Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
simvastatin, Quantity: 10 mg; ezetimibe, Quantity: 10 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet
Excipient Ingredients: croscarmellose sodium; magnesium stearate; citric acid; hypromellose; lactose monohydrate; butylated hydroxyanisole; iron oxide yellow; microcrystalline cellulose; propyl gallate; ascorbic acid; iron oxide red; iron oxide black
Oral
10, 5, 30
(S4) Prescription Only Medicine
Adults (?18 years),Prevention of Cardiovascular Disease APO-EZETIMIBE/SIMVASTATIN is indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of simvastatin 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 APO-EZETIMIBE/SIMVASTATIN is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate: ? Patients not appropriately controlled with a statin or ezetimibe alone. ? Patients already treated with a statin and ezetimibe.,Homozygous Familial Hypercholesterolaemia (HoFH) APO-EZETIMIBE/SIMVASTATIN is indicated in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis). Children and Adolescents 10-17 years (pubertal status: boys Tanner Stage II and above and girls who are at least one year post- menarche),Heterozygous Familial Hypercholesterolaemia (HeFH) APO-EZETIMIBE/SIMVASTATIN is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate: ? Patients not appropriately controlled with a statin or ezetimibe alone. ? Patients already treated with a statin and ezetimibe.,Homozygous Familial Hypercholesterolaemia (HoFH) APO-EZETIMIBE/SIMVASTATIN is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).
Visual Identification: Light tan, mottled, round about 6 mm, biconvex tablets. marking 511 on one side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2017-11-06
1 APO-EZETIMIBE/SIMVASTATIN _Ezetimibe/Simvastatin_ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 this medicine 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 THIS MEDICINE IS USED FOR APO-Ezetimibe/Simvastatin helps to lower cholesterol and triglyceride levels. It is used in people whose cholesterol levels are too high and when diet alone cannot lower these levels adequately. _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. _HOW THIS MEDICINE WORKS_ This medicine reduces elevated total- cholesterol, LDL (bad) cholesterol and triglycerides and increases HDL (good) cholesterol. This medicine works by decreasing the absorption of cholesterol in the small intestine and by reducing the amount of cholesterol made in the liver. this medicine does not help you lose weight. If you have heart disease and a history of heart attack or hospitalisation for unstable a Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION – APO-EZETIMIBE/SIMVASTATIN (EZETIMIBE/SIMVASTATIN) 1 NAME OF THE MEDICINE Ezetimibe and Simvastatin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION APO-EZETIMIBE/SIMVASTATIN is available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin (APO-EZETIMIBE/SIMVASTATIN 10/10), 10 mg of ezetimibe, and 20 mg of simvastatin (APO-EZETIMIBE/SIMVASTATIN 10/20), 10 mg of ezetimibe, and 40 mg of simvastatin (APO-EZETIMIBE/SIMVASTATIN 10/40), or 10 mg of ezetimibe, and 80 mg of simvastatin (APO-EZETIMIBE/SIMVASTATIN 10/80). Excipient with known effect: sugars (as lactose). For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM 10/10 MG TABLETS: Light tan, mottled, round, biconvex, 6mm tablets with markings “511” on one side. 10/20 MG TABLETS: Light tan, mottled, round, biconvex, 8mm tablets with markings “512” on one side. 10/40 MG TABLETS: Light tan, mottled, round, biconvex, 10mm tablets with markings “513” on one side. 10/80 MG TABLETS: Light tan, mottled, capsule shaped, biconvex, 17.5 x 7.55 mm tablets with markings “515” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS (≥18 YEARS) _PREVENTION OF CARDIOVASCULAR DISEASE _ Ezetimibe/Simvastatin is indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of simvastatin 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 SECTION 5.1 PHARMACODYNAMIC PROPERTIES, CLINICAL TRIALS). _PRIMARY HYPERCHOLESTEROLAEMIA_ Ezetimibe/Simvastatin is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate: • Patients not appropriately controlled with a statin or ezetimibe alone. • Patients already treated with a Read the complete document