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

sandoz pty ltd - sitagliptin hydrochloride monohydrate, quantity: 56.69 mg (equivalent: sitagliptin, qty 50 mg); metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; triethyl citrate; hyprolose; povidone; hypromellose; purified talc; titanium dioxide; microcrystalline cellulose; sodium lauryl sulfate; sodium stearylfumarate; iron oxide red - sitagliptin/metformin sandoz is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.

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

sandoz pty ltd - metformin hydrochloride, quantity: 850 mg; sitagliptin hydrochloride monohydrate, quantity: 56.69 mg (equivalent: sitagliptin, qty mg) - tablet, film coated - excipient ingredients: hypromellose; sodium lauryl sulfate; croscarmellose sodium; povidone; sodium stearylfumarate; hyprolose; titanium dioxide; iron oxide red; triethyl citrate; purified talc; microcrystalline cellulose; iron oxide yellow - sitagliptin/metformin sandoz is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.

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

sandoz pty ltd - metformin hydrochloride, quantity: 1000 mg; sitagliptin hydrochloride monohydrate, quantity: 56.69 mg (equivalent: sitagliptin, qty mg) - tablet, film coated - excipient ingredients: iron oxide yellow; titanium dioxide; hyprolose; povidone; iron oxide red; sodium lauryl sulfate; triethyl citrate; purified talc; microcrystalline cellulose; sodium stearylfumarate; hypromellose; croscarmellose sodium - sitagliptin/metformin sandoz is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.

European Union - English - EMA (European Medicines Agency)

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride mylan is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.sitagliptin/metformin hydrochloride mylan is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.sitagliptin/metformin hydrochloride mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparg) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparg agonist.sitagliptin/metformin hydrochloride mylan is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Ireland - English - HPRA (Health Products Regulatory Authority)

as grindeks - sitagliptin hydrochloride monohydrate; metformin hydrochloride - film-coated tablet - metformin and sitagliptin

Ireland - English - HPRA (Health Products Regulatory Authority)

norton waterford - sitagliptin hydrochloride monohydrate; metformin hydrochloride - film-coated tablet - metformin and sitagliptin

Ireland - English - HPRA (Health Products Regulatory Authority)

norton waterford - sitagliptin hydrochloride monohydrate; metformin hydrochloride - film-coated tablet - metformin and sitagliptin

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

lupin australia pty limited - sitagliptin hydrochloride monohydrate, quantity: 113.373 mg (equivalent: sitagliptin, qty 100 mg) - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; calcium hydrogen phosphate; hyprolose; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sitagliptin lupin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:,? monotherapy when metformin is considered inappropriate due to intolerance; or,? in combination with other antihyperglycaemic agents, including insulin.,(see section 5.1 pharmacodynamic properties - clinical trials and section 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies.)

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

lupin australia pty limited - sitagliptin hydrochloride monohydrate, quantity: 56.686 mg (equivalent: sitagliptin, qty 50 mg) - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; calcium hydrogen phosphate; microcrystalline cellulose; hyprolose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sitagliptin lupin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:,? monotherapy when metformin is considered inappropriate due to intolerance; or,? in combination with other antihyperglycaemic agents, including insulin.,(see section 5.1 pharmacodynamic properties - clinical trials and section 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies.)

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

lupin australia pty limited - sitagliptin hydrochloride monohydrate, quantity: 28.343 mg (equivalent: sitagliptin, qty 25 mg) - tablet, film coated - excipient ingredients: hyprolose; calcium hydrogen phosphate; croscarmellose sodium; microcrystalline cellulose; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sitagliptin lupin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:,? monotherapy when metformin is considered inappropriate due to intolerance; or,? in combination with other antihyperglycaemic agents, including insulin,(see section 5.1 pharmacodynamic properties - clinical trials and section 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies.)