Pioglitazone Teva

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

pioglitazone hydrochloride

Tilgængelig fra:

Teva B.V.

ATC-kode:

A10BG03

INN (International Name):

pioglitazone

Terapeutisk gruppe:

Alimentary tract and metabolism

Terapeutisk område:

Diabetes Mellitus, Type 2

Terapeutiske indikationer:

Pioglitazone is indicated in the treatment of type 2 diabetes mellitus:as monotherapy- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intoleranceas 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 sulphonylureaas 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.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.

Produkt oversigt:

Revision: 12

Autorisation status:

Withdrawn

Autorisation dato:

2012-03-26

Indlægsseddel

29
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
PIOGLITAZONE TEVA 15 MG TABLETS
PIOGLITAZONE TEVA 30 MG TABLETS
PIOGLITAZONE TEVA 45 MG TABLETS
Pioglitazone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pioglitazone Teva is and what it is used for
2.
What you need to know before you take Pioglitazone Teva
3.
How to take Pioglitazone Teva
4.
Possible side effects
5.
How to store Pioglitazone Teva
6.
Contents of the pack and other information
1.
WHAT PIOGLITAZONE TEVA IS AND WHAT IT IS USED FOR
Pioglitazone Teva contains pioglitazone. It is an anti-diabetic
medicine used to treat type 2 (non-
insulin dependent) diabetes mellitus in adults, when metformin is not
suitable or has failed to work
adequately. This is the diabetes that usually develops in adulthood.
Pioglitazone Teva helps control the level of sugar in your blood when
you have type 2 diabetes by
helping your body make better use of the insulin it produces. Your
doctor will check whether
Pioglitazone Teva is working 3 to 6 months after you start taking it.
Pioglitazone Teva may be used on its own in patients who are unable to
take metformin, and where
treatment with diet and exercise has failed to control blood sugar or
may be added to other therapies
(such as metformin, sulphonylurea or insulin) which have failed to
provide sufficient control of blood
sugar.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIOGLITAZONE TEVA
DO NOT TAKE PIOGLITAZONE TEVA
-
if you are allergic to pioglita

Produktets egenskaber

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Pioglitazone Teva 15 mg tablets
Pioglitazone Teva 30 mg tablets
Pioglitazone Teva 45 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pioglitazone Teva 15 mg tablets
Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Pioglitazone Teva 30 mg tablets
Each tablet contains 30 mg of pioglitazone (as hydrochloride).
Pioglitazone Teva 45 mg tablets
Each tablet contains 45 mg of pioglitazone (as hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Pioglitazone Teva 15 mg tablets
The tablets are white to off-white, round, convex and debossed with
the number ‘15’ on one side and
‘TEVA’ on the other side.
Pioglitazone Teva 30 mg tablets
The tablets are white to off-white, round, convex and debossed with
the number ‘30’ on one side and
‘TEVA’ on the other side.
Pioglitazone Teva 45 mg tablets
The tablets are white to off-white, round, convex and debossed with
the number ‘45’ on one side and
‘TEVA’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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
Medicinal Product no longer authorised
3
-
metformin and a sulphonylurea, in adult patients (particular