PREGALIX 75mg Capsules

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PREGABALIN

Boleh didapati daripada:

GENPHARMA SDN. BHD

INN (Nama Antarabangsa):

PREGABALIN

Unit dalam pakej:

56 Capsules

Dikeluarkan oleh:

Alembic Pharmaceuticals Limited (Formulation Division)

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PREGALIX CAPSULES
Pregabalin (75 mg and 150 mg Capsules)
WHAT IS IN THIS LEAFLET
1.
What
_PREGALIX _
is used for
2.
How
_PREGALIX _
works
_3._
_ _
Before you use
_PREGALIX _
_4._
_ _
How to use
_PREGALIX _
5.
While you are using it
6.
Side effects
_7._
_ _
Storage and disposal of
_PREGALIX _
8.
Product description
9.
Manufacturer
and
Product Registration Holder
10.
Date of revision
11.
Serial number
WHAT PREGALIX IS USED FOR
Pregalix is used to treat:
Neuropathic pain
Pregabalin
is
indicated
for
the
treatment
of
peripheral
and
central
neuropathic pain in adults.
Epilepsy
Pregabalin is indicated as adjunctive
therapy in adults with partial seizures
with
or
without
secondary
generalisation.
Generalised
anxiety
disorder
Pregabalin
is
indicated
for
the
treatment
of
Generalised
Anxiety
Disorder (GAD) in adults.
Fibromyalgia
Pregabalin
is
indicated
for
the
management of fibromyalgia.
HOW PREGALIX WORKS
Pregalix helps decrease the number of
nerve signals, and as a result calms
down overly sensitive nerve cells.
BEFORE YOU USE PREGALIX
-
_When you must not take it _
Do not start taking Pregalix if you are
allergic to pregabalin or any of the
ingredients in Pregalix. See the end of
this
leaflet
for
a
complete
list
of
ingredients in Pregalix.
Symptoms of an allergic reaction to
Pregalix may include:
•
Serious,
even
life-threatening
allergic reactions
•
Suicidal thoughts or actions
•
Swelling of your hands, legs and
feet
•
Dizziness and sleepiness
_Pregnancy and lactation _
_ _
It is not known if Pregalix will harm
your
unborn
baby.
You
and
your
healthcare provider will have to decide
if you should take Pregalix while you
are pregnant
It is known that Pregalix passes into
breast milk, but it is not known if it can
harm
your
baby.
You
and
your
healthcare
provider
should
discuss
whether
you
should
take
Pregalix
or
breast-feed, but you should not do both.
_ _
_-Before you start to use PREGALIX _
Tell your healthcare provider about all
your
medical
conditions
including

Ciri produk

1
1.
NAME OF THE MEDICINAL PRODUCT
PREGALIX 75mg Capsules
PREGALIX 150mg Capsules
2.
NAME AND STRENGTH OF ACTIVE SUBSTANCES
Pregabalin 75mg
Pregabalin 150mg
3.
PRODUCT DESCRIPTION
PREGALIX 75mg Capsules
Opaque white/ Orange Opaque size “4” Hard gelatin capsules
radially imprinted with ‘A’ on cap and
‘142’ on body with black ink filled with white to off white
powder.
PREGALIX 150mg Capsules
Opaque white/ opaque white size “2” Hard gelatin capsules radially
imprinted with ‘A’ on cap and ‘144’
on body with black ink filled with white to off white powder.
4.
DOSAGE FORM
Hard Gelatin Capsule
5.
PHARMACODYNAMIC PROPERTIES
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,
Clinical efficacy and safety
_Neuropathic pain _
Efficacy has been shown in diabetic neuropathy, post herpetic
neuralgia and spinal cord injury. Safety
and efficacy profiles for BID and TID dosing regimens are similar. For
both pheripheral and central
neuropathic pain, a reduction in pain is seen by Week 1 and it
maintained throughout the treatment
period.
_ _
_Epilepsy _
Adjunctive Treatment
The safety and efficacy profiles for BID and TID dosing regimens are
similar. A reduction in seizure
frequency is observed by Week 1.
Paediatric population
The efficacy and safety of pregabalin as adjunctive treatment for
epilepsy in paediatric patients below
the age of 12 and in adolescents has not been established.
2
Monotherapy (newly diagnosed patients)
Pregabalin and lamotrigine are similarly safe and well tolerated.
Generalized anxiety disorder
Relief of the symptoms of GAD as reflected by the Hamilton Anxiety
Rating Scale (HAM-A) is
observed by Week 1. Patients treated with pregabalin reported blurred
vision which resolved in a
majority of c