Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
amlodipine besilate, Quantity: 13.87 mg; atorvastatin calcium trihydrate, Quantity: 10.85 mg
Medis Pharma Pty Ltd
Tablet, film coated
Excipient Ingredients: calcium carbonate; colloidal anhydrous silica; hyprolose; magnesium stearate; pregelatinised maize starch; croscarmellose sodium; microcrystalline cellulose; polysorbate 80; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3000; indigo carmine aluminium lake
Oral
30, 10
(S4) Prescription Only Medicine
AMLODIPINE/ATORVASTATIN-ZP (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: Film-coated tablet, oval, biconvex, blue, "A18" on one side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-04-02
AMLOPDOPINE/ATORVASTATIN-ZP CMI ver002 06-16 Page 1 of 13 AMLODIPINE/ATORVASTATIN-ZP _Amlodipine Besilate and Atorvastatin Calcium _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about AMLODIPINE/ATORVASTATIN-ZP. 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 AMLODIPINE/ATORVASTATIN-ZP 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 AMLODIPINE/ATORVASTATIN-ZP IS USED FOR AMLODIPINE/ATORVASTATIN-ZP is used to treat high blood pressure and high cholesterol (fat in the blood). AMLODIPINE/ATORVASTATIN-ZP can also be used for angina (a certain type of chest pain). AMLODIPINE/ATORVASTATIN-ZP 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, AMLODIPINE/ATORVASTATIN-ZP 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. AMLOPDOP Olvassa el a teljes dokumentumot
Ezetimibe/simvastatin 10/10 mg, 10/20 mg, 10/40 mg, 10/80 mg tablets PRODUCT INFORMATION Medis Pharma Pty Ltd EZETIMIBE/SIMVASTATIN-ZP PI 0917 V5 Page 1 of 41 PRODUCT INFORMATION EZETIMIBE/SIMVASTATIN-ZP (ezetimibe and simvastatin) NAME OF THE MEDICINE _EZETIMIBE _ Chemical name: 1-(4-fluorophenyl)-3(_R_)-[3-(4-fluorophenyl)-3(_S_)- hydroxypropyl]-4(_S_)-(4-hydroxyphenyl)-2-azetidinone. Molecular formula: C 24 H 21 F 2 NO 3 Molecular weight: 409.4 CAS registry number: 163222-33-1 Its structural formula is: _SIMVASTATIN _ Chemical name: Simvastatin, an inactive lactone, is hydrolysed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin is (1_S_,3_R_,7_S_,8_S_,8a_R_)-8-[2- [(2_R_,4_R_)-4-Hydroxy-6-oxotetrahydro-2_H_-pyran-2-yl]ethyl]-3-7-dimethyl- 1,2,3,7,8,8ahexahydronaphtalen-1-yl 2,2-dimethylbutonate. Molecular formula: C 25 H 38 O 5 Molecular weight: 418.57 CAS registry number: 79902-63-9 Structural formula: Ezetimibe/simvastatin 10/10 mg, 10/20 mg, 10/40 mg, 10/80 mg tablets PRODUCT INFORMATION Medis Pharma Pty Ltd EZETIMIBE/SIMVASTATIN-ZP PI 0917 V5 Page 2 of 41 DESCRIPTION Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Simvastatin is a white to off-white, non-hygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. EZETIMIBE/SIMVASTATIN-ZP (ezetimibe/simvastatin) is a lipid-lowering product that selectively inhibits the intestinal absorption of cholesterol and related plant sterols and inhibits the endogenous synthesis of cholesterol. EZETIMIBE/SIMVASTATIN-ZP is available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin (EZETIMIBE/SIMVASTATIN-ZP 10/10), 20 mg of simvastatin (EZETIMIBE/SIMVASTATIN-ZP 10/20), 40 mg of simvastatin (EZETIMIBE/SIMVASTATIN-ZP 10/40), or 80 mg of simvastatin (EZETIMIBE/SIMVASTATIN-ZP 10/80). Each tablet contains the following inactive ingredien Olvassa el a teljes dokumentumot