Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
CALCIUM ; RISEDRONATE SODIUM
McDermott Laboratories Ltd t/a Gerard Laboratories
M05BB02
CALCIUM ; RISEDRONATE SODIUM
35/500 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
risedronic acid and calcium, sequential
Not Marketed
2012-10-26
1 PACKAGE LEAFLET: INFORMATION FOR THE USER RISEDRONATE/CALCIUM MYLAN 35 MG / 500 MG FILM-COATED TABLETS (RISEDRONATE SODIUM AND CALCIUM) 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 or nurse. - 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 or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Risedronate/Calcium Mylan is and what it is used for 2. What you need to know before you take Risedronate/Calcium Mylan 3. How to take Risedronate/Calcium Mylan 4. Possible side effects 5. How to store Risedronate/Calcium Mylan 6. Contents of the pack and other information 1. WHAT RISEDRONATE/CALCIUM MYLAN IS AND WHAT IT IS USED FOR A combination medicine packed as weekly units each containing 1 tablet of Risedronate Sodium (light orange tablet) and 6 tablets of Calcium (light lavender tablets). RISEDRONATE SODIUM TABLETS Risedronate Sodium tablets contain risedronate sodium which belongs to a group of non-hormonal medicines called bisphosphonates. These medicines 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 yo Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Risedronate/Calcium Mylan 35mg/500mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Risedronate/Calcium Mylan is a co-package product containing risedronate sodium film-coated tablets, 35 mg for once weekly dosing and calcium carbonate film-coated tablets for daily dosing for the remaining 6 days of the week. Each light orange film-coated tablet contains 35 mg of risedronate sodium equivalent to 32.5 mg risedronic acid. Each light lavender film-coated tablet contains 1250 mg calcium carbonate equivalent to 500 mg of calcium. Excipients with known effect: Also contains Allura red (E129) and polydextrose (contains glucose and sorbitol). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Risedronate Sodium: Light orange film-coated, round, biconvex, bevelled edge tablet debossed with ‘M’ on one side of the tablet and ‘714’ on the other side. Calcium: A light lavender, clear film-coated, modified oval, biconvex, bevelled edge tablet debossed with ‘M CC5’ on one side of the tablet and blank on the other 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). Risedronate/Calcium Mylan is only intended for use in assessed patients for whom the amount of calcium included is considered to provide adequate supplementation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ Risedronate/Calcium Mylan is a two component therapy consisting of 7 tablets in a blister, 1 Risedronate Sodium 35 mg film-coated tablet (light-orange tablet) and 6 Calcium 500 mg film-coated tablets (light lavender tablets). Risedronate/Calcium Mylan is intended for patients for whom the amount of calcium included is considered to provide adequate supplementation, based on individual assessment. Supplemental vitamin D should b Läs hela dokumentet