Pioglitazone Actavis

Страна: Европейски съюз

Език: английски

Източник: EMA (European Medicines Agency)

Активна съставка:

pioglitazone hydrochloride

Предлага се от:

Actavis Group PTC ehf  

АТС код:

A10BG03

INN (Международно Name):

pioglitazone

Терапевтична група:

Drugs used in diabetes

Терапевтична област:

Diabetes Mellitus, Type 2

Терапевтични показания:

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 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).

Каталог на резюме:

Revision: 9

Статус Оторизация:

Authorised

Дата Оторизация:

2012-03-15

Листовка

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
PIOGLITAZONE ACTAVIS 15 MG, 30 MG AND 45 MG TABLETS
PIOGLITAZONE ACTAVIS 15 MG TABLETS
PIOGLITAZONE ACTAVIS 30 MG TABLETS
PIOGLITAZONE ACTAVIS 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 Actavis is and what it is used for
2.
What you need to know before you take Pioglitazone Actavis
3.
How to take Pioglitazone Actavis
4.
Possible side effects
5.
How to store Pioglitazone Actavis
6.
Contents of the pack and other information
1.
WHAT PIOGLITAZONE ACTAVIS IS AND WHAT IT IS USED FOR
Pioglitazone Actavis 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 Actavis 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 Actavis is working 3 to 6 months after you start taking
it.
Pioglitazone Actavis 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 PIOGLITAZONE ACTAVIS
DO NOT TAKE PIOGLITA

Данни за продукта

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pioglitazone Actavis 15 mg tablets
Pioglitazone Actavis 30 mg tablets
Pioglitazone Actavis 45 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pioglitazone Actavis 15 mg tablets
Each tablet contains 15 mg of pioglitazone (as hydrochloride).
_Excipients with known effect: _
Each tablet contains 37.77 mg of lactose monohydrate (see section
4.4).
Pioglitazone Actavis 30 mg tablets
Each tablet contains 30 mg of pioglitazone (as hydrochloride).
_Excipients with known effect: _
Each tablet contains 75.54 mg of lactose monohydrate (see section
4.4).
Pioglitazone Actavis 45 mg tablets
Each tablet contains 45 mg of pioglitazone (as hydrochloride).
_Excipients with known effect: _
Each tablet contains 113.31 mg of lactose monohydrate (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Pioglitazone Actavis 15 mg tablets
The tablets are white, round, flat, bevelled, 5.5 mm in diameter and
engraved with ‘TZ15’ on one side.
Pioglitazone Actavis 30 mg tablets
The tablets are white, round, flat, bevelled, 7 mm in diameter and
engraved with ‘TZ30’ on one side.
Pioglitazone Actavis 45 mg tablets
The tablets are white, round, flat, bevelled, 8 mm in diameter and
engraved with ‘TZ45’ on one 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.
3
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 glycaem