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 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 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.

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.

European Union - English - EMA (European Medicines Agency)

vaia s.a. - 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:metformin, 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 with:metformin 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 three to six 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).

Israel - English - Ministry of Health

tzamal bio-pharma ltd - pioglitazone as hydrochloride - tablets - pioglitazone as hydrochloride 15 mg - pioglitazone - pioglitazone - 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 - metformin, 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 with- metformin 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 .

Israel - English - Ministry of Health

tzamal bio-pharma ltd - pioglitazone as hydrochloride - tablets - pioglitazone as hydrochloride 30 mg - pioglitazone - pioglitazone - 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 - metformin, 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 with- metformin 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 .

Israel - English - Ministry of Health

tzamal bio-pharma ltd - pioglitazone as hydrochloride - tablets - pioglitazone as hydrochloride 45 mg - pioglitazone - pioglitazone - 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 intoleranceas dual oral therapy in combination with- metformin, 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 with- metformin 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 .

European Union - English - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - pioglitazone hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - pioglitazone is indicated in the treatment of type-2 diabetes mellitus:as monotherapy:in 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:metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;a sulphonylurea, only in 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 with:metformin and a sulphonylurea, in 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 patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.

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)

teva pharma b.v. - pioglitazone hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - pioglitazone is indicated in the treatment of type-2 diabetes mellitus as monotherapy: , in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. , 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. 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)

teva b.v. - pioglitazone hydrochloride - diabetes mellitus, type 2 - alimentary tract and metabolism - pioglitazone is indicated in the treatment of type 2 diabetes mellitus:as monotherapy- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intoleranceas dual oral therapy in combination with- metformin, 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 sulphonylureaas triple oral therapy in combination with- metformin 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.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.