PREGEB CAPSULES 75 MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PREGABALIN

Boleh didapati daripada:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

PREGABALIN

Unit dalam pakej:

10capsule Capsules; 30capsule Capsules; 60capsule Capsules; 100capsule Capsules

Dikeluarkan oleh:

TORRENT PHARMACEUTICALS LTD

Risalah maklumat

PREGEB CAPSULES
_ _
Pregabalin (75 mg, 150 mg)
_ _
_ _
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is Pregeb used for
2.
How Pregeb works
3.
Before you use Pregeb
4.
How to use Pregeb
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Pregeb
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT PREGEB IS USED FOR
Pregabalin
belongs
to
a
group
of
medicines
used
to
treat
epilepsy,
neuropathic
pain,
fibromyalgia
and
Generalised
Anxiety
Disorder
(GAD)
in adults.
HOW PREGEB WORKS
Pregeb corrects chemical imbalance in
brain and provides relief in epilepsy,
neuropathic
pain,
fibromyalgia
and
generalised anxiety disorder.
BEFORE YOU USE PREGEB
-
_When you must not use it _
Talk
to
your
doctor
or
pharmacist
before taking Pregeb if you experience
below symptoms: -

Some patients taking Pregeb have
reported symptoms suggesting an
allergic reaction, these symptoms
include swelling of the face, lips,
tongue,
and
throat,
as
well
as
diffuse skin rash.

Pregeb
has
been
associated
with
dizziness
and
somnolence,
which
could
increase
the
occurrence
of
accidental
injury
(fall)
in
elderly
patients. Therefore, you should be
careful until you are used to any
effect the medicine might have.

Pregeb may cause blurring or loss
of
vision,
or
other
changes
in
eyesight,
many
of
which
are
temporary you should immediately
tell your doctor if you experience
any changes in your vision.

Some patients with diabetes who
gain
weight
while
taking
Pregabalin may need an alteration
in their diabetic medicines.

Certain side effects may be more
common,
such
as
sleepiness,
because patients with spinal cord
injury
may
be
taking
other
medicines
to
treat,
for
example,
pain or spasticity, that have similar
side effects to Pregabalin and the
severity
of
these
effects
may
be
increased when taken together.

There have been reports of heart
failure
in
some
patients
when
taking Pregeb; these patients were
mostly elderly with cardiovascular
cond

Ciri produk

Proposed Prescribing Information
For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory only
PREGEB CAPSULES 75 MG
PREGEB CAPSULES 150 MG
(Pregabalin Capsules)
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
PREGEB CAPSULES 75 MG
Each hard gelatin capsules contains:
Pregabalin …… 75 mg
Approved colours used in hard capsules shells
PREGEB CAPSULES 150 MG
Each hard gelatin capsules contains:
Pregabalin …… 150 mg
Approved colours used in hard capsules shells
DOSAGE FORM
Hard gelatin capsules
PRODUCT DESCRIPTION
PREGEB CAPSULES 75 MG
S i z e
‘ 4 ’ ,
h a r d
g e l a t i n
c a p s u l e
h a v i n g
o r a n g e
o p a q u e
c a p
a n d
w h i t e
o p a q u e
b o d y ,
imprinted
‘1360'
on
cap
and
'75’
on
body
with
black
ink
containing
white
to
off-white
powder.
PREGEB CAPSULES 150 MG
Size ‘1’, hard gelatin capsule having white opaque cap and white
opaque body, imprinted
‘1362' on cap and '150’ on body with black ink containing white to
off-white powder.
PHARMACODYNAMICS / PHARMACOKINETICS
PHARMACODYNAMICS
Pharmacotherapeutic group: Antiepileptics, other antiepileptics
T h e
a c t i v e
s u b s t a n c e ,
p r e g a b a l i n ,
i s
a
g a m m a - a m i n o b u t y r i c
a c i d
a n a l o g u e
((S)-3-
(aminomethyl)-5-methylhexanoic acid).
_ _
_MECHANISM OF ACTION _
Pregabalin binds to an auxiliary subunit (α2-δ protein) of
voltage-gated calcium channels
in the central nervous system.
PHARMACOKINETICS
ABSORPTION
Pregabalin
is
rapidly
absorbed
when
administered
in
the
fasted
state,
with
peak
plasma
c o n c e n t r a t i o n s
o c c u r r i n g
w i t h i n
1
h o u r
f o l l o w i n g
b o t h
s i n g l e
a n d
m u l t i p l e
d o s e
administration. Pregabalin oral bioavailability is reported to be
≥90% and is independent
of
dose.
Following
repeated
administration,
steady
state
is
achieved
within
24
to
48
hours. The rate of pregabalin absorption is decreased when given with
food resulting in a
decrease
in
C
max
by
approximately
25-30 %
and
a
delay
in
t
max
to
approximately
2.5
ho