Glidipion (previously Pioglitazone Actavis Group)

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

pioglitazone hydrochloride

Tillgänglig från:

Actavis Group PTC ehf   

ATC-kod:

A10BG03

INN (International namn):

pioglitazone

Terapeutisk grupp:

Drugs used in diabetes

Terapiområde:

Diabetes Mellitus, Type 2

Terapeutiska indikationer:

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.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.

Produktsammanfattning:

Revision: 8

Bemyndigande status:

Withdrawn

Tillstånd datum:

2012-03-15

Bipacksedel

29
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLIDIPION 15 MG, 30 MG AND 45 MG TABLETS
GLIDIPION 15 MG TABLETS
GLIDIPION 30 MG TABLETS
GLIDIPION 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 Glidipion is and what it is used for
2.
What you need to know before you take Glidipion
3.
How to take Glidipion
4.
Possible side effects
5.
How to store Glidipion
6.
Contents of the pack and other information
1.
WHAT GLIDIPION IS AND WHAT IT IS USED FOR
Glidipion contains pioglitazone. It is an anti-diabetic medicine used
to treat type 2 (non-insulin
dependent) diabetes mellitus, when metformin is not suitable or has
failed to work adequately. This is
the diabetes that usually develops in adulthood.
Glidipion 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 Glidipion is working
3 to 6 months after you start taking it.
Glidipion 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 GLIDIPION
DO NOT TAKE GLIDIPION
-
if you are hypersensitive (allergic) to pioglitazone or any of the
other ingredients of Glidipion
(see section

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Glidipion 15 mg tablets
Glidipion 30 mg tablets
Glidipion 45 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glidipion 15 mg tablets
Each tablet contains 15 mg of pioglitazone (as hydrochloride).
_Excipients with known effect: _
Each tablet contains 37.77 mg of lactose monohydrate (see section
4.4).
Glidipion 30 mg tablets
Each tablet contains 30 mg of pioglitazone (as hydrochloride).
_Excipients with known effect: _
Each tablet contains 75.54 mg of lactose monohydrate (see section
4.4).
Glidipion 45 mg tablets
Each tablet contains 45 mg of pioglitazone (as hydrochloride).
_Excipients with known effect: _
Each tablet contains 113.31 mg of lactose monohydrate (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Glidipion 15 mg tablets
The tablets are white, round, flat, bevelled, 5.5 mm in diameter and
engraved with ‘TZ15’ on one side.
Glidipion 30 mg tablets
The tablets are white, round, flat, bevelled, 7 mm in diameter and
engraved with ‘TZ30’ on one side.
Glidipion 45 mg tablets
The tablets are white, round, flat, bevelled, 8 mm in diameter and
engraved with ‘TZ45’ on one 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.
Medicinal Product no longer authorised
3
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 ma