Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
simvastatin, Quantity: 80 mg; ezetimibe, Quantity: 10 mg
Sandoz Pty Ltd
Tablet
Excipient Ingredients: propyl gallate; iron oxide black; croscarmellose sodium; citric acid; butylated hydroxyanisole; microcrystalline cellulose; lactose monohydrate; ascorbic acid; iron oxide yellow; iron oxide red; magnesium stearate; hypromellose
Oral
5, 10, 30
(S4) Prescription Only Medicine
Adults (?18 years),Prevention of Cardiovascular Disease EZETIMIBE/SIMVASTATIN-SANDOZ 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 EZETIMIBE/SIMVASTATIN-SANDOZ 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) EZETIMIBE/SIMVASTATIN-SANDOZ 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) EZETIMIBE/SIMVASTATIN-SANDOZ 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) EZETIMIBE/SIMVASTATIN-SANDOZ 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, capsule shaped about 17.5 x 7.55 mm, biconvex tablets. marking 515 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
EZETIMIBE/SIMVASTATIN SANDOZ ® 1 EZETIMIBE/SIMVASTATIN SANDOZ ® _Ezetimibe/Simvastatin _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Ezetimibe/Simvastatin Sandoz. 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/Simvastatin Sandoz 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/SIMVASTATIN SANDOZ IS USED FOR Ezetimibe/Simvastatin Sandoz 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 _ _EZETIMIBE/SIMVASTATIN _ _SANDOZ WORKS _ Ezetimibe/Simvastatin Sandoz reduces elevated total-cholesterol, LDL (bad) cholesterol and triglycerides and increases HDL (good) cholesterol. Ezetimibe/Simvastatin Sandoz works by decreasing the absorption of cholesterol in the small intestine and by reducing the amount of cholesterol made in the liv read_full_document
220513-Ezetimibe/Simvastatin Sandoz-pi Page 1 of 46 AUSTRALIAN PRODUCT INFORMATION EZETIMIBE/SIMVASTATIN SANDOZ (EZETIMIBE AND SIMVASTATIN) 1. NAME OF THE MEDICINE Ezetimibe and simvastatin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ezetimibe/Simvastatin Sandoz is available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin (Ezetimibe/Simvastatin Sandoz 10/10), 20 mg of simvastatin (Ezetimibe/Simvastatin Sandoz 10/20), 40 mg of simvastatin (Ezetimibe/Simvastatin Sandoz 10/40), or 80 mg of simvastatin (Ezetimibe/Simvastatin Sandoz 10/80). _Excipients with known effect:_ Lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Ezetimibe/Simvastatin Sandoz 10/10: [10 mg Ezetimibe/ 10 mg Simvastatin]: Light tan, mottled, round, biconvex, 6mm tablets with markings “511” on one side. Ezetimibe/Simvastatin Sandoz 10/20 [10 mg Ezetimibe/ 20 mg Simvastatin]: Light tan, mottled, round, biconvex, 8mm tablets with markings “512” on one side. Ezetimibe/Simvastatin Sandoz 10/40 [10 mg Ezetimibe/ 40 mg Simvastatin]: Light tan, mottled, round, biconvex, 10mm tablets with markings “513” on one side. Ezetimibe/Simvastatin Sandoz 10/80 [10 mg Ezetimibe/ 80 mg Simvastatin]: Light tan, mottled, capsule shaped, biconvex, 17.5 x 7.55 mm tablets with markings “515” on one side. _Not all strengths may be available in Australia. _ 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS _ADULTS (≥ 18 YEARS) _ _PREVENTION OF CARDIOVASCULAR DISEASE _ Ezetimibe/Simvastatin Sandoz 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 Sandoz is indicated as adju read_full_document