Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
atorvastatin calcium trihydrate, Quantity: 10.844 mg (Equivalent: atorvastatin, Qty 10 mg)
Alphapharm Pty Ltd
Tablet, film coated
Excipient Ingredients: magnesium stearate; hyprolose; microcrystalline cellulose; lactose; sodium carbonate; arginine; croscarmellose sodium; colloidal anhydrous silica; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350
Oral
90, 10, 500 (for dispensing only), 30
(S4) Prescription Only Medicine
LORSTAT is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia.,Prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.,LORSTAT is indicated in hypertensive patients with multiple risk factors for coronary heart disease (CHD) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic CHD (Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,These effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.
Visual Identification: White, oval, biconvex, film coated tablet plain on one side and debossed '10' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2020-08-18
LORSTAT _Atorvastatin (as calcium trihydrate) tablets_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about LORSTAT. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking LORSTAT against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT LORSTAT IS USED FOR LORSTAT is used to treat • lowers high cholesterol levels • to reduce the risk of having a heart attack or stroke in people who have high blood pressure and coronary heart disease (CHD) or who are at risk of CHD. Examples of risk factors for CHD include diabetes, a history of stroke, or small blood vessel disease. _WHAT IS CHOLESTEROL_ Everyone has cholesterol in their blood. It is a type of blood fat needed by the body for many things, such as building cell walls, making bile acids (which help to digest food) and some hormones. However, too much cholesterol can be a problem. Cholesterol is present in many foods and is also made in your body by the liver. If your body makes too much cholesterol or you have too much cholesterol in your diet, then your cholesterol level becomes too high. High cholesterol is more likely to occur with certain diseases or if you have a family history of high cholesterol. There are different types of cholesterol. LDL, or low-density lipoprotein, is the 'bad' cholesterol that can block your blood vessels. HDL, or high density lipoprotein cholesterol is the 'good' cholesterol that is thought to remove the 'bad' cholesterol from the blood vessels. When you have high levels of 'bad' cholesterol in your blood, it may 'stick' to the inside of your blood vessels instead of being carried to the parts of the body where it is needed. Over time, this can form hard areas (called plaques) on the walls of Les hele dokumentet
AUSTRALIAN PRODUCT INFORMATION LORSTAT ® _Atorvastatin (as calcium trihydrate) tablets _ 1 NAME OF THE MEDICINE Atorvastatin calcium trihydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION LORSTAT contains atorvastatin (as calcium) and is available in four strengths: Each LORSTAT 10 tablet contains atorvastatin calcium equivalent to 10 mg atorvastatin. Each LORSTAT 20 tablet contains atorvastatin calcium equivalent to 20 mg atorvastatin. Each LORSTAT 40 tablet contains atorvastatin calcium equivalent to 40 mg atorvastatin. Each LORSTAT 80 tablet contains atorvastatin calcium equivalent to 80 mg atorvastatin. Excipients with known effect: Contains sugars (as lactose). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Oral. Film-coated tablets. Presentations: LORSTAT 10 – White, oval, biconvex, film coated tablet plain on one side and debossed ‘ 10 ’ on the other side. LORSTAT 20 – White, oval, biconvex, film coated tablet with break line on one side and debossed ‘ 20 ’ on the other side. LORSTAT 40 – White, oval, biconvex, film coated tablet with break line on one side and debossed ‘ 40 ’ on the other side. LORSTAT 80 - White, oval, biconvex, film coated tablet with break line on one side and debossed ‘ 80 ’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LORSTAT is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia. Prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated. LORSTAT is indicated in hypertensive patients with multiple risk factors for coronary heart disease (CHD) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic CHD (see section 5.1 PHARMACODYNAMIC PROPERTIES, CLINICAL TRIALS Les hele dokumentet