Paglitaz
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
14-07-2014
Charakterystyka produktu
(SPC)
14-07-2014
Sprawozdanie z oceny publicznego
(PAR)
26-04-2012
Składnik aktywny:
pioglitazone hydrochloride
Dostępny od:
Krka, d.d., Novo mesto
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 monotherapyin 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 withmetformin, 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 withmetformin 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 in 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.
Podsumowanie produktu:
Revision: 1
Status autoryzacji:
Withdrawn
Data autoryzacji:
2012-03-21
Ulotka dla pacjenta
55
B. PACKAGE LEAFLET
Medicinal product no longer authorised
56
PACKAGE LEAFLET: INFORMATION FOR THE USER
PAGLITAZ 15 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 Paglitaz is and what it is used for
2.
What you need to know before you take Paglitaz
3.
How to take Paglitaz
4.
Possible side effects
5.
How to store Paglitaz
6.
Contents of the pack and other information
1.
WHAT PAGLITAZ IS AND WHAT IT IS USED FOR
Paglitaz 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.
Paglitaz 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 Paglitaz is working 3
to 6 months after you start taking it.
Paglitaz 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 in blood sugar.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PAGLITAZ
DO NOT TAKE PAGLITAZ:
-
if you are hypersensitive (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 past.
-
if you have liver d
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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
Paglitaz 15 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Excipient with known effect:
Each tablet contains 88.83 mg of lactose (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to almost white round tablets with bevelled edges and with
engraved "15" on one side of tablet
(diameter 7.0 mm).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pioglitazone is indicated as second or third line in the 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 in 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 potenti
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