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

bryant ranch prepack - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - monotherapy and combination therapy pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see clinical studies (14)] . important limitations of use pioglitazone tablet exerts its antihyperglycemic effect only in the presence of endogenous insulin. pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.3)] . - initiation in patients with established nyha class iii or iv heart failure [see boxed warning]. - use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone tablets. risk summary limited data with pioglitazone hydrochloride in pregnant women are not sufficient to de

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

avkare - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - pioglitazone and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and metformin is appropriate [see clinical studies (14)] . important limitations of use pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. pioglitazone and metformin hydrochloride tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as they would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.5)] . - initiation in patients with established nyha class iii or iv heart failure [see boxed warning] . - severe renal impairment (egfr below 30 ml/min/1.73 m 2 ) [see 

Israel - English - Ministry of Health

tzamal bio-pharma ltd - metformin hydrochloride; pioglitazone as hydrochloride - film coated tablets - metformin hydrochloride 850 mg; pioglitazone as hydrochloride 15 mg - metformin - metformin - competact is indicated as second line treatment of type 2 diabetes mellitus adult patients,particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.after initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in hba1c). in patients who fail to show an adequate response, pioglitazone should be discontinued. in light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.

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

arrotex pharmaceuticals pty ltd - pioglitazone hydrochloride, quantity: 33.069 mg (equivalent: pioglitazone, qty 30 mg) - tablet, uncoated - excipient ingredients: lactose monohydrate; hyprolose; magnesium stearate; carmellose calcium - treatment of type 2 diabetes mellitus inadequately controlled by diet and exercise:,as monotherapy,as dual therapy to improve glycaemic control,- in combination with metformin or sulfonylurea,- in combination with insulin,as triple therapy to improve glycaemic control,- in combination with metformin and sulfonylurea

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

arrotex pharmaceuticals pty ltd - pioglitazone hydrochloride, quantity: 49.604 mg (equivalent: pioglitazone, qty 45 mg) - tablet, uncoated - excipient ingredients: magnesium stearate; hyprolose; lactose monohydrate; carmellose calcium - treatment of type 2 diabetes mellitus inadequately controlled by diet and exercise:,as monotherapy,as dual therapy to improve glycaemic control,- in combination with metformin or sulfonylurea,- in combination with insulin,as triple therapy to improve glycaemic control,- in combination with metformin and sulfonylurea

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

arrotex pharmaceuticals pty ltd - pioglitazone hydrochloride, quantity: 16.535 mg (equivalent: pioglitazone, qty 15 mg) - tablet, uncoated - excipient ingredients: lactose monohydrate; carmellose calcium; hyprolose; magnesium stearate - treatment of type 2 diabetes mellitus inadequately controlled by diet and exercise:,as monotherapy,as dual therapy to improve glycaemic control,- in combination with metformin or sulfonylurea,- in combination with insulin,as triple therapy to improve glycaemic control,- in combination with metformin and sulfonylurea

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - pioglitazone hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - pioglitazone is indicated in the treatment of type-2 diabetes mellitus:as monotherapyin adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.after initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in hba1c). in patients who fail to show an adequate response, pioglitazone should be discontinued. in light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.

European Union - English - EMA (European Medicines Agency)

actavis group ptc ehf   - pioglitazone hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:as monotherapyin adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.as dual oral therapy in combination withmetformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin.a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea.as triple oral therapy in combination withmetformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).after initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in hba1c). in patients who fail to show an adequate response, pioglitazone should be discontinued. in light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - pioglitazone hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below: as monotherapy- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance;as dual oral therapy in combination with- a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus in adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.after initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in hba1c). in patients who fail to show an adequate response, pioglitazone should be discontinued. in light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.

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

sandoz pty ltd - pioglitazone hydrochloride, quantity: 49.605 mg - tablet, uncoated - excipient ingredients: carmellose calcium; hyprolose; lactose monohydrate; magnesium stearate - treatment of type 2 diabetes mellitus inadequately controlled by diet and exercise: as monotherapy; as dual therapy to improve glycaemic control: in combination with metformin or sulfonylurea, in combination with insulin; as triple therapy to improve glycaemic control: in combination with metformin and sulfonylurea.