Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
Risedronate sodium; Calcium carbonate; Colecalciferol
Sanofi-Aventis Australia Pty Ltd
Medicine Registered
ACTONEL ® EC COMBI D _risedronate sodium (enteric-coated), calcium carbonate, cholecalciferol (Vitamin D3)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Actonel EC Combi D. 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 D 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 D IS USED FOR Actonel EC Combi D is used to treat bone disease. Actonel EC Combi D works directly on your bones to make them stronger and therefore less likely to break or fracture. Actonel EC Combi D is a combination medicine consisting of risedronate sodium, calcium carbonate and cholecalciferol (Vitamin D3). Each week of therapy includes: One Actonel EC 35mg Once-a-Week enteric-coated tablet (the small yellow tablet) and 6 sachets containing calcium carbonate 2500mg and cholecalciferol 22mcg (Vitamin D3 880 IU). The active ingredient in Actonel EC 35mg Once-a-Week enteric-coated tablets is called risedronate sodium and belongs to a group of medicines called bisphosphonates. 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 contained in the sachet helps to supply the calcium your body needs to build new bone. The cholecalciferol (Vitamin D3) contained in the sachet is an essential nutrient required for calcium absorption. 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 mu Lue koko asiakirja
_Actonel EC, Actonel EC Combi, Actonel _ _EC Combi D PI _ _#113742 v1.0 _ _Page 1 _ PRODUCT INFORMATION ACTONEL EC, ACTONEL EC COMBI & ACTONEL EC COMBI D NAME OF THE MEDICINE 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 g (880 IU) cholecalciferol, which is equivalent to 1000 mg elemental calcium and 22 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: Molecular Weight: 384.6 The CAS registry number is 67-97-0 _Actonel EC, Actonel EC Combi, Actonel _ _EC Combi D PI _ _#113742 v1.0 _ _Page 2 _ DESCRIPTION Risedronate sodium is a fine, white to off-white, odourless, crystalline powder. It is solu Lue koko asiakirja