Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
rosuvastatin calcium, Quantity: 41.68 mg
Accord Healthcare Pty Ltd
Rosuvastatin calcium
Tablet, film coated
Excipient Ingredients: lactose; crospovidone; magnesium stearate; microcrystalline cellulose; light magnesium oxide; titanium dioxide; lactose monohydrate; hypromellose; sunset yellow FCF aluminium lake; triacetin; brilliant blue FCF aluminium lake; allura red AC aluminium lake
Oral
90 tablets in HDPE bottle with CRC, 500 tablets in HDPE bottle without CRC, 100 tablets in HDPE bottle with CRC, 30 tablets in HDPE bottle with CRC
(S4) Prescription Only Medicine
APO-Rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate. ,Prevention of Cardiovascular Events APO-Rosuvastatin is indicated for prevention of major cardiovascular events in men ?50 years old and women ?60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease). APO-Rosuvastatin is indicated to:,? Reduce the risk of nonfatal myocardial infarction ? Reduce the risk of nonfatal stroke ? Reduce the risk of coronary artery revascularisation procedures.,In patients with hypercholesterolaemia APO-Rosuvastatin is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). ,Prior to initiating therapy with APO-Rosuvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.
Visual Identification: Pink, oval, biconvex, film-coated tablet, debossed 40 on one side and R on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2016-02-04
ROSUVASTATIN APOTEX CONSUMER MEDICINE INFORMATION Version: 2.0 -2018- Page 1 of 6 ROSUVASTATIN APOTEX (ROSUVASTATIN FILM-COATED TABLETS 5, 10, 20 AND 40 MG) _Rosuvastatin calcium _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about ROSUVASTATIN APOTEX. It does not contain all the information that is known about ROSUVASTATIN APOTEX. It does not take the place of talking to your doctor and pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking ROSUVASTATIN APOTEX 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 APOTEX IS FOR ROSUVASTATIN APOTEX is used to lower high cholesterol levels. Even though you may have normal cholesterol, ROSUVASTATIN APOTEX can also be used to reduce the risk of you having a stroke or heart attack if you are a man 50 or more years old or a women 60 or more years old and have at least 2 risk factors for having a heart attack or stroke, such as high blood pressure, low levels of good cholesterol (HDL), smoking or a family history of premature coronary heart disease. Your doctor may also do a blood test to measure a substance called C Reactive Protein to help decide if you should be given ROSUVASTATIN APOTEX for this use. _ _ _CHOLESTEROL AND TRIGLYCERIDES _ 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 used for such things as building cells, making bile acids (which help to digest foods) 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 c Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION – ROSUVASTATIN APOTEX (ROSUVASTATIN CALCIUM) 1 NAME OF THE MEDICINE Rosuvastatin calcium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 5 mg, 10 mg, 20 mg or 40 mg rosuvastatin (as calcium) per tablet Ingredients with known effects: ▪ lactose (all tablet strengths contain lactose) For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM 5 mg film-coated tablets: Yellow, round, biconvex, film-coated tablet, debossed “5” on one side and “R” on other side. 10 mg film-coated tablets: Pink, round, biconvex, film-coated tablet, debossed “10” on one side and “R” on other side. 20 mg film-coated tablets: Pink, round, biconvex, film-coated tablet, debossed “20” on one side and “R” on other side. 40 mg film-coated tablets: Pink, oval, biconvex, film-coated tablet, debossed “40” on one side and “R” on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate. PREVENTION OF CARDIOVASCULAR EVENTS Rosuvastatin is indicated for prevention of major cardiovascular events in men ≥50 years old and women ≥60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease). Rosuvastatin is indicated to: • Reduce the risk of nonfatal myocardial infarction • Reduce the risk of nonfatal stroke • Reduce the risk of coronary artery revascularisation procedures. IN PATIENTS WITH HYPERCHOLESTEROLAEMIA Rosuvastatin is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). Prior to initiating therapy with rosuvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identi Read the complete document