PREZEL 75 (PREGABALIN CAPSULES 75MG)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PREGABALIN

Boleh didapati daripada:

SYNERRV SDN BHD

INN (Nama Antarabangsa):

PREGABALIN

Unit dalam pakej:

3 x 10 Capsules

Dikeluarkan oleh:

IND-SWIFT LIMITED

Risalah maklumat

1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PREZEL 75 (PREGABALIN CAPSULES 75MG)
PREZEL 150 (PREGABALIN CAPSULES 150MG)
Pregabalin Capsules 75mg/150mg
WHAT IS IN THIS LEAFLET
1.
What
_Prezel _
is used for
2.
How
_Prezel _
works
_3._
_ _
Before you use
_Prezel _
_4._
_ _
How to use
_Prezel _
5.
While you are using it
6.
Side effects
_7._
_ _
Storage and Disposal of
_Prezel _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _PREZEL _IS USED FOR
Prezel belongs to a group of medicines
used to treat epilepsy, neuropathic pain
and Generalised Anxiety Disorder
(GAD) and Fibromyalgia in adults.
PERIPHERAL AND CENTRAL NEUROPATHIC
PAIN:
Prezel 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:
Prezel is used to treat a
certain form of epilepsy (partial
seizures with or without secondary
generalisation) in adults. Your doctor
will prescribe Prezel for you to help
treat your epilepsy when your current
treatment is not controlling your
condition. You should take Prezel in
addition to your current treatment.
Prezel is not intended to be used alone,
but should always be used in
combination with other anti-epileptic
treatment.
GENERALISED ANXIETY DISORDER:
Prezel 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 disturbanc

Ciri produk

PREZEL 75 (PREGABALIN CAPSULES 75MG)
PREZEL 150 (PREGABALIN CAPSULES 150MG)
COMPOSITION:
Prezel 75 (Pregabalin Capsules 75mg)
Each hard gelatin capsule contains
Pregabalin........75mg
Excipients.........q.s.
Approved colours used in capsule shell
Prezel 150 (Pregabalin Capsules 150mg)
Each hard gelatin capsule contains
Pregabalin........150mg
Excipients.........q.s.
Approved colours used in capsule shell
PRESENTATION:
Prezel 75 (Pregabalin Capsule 75mg):
Size '4' hard gelatin capsules, reddish brown cap with creamish colour
body.
Prezel 150 (Pregabalin Capsule 150mg):
Size '2' hard gelatin capsules, creamish cap with creamish colour
body.
CLINICAL PHARMACOLOGY:
PHARMACODYNAMICS
Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics ATC
code: N03AX16
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 (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 concentrations
occurring within 1 hour following both single and multiple dose
administration. Pregabalin oral
bioavailability is estimated 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 by
approximately 25-30% and a delay in
t to approximately 2.5 max max hours. However, administration of
pregabalin with food has no
clinically significant effect on the extent of pregabalin absorption.
_Distribution _
In preclinical studies, pregabalin has been shown to cross the blood
brain barrier in mice, rats, and
monkeys. Pregabalin has been shown to cross the placenta in rats and
is present in the milk of
lactating rats. In humans, the apparent volume of distribution of
pregabalin following oral
administration is approxima