Pioglitazone - EPARs for authorised medicinal products for human use - Actos

FICHA FARMACOLÓGICA de Pioglitazone . Contiene la Monografía en distintos idiomas (de la Unión Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. JULIO 03, 2010.-

abrir aquí para acceder al documento EMA completo:
EPARs for authorised medicinal products for human use - Actos

Active Substance
Pioglitazone
International Nonproprietary Name or Common Name
Pioglitazone
Pharmaco-therapeutic Group
Thiazolidinediones
ATC Code
A10BG03

Therapeutic Indication:
Pioglitazone is indicated in the treatment of type 2 diabetes mellitus:

as monotherapy

1. 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

1. metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin

2. 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

1. 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.


Date of issue of Marketing Authorisation valid throughout the European Union
13 October 2000

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use