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

arrotex pharmaceuticals pty ltd - hydrochlorothiazide, quantity: 12.5 mg; amlodipine besilate, quantity: 6.95 mg; olmesartan medoxomil, quantity: 20 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; silicified microcrystalline cellulose; isopropyl alcohol; magnesium stearate; lactose monohydrate; povidone; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - apo-olmesartan/amlodipine/hctz 20/5/12.5 mg is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination. this fixed dose combination is not indicated for initial therapy.

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

arrotex pharmaceuticals pty ltd - amlodipine besilate, quantity: 13.9 mg; hydrochlorothiazide, quantity: 25 mg; olmesartan medoxomil, quantity: 40 mg - tablet, film coated - excipient ingredients: isopropyl alcohol; silicified microcrystalline cellulose; povidone; lactose monohydrate; pregelatinised maize starch; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - apo-olmesartan/amlodipine/hctz 40/10/25 mg is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination. this fixed dose combination is not indicated for initial therapy.

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

alphapharm pty ltd - spironolactone, quantity: 100 mg - tablet, uncoated - excipient ingredients: sunset yellow fcf aluminium lake; maize starch; povidone; magnesium stearate; peppermint oil; sodium starch glycollate; purified talc; erythrosine aluminium lake; polysorbate 80; quinoline yellow aluminium lake; lactose monohydrate; microcrystalline cellulose - essential hypertension; oedematous disorders such as oedema and ascites of congestive cardiac failure, cirrhosis of the liver and nephrotic syndrome; diagnosis and treatment of primary aldosteronism; as adjunctive therapy in malignant hypertension; in diuretic induced hypokalaemia when other measures are considered inappropriate or inadequate; prophylaxis of hypokalaemia in patients taking digitalis when other measures are considered inadequate or inappropriate; hirsutism. essential hypertension. spironolactone, when used alone, is effective in lowering both systolic and diastolic blood pressure. spironolactone improves the hypotensive action of thiazide diuretics, while at the same time reducing or preventing potassium loss due to the thiazide. spironolactone enhances the effectiveness of other antihypertensive agents such as beta-blockers, vasodilators, etc. congestive cardiac failure. when used alone, spironolactone is effective in the management of oedema and sodium retention associated with congestive cardiac failure. spironolactone may be used in combination with a thiazide or other conventional diuretics for achieving diuresis in patients whose oedema is resistant to a thiazide or other conventional diuretics. unlike conventional diuretics, spironolactone does not produce hypokalaemia. when administered with a thiazide or other conventional diuretics, spironolactone offsets hypokalaemia induced by these diuretics. the prevention of potassium loss is particularly important in the treatment of digitalised patients, since digitalis intoxication may be precipitated if hypokalaemia is induced by conventional diuretic therapy. hepatic cirrhosis with ascites and oedema. when used alone, spironolactone is frequently adequate for the relief of ascites and oedema associated with hepatic cirrhosis. it provides a mild and even diuresis and prevents excessive potassium excretion caused by thiazide diuretics, thus avoiding possible precipitation of hepatic coma. nephrotic syndrome. although glucocorticoids, whose anti-inflammatory activity appears to benefit the primary pathological process in the renal glomerulus, should probably be employed first, spironolactone either alone or in combination with a conventional diuretic is useful for inducing diuresis. primary hyperaldosteronism. spironolactone may be used to establish the diagnosis of primary hyperaldosteronism by therapeutic trial. spironolactone may also be used for the short-term preoperative treatment of patients with primary hyperaldosteronism, long-term maintenance therapy for patients with discrete aldosterone producing adrenal adenomas who are judged to be poor operative risks (or who decline surgery), and long-term maintenance therapy for patients with bilateral micro- or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). hirsutism in females. spironolactone is effective in the treatment of females with hirsutism, an androgen related increase in facial and body hair. a reduction in hair growth, hair shaft diameter and hair pigmentation is seen. use of spiractin should be considered only after all other alternatives of non-drug therapy have been explored. for women of childbearing age, see contraindications and use in pregnancy.

