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

lupin australia pty limited - lansoprazole, quantity: 30 mg - tablet, orally disintegrating - excipient ingredients: purified talc; magnesium carbonate hydrate; polyacrylate dispersion (30 per cent); titanium dioxide; triethyl citrate; aspartame; hyprolose; macrogol 6000; magnesium stearate; methacrylic acid - ethyl acrylate copolymer (1:1); hypromellose; crospovidone; citric acid; iron oxide red; glyceryl monostearate; iron oxide yellow; purified water; mannitol; polysorbate 80; microcrystalline cellulose; flavour; xylitol; calcium hydrogen phosphate - adults:,1.healing and long-term management of reflux oesophagitis.,2.healing and long-term management for patients with duodenal ulcer.,3.healing of benign gastric ulcer. patients whose gastric or duodenal ulcer is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence.,4.lansoprazole is also effective in patients with benign peptic lesions that do not respond to h2-receptor antagonists.,5.eradication of h. pylori from the upper gastrointestinal tract in patients with peptic ulcer or chronic gastritis when used in combination with appropriate antibiotics (see clinical trials).,6.relief of reflux-like and/or ulcer-like symptoms associated with acid-related dyspepsia.,paediatric patients 6 to 17 years of age.,1.treatment of gastro-oesophageal reflux disease, including all grades of oesophagitis.,2.healing of erosive oesophagitis.

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

lupin australia pty limited - lansoprazole, quantity: 15 mg - tablet, orally disintegrating - excipient ingredients: macrogol 6000; magnesium carbonate hydrate; purified water; hypromellose; polyacrylate dispersion (30 per cent); microcrystalline cellulose; triethyl citrate; iron oxide red; polysorbate 80; glyceryl monostearate; citric acid; titanium dioxide; purified talc; hyprolose; iron oxide yellow; methacrylic acid - ethyl acrylate copolymer (1:1); crospovidone; magnesium stearate; mannitol; aspartame; xylitol; calcium hydrogen phosphate; flavour - adults:,1.healing and long-term management of reflux oesophagitis.,2.healing and long-term management for patients with duodenal ulcer.,3.healing of benign gastric ulcer. patients whose gastric or duodenal ulcer is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence.,4.lansoprazole is also effective in patients with benign peptic lesions that do not respond to h2-receptor antagonists.,5.eradication of h. pylori from the upper gastrointestinal tract in patients with peptic ulcer or chronic gastritis when used in combination with appropriate antibiotics (see clinical trials).,6.relief of reflux-like and/or ulcer-like symptoms associated with acid-related dyspepsia.,paediatric patients 6 to 17 years of age.,1.treatment of gastro-oesophageal reflux disease, including all grades of oesophagitis.,2.healing of erosive oesophagitis.

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

astrazeneca pty ltd - saxagliptin, quantity: 2.5 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; magnesium stearate; lactose monohydrate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; indigo carmine aluminium lake; ethanol; shellac; sulfuric acid; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - add-on combination: onglyza is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicines, when these together with diet and exercise, do not provide adequate glycaemic control (see clinical trials and precautions for available data on different add-on combination therapies).,initial combination: onglyza is indicated for use as initial combination therapy with metformin, in patients with type 2 diabetes mellitus, to improve glycaemic control as an adjunct to diet and exercise, when dual saxagliptin and metformin therapy is appropriate (i.e. high initial hba1c levels and poor prospects for response to monotherapy).

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

alphapharm pty ltd - atorvastatin calcium trihydrate, quantity: 43.376 mg (equivalent: atorvastatin, qty 40 mg); amlodipine besilate, quantity: 13.88 mg (equivalent: amlodipine, qty 10 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; arginine; sodium carbonate; magnesium stearate; colloidal anhydrous silica; pregelatinised maize starch; microcrystalline cellulose; hyprolose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin; indigo carmine aluminium lake - 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.

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

alphapharm pty ltd - atorvastatin calcium trihydrate, quantity: 21.688 mg (equivalent: atorvastatin, qty 20 mg); amlodipine besilate, quantity: 13.88 mg (equivalent: amlodipine, qty 10 mg) - tablet, film coated - excipient ingredients: arginine; sodium carbonate; croscarmellose sodium; colloidal anhydrous silica; hyprolose; microcrystalline cellulose; magnesium stearate; pregelatinised maize starch; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin; indigo carmine aluminium lake - 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.

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

alphapharm pty ltd - atorvastatin calcium trihydrate, quantity: 21.688 mg (equivalent: atorvastatin, qty 20 mg); amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg) - 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 - 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.

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

alphapharm pty ltd - amlodipine besilate, quantity: 13.88 mg (equivalent: amlodipine, qty 10 mg); atorvastatin calcium trihydrate, quantity: 86.751 mg (equivalent: atorvastatin, qty 80 mg) - tablet, film coated - excipient ingredients: hyprolose; magnesium stearate; arginine; croscarmellose sodium; pregelatinised maize starch; microcrystalline cellulose; colloidal anhydrous silica; sodium carbonate; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin; indigo carmine aluminium lake - 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.

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

alphapharm pty ltd - amlodipine besilate, quantity: 13.88 mg (equivalent: amlodipine, qty 10 mg); atorvastatin calcium trihydrate, quantity: 10.844 mg (equivalent: atorvastatin, qty 10 mg) - tablet, film coated - excipient ingredients: sodium carbonate; arginine; magnesium stearate; colloidal anhydrous silica; pregelatinised maize starch; croscarmellose sodium; hyprolose; microcrystalline cellulose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin; indigo carmine aluminium lake - 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.

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

alphapharm pty ltd - amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg); atorvastatin calcium trihydrate, quantity: 43.376 mg (equivalent: atorvastatin, qty 40 mg) - tablet, film coated - excipient ingredients: hyprolose; croscarmellose sodium; colloidal anhydrous silica; microcrystalline cellulose; sodium carbonate; magnesium stearate; pregelatinised maize starch; arginine; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - 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.

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

alphapharm pty ltd - atorvastatin calcium trihydrate, quantity: 10.844 mg (equivalent: atorvastatin, qty 10 mg); amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg) - tablet, film coated - excipient ingredients: sodium carbonate; microcrystalline cellulose; arginine; croscarmellose sodium; magnesium stearate; colloidal anhydrous silica; hyprolose; pregelatinised maize starch; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - 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.