PG-LIN 75 (Pregabalin Capsules 75 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PREGABALIN

Boleh didapati daripada:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

PREGABALIN

Unit dalam pakej:

2 x 7 Capsules

Dikeluarkan oleh:

GRACURE PHARMACEUTICALS LTD.

Risalah maklumat

PG-LIN 75
_Consumer Medication Information Leaflet (RiMUP)_
Pregabalin Capsules 75 mg
1
WHAT IS IN THIS LEAFLET
1.
What PG-LIN 75 is used for
2.
How PG-LIN 75 works
3.
Before you use PG-LIN 75
4.
How to use PG-LIN 75
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
PG-LIN 75
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS PG-LIN 75 USED FOR
PG-LIN 75 belongs to a group of
medicines
used
to
treat
epilepsy,
neuropathic
pain
and
Generalised
Anxiety
Disorder
(GAD)
and
_Fibromyalgia i_
n adults.
_Neuropathic pain _
Pregabalin Capsules are indicated for
the treatment of peripheral and central
neuropathic pain in adults.
_Epilepsy _
Pregabalin Capsules are indicated as
adjunctive
therapy
in
adults
with
partial
seizures
with
or
without
secondary generalisation.
_Generalised anxiety disorder _
Pregabalin Capsules are indicated for
the treatment of Generalised Anxiety
Disorder (GAD) in adults.
_Fibromyalgia _
Pregabalin
is
indicated
for
the
management of fibromyalgia.
HOW PG-LIN 75 WORKS
Pregabalin
binds
to
an
auxiliary
subunit
(α2-δ
protein)
of
voltage-
gated calcium channels in the central
nervous system.
BEFORE YOU USE PG-LIN 75
_-When you must not use it _
Do not start taking PG-LIN 75 if you
have
hypersensitivity
to
the
active
substance or to any of the excipients
used in PG-LIN 75.
See
the
end
of
this
leaflet
for
a
complete list of ingredients in PG-
LIN 75.
_ _
_-Before you start to use it _
Tell your healthcare provider about
all your medical conditions including
if you:
-
have
or
had
depression,
mood
problems
or
suicidal
thoughts
or
behaviour
- have heart problems including heart
failure
- have a bleeding problem or a low
blood platelet count
- have abused prescription medicines,
street drugs, or alcohol in the past
- have ever had swelling in your face,
mouth, tongue, lips, gums, neck or
throat (angiodema)
- plan to father a child.
-
have
brain
malfunction
(encephalopathy)
-
cases
of
misuse,
abuse
and
dependence have been

Ciri produk

_Gracure Pharmaceuticals Ltd _
NAME OF THE PRODUCT
PG-LIN 75
PART-I
Administrative Data
D3. PROPOSED PACKAGE INSERT
Enclosed
For the use only of a registered Medical Practitioner or a Hospital or
a Laboratory
PG-LIN 75
(PREGABALIN CAPSULES 75 MG)
COMPOSITION:
Each hard gelatin capsule contains:
Pregabalin 75 mg
DESCRIPTION:
PG-LIN 75 is Dark Orange/white coloured hard gelatin capsules size
“2” filled with
white granular powder. It contains Lactose Monohydrate NF 316, Talc,
Maize Starch
and Size '2' Dark Orange/White hard gelatin capsule shell as
excipients.
PHARMACODYNAMICS / PHARMACOKINETICS:
_Mechanism of action _
Pregabalin binds to an auxiliary subunit (α
-δ protein) of voltage-gated calcium
channels in the central nervous system. 2
_PHARMACOKINETIC PROPERTIES: _
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 hours.
However, administration of pregabalin with food has no max max
clinically significant effect on the extent of pregabalin absorption.
DISTRIBUTION
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 approximately 0.56 l/kg. Pregabalin
is not bound
plasma proteins.
BIOTRANSFORMATION
Pregabalin
undergoes
negligible
metabolism
in
humans.
Following
a
dose
of
radiolabelled pregabalin, approximately 98% of the radioactivity
recovered in the urine was unchanged pregabalin. The N-methylated
derivative of
pre