|
Product class:
|
Authorized package
|
|
Medicinal product class:
|
For human use
|
|
Package code:
|
1212444
|
|
Name of medicinal product:
|
ACTOS
|
|
Active substances:
|
|
|
ATC code:
|
A10BG03
|
|
Dosage form:
|
tablet
|
|
Route of administration:
|
oral use
|
|
Strengh:
|
30mg
|
|
Amount in package:
|
56TK
|
|
Legal status for supply*:
|
Subject to medicinal prescription
|
|
Class of active substance:
|
|
|
Additional information:
|
|
|
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
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).
|
|
Safety features:
|
Yes
|
|
Summary of product characteristics (SPC):
|
|
|
Package information leaflet (PIL):
|
EST
|
|
Labelling:
|
|
|
Last imported to Estonia:
|
Never imported to Estonia
|
|
Marketing authorization holder:
|
Cheplapharm Arzneimittel GmbH
|
|
Marketing authorization number:
|
EU/1/00/150
|
|
Marketing authorization issued on:
|
08 February 2002
|
|
Marketing authorization expires on:
|
Unlimited
|
|
Marketing authorization procedure type:
|
Centralised
|
|
Reference price:
|
|
|
Under reference price:
|
|
|
Reference price of daily dose:
|
|
|
Description
|
Additional condition
|
|
Perearsti õel on õigus välja kirjutada
|
Välja arvatud esmane retsept
|
Entry/Changing date:
15 September 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription