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Sepioglin

Active Substance: pioglitazone hydrochloride
Common Name: pioglitazone
ATC Code: A10BG03
Marketing Authorisation Holder: Vaia S.A.
Active Substance: pioglitazone hydrochloride
Status: Withdrawn
Authorisation Date: 2012-03-09
Therapeutic Area: Diabetes Mellitus, Type 2
Pharmacotherapeutic Group: Drugs used in diabetes

Therapeutic Indication

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).

The marketing authorisation for Sepioglin has been withdrawn at the request of the marketing-authorisation holder.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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