País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
calcium carbonate,risedronate sodium
Alphapharm Pty Ltd
Calcium carbonate,Risedronate sodium
Registered
ACRIS COMBI _contains the active ingredient risedronate sodium and calcium carbonate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Acris 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 benefits and risks. Your doctor has weighed the risks of you taking Acris Combi against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT ACRIS COMBI IS USED FOR Acris Combi is a combination medicine consisting of 7 tablets for each week of therapy. Each week of therapy includes: One Acris 35mg Once-a-Week tablet (the small light-orange tablet) and 6 Calcium Carbonate 1250mg tablets (the light lavender tablets). Acris Combi belongs to a group of medicines called bisphosphonates. It is used to treat: • osteoporosis (brittle or fragile bones that may fracture easily) • osteoporosis caused by taking steroids. Bone is a living tissue consisting of calcium and other minerals. Throughout life, old bone is constantly broken down and replaced by new bone. Acris 35mg Once-a-Week tablets works by helping to: • slow down the process of removing old bone. This allows the cells time to rebuild • maintaining and increasing bone density. • reverse the progression of osteoporosis. The Calcium Carbonate tablets help to supply the calcium your body needs to build new bone. _OSTEOPOROSIS_ Osteoporosis is a disease which causes bones to become less dense, gradually making them weaker, more brittle and consequently, more likely to break. Broken bones may result from injury or falls. Breaks may occur in normal, everyday activity, such as lifting, or from minor injury that would not ordinarily fracture normal bone. Fractures usually occur at the hip, spine or wrist, although can occur in any bone of the body. Osteoporosis can also cause back pain, heig Leia o documento completo
PRODUCT INFORMATION ACRIS COMBI _Risedronate sodium tablets and calcium carbonate tablets _ NAME OF THE MEDICINE RISEDRONATE SODIUM Active ingredient : Risedronate sodium hemipentahydrate Chemical name : [1-hydroxy-2-(3- pyridinyl)ethylidene]bis(phosphonic acid) monosodium salt hemipentahydrate Structural formula : Molecular formula : C 7 H 10 NO 7 P 2 Na.2.5H 2 O Molecular weight : 350.13 CAS Registry no. : 329003-65-8 CALCIUM CARBONATE Active ingredient : Calcium carbonate Molecular formula : CaCO 3 Molecular weight : 100.1 CAS Registry no. : 471-34-1 DESCRIPTION RISEDRONATE Risedronate sodium (as hemipentahydrate) 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. Each risedronate tablet contains 35 mg risedronate sodium (as hemipentahydrate) and the following inactive ingredients: Mannitol, microcrystalline cellulose, crospovidone, silicon dioxide, magnesium stearate, Opadry II beige 40L97490 (ARTG No. 107225) and Opadry clear YS-1-7006 (ARTG No. 12789). CALCIUM CARBONATE Calcium carbonate is a white powder, practically insoluble in water. Each calcium tablet contains 1250 mg calcium carbonate as a mixture of calcium carbonate and pregelatinised maize starch and the following inactive ingredients: Hydroxypropylcellulose, polysorbate 80, purified water, microcrystalline cellulose, croscarmellose sodium, Indigo carmine, Allura red AC, purified talc, magnesium stearate, Opadry Aqueous film coating Y-19-7483 (ARTG No. 3751). ACRIS Combi – PRODUCT INFORMATION 2 PHARMACOLOGY PHARMACODYNAMICS RISEDRONATE Risedronate is a potent pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast- mediated bone resorption. Risedronate is a third generation bisphosphonate. In preclinical studies risedronate demonstrated potent anti-osteoclast and anti-resorptive activity, increasing bone mass and biomechanical strength dose-dependently. The activity of risedronate was confirmed by bone marke Leia o documento completo