PIOLET 30MG TABLETS

Nchi: Malesia

Lugha: Kiingereza

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

Viambatanisho vya kazi:

Pioglitazone Hydrochloride..

Inapatikana kutoka:

JETPHARMA SDN. BHD.

INN (Jina la Kimataifa):

Pioglitazone Hydrochloride..

Vitengo katika mfuko:

14 Tablets

Viwandani na:

INTAS PHARMACEUTICALS LIMITED

Taarifa za kipeperushi

_CONSUMER MEDICATION INFORMATION LEAFLET_
PIOLET TABLETS
PIOGLITAZONE (15MG, 30MG, 45MG)
Page no. 1
WHAT IS IN THIS LEAFLET?
1.
What
Pioglitazone
Tablets
is used for?
2.
How
Pioglitazone
Tablets
works.
3.
Before you use Pioglitazone
Tablets.
4.
H o w
t o
t a k e
Pioglitazone
Tablets.
5.
W h i l e
y o u
a
r e
u
sing
Pioglitazone Tablets
6.
Side effects.
7.
After
using
Pioglitazone
Tablets.
WHAT
PIOGLITAZONE
TABLETS
IS
USED FOR?
•
P i o g l i t a z o n e
i s
in dicated
in t he t reatment o f t ype 2
diabetes mellitus.
•
I t
m a y
b e
u s e d
o n
t heir
o w n
o r
i n
c ombination
with metformin and / or a
s u l p h o n y l u r e a
w hich
are
a l s o
o
r a l
an
ti-diabetic
medicines.
HOW
P I O G L I T A Z O N E
T
ABLETS
WORKS
Pioglitazone belong the group of
oral
b l o o d
g
l u c o s e
l
o w e r i n g
drugs.
I t
h e l p s
c o n t r o l
t h e
l e v e l
o f
sugar
in
y our
blood
w hen
you
have t ype 2 d iabetes b y
helping
your body make better use of the
insulin it produces.
B E F O R E
Y O U
U S E
PIOGLITAZONE
TABLETS
_WHEN YOU MUST NOT TAKE IT _
•
Y o u
ar
e
al
l e r g i c
t
o
pioglitazone or any
o f
t he
o t h e r
in
g r e d i e n t s
of
pioglitazone tablets.
•
If you have heart failure
•
If you have liver disease
_BEFORE YOU START TO TAKE IT _
•
If you have a special type of
diabetic eye
d i s e a s e
cal led
macular oedema.
•
I f
y o u
a
r e
p
l a n n i n g
t
o
become pregnant.
•
If you are breast-feeding.
•
If you have polycystic ovary
syndrome. There may be an
increased possibility of your
becoming
p regnant
because
o f
h o w
y o u r
medicine
works.
•
If
you
have
a
problem
with
your liver or heart.
•
If you are under 18 years of
a g e
b e c a u s e
u s e
i
n
s uch
p a t i e n t s
is
n
ot
recommended
_TAKING OTHER MEDICINES _
•
P l e a s e
t e l l
y o u r
d o c t o r
o r
p h a r m a c i s t
i
f
y o u
ar
e
t a k i n g
o
r
ha
v e
r
ecently
taken
an y
o ther
medicines,
i n c l u d i n g
m
edicines
o b t a i n e d
w i t h o u t
a
prescription.
C H I L D R E N
A
N D
A
D O L E S C E N T S
(BELO

Tabia za bidhaa

PIOLET
(Pioglitazone Tablets 15, 30 & 45mg)
COMPOSITION
PIOLET 15
Each tablet contains:
Pioglitazone Hydrochloride equivalent to Pioglitazone 15mg
PIOLET 30
Each tablet contains:
Pioglitazone Hydrochloride equivalent to Pioglitazone 30mg
PIOLET 45
Each tablet contains:
Pioglitazone Hydrochloride equivalent to Pioglitazone 45mg
DOSAGE FORM
Uncoated Tablet
PRODUCT DESCRIPTION
Piolet 15mg White to off white, round, biconvex, uncoated tablets
debossed with 'P' on one side
and '15' on other side.
Piolet 30m g W hite t o of f w hite, f lat, round unc oated t ablets w
ith be veled e dges de bossed w ith
‘PIO’ on one side and ‘30’ on the other side.
Piolet 4 5mg W hite to o ff w hite, f lat, round unc oated t ablets w
ith be veled e dges de bossed w ith
‘PIO’ on one side and ‘45’ on the other side.
PHARMACODYNAMICS PROPERTIES
Pharmacotherapeutic group: oral blood glucose lowering drugs;
Thiazolidinediones; 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 pi oglitazone ha s be en s hown t o r educe h epatic g lucose out
put a nd
to i ncrease pe ripheral
glucose disposal in the c ase 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.
PHARMACOKINETIC PROPERTIES
ABSORPTION:
Following oral administration, pioglitazone is rapidly absorbed, and
peak plasma concentrations
o f
u n c h a n g e d
p i o g l i t a z o n e
a r e
u s u a l l y
a c h i e v e d
2
hour
s
a f t e r
a d m i n i s t r a t i o n .
P r o p o r t i o n a l
increases of t he pl asma c oncentration w ere obs erved f or dos es f
rom 2
– 60 mg. Steady state is
achieved
after
4 –7
d