Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
rosuvastatin calcium
Apotex Pty Ltd
Rosuvastatin calcium
Medicine Registered
Registered
CHEMMART ROSUVASTATIN _5 MG/ 10 MG/ 20 MG/ 40 MG_ _Contains the active ingredient rosuvastatin calcium_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about rosuvastatin. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may need to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Chemmart Rosuvastatin. It contains the active ingredient rosuvastatin (as rosuvastatin calcium). This medicine is used to lower high cholesterol levels. Even though you may have normal cholesterol, this medicine 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 woman 60 or more years old and have at least 2 risk factors for having a heart attack or stroke. Risk factors include: 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 this medicine for this use. _CHOLESTEROL AND_ _TRIGLYCERIDES_ Everyone has cholesterol and triglycerides in their blood. They are fatty substances needed by the body for Прочитајте комплетан документ
1 AUSTRALIAN PRODUCT INFORMATION – CHEMMART ROSUVASTATIN (ROSUVASTATIN) 1 NAME OF THE MEDICINE Rosuvastatin calcium. 2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Each tablet contains 5 mg, 10 mg, 20 mg or 40 mg rosuvastatin calcium, as the active ingredient. In addition, each tablet contains the following inactive ingredients: lactose, cellulose-microcrystalline, crospovidone, magnesium stearate, colloidal anhydrous silica, hypromellose, hydroxypropylcellulose, macrogol 8000. 5 MG TABLETS White, round, biconvex, film coated tablet, engraved “APO” on one side, “ROS” over “5” on the other side. 10 MG TABLETS White, round, biconvex, film-coated tablet, engraved “APO” on one side, “ROS” over “10” on the other side. 20 MG TABLETS White, round, biconvex, film-coated tablet, engraved “APO” on one side, “ROS” over “20” on the other side. 40 mg tablets White, oval, biconvex, film-coated tablet, engraved “APO” on one side, “ROS40” on the other side. Not all strengths, pack types and/or pack sizes may be available. 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. 2 IN PATIENTS WITH HYPERCHOLESTEROLAEMIA Rosuvastatin is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). Prior to initiating therapy with Rosuvastatin, secondary causes of hyperchol Прочитајте комплетан документ