GLIT 30 (PIOGLITAZONE TABLETS 30MG)

Country: Malasja

Lingwa: Ingliż

Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredjent attiv:

PIOGLITAZONE HYDROCHLORIDE

Disponibbli minn:

SYNERRV SDN BHD

INN (Isem Internazzjonali):

PIOGLITAZONE HYDROCHLORIDE

Unitajiet fil-pakkett:

28 Tablets

Manifatturat minn:

IND-SWIFT LIMITED

Fuljett ta 'informazzjoni

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
GLIT 15 (PIOGLITAZONE TABLETS 15MG)
GLIT 30 (PIOGLITAZONE TABLETS 30MG)
Pioglitazone hydrochloride (15mg, 30mg)
WHAT IS IN THIS LEAFLET
1.
What GLIT is used for
2.
How GLIT works
3.
Before you use GLIT
4.
How to use GLIT
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of GLIT
8.
Product Description
9.
Manufacturer and
Product registration
Holder
10.
Date of revision
11.
Serial number
WHAT GLIT IS USED FOR
•
GLIT is used as oral monotherapy
in type 2 diabetes mellitus
patients, particularly overweight
patients whom are inadequately
controlled by diet and exercise
and where metformin cannot be
tolerated.
•
GLIT is used for oral combination
treatment in type 2 diabetes
mellitus patients with insufficient
glycaemic control despite
maximal tolerated dose of oral
monotherapy with either
metformin or sulfonylurea.
HOW GLIT WORKS
GLIT is a thiazolidonedione
antidiabetic agent that depends on the
presence of insulin for its mechanism
of action. It acts primarily by
decreasing insulin resistance. It
decreases insulin resistance in the
body, resulting in increased insulin-
dependent glucose disposal and
decreased liver glucose output.
BEFORE YOU USE GLIT
-
_When you must not use it _
Do not use GLIT if you are:
a)
Hypersensitive to pioglitazone or
to any of the excipients of the
tablet listed at the end of this
leaflet.
b)
Having heart failure or history of
heart failure (all stages).
c)
A patient of reduced liver
function.
d)
Pregnant or breastfeeding.
e)
A type 1 diabetes patient.
f)
A bladder cancer patient or have a
history of bladder cancer.
g)
Having blood in your urine.
-
_Before you start to use it _
•
You must undergo blood tests for
liver function prior to the start of
therapy, and periodically
thereafter per clinical judgment of
the health care professional.
•
Talk to your doctor if you are
pregnant.
-
_Taking other medicines _
•
GLIT can be co-administered
with:
a)
Oral contraceptives
b)
Fexofenadine HCI
c)
Glipizide
d)
Digoxin
e)
W

Karatteristiċi tal-prodott

GLIT 15 / GLIT 30
Pioglitazone Tablets 15mg & 30mg
COMPOSITION:
GLIT 15 (Pioglitazone Tablets 15mg)
Each uncoated tablet contains
Pioglitazone Hydrochloride equivalent to Pioglitazone
15mg
Excipients
q.s.
GLIT 30 (Pioglitazone Tablets 30mg)
Each uncoated tablet contains
Pioglitazone Hydrochloride equivalent to Pioglitazone
30mg
Excipients
q.s.
PRESENTATION:
GLIT 15 (Pioglitazone Tablets 15mg) - White to off white, round,
biconvex, uncoated
tablets embossed "15" on one side and plain on other side.
GLIT 30 (Pioglitazone Tablets 30mg) - White to off white, round,
flat, beveled edged,
uncoated tablets embossed "30" on one side and plain on the other
side.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS:
Pharmacotherapeutic group: Drugs used in diabetes, blood glucose
lowering drugs,
excl. insulins; ATC code: A10BG03.
Pioglitazone effects may be mediated by a reduction of insulin
resistance.
Pioglitazone appears to act via activation of specific nuclear
receptors (peroxisome
proliferator activated receptor gamma) leading to increased insulin
sensitivity of liver,
fat and skeletal muscle cells in animals. Treatment with pioglitazone
has been shown
to reduce hepatic glucose output and to increase peripheral glucose
disposal in the
case of insulin resistance.
Fasting and postprandial glycaemic control is improved in patients
with type 2
diabetes mellitus. The improved glycaemic control is associated with a
reduction in
both fasting and postprandial plasma insulin concentrations.
Pioglitazone was associated with significant weight gain. Visceral
fat was significantly
decreased, while there was an increase in extra-abdominal fat mass.
Similar changes
in body fat distribution on pioglitazone have been accompanied by an
improvement in
insulin sensitivity. Reduced total plasma triglycerides and free fatty
acids, and
increased HDL-cholesterol levels were observed with small, but not
clinically
significant increases in LDL-cholesterol levels.
Pioglitazone reduced total plasma triglycerides and free fatty acids,
and increased
HD