Pioglitazon Torrent 30 mg, tabletten

Krajina: Holandsko

Jazyk: holandčina

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

Aktívna zložka:

PIOGLITAZONHYDROCHLORIDE SAMENSTELLING overeenkomend met ; PIOGLITAZON

Dostupné z:

Torrent Pharma GmbH Sudwestpark 50 90449 NURNBERG (DUITSLAND)

ATC kód:

A10BG03

INN (Medzinárodný Name):

PIOGLITAZONHYDROCHLORIDE COMPOSITION corresponding to ; PIOGLITAZON

Forma lieku:

Tablet

Zloženie:

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

Spôsob podávania:

Oraal gebruik

Terapeutické oblasti:

Pioglitazone

Prehľad produktov:

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

Dátum Autorizácia:

2011-11-02

Príbalový leták

Pioglitazon Torrent 15/30/45 mg tabletten – NL/H/2056/001-003/DC
NL pl
NL/p/014/19/1
Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PIOGLITAZON TORRENT 15 MG TABLETTEN
PIOGLITAZON TORRENT 30 MG TABLETTEN
PIOGLITAZON TORRENT 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 further questions, ask your doctor or your 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 Pioglitazon Torrent is and what it is used for
2.
What you need to know before you take Pioglitazon Torrent
3.
How to take Pioglitazon Torrent
4.
Possible side effects
5.
How to store Pioglitazon Torrent
6.
Contents of the pack and other information
1.
WHAT PIOGLITAZON TORRENT IS AND WHAT IT IS USED FOR
Pioglitazon Torrent 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.
Pioglitazon Torrent tablets 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 Pioglitazon Torrent is working 3 to 6 months after you start
taking it.
Pioglitazon Torrent tablets 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.
WHAT YOU NEED TO KNOW BEFORE YOU

Súhrn charakteristických

Pioglitazon Torrent 15/30/45 mg tabletten – NL/H/2056/001-003/DC
NL spc
NL/s/012/19/1
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PIOGLITAZON TORRENT 15 MG, TABLETTEN
PIOGLITAZON TORRENT 30 MG, TABLETTEN
PIOGLITAZON TORRENT 45 MG, TABLETTEN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PIOGLITAZON TORRENT 15 MG TABLETS
Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Each tablet contains 33.031 mg of lactose monohydrate (see section
4.4).
PIOGLITAZON TORRENT 30 MG TABLETS
Each tablet contains 30 mg of pioglitazone (as hydrochloride).
Each tablet contains 66.062 mg of lactose monohydrate (see section
4.4).
PIOGLITAZON TORRENT 45 MG TABLETS
Each tablet contains 45 mg of pioglitazone (as hydrochloride).
Each tablet contains 99.090 mg of lactose monohydrate (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
PIOGLITAZON TORRENT 15 MG TABLETS
White to off-white, round, flat faced beveled edge uncoated tablets
debossed with ‘15’ on one side and
plain on the other side.
DIAMETER: 5.20 ± 0.25mm (4.95 mm to 5.45 mm)
PIOGLITAZON TORRENT 30 MG TABLETS
White to off-white, round, flat faced beveled edge uncoated tablets
with breakline on both sides.
DIAMETER: 7.00 ± 0.25 mm (6.75 mm to 7.25 mm). The tablet can be
divided into equal halves.
PIOGLITAZON TORRENT 45 MG TABLETS
White to off-white, round, flat faced beveled edge uncoated tablets
debossed with ‘T’ shape breakline
on both sides.
DIAMETER: 8.60 ± 0.25 mm (8.35 mm to 8.85 mm) The tablet can be
divided into equal thirds.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pioglitazon Torrent 15/30/45 mg tabletten – NL/H/2056/001-003/DC
NL spc
NL/s/012/19/1
Page 2 of 15
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
intol