Neurogab 75 (Pregabalin Capsules 75 mg)

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
03-03-2023
Ciri produk Ciri produk (SPC)
07-08-2023

Bahan aktif:

PREGABALIN

Boleh didapati daripada:

Macleods Pharmaceuticals Sdn. Bhd.

INN (Nama Antarabangsa):

PREGABALIN

Unit dalam pakej:

3X10 Capsules

Dikeluarkan oleh:

Macleods Pharmaceuticals Limited

Risalah maklumat

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
NEUROGAB 75
Pregabalin Capsules 75mg
Page 1 of 4
WHAT IS IN THIS LEAFLET
1.
What Neurogab 75 is used for
2.
How Neurogab 75 works
3.
Before you use Neurogab75
4.
How to use Neurogab 75
5.
While you are using
Neurogab 75
6.
Side effects
7.
Storage and Disposal of
Neurogab 75
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT NEUROGAB 75 IS USED FOR:
Neurogab 75 belongs to a group of
medicines used to treat epilepsy,
neuropathic pain and Generalised
Anxiety Disorder (GAD) in adults.
PERIPHERAL AND CENTRAL
NEUROPATHIC PAIN:
Neurogab 75 is used to treat long
lasting pain caused by damage to
the nerves. A variety of diseases
can cause peripheral neuropathic
pain, such as diabetes or shingles.
Pain sensations may be described
as hot, burning, throbbing,
shooting, stabbing, sharp,
cramping, aching, tingling,
numbness, pins and needles.
Peripheral and central neuropathic
pain may also be associated with
mood changes, sleep disturbance,
fatigue (tiredness), and can have an
impact on physical and social
functioning and overall quality of
life.
EPILEPSY: Neurogab 75 is used to
treat a certain form of epilepsy
(partial seizures with or without
secondary generalisation) in adults.
Your doctor will prescribe
Neurogab 75 for you to help treat
your epilepsy when your current
treatment is not controlling your
condition. You should take
Neurogab 75 in addition to your
current treatment. Neurogab 75 is
not intended to be used alone, but
should always be used in
combination with other anti-
epileptic treatment.
GENERALISED ANXIETY DISORDER:
Neurogab 75 is used to treat
Generalised Anxiety Disorder
(GAD). The symptoms of GAD are
prolonged excessive anxiety and
worry that are difficult to control.
GAD can also cause restlessness or
feeling keyed up or on edge, being
easily fatigued (tired), having
difficulty concentrating or mind
going blank, feeling irritable,
having muscle tension or sleep
disturbance. This is different
                                
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                                1
FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR
A
LABORATORY
NEUROGAB75 (Pregabalin Capsules 75mg)
COMPOSITION
Each capsule contains:
Pregabalin USP…………….75mg
DESCRIPTION
Orange/White size ‘4’ hard gelatin capsules imprinted with
‘M3’ on cap and
‘75mg’ on body containing white coloured powder.
PHARMACODYNAMICS
Pharmacotherapeutic group: Antiepileptics, ATC code: N03A (proposed).
The active substance, pregabalin, is a gamma-aminobutyric acid
analogue ((S)-3-
(aminomethyl)-5-methylhexanoic acid).
_MECHANISM OF ACTION: _
Pregabalin binds to an auxiliary subunit (α
2
-δ protein) of voltage-gated calcium
channels in the central nervous system._ _
Although the mechanism of action of pregabalin has not been fully
elucidated,
results with genetically modified mice and with compounds structurally
related to
pregabalin (such as gabapentin) suggest that binding to the alpha
2
-delta subunit
may
be
involved
in
pregabalin's
anti-nociceptive
and
antiseizure
effects
in
animals.
In
animal
models
of
nerve
damage,
pregabalin
has
been
shown
to
reduce
calcium-dependent release of pro-nociceptive neurotransmitters in the
spinal
cord, possibly by disrupting alpha2-delta containing-calcium channel
trafficking
and/or reducing calcium currents. Evidence from other animal models of
nerve
damage and persistent pain suggest the anti-nociceptive activities of
pregabalin
may also be mediated through interactions with descending
noradrenergic and
serotonergic
pathways
originating
from
the
brainstem
that
modulate
pain
transmission in the spinal cord. While pregabalin is a structural
derivative of the
inhibitory neurotransmitter gammaaminobutyric acid (GABA), it does not
bind
directly to GABAA, GABAB, or benzodiazepine receptors, does not
augment
GABAA
responses
in
cultured
neurons,
does
not
alter
rat
brain
GABA
concentration or have acute effects on GABA uptake or degradation.
However, in
cultured neurons prolonged application of pregabalin increases the
density of
GABA transporter protein and in
                                
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