Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Rosuvastatin calcium 41.584mg equivalent to rosuvastatin 40 mg
Viatris Limited
Rosuvastatin calcium 41.584 mg (equivalent to rosuvastatin 40 mg)
40 mg
Film coated tablet
Active: Rosuvastatin calcium 41.584mg equivalent to rosuvastatin 40 mg Excipient: Colloidal silicon dioxide Crospovidone Iron oxide red Lactose monohydrate Light magnesium oxide Magnesium stearate Microcrystalline cellulose Opadry Pink
Blister pack, laminate layer (polyamide/aluminium/LDPE dessicant-HDPE)/aluminium foil, 30 tablets
Prescription
Prescription
Assia Chemical Industries Ltd
Rosuvastatin calcium is indicated to: · Reduce elevated LDL-C, total cholesterol, triglycerides and to increase HDLcholesterol in patients with primary hypercholesterolemia (heterozygous familial and non familial) and mixed dyslipidaemia (Fredrickson Types IIa and IIb). Rosuvastatin calcium also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios and increase Apo-A-I in these populations. · Treat isolated hypertriglyceridaemia (Fredrickson Type IV hyperlipidaemia). · Reduce total cholesterol and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or alone if such treatments are unavailable.
Package - Contents - Shelf Life: Blister pack, PVC/Polyamide/Al - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar/Al - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, laminate layer (polyamide/aluminium/LDPE dessicant-HDPE)/aluminium foil - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE white bottle/PP screw closure - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE white bottle/PP screw closure - 500 tablets - 24 months from date of manufacture stored at or below 25°C
2013-04-03
Page 1 of 5 NEW ZEALAND CONSUMER MEDICINE INFORMATION ROSUVASTATIN VIATRIS _ROSUVASTATIN FILM COATED TABLET 5 MG, 10 MG, 20 MG & 40 MG_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking ROSUVASTATIN VIATRIS. This leaflet answers some common questions about ROSUVASTATIN VIATRIS. 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 ROSUVASTATIN VIATRIS 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 ROSUVASTATIN VIATRIS IS USED FOR ROSUVASTATIN VIATRIS is used to treat • High levels of “bad” cholesterol It reduces the • risk of heart attacks • risk of strokes • need for a heart bypass ROSUVASTATIN VIATRIS contains the active ingredient rosuvastatin. It belongs to a group of medicines called HMG-CoA reductase inhibitors (also known as ‘statins’). It works by lowering the "bad" cholesterol and raising the "good" cholesterol when exercise and changes to diet are not enough on their own. It also lowers the risk of heart attacks and strokes. Everyone has cholesterol and triglycerides in their blood. They are fatty substances needed by the body for many things. Triglycerides are an energy source for the body. Cholesterol is essential for such things as building cells, making bile acids (which help to digest food) and making some hormones. There are different types of cholesterol. Too much of the "bad" cholesterol (LDL) can block the blood vessels that supply your heart and brain with blood, and can cause heart attack, angina and stroke. The "good" cholesterol (HDL) helps to remove the bad cholesterol from the blood vessels. High levels of triglycerides can be associated with a low level of "good" cholesterol and may increase the risk of heart disease. Cholestero Read the complete document
Page 1 of 21 NEW ZEALAND DATA SHEET ROSUVASTATIN VIATRIS 1. PRODUCT NAME ROSUVASTATIN VIATRIS, 5 mg, 10 mg, 20 mg & 40 mg, film coated tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin (as rosuvastatin calcium). Excipients with known effect: lactose. Allergen Declaration: Contains sugars as lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM ROSUVASTATIN VIATRIS 5 mg: A yellow, film-coated, round, biconvex tablet, debossed with "M" on one side and “RS” on the other side. ROSUVASTATIN VIATRIS 10 mg: A pink, film-coated, round, biconvex tablet, debossed with “M” on one side and “RS1” on the other side. ROSUVASTATIN VIATRIS 20 mg: A pink, film-coated, round, biconvex tablet, debossed with "M" on one side and “RS2” on the other side. ROSUVASTATIN VIATRIS 40 mg: A pink, film-coated, oval, biconvex tablet, debossed with "M" on one side and "RS4" on the other side. DO NOT HALVE THE TABLET. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ ROSUVASTATIN VIATRIS should be used as an adjunct to diet when the response to diet and exercise is inadequate. _PREVENTION OF MAJOR CARDIOVASCULAR EVENTS_ In adult patients without documented history of cardiovascular or cerebrovascular events, but with at least two conventional risk factors for cardiovascular disease (see section 5.1), ROSUVASTATIN VIATRIS is indicated to: • Reduce the risk of nonfatal myocardial infarction • Reduce the risk of nonfatal stroke • Reduce the risk of coronary artery revascularisation Page 2 of 21 _HYPERCHOLESTEROLAEMIA_ ROSUVASTATIN VIATRIS is indicated to: • Reduce elevated LDL-C, total cholesterol, triglycerides and to increase HDL-cholesterol in patients with primary hypercholesterolaemia (heterozygous familial and non familial) and mixed dyslipidaemia (Fredrickson Types Ila and lIb). ROSUVASTATIN VIATRIS also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I rati Read the complete document