Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
atorvastatin calcium trihydrate, Quantity: 21.69 mg (Equivalent: atorvastatin, Qty 20 mg)
Sandoz Pty Ltd
atorvastatin calcium trihydrate
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; calcium carbonate; magnesium stearate; Euphorbia antisyphilitica; hyprolose; croscarmellose sodium; polysorbate 80; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; PEG-4 stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc
Oral
6, 30
(S4) Prescription Only Medicine
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.,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 CLINICAL TRIALS, Prevention of Cardiovascular Disease) 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 to off-white, elliptical, film-coated tablets debossed with "AS20" on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2011-09-23
ATORVASTATIN SZ 1 ATORVASTATIN SZ _atorvastatin calcium trihydrate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ATORVASTATIN SZ. 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 ATORVASTATIN SZ against the benefits it is expected to 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 ATORVASTATIN SZ IS USED FOR ATORVASTATIN SZ is used to lower high cholesterol levels in your blood. ATORVASTATIN SZ also helps 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. Itis a type of blood fat needed by the body for many things, such as building cell lining, 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 its level may become 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-C, or low-density- lipoprotein cholesterol, is the 'bad' cholesterol that can block your blood vessels. HDL-C, 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 begin to 'stick' to the inside of your blood vessels instead of being carried to the part Lesen Sie das vollständige Dokument
210430-Atorvastatin SZ-pi Page 1 of 21 AUSTRALIAN PRODUCT INFORMATION ATORVASTATIN SZ (ATORVASTATIN CALCIUM TRIHYDRATE) TABLETS 1 NAME OF THE MEDICINE Atorvastatin calcium trihydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ATORVASTATIN SZ tablets contain atorvastatin calcium trihydrate equivalent to 10, 20, 40 and 80 mg atorvastatin. _Excipients with known effect: _ Sugars as lactose monohydrate _ _ For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM ATORVASTATIN SZ 10 mg tablets are white to off-white; elliptical, film-coated tablets debossed ‘AS10’ on one side and plain on the other side. ATORVASTATIN SZ 20 mg tablets are white to off-white; elliptical, film-coated tablets debossed ‘AS20’ on one side and plain on the other side. ATORVASTATIN SZ 40 mg tablets are white to off-white; elliptical, film-coated tablets debossed ‘AS40’ on one side and plain on the other side. ATORVASTATIN SZ 80 mg tablets are white to off-white; elliptical, film-coated tablets debossed ‘AS80’ on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS ATORVASTATIN SZ 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. ATORVASTATIN SZ 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 - Prevention of cardiovascular disease) 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 cardiovascu Lesen Sie das vollständige Dokument