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

alphapharm pty ltd - spironolactone, quantity: 25 mg - tablet, uncoated - excipient ingredients: quinoline yellow aluminium lake; peppermint oil; purified talc; sodium starch glycollate; lactose monohydrate; povidone; microcrystalline cellulose; magnesium stearate; polysorbate 80; sunset yellow fcf aluminium lake; erythrosine aluminium lake; maize starch - essential hypertension; oedematous disorders such as oedema and ascites of congestive cardiac failure, cirrhosis of the liver and nephrotic syndrome; diagnosis and treatment of primary aldosteronism; as adjunctive therapy in malignant hypertension; in diuretic induced hypokalaemia when other measures are considered inappropriate or inadequate; prophylaxis of hypokalaemia in patients taking digitalis when other measures are considered inadequate or inappropriate; hirsutism. essential hypertension. spironolactone, when used alone, is effective in lowering both systolic and diastolic blood pressure. spironolactone improves the hypotensive action of thiazide diuretics, while at the same time reducing or preventing potassium loss due to the thiazide. spironolactone enhances the effectiveness of other antihypertensive agents such as beta-blockers, vasodilators, etc. congestive cardiac failure. when used alone, spironolactone is effective in the management of oedema and sodium retention associated with congestive cardiac failure. spironolactone may be used in combination with a thiazide or other conventional diuretics for achieving diuresis in patients whose oedema is resistant to a thiazide or other conventional diuretics. unlike conventional diuretics, spironolactone does not produce hypokalaemia. when administered with a thiazide or other conventional diuretics, spironolactone offsets hypokalaemia induced by these diuretics. the prevention of potassium loss is particularly important in the treatment of digitalised patients, since digitalis intoxication may be precipitated if hypokalaemia is induced by conventional diuretic therapy. hepatic cirrhosis with ascites and oedema. when used alone, spironolactone is frequently adequate for the relief of ascites and oedema associated with hepatic cirrhosis. it provides a mild and even diuresis and prevents excessive potassium excretion caused by thiazide diuretics, thus avoiding possible precipitation of hepatic coma. nephrotic syndrome. although glucocorticoids, whose anti-inflammatory activity appears to benefit the primary pathological process in the renal glomerulus, should probably be employed first, spironolactone either alone or in combination with a conventional diuretic is useful for inducing diuresis. primary hyperaldosteronism. spironolactone may be used to establish the diagnosis of primary hyperaldosteronism by therapeutic trial. spironolactone may also be used for the short-term preoperative treatment of patients with primary hyperaldosteronism, long-term maintenance therapy for patients with discrete aldosterone producing adrenal adenomas who are judged to be poor operative risks (or who decline surgery), and long-term maintenance therapy for patients with bilateral micro- or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). hirsutism in females. spironolactone is effective in the treatment of females with hirsutism, an androgen related increase in facial and body hair. a reduction in hair growth, hair shaft diameter and hair pigmentation is seen. use of spiractin should be considered only after all other alternatives of non-drug therapy have been explored. for women of childbearing age, see contraindications and use in pregnancy.

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

organon pharma pty ltd - olmesartan medoxomil, quantity: 40 mg; hydrochlorothiazide, quantity: 25 mg; amlodipine besilate, quantity: 6.944 mg (equivalent: amlodipine, qty mg) - tablet - excipient ingredients: microcrystalline cellulose; pregelatinised maize starch; croscarmellose sodium; magnesium stearate; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - sevikar hct is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination (see dosage and administration). this fixed dose combination is not indicated for initial therapy

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

organon pharma pty ltd - amlodipine besilate, quantity: 6.944 mg (equivalent: amlodipine, qty mg); olmesartan medoxomil, quantity: 40 mg; hydrochlorothiazide, quantity: 12.5 mg - tablet - excipient ingredients: magnesium stearate; croscarmellose sodium; pregelatinised maize starch; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - sevikar hct is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination (see dosage and administration). this fixed dose combination is not indicated for initial therapy

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

organon pharma pty ltd - hydrochlorothiazide, quantity: 12.5 mg; amlodipine besilate, quantity: 13.888 mg (equivalent: amlodipine, qty mg); olmesartan medoxomil, quantity: 40 mg - tablet - excipient ingredients: pregelatinised maize starch; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sevikar hct is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination (see dosage and administration). this fixed dose combination is not indicated for initial therapy

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

organon pharma pty ltd - olmesartan medoxomil, quantity: 40 mg; amlodipine besilate, quantity: 13.888 mg/mg (equivalent: amlodipine, qty mg); hydrochlorothiazide, quantity: 25 mg - tablet - excipient ingredients: magnesium stearate; microcrystalline cellulose; croscarmellose sodium; pregelatinised maize starch; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sevikar hct is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination (see dosage and administration). this fixed dose combination is not indicated for initial therapy

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

organon pharma pty ltd - olmesartan medoxomil, quantity: 20 mg; amlodipine besilate, quantity: 6.944 mg (equivalent: amlodipine, qty mg); hydrochlorothiazide, quantity: 12.5 mg - tablet - excipient ingredients: microcrystalline cellulose; magnesium stearate; pregelatinised maize starch; croscarmellose sodium; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - sevikar hct is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination (see dosage and administration). this fixed dose combination is not indicated for initial therapy

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

accord healthcare pty ltd - hydrochlorothiazide, quantity: 12.5 mg; olmesartan medoxomil, quantity: 40 mg; amlodipine besilate, quantity: 13.9 mg - tablet, film coated - excipient ingredients: lactose monohydrate; isopropyl alcohol; magnesium stearate; pregelatinised maize starch; povidone; silicified microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - olamlo hct is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination. this fixed dose combination is not indicated for initial therapy.