Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
atorvastatin calcium trihydrate, Quantity: 21.7 mg (Equivalent: atorvastatin, Qty 20 mg); ezetimibe, Quantity: 10 mg
ORGANON PHARMA PTY LTD
atorvastatin calcium trihydrate,Ezetimibe
Tablet, multilayer
Excipient Ingredients: lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; calcium carbonate; polysorbate 80; sodium lauryl sulfate; silicon dioxide; povidone; magnesium stearate; hyprolose; titanium dioxide; macrogol 8000; hypromellose; purified talc
Oral
30, 10
(S4) Prescription Only Medicine
Prevention of Cardiovascular Disease ATOZET is indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of atorvastatin and in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see Clinical Trials). Primary Hypercholesterolaemia ATOZET is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe Homozygous Familial Hypercholesterolaemia (HoFH) ATOZET is indicated in patients with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis).
Visual Identification: Capsule shaped, biconvex, white to off white tablets, with "333" debossed on one side of the tablet; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2015-02-04
ATOZET ® _ezetimibe and atorvastatin calcium trihydrate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Atozet. 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 Atozet against the benefits they expect it will 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 ATOZET IS USED FOR Atozet helps to lower cholesterol and triglyceride levels. It is used in people whose cholesterol and triglyceride levels are too high and when diet alone cannot lower these levels adequately. _WHAT IS HIGH CHOLESTEROL_ Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol. LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build- up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke. HDL cholesterol is often called “good” cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease. _TRIGLYCERIDES_ Triglycerides are another form of fat in your blood that may increase your risk for heart disease. _HEART DISEASE_ If you have heart disease and a history of heart attack or hospitalisation for unstable angina (chest pain), Atozet reduces the risk of heart attack, stroke, surgery to increase heart blood flow, or hospitalization for chest pain. _HOW ATOZET WORKS_ Atozet contains two different medicines. One is Ezetrol (ezetimibe) and the other is atorvastatin (atorvastatin calcium trihydrate). Atozet reduces elevated total- cholest Lugege kogu dokumenti
ATOZET PI A190418 v5.0 S-CCDS-MK0653C-T-122018 Page 1 of 37 AUSTRALIAN PRODUCT INFORMATION ATOZET ® (EZETIMIBE, ATORVASTATIN (AS CALCIUM TRIHYDRATE)) TABLETS 1 NAME OF THE MEDICINE Ezetimibe Atorvastatin (as calcium trihydrate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ATOZET 10 mg/10 mg containing ezetimibe 10 mg and atorvastatin (as calcium trihydrate) 10 mg ATOZET 10 mg/20 mg containing ezetimibe 10 mg and atorvastatin (as calcium trihydrate) 20 mg ATOZET 10 mg/40 mg containing ezetimibe 10 mg and atorvastatin (as calcium trihydrate) 40 mg ATOZET 10 mg/80 mg containing ezetimibe 10 mg and atorvastatin (as calcium trihydrate) 80 mg ATOZET is available for oral use as tablets containing 10 mg of ezetimibe and: 10.9 mg of atorvastatin calcium trihydrate, equivalent to 10 mg of atorvastatin (ATOZET 10 mg/10 mg); 21.7 mg of atorvastatin calcium trihydrate, equivalent to 20 mg of atorvastatin (ATOZET 10 mg/20 mg); 43.4 mg of atorvastatin calcium trihydrate, equivalent to 40 mg of atorvastatin (ATOZET 10 mg/40 mg); or 86.8 mg of atorvastatin calcium trihydrate, equivalent to 80 mg of atorvastatin (ATOZET 10 mg/80 mg). List of excipients with known effect: - lactose (as monohydrate) For full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM ATOZET is a film-coated tablet containing ezetimibe 10 mg and atorvastatin 10, 20, 40 or 80 mg. ATOZET 10/10 contains 10 mg of ezetimibe and 10.9 mg of atorvastatin calcium trihydrate, equivalent to 10 mg of atorvastatin. The tablets are white to off-white capsule-shaped, biconvex, film-coated with code 257 on one side and plain on the other. ATOZET 10/20 contains 10 mg of ezetimibe and 21.7 mg of atorvastatin calcium trihydrate, equivalent to 20 mg of atorvastatin. The tablets are white to off-white capsule-shaped, biconvex, film-coated with code 333 on one side and plain on the other. ATOZET 10/40 contains 10 mg of ezetimibe and 43.4 mg of atorvastatin calcium trihydrate, equivalent to 40 mg of atorvastatin. The tablets are white to off-white capsule Lugege kogu dokumenti