Glustin
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
17-10-2022
Charakterystyka produktu
(SPC)
17-10-2022
Sprawozdanie z oceny publicznego
(PAR)
17-10-2022
Składnik aktywny:
pioglitazone hydrochloride
Dostępny od:
Takeda Pharma A/S
Kod ATC:
A10BG03
INN (International Nazwa):
pioglitazone
Grupa terapeutyczna:
Drugs used in diabetes
Dziedzina terapeutyczna:
Diabetes Mellitus, Type 2
Wskazania:
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 three to six 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.
Podsumowanie produktu:
Revision: 28
Status autoryzacji:
Withdrawn
Data autoryzacji:
2000-10-11
Ulotka dla pacjenta
32
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
33
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GLUSTIN 15 MG TABLETS
GLUSTIN 30 MG TABLETS
GLUSTIN 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 Glustin is and what it is used for
2.
What you need to know before you take Glustin
3.
How to take Glustin
4.
Possible side effects
5.
How to store Glustin
6.
Contents of the pack and other information
1.
WHAT GLUSTIN IS AND WHAT IT IS USED FOR
Glustin 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.
Glustin 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 Glustin is working
3 to 6 months after you start taking it.
Glustin 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 GLUSTIN
DO NOT TAKE GLUSTIN
-
if you are allergic to pioglitazone or any of the other ingredients of
this medicine (listed in
section 6).
-
if you have heart failure or have had heart failure in the
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Glustin 15 mg tablets
Glustin 30 mg tablets
Glustin 45 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glustin 15 mg tablets
Each tablet contains 15 mg of pioglitazone (as hydrochloride).
_Excipient with known effect_
Each tablet contains 92.87 mg of lactose monohydrate (see section
4.4).
Glustin 30 mg tablets
Each tablet contains 30 mg of pioglitazone (as hydrochloride).
_Excipient with known effect_
Each tablet contains 76.34 mg of lactose monohydrate (see section
4.4).
Glustin 45 mg tablets
Each tablet contains 45 mg of pioglitazone (as hydrochloride).
_Excipient with known effect_
Each tablet contains 114.51 mg of lactose monohydrate (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Glustin 15 mg tablets
The tablets are white to off-white, round, convex and marked ‘15’
on one face, ‘AD4’ on the other.
Glustin 30 mg tablets
The tablets are white to off-white, round, flat and marked ‘30’ on
one face, ‘AD4’ on the other.
Glustin 45 mg tablets
The tablets are white to off-white, round, flat and marked ‘45’ on
one face, ‘AD4’ on the other.
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 maximal tolerated
dose of monot
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