Pregal 150 mg capsule

Country: Malaysia

Language: English

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

Active ingredient:

PREGABALIN

Available from:

SM PHARMACEUTICALS SDN. BHD.

INN (International Name):

PREGABALIN

Units in package:

8x7 Capsules

Manufactured by:

SM PHARMACEUTICALS SDN. BHD.

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP) _
PREGAL 150 MG CAPSULE
Pregabalin 150 mg
_ _
______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1. WHAT PREGAL 150MG CAPSULE IS USED
FOR
2. HOW PREGAL 150MG CAPSULE WORKS
3. BEFORE YOU TAKE PREGAL 150MG
CAPSULE
4. HOW TO TAKE PREGAL 150MG CAPSULE
5. WHILE YOU ARE USING PREGAL 150
CAPSULE
6. SIDE EFFECTS
7. STORAGE AND DISPOSAL OF PREGAL
150MG CAPSULE
8. PRODUCT DESCRIPTION
9. MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10. DATE OF REVISION
WHAT PREGAL 150MG CAPSULE IS USED FOR
•
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 eizures
with or without secondary
generalisation.
•
Generalised Anxiety Disorder
Pregabalin is indicated for the
treatment of Generalised Anxiety
Disorder (GAD) in adults.
•
Fibromyalgia
Pregabalinis is indicated for the
management of fibromyalgia.
HOW PREGAL 150MG CAPSULE WORKS
Pregabalin is in a class of
medications called anticonvulsants.
It works by decreasing the number
of pain signals that are sent out by
damaged nerves in the body.
BEFORE YOU TAKE PREGAL 150MG CAPSULE_ _
-When you must not take it
If you are allergic to Pregabalin or any of
the other ingredients of this medicine.
- Before you start to take it
Inform your doctor if you have
•
Heart problem
•
If you are pregnant or plan to
get pregnant or breastfeeding.
•
If you have diabetic
- Taking other medicines
Talk to your doctor / pharmacist if you
are taking any medicine, including those
you buy without prescription.
- Do not take Pregabalin if you are
already taking other medicines
containing Pregabalin.
- Do not take Pregal 150mg Capsule
together with medicines containing
•
OTHER ANTIEPILEPTIC
drugs(medications work in
d

Summary of Product characteristics

SM PHARMACEUTICALS SDN BHD
PREGAL CAPSULES
(PREGABALIN 75 MG AND 150 MG)
DESCRIPTION:
75 MG: Size '4' Capsules with dark brown cap and white body imprinted
with "SM-LU" on cap and
"75"
on
body
in
black
ink
containing
white
to
off
white
powder.
150 MG: Size '2' Capsules with white cap and white body imprinted with
"SM-LU" on cap and "150”
on body in black ink containing white to off white powder.
COMPOSITION:
75 mg: Each capsule contains: Pregabalin 75mg
150mg: Each capsule contains: Pregabalin 150mg
PHARMACODYNAMICS:
The
active
substance,
pregabalin,
is
a
gamma=aminobutyric
acid
analogue
[(5)-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.
Clinical efficacy and safety
_Neuropathic pain_
Efficacy has been shown in diabetic neuropathy, post herpetic
neuralgia and spinal cord injury. Efficacy
has not been studied in other models of neuropathic pain.
_Epilepsy_
Adjunctive Treatment
Pregabalin has been studied with either BID or TID dosing. Overall,
the safety and efficacy profiles for
BID and TID dosing regimens are similar. A reduction in seizure
frequency was 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 adolescents has not been established.
Monotherapy (newly diagnosed patients)
Pregabalin and lamotrigine were similarly safe and well tolerated.
Generalised Anxiety Disorder
Relief of the symptoms of GAD as reflected by the Hamilton Anxiety
Rating Scale (HAM-A) has been
observed.
PHARMACOKINETICS:
Pregabalin steady-state pharmacokinetics are similar in healthy
volunteers, patients with epilepsy
receiving anti-epileptic drugs and patients with chronic pain.
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 ora