Sepioglin
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
18-07-2013
Valmisteyhteenveto
(SPC)
18-07-2013
Julkisesta arviointikertomuksesta
(PAR)
18-07-2013
Aktiivinen ainesosa:
pioglitazone hydrochloride
Saatavilla:
Vaia S.A.
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: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 (see section 4.4).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 (see section 4.4).
Tuoteyhteenveto:
Revision: 1
Valtuutuksen tilan:
Withdrawn
Valtuutus päivämäärä:
2012-03-09
Pakkausseloste
B. PACKAGE LEAFLET
53
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEPIOGLIN 15 MG TABLETS
Pioglitazone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Sepioglin is and what it is used for
2.
Before you take Sepioglin
3.
How to take Sepioglin
4.
Possible side effects
5.
How to store Sepioglin
6.
Further information
1.
WHAT SEPIOGLIN IS AND WHAT IT IS USED FOR
Sepioglin 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.
Sepioglin 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 Sepioglin is
working 3 to 6 months after you start taking it.
Sepioglin 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.
BEFORE YOU TAKESEPIOGLIN
DO NOT TAKE SEPIOGLIN
-
if you are hypersensitive (allergic) to pioglitazone or any of the
other ingredients of Sepioglin.
-
if you have heart failure or have had heart failure in the past.
-
if you have liver disease.
-
if you have had diabetic ketoacidosis (a complication of diabetes
causing rapid weight loss,
nausea or vomiting).
-
if you have or have ever had blad
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Valmisteyhteenveto
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Sepioglin15 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Excipients:
Each tablet contains 36.866 mg of lactose monohydrate (see section
4.4).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, round, flat tablets, with “15” embossed on one side and a
diameter of approximately 5.5 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
-
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 (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,
pre
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