Sepioglin - Pioglitazone

PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED

What is Sepioglin - Pioglitazone?

Sepioglin is a medicine that contains the active substance pioglitazone. It is available in tablets (15, 30 and 45 mg).
Sepioglin is a 'generic medicine'. This means that Spioglin is similar to a 'reference medicine' already authorized in the European Union (EU) called Actos.

What is Sepioglin - Pioglitazone used for?

Sepioglin is indicated for the treatment of type 2 diabetes in adults (aged 18 years and over), particularly in those who are overweight. It is used in conjunction with diet and exercise.
Sepioglin is used on its own in patients for whom metformin (another antidiabetic 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 diabetes medicine) when metformin is not adequate ("dual therapy").
Sepioglin can also be used in combination 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 in combination with insulin in patients who are not satisfactorily controlled on insulin alone and cannot take metformin.
The medicine can only be obtained with a prescription.

How is Sepioglin used?

The recommended starting dose of Sepioglin is 15 or 30 mg once daily. After one or two weeks the dose may need to be increased up to 45 mg once a day if better control of blood glucose (sugar) is required. Sepioglin must not be used in patients on dialysis (a blood clearance technique used in people with kidney disease). The tablets should be swallowed with water.
Sepioglin therapy should be reviewed after three to six months and discontinued in patients who do not derive sufficient benefit. Prescribing physicians must confirm continuity of treatment benefits during subsequent check-ups.

How does Sepioglin - Pioglitazone work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or where the body is unable to use insulin effectively. The active substance in Sepioglin, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which allows the body to make better use of the insulin it produces. As a result, blood levels are reduced. blood glucose levels and this helps control type 2 diabetes.

How has Sepioglin - Pioglitazone been studied?

Since Sepioglin is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence to the reference medicine, Actos. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Sepioglin - Pioglitazone?

Because Sepioglin is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why has Sepioglin - Pioglitazone been approved?

The CHMP concluded that, in accordance with EU requirements, Sepioglin has been shown to have comparable quality and to be bioequivalent to Actos. Therefore, the CHMP considered that, as in the case of Actos, the benefits outweigh the identified risks. The Committee therefore recommended the granting of a marketing authorization for Sepioglin.

More information about Sepioglin - Pioglitazone

On 9 March 2012, the European Commission issued a "Marketing Authorization" for Sepioglin, valid throughout the European Union.
For more information about Sepioglin therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 10-2011.

The information on Sepioglin - Pioglitazone published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.