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

boehringer ingelheim pty ltd - empagliflozin, quantity: 12.5 mg; metformin hydrochloride, quantity: 1000 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide red; iron oxide black; macrogol 400 - jardiamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see section 5.1 pharmacodynamic properties - clinical trials).,to prevent cardiovascular deaths, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

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

boehringer ingelheim pty ltd - empagliflozin, quantity: 12.5 mg; metformin hydrochloride, quantity: 850 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide red; iron oxide black; macrogol 400 - jardiamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see section 5.1 pharmacodynamic properties - clinical trials).,to prevent cardiovascular deaths, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

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

boehringer ingelheim pty ltd - empagliflozin, quantity: 12.5 mg; metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide red; iron oxide black; macrogol 400 - jardiamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see section 5.1 pharmacodynamic properties - clinical trials).,to prevent cardiovascular deaths, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

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

boehringer ingelheim pty ltd - empagliflozin, quantity: 5 mg; metformin hydrochloride, quantity: 1000 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; hypromellose; purified talc; iron oxide yellow; macrogol 400 - jardiamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see section 5.1 pharmacodynamic properties - clinical trials).,to prevent cardiovascular deaths, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

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

boehringer ingelheim pty ltd - empagliflozin, quantity: 5 mg; metformin hydrochloride, quantity: 850 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 400 - jardiamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see section 5.1 pharmacodynamic properties - clinical trials).,to prevent cardiovascular deaths, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

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

boehringer ingelheim pty ltd - empagliflozin, quantity: 5 mg; metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 400 - jardiamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see section 5.1 pharmacodynamic properties - clinical trials).,to prevent cardiovascular deaths, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

United States - English - NLM (National Library of Medicine)

boehringer ingelheim pharmaceuticals, inc. - empagliflozin (unii: hdc1r2m35u) (empagliflozin - unii:hdc1r2m35u), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - empagliflozin 10 mg - synjardy synjardy is a combination of empagliflozin and metformin hydrochloride (hcl) indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. synjardy xr synjardy xr is a combination of empagliflozin and metformin hcl indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. empagliflozin empagliflozin, when used as a component of synjardy or synjardy xr, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: - cardiovascular death in adults with established cardiovascular disease. - cardiovascular death and hospitalization for heart failure in adults with heart failure. limitations of use - synjardy and synjardy xr are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. it may increase the risk of diabetic ketoacidosis in these patients [see warnings and precautions (5.2)] . - because

Israel - English - Ministry of Health

boehringer ingelheim israel ltd. - empagliflozin; metformin hydrochloride - film coated tablets - empagliflozin 12.5 mg; metformin hydrochloride 500 mg - metformin and empagliflozin - jardiance duo is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control• in patients inadequately controlled on their maximally tolerated dose of metformin alone.• in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin.• in patients already being treated with the combination of empagliflozin and metformin as separate tablets.

Israel - English - Ministry of Health

boehringer ingelheim israel ltd. - empagliflozin; metformin hydrochloride - film coated tablets - empagliflozin 12.5 mg; metformin hydrochloride 500 mg - metformin and empagliflozin - jardiance duo is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control• in patients inadequately controlled on their maximally tolerated dose of metformin alone.• in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin.• in patients already being treated with the combination of empagliflozin and metformin as separate tablets.

Israel - English - Ministry of Health

boehringer ingelheim israel ltd. - empagliflozin; metformin hydrochloride - film coated tablets - empagliflozin 12.5 mg; metformin hydrochloride 850 mg - metformin and empagliflozin - jardiance duo is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control• in patients inadequately controlled on their maximally tolerated dose of metformin alone.• in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin.• in patients already being treated with the combination of empagliflozin and metformin as separate tablets.