This is a summary of the European public assessment report (EPAR) for Sepioglin. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sepioglin.
Sepioglin is a ‘generic medicine’. This means that Sepioglin is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Actos. For more information on generic medicines, see
What is SepioglinMedicinalused for?
- Pioglitazone accord - pioglitazone hydrochloride
Popisanih lijekova na recept. Tvar: "Pioglitazone hydrochloride"
Sepioglin is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight. It is us in addition to diet and exercise.
Sepioglin is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Sepioglin can also be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy’).
Sepioglin can also be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy’).
Sepioglin can also be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.