País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
atorvastatin calcium trihydrate, Quantity: 43.4 mg (Equivalent: atorvastatin, Qty 40 mg); amlodipine besilate, Quantity: 13.87 mg (Equivalent: amlodipine, Qty 10 mg)
Aspen Pharmacare Australia Pty Ltd
amlodipine besilate,Atorvastatin calcium
Tablet, film coated
Excipient Ingredients: colloidal anhydrous silica; calcium carbonate; microcrystalline cellulose; croscarmellose sodium; hyprolose; magnesium stearate; pregelatinised maize starch; polysorbate 80; titanium dioxide; indigo carmine; purified talc; polyvinyl alcohol; macrogol 3000
Oral
10 tablets, 30 tablets
(S4) Prescription Only Medicine
CADUET (amlodipine and atorvastatin) is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented. The indications for amlodipine are: 1. Hypertension: Amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin-converting enzyme inhibitor. 2. Angina: Amlodipine is indicated for the first line treatment of chronic stable angina. Amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs. The indications for atorvastatin are: 1. Atorvastatin 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. 2. 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 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: blue oval film-coated tablets debossed with "A10" on one side and "AT40" on the other.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2005-07-20
1 CADUET ® _Amlodipine Besilate and Atorvastatin Calcium _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Caduet. 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 Caduet 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 CADUET IS USED FOR Caduet is used to treat high blood pressure and high cholesterol (fat in the blood). Caduet can also be used for angina (a certain type of chest pain). Caduet can be 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, Caduet is used to help reduce the risk of having a heart attack or stroke. _WHAT IS HIGH BLOOD _ _PRESSURE? _ There are usually no symptoms of high blood pressure (hypertension). The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems. _WHAT IS CHOLESTEROL? _ Everyone has cholesterol in their blood. It is a type of blood fat needed by the body for 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 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, or low-density lipoprotein, is the 'bad' cholesterol that can b Leia o documento completo
Page 1 of 38 AUSTRALIAN PRODUCT INFORMATION - CADUET 5/10, 5/20, 5/40, 5/80, 10/10, 10/20, 10/40 AND 10/80 (AMLODIPINE BESILATE AND ATORVASTATIN CALCIUM) 1. NAME OF THE MEDICINE amlodipine (as besilate) and atorvastatin (as calcium) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CADUET contains the active ingredients amlodipine besilate and atorvastatin calcium. Each 5 mg/ 10mg tablet contains 5 mg amlodipine (as besilate) and 10 mg atorvastatin (as calcium) Each 5 mg/ 20mg tablet contains 5 mg amlodipine (as besilate) and 20 mg atorvastatin (as calcium) Each 5 mg/ 40mg tablet contains 5 mg amlodipine (as besilate) and 40 mg atorvastatin (as calcium) Each 5 mg/ 80mg tablet contains 5 mg amlodipine (as besilate) and 80 mg atorvastatin (as calcium) Each10 mg/ 10mg tablet contains 10 mg amlodipine (as besilate) and 10 mg atorvastatin (as calcium) Each 10 mg/ 20mg tablet contains 10 mg amlodipine (as besilate) and 20 mg atorvastatin (as calcium) Each 10 mg/ 40mg tablet contains 10 mg amlodipine (as besilate) and 40 mg atorvastatin (as calcium) Each 10 mg/ 80mg tablet contains 10 mg amlodipine (as besilate) and 80 mg atorvastatin (as calcium) For the full list of excipients, see section 6.1, List of excipients. 3. PHARMACEUTICAL FORM CADUET, amlodipine besilate/atorvastatin calcium tablets, are formulated for oral administration and are available in combinations of 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg. CADUET 5 mg/10 mg is available as white, oval, film coated tablets debossed with “Pfizer” on one side and “CDT” and “051” on the other. Page 2 of 38 CADUET 5 mg/20 mg is available as white, oval, film coated tablets debossed with “Pfizer” on one side and “CDT” and “052” on the other. CADUET 5 mg/40 mg is available as white, oval, film coated tablets debossed with “Pfizer” on one side and “CDT” and “054” on the other. CADUET 5 mg/80 mg is available as white, oval, film coated tablets debossed with “Pfizer” on one side an Leia o documento completo