BRIEKA capsules 75mg

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

PREGABALIN

Verfügbar ab:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (Internationale Bezeichnung):

PREGABALIN

Einheiten im Paket:

6x10 Capsules

Hergestellt von:

Balkanpharma Dupnitsa AD

Gebrauchsinformation

_Consumer Medication Information Leaflet (RiMUP)_
BRIEKA CAPSULES
Pregabalin (50mg, 75mg, 150mg)
1
WHAT IS IN THIS LEAFLET
1.
What Brieka is used for
2.
How Brieka works
3.
Before you use Brieka
4.
How to take Brieka
5.
While you are using Brieka
6.
Side Effects
7.
Storage
and
Disposal
of
Brieka
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT BRIEKA IS USED FOR
Pregabalin is indicated for the
treatment
of
peripheral
and
central
neuropathic
pain
in
adults.
Pregabalin
is
indicated
as
adjunctive
therapy
in
adults
with
partial
seizures
with
or
without
secondary
generalisation.
Pregabalin is indicated for the
treatment
of
Generalised
Anxiety
Disorder
(GAD)
in
adults.
Pregabalin is indicated for the
management of fibromyalgia.
HOW BRIEKA WORKS
Pregabalin
helps
decrease
the
number of nerve signals, and as
a
result
calms
down
overly
sensitive nerve cells.
BEFORE YOU USE BRIEKA
_-When you must not take it _
Do not start taking if you are
allergic to pregabalin or any of
the ingredients in Brieka.
Symptoms
of
an
allergic
reaction
to
pregabalin
may
include
swelling
of
the
face,
lips,
tongue,
and
throat,
shortness of breath, wheezing as
well as skin rashes.
_-Before you start to take it _
Talk
to
your
doctor
or
pharmacist
before
you
take
Brieka:
- have or had depression, mood
problems or suicidal thoughts or
behaviour
- have kidney problems or get
kidney dialysis
- 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
swellings
in
your face, mouth, tongue, lips,
gums,
neck
or
throat
(angioedema)
-
have
eye
problems.
Pregabalin may cause blurring
or
loss
of
vision,
or
other
changes
in
eyesight,
many
of
which
are
temporary.
You
should
immediately
tell
your
doctor
if
you
experience
any
changes in your vision.
- are pregnant or plan to become
pregnant.
It
is
not
known
if
pregabalin
will
harm
your
unborn
baby.
You
and
your
doctor will have to deci

Fachinformation

PRODUCT NAME
BRIEKA capsules 50mg
BRIEKA capsules 75mg
BRIEKA capsules 150mg
COMPOSITION
_Name and Strength of Active Substance(s) _
50mg: Each capsule contains Pregabalin 50mg
75mg: Each capsule contains Pregabalin 75mg
150mg: Each capsule contains Pregabalin 150mg
PRODUCT DESCRIPTION
50mg: White cap and white body, hard gelatine capsules size 3.
Markings in black ink on body: “PGB 50“ with a black band.
75mg: Orange cap and white body, hard gelatine capsules size 4.
Markings in black ink on body: “PGB 75“.
150mg: White cap and white body, hard gelatine capsules size 2.
Markings in black ink on body: “PGB 150“.
PHARMACOLOGY
Pharmacotherapeutic group: Antiepileptics, other antiepileptics
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 (α
2
-δ protein) of voltage-
gated calcium channels in the central nervous system, potently
displacing [
3
H]-gabapentin.
PHARMACOKINETICS
Pregabalin steady-state pharmacokinetics is similar in healthy
volunteers, patients with epilepsy receiving antiepileptic 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
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
max
by approximately 25-30% and a delay in t
max
to approximately 2.5
hours. However, administration of pregabalin with food has no
clinically significant effect on the extent of pregabalin absorption.
Distribution
The apparent volume of distribution of pregabalin following oral
administration is approximately 0.56 l/kg. Pregabalin is not bound
to plasma proteins.
Biotransformati