Pioglitazon Lek 45 mg, tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

PIOGLITAZONHYDROCHLORIDE SAMENSTELLING overeenkomend met ; PIOGLITAZON

Beschikbaar vanaf:

Lek Pharmaceuticals d.d. Verovskova ulica 57 1526 LJUBLJANA (SLOVENIË)

ATC-code:

A10BG03

INN (Algemene Internationale Benaming):

PIOGLITAZONHYDROCHLORIDE COMPOSITION corresponding to ; PIOGLITAZON

farmaceutische vorm:

Tablet

Samenstelling:

CARMELLOSE CALCIUM (E 466) ; HYPROLOSE (E 463) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Pioglitazone

Product samenvatting:

Hulpstoffen: CARMELLOSE CALCIUM (E 466); HYPROLOSE (E 463); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b);

Autorisatie datum:

2011-10-18

Bijsluiter

Sandoz B.V.
Page 1/8
Pioglitazon Lek 15/30/45 mg, tabletten
RVG 108649/50/51
1313-v5
1.3.1.3 Bijsluiter
November 2018
PACKAGE LEAFLET: INFORMATION FOR THE USER
Pioglitazon Lek
15 mg, tabletten
Pioglitazon Lek
30 mg, tabletten
Pioglitazon Lek
45 mg, tabletten
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 [Nationally completed name] is and what it is used for
2. What you need to know before you take [Nationally completed name]
3. How to take [Nationally completed name]
4. Possible side effects
5. How to store [Nationally completed name]
6. Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name]
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.
[Nationally completed name] 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 [Nationally completed name] is working 3 to 6 months after you
start taking it.
[Nationally completed name] 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

Productkenmerken

Sandoz B.V.
Page 1/17
Pioglitazon Lek 15/30/45 mg, tabletten
RVG 108649/50/51
1311-V5
1.3.1.1 Samenvatting van de Productkenmerken
November 2018
1.3.1.1 SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pioglitazon Lek
15 mg, tabletten
Pioglitazon Lek
30 mg, tabletten
Pioglitazon Lek
45 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[nationally completed name] 15 mg
Each tablet contains 15 mg pioglitazone (as pioglitazone
hydrochloride).
Excipient(s) with known effect: Lactose monohydrate 77 mg
[nationally completed name] 30 mg
Each tablet contains 30 mg pioglitazone (as pioglitazone
hydrochloride).
Excipient(s) with known effect: Lactose monohydrate 154 mg
[nationally completed name] 45 mg
Each tablet contains 45 mg pioglitazone (as pioglitazone
hydrochloride).
Excipient(s) with known effect: Lactose monohydrate 231 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
[nationally completed name] 15 mg
white, round tablet, with imprint “PGT 15” on one side and with
score line on both sides
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
[nationally completed name] 30 mg
white, round tablet, with imprint “PGT 30” on one side and with
score line on both sides
The tablet can be divided into equal halves.
[nationally completed name] 45 mg
white, round tablet, with imprint “PGT 45” on one side and with
three-part score line on the other side
The tablet can be divided into three equal parts.
4.
CLINICAL PARTICULARS
Sandoz B.V.
Page 2/17
Pioglitazon Lek 15/30/45 mg, tabletten
RVG 108649/50/51
1311-V5
1.3.1.1 Samenvatting van de Productkenmerken
November 2018
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 ORA