Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
rosuvastatin calcium, Quantity: 41.68 mg
Pharmacor Pty Ltd
Rosuvastatin calcium
Tablet, film coated
Excipient Ingredients: magnesium stearate; light magnesium oxide; lactose; microcrystalline cellulose; crospovidone; 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, 100 tablets in HDPE bottle with CRC, 500 tablets in HDPE bottle without CRC, 30 tablets in HDPE bottle with CRC
(S4) Prescription Only Medicine
PHARMACOR ROSUVASTATIN should be used as an adjunct to diet when the response to diet and exercise is inadequate. ,Prevention of Cardiovascular Events PHARMACOR 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). PHARMACOR 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 PHARMACOR ROSUVASTATIN is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). ,Prior to initiating therapy with PHARMACOR 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
Registered
2016-02-04
PHARMACOR ROSUVASTATIN _Rosuvastatin calcium _ CONSUMER MEDICINE INFORMATION Pharmacor Rosuvastatin (V 02) Page 1 of 4 WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about PHARMACOR ROSUVASTATIN. It does not contain all the information that is known about PHARMACOR ROSUVASTATIN. 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 PHARMACOR ROSUVASTATIN 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 PHARMACOR ROSUVASTATIN IS FOR PHARMACOR ROSUVASTATIN is used to lower high cholesterol levels. Even though you may have normal cholesterol, PHARMACOR ROSUVASTATIN 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 PHARMACOR ROSUVASTATIN 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 cholesterol from the blood vessels. High levels of triglycerides can be asso Leggi il documento completo
Pharmacor Rosuvastatin (V 02) Page 1 of 28 AUSTRALIAN PRODUCT INFORMATION PHARMACOR ROSUVASTATIN (ROSUVASTATIN (AS CALCIUM) TABLETS 1 NAME OF THE MEDICINE Rosuvastatin (as calcium) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Pharmacor Rosuvastatin film-coated tablets contain 5 mg, 10 mg, 20 mg and 40 mg of rosuvastatin (as calcium). Excipients with known effect: lactose, lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Pharmacor Rosuvastatin 5 film-coated tablets: Yellow, round, biconvex, film-coated tablet, debossed “5” on one side and “R” on other side. Pharmacor Rosuvastatin 10 film-coated tablets: Pink, round, biconvex, film-coated tablet, debossed “10” on one side and “R” on other side. Pharmacor Rosuvastatin 20 film-coated tablets: Pink, round, biconvex, film-coated tablet, debossed “20” on one side and “R” on other side. Pharmacor Rosuvastatin 40 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 Pharmacor Rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate. PREVENTION OF CARDIOVASCULAR EVENTS Pharmacor 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). Pharmacor 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. Pharmacor Rosuvastatin (V 02) Page 2 of 28 IN PATIENTS WITH HYPERCHOLESTEROLAEMIA Pharmacor Rosuvastatin is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). Prior to initiating Leggi il documento completo