País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
atorvastatin calcium propylene glycol solvate
Apotex Pty Ltd
Atorvastatin calcium propylene glycol solvate
Registered
APO-ATORVASTATIN _Atorvastatin calcium trihydrate_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about APO-Atorvastatin. 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 this medicine 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 THIS MEDICINE IS USED FOR The name of your medicine is APO- Atorvastatin. It contains the active ingredient atorvastatin. Atorvastatin lowers high cholesterol levels. It is also used in people who have high blood pressure and coronary heart disease (CHD) or who are at risk of CHD (for example, if they have diabetes, a history of stroke, or small blood vessel disease). In these people, this medicine is used to reduce the risk of having a heart attack or stroke. _WHAT IS CHOLESTEROL?_ Everyone has cholesterol in their blood. It is a type of 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 take too much cholesterol in your diet, then your 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 is the 'bad' cholesterol that can block your blood vessels. HDL 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 ins Leia o documento completo
1 AUSTRALIAN PRODUCT INFORMATION APO-ATORVASTATIN TABLET (ATORVASTATIN CALCIUM) 1 NAME OF THE MEDICINE Atorvastatin Calcium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION APO-Atorvastatin 10 mg tablet contains atorvastatin calcium equivalent to 10 mg atorvastatin APO-Atorvastatin 20 mg tablet contains atorvastatin calcium equivalent to 20 mg atorvastatin APO-Atorvastatin 40 mg tablet contains atorvastatin calcium equivalent to 40 mg atorvastatin APO-Atorvastatin 80 mg tablet contains atorvastatin calcium equivalent to 80 mg atorvastatin Excipient with known effects: Each tablet contains 32.805 mg of lactose monohydrate. For the full list of excipients, see Section 6.1 list of excipients. 3 PHARMACEUTICAL FORM Tablet. 10 mg: White to off-white, elliptical, film-coated tablet debossed ‘AS10’ on one side and plain on the other side. 20 mg: White to off-white, elliptical, film-coated tablet debossed ‘AS20’ on one side and plain on the other side. 40 mg: White to off-white, elliptical, film-coated tablet debossed ‘AS40’ on one side and plain on the other side. 60 mg: White to off-white, elliptical, film-coated tablet debossed ‘AS60’ on one side and plain on the other side. 80 mg: White to off-white, elliptical, film-coated tablet debossed ‘AS80’ on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia. 2 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 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 5.1 PHARMACODYNAMIC PROPERTIES - CL Leia o documento completo