PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is Pioglitazone Krka?
Pioglitazone Krka is a medicine that contains the active substance pioglitazone. It is available as tablets (15, 30 and 45 mg).
Pioglitazone Krka is a "generic medicine". This means that Pioglitazone Krka is similar to a "reference medicine" already authorized in the European Union (EU) called Actos.
What is Pioglitazone Krka used for?
Pioglitazone Krka is indicated for the treatment of type 2 diabetes in adults (aged 18 years or older), particularly those who are overweight. It is used in association with diet and exercise.
Pioglitazone Krka is used on its own in patients for whom metformin (another antidiabetes medicine) is not adequate.
Pioglitazone Krka can also be used in combination with a sulphonylurea (another type of antidiabetic medicine) when metformin is not adequate ("double therapy").
Pioglitazone Krka 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 Pioglitazone Krka used?
The recommended starting dose of Pioglitazone Krka is 15 or 30 mg once a day. This dose can be increased after one or two weeks up to 45 mg once a day if better blood glucose (sugar) control is needed. Pioglitazone Krka should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease). The tablets should be swallowed with water.
Treatment with Pioglitazone Krka should be re-examined after 3-6 months and discontinued in the case of patients who do not receive sufficient benefits. Upon further reviews, prescribers must confirm the continuity of benefits deriving from treatment for patients.
How does Pioglitazone Krka work?
Type 2 diabetes is a disease in which the pancreas does not produce 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 Pioglitazone Krka, 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 glucose levels are reduced and this helps to control type 2 diabetes.
How has Pioglitazone Krka been studied?
Because Pioglitazone Krka 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 active ingredient in the body.
What are the benefits and risks of Pioglitazone Krka?
Because Pioglitazone Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Pioglitazone Krka been approved?
The CHMP concluded that, in accordance with EU requirements, Pioglitazone Krka 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 and recommended the granting of the marketing authorization for Pioglitazone Krka.
More information on Pioglitazone Krka
On March 21, 2012, the European Commission issued a marketing authorization for Pioglitazone Krka, valid throughout the European Union.
For more information about treatment with Pioglitazone Krka, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 08-2011.
