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Pioglitazone Actavis

Active Substance: pioglitazone hydrochloride
Common Name: pioglitazone
ATC Code: A10BG03
Marketing Authorisation Holder: Actavis Group PTC ehf  
Active Substance: pioglitazone hydrochloride
Status: Authorised
Authorisation Date: 2012-03-15
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.

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 3 to 6 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).

What is Pioglitazone Actavis?

Pioglitazone Actavis is a medicine that contains the active substance pioglitazone. It is available as tablets (15, 30 and 45 mg).

Pioglitazone Actavis is a ‘generic medicine’. This means that Pioglitazone Actavis is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Actos.

What is Pioglitazone Actavis used for?

Pioglitazone Actavis is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight. It is used in addition to diet and exercise.

Pioglitazone Actavis is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.

Pioglitazone Actavis can also be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.

The medicine can only be obtained with a prescription.

How is Pioglitazone Actavis used?

The recommended starting dose of Pioglitazone Actavis is 15 or 30 mg once a day. This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed. Pioglitazone Actavis should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease).

Treatment with Pioglitazone Actavis should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit. At subsequent reviews prescribers should confirm that benefits to patients are maintained.

How does Pioglitazone Actavis 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 when the body is unable to use insulin effectively. The active substance in Pioglitazone Actavis, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces. As a consequence, the blood glucose levels are reduced and this helps to control type 2 diabetes.
Treatment with Pioglitazone Actavis should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit. At subsequent reviews prescribers should confirm that benefits to patients are maintained.

How has Pioglitazone Actavis been studied?

Because Pioglitazone Actavis is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What is the risk associated with Pioglitazone Actavis?

Because Pioglitazone Actavis 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 Pioglitazone Actavis been approved?

The CHMP concluded that, in accordance with EU requirements, Pioglitazone Actavis has been shown to have comparable quality and to be bioequivalent to Actos. Therefore, the CHMP’s view was that, as for Actos, the benefit outweighs the identified risk. The Committee recommended that Pioglitazone Actavis be given marketing authorisation.

Other information about Pioglitazone Actavis

The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Actavis on 15 March 2012.

For more information about treatment with Pioglitazone Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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