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Product class:
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Medicinal product with marketing authorization
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Medicinal product class:
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Human medicine
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Name of medicinal product:
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ACTOS
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Active substances:
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ATC code:
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A10BG03
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Dosage form:
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tablet
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Strength:
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15mg
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Legal status for supply*:
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Subject to medicinal prescription
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Summary of product characteristics (SPC):
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Package information leaflet (PIL):
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EST
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Labelling:
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Indication:
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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
as dual oral therapy in combination with
- metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin
- a sulphonylurea, only in adult 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
- metformin and a sulphonylurea, in adult 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 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).
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Safety features:
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Yes
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Marketing authorization holder:
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Cheplapharm Arzneimittel GmbH
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Marketing authorization number:
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EU/1/00/150
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Marketing authorization issued on:
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February 8, 2002
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Centralised
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Assessment report:
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Description
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Additional condition
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Perearsti õel on õigus välja kirjutada
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Välja arvatud esmane retsept
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Package code
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Name of medicinal product
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Dosage form
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Package
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Legal status
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Reimbursements
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Reference price
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Last imported
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PƤritolumaa
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Additional information
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1013566
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ACTOS
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tablet
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15mg 28TK
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Prescription
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10.12.2014
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1209372
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ACTOS
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tablet
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15mg 14TK
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Prescription
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1209383
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ACTOS
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tablet
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15mg 30TK
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Prescription
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1209394
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ACTOS
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tablet
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15mg 50TK
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Prescription
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|
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1209406
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ACTOS
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tablet
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15mg 56TK
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Prescription
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|
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1209417
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ACTOS
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tablet
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15mg 84TK
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Prescription
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1209428
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ACTOS
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tablet
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15mg 90TK
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Prescription
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1209439
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ACTOS
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tablet
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15mg 98TK
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Prescription
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1494402
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ACTOS
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tablet
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15mg 112TK
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Prescription
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1494413
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ACTOS
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tablet
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15mg 196TK
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Prescription
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Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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