Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
atorvastatin calcium trihydrate, Quantity: 10.341 mg (Equivalent: atorvastatin, Qty 10 mg); ezetimibe, Quantity: 10 mg
Lupin Australia Pty Limited
Tablet, film coated
Excipient Ingredients: lactose; colloidal anhydrous silica; crospovidone; sodium lauryl sulfate; sodium stearylfumarate; microcrystalline cellulose; povidone; lactose monohydrate; calcium carbonate; hyprolose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin
Oral
30's
(S4) Prescription Only Medicine
Prevention of Cardiovascular Disease Ezetimibe/Atorvastatin 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,Primary Hypercholesterolaemia Ezetimibe/Atorvastatin 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) Ezetimibe/Atorvastatin is indicated in patients with HoFH. Patients may also receive adjunctive treatments (eg. LDL apheresis).
Visual Identification: White to off-white, capsule-shaped, biconvex, film-coated tablet debossed with 'AE' on one side and '1' on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2019-11-01
CONSUMER MEDICINE INFORMATION EZETIMIBE/ATORVASTATIN GH EZETIMIBE AND ATORVASTATIN (AS CALCIUM TRIHYDRATE)) TABLETS WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Ezetimibe/Atorvastatin GH. 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 Ezetimibe/Atorvastatin GH 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 EZETIMIBE/ ATORVASTATIN GH IS USED FOR Ezetimibe/Atorvastatin GH 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), Ezetimibe/Atorvastatin GH reduces the risk of heart attack, stroke, surgery to increase heart blood flow, or hospitalization for chest pain. _HOW _EZETIMIBE/ATORVASTATIN GH_ WORKS _ Ezetimibe/Atorvastatin GH contai Leggi il documento completo
AUSTRALIAN PRODUCT INFORMATION – EZETIMIBE/ATORVASTATIN GH (EZETIMIBE AND ATORVASTATIN (AS CALCIUM TRIHYDRATE)) TABLETS 1 NAME OF THE MEDICINE Ezetimibe. Atorvastatin (as calcium trihydrate). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ezetimibe/Atorvastatin GH is a film-coated tablet containing ezetimibe 10 mg and atorvastatin 10, 20, 40 or 80 mg. Ezetimibe/Atorvastatin GH 10/10 : Each tablet contains 10 mg of ezetimibe and atorvastatin calcium trihydrate equivalent to 10 mg of atorvastatin. Ezetimibe/Atorvastatin GH 10/20 : Each tablet contains 10 mg of ezetimibe and atorvastatin calcium trihydrate equivalent to 20 mg of atorvastatin. Ezetimibe/Atorvastatin GH 10/40 : Each tablet contains 10 mg of ezetimibe and atorvastatin calcium trihydrate equivalent to 40 mg of atorvastatin. Ezetimibe/Atorvastatin GH 10/80 : Each tablet contains 10 mg of ezetimibe and atorvastatin calcium trihydrate equivalent to 80 mg of atorvastatin. Ezetimibe/Atorvastatin GH tablets contain the following excipients: lactose anhydrous and lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Ezetimibe/Atorvastatin GH 10/10 : White to off-white, capsule-shaped, biconvex, film-coated tablet debossed with ‘AE’ on one side and ‘1’ on the other side. Ezetimibe/Atorvastatin GH 10/20 : White to off-white, capsule-shaped, biconvex, film-coated tablet debossed with ‘AE’ on one side and ‘2’ on the other side. Ezetimibe/Atorvastatin GH 10/40 : White to off-white, capsule-shaped, biconvex, film-coated tablet debossed with ‘AE’ on one side and ‘3’ on the other side. Ezetimibe/Atorvastatin v2.0 Page 2 of 40 (Ezetimibe and atorvastatin (as calcium trihydrate)) tablets Ezetimibe/Atorvastatin GH 10/80 : White to off-white, capsule-shaped, biconvex, film-coated tablet debossed with ‘AE’ on one side and on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PREVENTION OF CARDIOVASCULAR DISEASE Ezetimibe/Atorvastatin GH is indicated in patients with coronary Leggi il documento completo