patients should not chew or suck on the tablet because of the potential for oropharyngeal irritation. OSTEOPOROSIS The recommended dose is 35 mg once a week, taken on the same day each week. USE IN THE ELDERLY 2 No dose adjustment is necessary. RENAL IMPAIRMENT No dose adjustment is necessary in patients with mild to moderate renal insufficiency (creatinine clearance 30 to 60 mL/minute). Risedronate is not recommended in patients with severe renal impairment (creatinine clearance < 30 mL/minute) due to limited clinical data. USE IN CHILDREN Safety and efficacy of risedronate has not been established in patients under 18 years of age. COMPATIBILITY WITH OTHER DRUGS Calcium, antacids, aluminium and some oral medications will interfere with the absorption of risedronate and therefore should be taken at a different time of the day. 4.3 C ONTRAI Leggi il documento completo