Actos

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

pioglitazone hydrochloride

Διαθέσιμο από:

CHEPLAPHARM Arzneimittel GmbH

Φαρμακολογική κατηγορία (ATC):

A10BG03

INN (Διεθνής Όνομα):

pioglitazone

Θεραπευτική ομάδα:

Drugs used in diabetes

Θεραπευτική περιοχή:

Diabetes Mellitus, Type 2

Θεραπευτικές ενδείξεις:

Pioglitazone is indicated in the treatment of type-2 diabetes mellitus:as monotherapy:in 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 patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;a sulphonylurea, only in 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 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 patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.

Περίληψη προϊόντος:

Revision: 30

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2000-10-13

Φύλλο οδηγιών χρήσης

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACTOS 15 MG TABLETS
ACTOS 30 MG TABLETS
ACTOS 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 Actos is and what it is used for
2.
What you need to know before you take Actos
3.
How to take Actos
4.
Possible side effects
5.
How to store Actos
6.
Contents of the pack and other information
1.
WHAT ACTOS IS AND WHAT IT IS USED FOR
Actos 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.
Actos 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 Actos is working 3 to
6 months after you start taking it.
Actos 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 ACTOS
DO NOT TAKE ACTOS
-
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 past.
-
if you have liver disease.
-
if you have had diabetic ketoa

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Actos 15 mg tablets
Actos 30 mg tablets
Actos 45 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Actos 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).
Actos 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).
Actos 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
Actos 15 mg tablets
The tablets are white to off-white, round, convex and marked ‘15’
on one face and ‘ACTOS’ on the
other face.
Actos 30 mg tablets
The tablets are white to off-white, round, flat and marked ‘30’ on
one face and ‘ACTOS’ on the other
face.
Actos 45 mg tablets
The tablets are white to off-white, round, flat and marked ‘45’ on
one face and ‘ACTOS’ on the other
face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pioglitazone is indicated as second or third line treatment of type 2
diabetes mellitus as described
below:
3
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