Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
rosuvastatin calcium, Quantity: 10.396 mg
ORGANON PHARMA PTY LTD
Ezetimibe,Rosuvastatin calcium
Tablet, film coated
Excipient Ingredients: hypromellose; sodium stearylfumarate; lactose; colloidal anhydrous silica; purified talc; maize starch; macrogol 6000; mannitol; microcrystalline cellulose; silicon dioxide; titanium dioxide; iron oxide yellow; iron oxide red
Oral
60 tablets, 20 tablets
(S4) Prescription Only Medicine
Primary Hypercholesterolaemia: EZALO Composite Pack 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 rosuvastatin or ezetimibe alone; or - already treated with rosuvastatin and ezetimibe.,Homozygous Familial Hypercholesterolaemia (HoFH): EZALO Composite Pack is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).
Visual Identification: Brown, round, film coated tablets with "RSV 10" debossed on one side.; Container Type: Multiple containers; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2013-11-26
EZALO COMPOSITE PACK _ezetimibe and rosuvastatin calcium_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about EZALO COMPOSITE PACK. 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 EZALO COMPOSITE PACK 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 EZALO COMPOSITE PACK IS USED FOR EZALO COMPOSITE PACK helps to lower cholesterol levels. It is used in people whose cholesterol 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. _HOW EZALO COMPOSITE_ _PACK WORKS_ EZALO COMPOSITE PACK is a combination pack, which contains two different medicines. One is Ezetrol (ezetimibe) and the other is rosuvastatin (rosuvastatin calcium). EZALO COMPOSITE PACK reduces elevated total-cholesterol, LDL ('bad') cholesterol and increases HDL ('good') cholesterol. EZALO COMPOSITE PACK works by decreasing the absorption of cholesterol in the small intestine and by reducing the amount of cholesterol made in the liver. Your doctor may have prescribed EZALO COMPOSITE PACK f Přečtěte si celý dokument
Page 1 of 32 AUSTRALIAN PRODUCT INFORMATION EZALO COMPOSITE PACK (EZETIMIBE, ROSUVASTATIN AS CALCIUM) TABLETS 1 NAME OF THE MEDICINE Ezetimibe Rosuvastatin, as calcium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EZETROL ® Each tablet of EZETROL for oral administration contains 10 mg ezetimibe. List of excipients with known effect: - lactose (as monohydrate) OGN ROSUVASTATIN OGN ROSUVASTATIN tablets contain 5 mg, 10 mg, 20 mg or 40 mg rosuvastatin (as calcium). List of excipients with known effect: - sugars (as lactose) For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM EZETROL OGN ROSUVASTATIN EZALO COMPOSITE PACK 10 mg + 5 mg ezetimibe 10 mg white to off-white capsule shaped tablets, debossed with “414” on one side rosuvastatin (as calcium) 5 mg Brown, round, film coated tablets. EZALO COMPOSITE PACK 10 mg + 10 mg rosuvastatin (as calcium) 10 mg Brown, round, film coated tablets with “RSV 10” debossed on one side. EZALO COMPOSITE PACK 10 mg + 20 mg rosuvastatin (as calcium) 20 mg Brown, round, film coated tablets with “RSV 20” debossed on one side. EZALO COMPOSITE PACK 10 mg + 40 mg rosuvastatin (as calcium) 40 mg Brown, round, film coated tablets with “RSV 40” debossed on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PRIMARY HYPERCHOLESTEROLAEMIA EZALO COMPOSITE PACK 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 rosuvastatin or ezetimibe alone; or Page 2 of 32 • already treated with rosuvastatin and ezetimibe HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH) EZALO COMPOSITE PACK is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis). 4.2 DOSE AND METHOD OF ADMINISTRATION This combination product is not indicated for first-line use. The patient should be on an appropriate lipid-lowering diet and should Přečtěte si celý dokument