Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
calcium carbonate,risedronate sodium
Theramex Australia Pty Ltd
Calcium carbonate,Risedronate sodium
Registered
ACTONEL ® EC Combi - CMI Version 2.0 1 ACTONEL ® EC COMBI _risedronate sodium (enteric-coated) and calcium carbonate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Actonel EC Combi. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Actonel EC Combi against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ACTONEL EC COMBI IS USED FOR Actonel EC Combi is used to treat bone disease and belongs to a group of medicines called bisphosphonates. Actonel EC Combi works directly on your bones to make them stronger and therefore less likely to break or fracture. Actonel EC Combi is a combination medicine consisting of 7 tablets for each week of therapy. Each week of therapy includes: One Actonel EC 35mg Once-a-Week enteric-coated tablet (the small yellow tablet) and 6 Calcium Carbonate 1250mg tablets (the blue tablets). Actonel EC 35mg Once-a-Week enteric-coated tablets are used to treat: • osteoporosis (brittle or fragile bones that may fracture easily) • osteoporosis caused by taking steroids The Calcium Carbonate tablets help to supply the calcium your body needs to build new bone. Bone is a living tissue consisting of calcium and other minerals. Throughout life, old bone is constantly broken down and replaced with new bone. After the age of 35, bone loss may occur faster than your body can replace it. If you lose too much bone then they become weaker and are more likely to break. Osteoporosis (brittle bone disease) is a disease that causes bones to become weaker. Weak bones break (fracture) easily. Many patients with osteoporosis have no symptoms and may not even know that they have osteoporosis. However osteoporosis makes you more likely to b Baca dokumen lengkap
ACTONEL EC, ACTONEL EC COMBI & ACTONEL EC COMBI D PI V2 160511 1 PRODUCT INFORMATION ACTONEL EC, ACTONEL EC COMBI & ACTONEL EC COMBI D NAME OF THE MEDICINE AUSTRALIAN APPROVED NAME Risedronate, Calcium carbonate, Cholecalciferol NON-PROPRIETARY NAME Risedronate Each Actonel EC enteric-coated tablet contains the equivalent of 35 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. The empirical formula for risedronate sodium is C 7 H 10 NO 7 P 2 Na. The chemical name of risedronate sodium is [1- hydroxy-2-(3- pyridinyl)ethylidene]bis(phosphonic acid) monosodium salt. Calcium Carbonate Tablet Actonel EC Combi also contains 1250 mg calcium carbonate tablets. Each calcium tablet contains 1250 mg calcium carbonate, which is equivalent to 500 mg elemental calcium. Calcium Carbonate/Cholecalciferol Sachet Actonel EC Combi D also contains calcium carbonate/cholecalciferol sachets. Each sachet contains 2500 mg calcium carbonate and 22 µ g (880 IU) cholecalciferol, which is equivalent to 1000 mg elemental calcium and 22 µ g (880 IU) vitamin D3. The terms cholecalciferol and vitamin D3 are equivalent. The chemical name of cholecalciferol is (5Z,7E)-9,10-secocholesta-5,7,10(19)- trien-3β-ol. Molecular formula: C 27 H 44 O. CHEMICAL STRUCTURE The chemical structure of risedronate sodium is the following: Molecular Weight Anhydrous: 305.10 Hemi-pentahydrate: 350.13 The CAS registry number is 115436-72-1 The chemical structure of cholecalciferol: ACTONEL EC, ACTONEL EC COMBI & ACTONEL EC COMBI D PI V2 160511 2 Molecular Weight: 384.6 The CAS registry number is 67-97-0 DESCRIPTION Risedronate sodium is a fine, white to off-white, odourless, crystalline powder. It is soluble in water and in aqueous solutions and essentially insoluble in common organic solvents. Calcium carbonate is a white powder, practically insoluble in water, with a relative molecular weight of 100.1. Cholecalciferol is a secosterol that is a natural precursor of the calcium-regulating hormone calcitriol Baca dokumen lengkap