Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
atorvastatin calcium trihydrate, Quantity: 21.688 mg (Equivalent: atorvastatin, Qty 20 mg); amlodipine besilate, Quantity: 6.94 mg (Equivalent: amlodipine, Qty 5 mg)
Alphapharm Pty Ltd
amlodipine besilate,atorvastatin calcium trihydrate
Tablet, film coated
Excipient Ingredients: arginine; croscarmellose sodium; pregelatinised maize starch; hyprolose; sodium carbonate; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin
Oral
30, 90, 500 (for dispensing only, no CRC)
(S4) Prescription Only Medicine
Amlodipine besilate and atorvastatin calcium trihydrate tablet 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 Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials, Atorvastatin Component, 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: A white to off-white, film-coated, round, biconvex tablet debossed with AA 5 on one side of the tablet and M on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2014-01-09
CADIVAST _Amlodipine (as besilate) and atorvastatin (as calcium trihydrate) tablets_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cadivast. 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 Cadivast 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 CADIVAST IS USED FOR Cadivast is used to treat: • high blood pressure and high cholesterol (fat in the blood). • angina (a certain type of chest pain). • 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, Cadivast is used to help reduce the risk of having a heart attack or stroke. Cadivast contains a combination of two medicines. One is amlodipine and the other is atorvastatin. Amlodipine belongs to a group of medicines called calcium channel blockers. They work by relaxing your blood vessels, making it easier for your heart to pump blood around the body and help increase the supply of blood and oxygen to your heart. Calcium channel blockers do not change the amount of calcium in your blood or bones. Atorvastatin belongs to a group of medicines called statins. It works by reducing the amount of cholesterol made by the liver. It reduces the 'bad' cholesterol and can raise the 'good' cholesterol. Atorvastatin also helps to protect you from a heart attack or stroke. Cadivast may be used alone, or in combination with other medicines, to treat your condition. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine Прочитајте комплетан документ
AUSTRALIAN PRODUCT INFORMATION CADIVAST ® _Amlodipine (as besilate) and atorvastatin (as calcium trihydrate) tablets _ 1 NAME OF THE MEDICINE Amlodipine (as besilate) and atorvastatin (as calcium trihydrate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredients in Cadivast are amlodipine besilate and atorvastatin calcium trihydrate. Excipients with known effect: Soya bean products For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM CADIVAST 5/10 TABLETS : A white to off-white, film-coated, oval, biconvex tablet debossed with “AA 4” on one side of the tablet and “M” on the other side. CADIVAST 5/20 TABLETS : A white to off-white, film-coated, round, biconvex tablet debossed with “AA 5” on one side of the tablet and “M” on the other side. CADIVAST 5/40 TABLETS : A white to off-white, film-coated, capsule shaped, biconvex tablet debossed with “AA 6” on one side of the tablet and “M” on the other side. CADIVAST 5/80 TABLETS : A white to off-white, film-coated, oval, biconvex tablet debossed with “AA 7” on one side of the tablet and “M” on the other side CADIVAST 10/10 TABLETS : A blue, film-coated, barrel shaped, biconvex tablet debossed with “AA 8” on one side of the tablet and “M” on the other side. CADIVAST 10/20 TABLETS : A blue, film-coated, oval, biconvex tablet debossed with “AA 9” on one side of the tablet and “M” on the other side. CADIVAST 10/40 TABLETS : A blue, film-coated, round, biconvex tablet debossed with “AA 10” on one side of the tablet and “M” on the other side. CADIVAST 10/80 TABLETS : A blue, film-coated, capsule shaped, biconvex tablet debossed with “AA 11” on one side of the tablet and “M” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amlodipine besilate and atorvastatin calcium trihydrate tablet is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented. THE INDICATIONS FOR AMLODIPINE ARE: 1. Hyperte Прочитајте комплетан документ