Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - amlodipine besilate, quantity: 13.87 mg; atorvastatin calcium trihydrate, quantity: 86.8 mg - 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 - amlodipine/atorvastatin-medis (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.

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - amlodipine besilate, quantity: 13.87 mg; atorvastatin calcium trihydrate, quantity: 43.4 mg - 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 - amlodipine/atorvastatin-medis (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.

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg); atorvastatin calcium trihydrate, quantity: 21.7 mg (equivalent: atorvastatin, qty 20 mg) - 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 - amlodipine/atorvastatin-medis (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.

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg); atorvastatin calcium trihydrate, quantity: 10.85 mg (equivalent: atorvastatin, qty 10 mg) - 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 - amlodipine/atorvastatin-medis (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.

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg); atorvastatin calcium trihydrate, quantity: 86.8 mg (equivalent: atorvastatin, qty 80 mg) - 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 3350 - amlodipine/atorvastatin-medis (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.

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg); atorvastatin calcium trihydrate, quantity: 43.4 mg (equivalent: atorvastatin, qty 40 mg) - 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 3350 - amlodipine/atorvastatin-medis (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.

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg); atorvastatin calcium trihydrate, quantity: 21.7 mg (equivalent: atorvastatin, qty 20 mg) - 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 3350 - amlodipine/atorvastatin-medis (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.

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg); atorvastatin calcium trihydrate, quantity: 10.85 mg (equivalent: atorvastatin, qty 10 mg) - 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 3350 - amlodipine/atorvastatin-medis (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.

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - simvastatin, quantity: 10 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: citric acid; propyl gallate; butylated hydroxyanisole; hypromellose; iron oxide red; lactose monohydrate; iron oxide black; magnesium stearate; microcrystalline cellulose; croscarmellose sodium; ascorbic acid; iron oxide yellow - adults (?18 years),prevention of cardiovascular disease ezetimibe/simvastatin-medis is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see clinical trials).,primary hypercholesterolaemia ezetimibe/simvastatin-medis is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate: ? patients not appropriately controlled with a statin or ezetimibe alone. ? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh) ezetimibe/simvastatin-medis is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis). children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year post- menarche),heterozygous familial hypercholesterolaemia (hefh) ezetimibe/simvastatin-medis is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate: ? patients not appropriately controlled with a statin or ezetimibe alone. ? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh) ezetimibe/simvastatin-medis is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - simvastatin, quantity: 40 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; iron oxide black; magnesium stearate; hypromellose; iron oxide yellow; lactose monohydrate; ascorbic acid; butylated hydroxyanisole; propyl gallate; citric acid; iron oxide red - adults (?18 years),prevention of cardiovascular disease ezetimibe/simvastatin-medis is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see clinical trials).,primary hypercholesterolaemia ezetimibe/simvastatin-medis is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate: ? patients not appropriately controlled with a statin or ezetimibe alone. ? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh) ezetimibe/simvastatin-medis is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis). children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year post- menarche),heterozygous familial hypercholesterolaemia (hefh) ezetimibe/simvastatin-medis is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate: ? patients not appropriately controlled with a statin or ezetimibe alone. ? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh) ezetimibe/simvastatin-medis is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).