Pioglitazone Teva Pharma
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
30-08-2022
Valmisteyhteenveto
(SPC)
30-08-2022
Julkisesta arviointikertomuksesta
(PAR)
30-08-2022
Aktiivinen ainesosa:
pioglitazone hydrochloride
Saatavilla:
Teva Pharma B.V.
ATC-koodi:
A10BG03
INN (Kansainvälinen yleisnimi):
pioglitazone
Terapeuttinen ryhmä:
Drugs used in diabetes
Terapeuttinen alue:
Diabetes Mellitus, Type 2
Käyttöaiheet:
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 intolerance. , 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.,
Tuoteyhteenveto:
Revision: 13
Valtuutuksen tilan:
Withdrawn
Valtuutus päivämäärä:
2012-03-26
Pakkausseloste
29
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
PIOGLITAZONE TEVA PHARMA 15 MG TABLETS
PIOGLITAZONE TEVA PHARMA 30 MG TABLETS
PIOGLITAZONE TEVA PHARMA 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 Pharma is and what it is used for
2.
What you need to know before you take Pioglitazone Teva Pharma
3.
How to take Pioglitazone Teva Pharma
4.
Possible side effects
5.
How to store Pioglitazone Teva Pharma
6.
Contents of the pack and other information
1.
WHAT PIOGLITAZONE TEVA PHARMA IS AND WHAT IT IS USED FOR
Pioglitazone Teva Pharma 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 Pharma 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 Pharma is working 3 to 6 months after you
start taking it.
Pioglitazone Teva Pharma may also be used 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 insulin therapy
when it fails to provide sufficient control of blood sugar.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIOGLITAZONE TEVA PHARMA
DO NOT TAKE PIOGLITAZONE TEVA
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Pioglitazone Teva Pharma 15 mg tablets
Pioglitazone Teva Pharma 30 mg tablets
Pioglitazone Teva Pharma 45 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pioglitazone Teva Pharma 15 mg tablets
Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Pioglitazone Teva Pharma 30 mg tablets
Each tablet contains 30 mg of pioglitazone (as hydrochloride).
Pioglitazone Teva Pharma 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 Pharma 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 Pharma 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 Pharma 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
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 HbA
1c
). In patients who fail to show an adequate
response, pioglitazone should be discontinued. In
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