Pioglitazone Krka

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

pioglitazone hydrochloride

Saatavilla:

Krka, d.d., Novo mesto

ATC-koodi:

A10BG03

INN (Kansainvälinen yleisnimi):

pioglitazone

Terapeuttinen ryhmä:

Drugs used in diabetes

Terapeuttinen alue:

Diabetes Mellitus, Type 2

Käyttöaiheet:

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- 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; 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.

Tuoteyhteenveto:

Revision: 2

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2012-03-21

Pakkausseloste

55
B. PACKAGE LEAFLET
Medicinal product no longer authorised
56
PACKAGE LEAFLET: INFORMATION FOR THE USER
PIOGLITAZONE KRKA 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 Pioglitazone Krka is and what it is used for
2.
What you need to know before you take Pioglitazone Krka
3.
How to take Pioglitazone Krka
4.
Possible side effects
5.
How to store Pioglitazone Krka
6.
Contents of the pack and other information
1.
WHAT PIOGLITAZONE KRKA IS AND WHAT IT IS USED FOR
Pioglitazone Krka 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.
Pioglitazone Krka 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 Krka is working 3 to 6 months after you start taking it.
Pioglitazone Krka 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 sulphonylurea or insulin) which have failed to provide
sufficient control of blood sugar.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIOGLITAZONE KRKA
DO NOT TAKE PIOGLITAZONE KRKA:
-
if you are allergic to pioglitazone or any of the other ingredients of
this medicine (listed in
section 6).
-
if yo

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Pioglitazone Krka 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 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
-
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;
-
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 potential
risks with prolonged therapy,
prescribers should confirm at subsequent routine reviews that the
benefit of pioglitazone is maintained
(see section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Pioglitazone treatment may be initiated at 15 mg or 30 mg once daily.
The dose may be increased in
increments up to 45 mg once daily.
Medicinal pro