Prelica Capsule 150mg

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

PREGABALIN

Dostępny od:

DUOPHARMA (M) SDN. BHD.

INN (International Nazwa):

PREGABALIN

Sztuk w opakowaniu:

30capsule Capsules; 100capsule Capsules; 60 Capsules Capsules

Wyprodukowano przez:

DUOPHARMA (M) SDN. BHD.

Ulotka dla pacjenta

1
PRELICA
CAPSULE
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
Pregabaline (75mg, 150mg)
WHAT IS IN THE LEAFLET
1.
What PRELICA is used for
2.
How PRELICA works
3.
Before you use PRELICA
4.
How to use PRELICA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of PRELICA
Capsule
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT PRELICA IS USED FOR
PRELICA is used to treat following:
NEUROPATHIC PAIN.
For the treatment of peripheral and
central neuropathic pain in adults.
EPILEPSY
As adjunctive t h e r a p y in adults wi
t
h
partial
seizures
with
or
without
secondary generalization.
GENERALIZED ANXIETY DISORDER
For the treatment of Generalized Anxiety
Disorder (GAD) in adults.
FIBROMYALGIA
For the management of fibromyalgia
HOW PRELICA WORKS
PRELICA helps decrease the number of
nerve signals, and as a result calms down
overly sensitive nerve cells.
Your doctor ma y have prescribed this
medicine for another reason.
Ask
your
doctor
if
you
have
any
questions
about
why
it
has
been
prescribed for you.
BEFORE YOU USE PRELICA
_When you must not use it _
Do not start taking PRELICA if you
are allergic to:
•
Pregabalin, the active ingredient
•
Any of the other ingredients in
PRELICA.
Do
not
take
this
medicine after
the
expiry date printed on the pack or if the
packaging
is
torn
or
shows
signs
of
tampering.
If it has expired or is damaged, return it
to your pharmacist for disposal.
If you are not sure whether you should
start taking this medicine, talk to your
doctor or pharmacist.
-
_Before you start use it _
_ _
Tell your healthcare provider about all
your medical condition including if you:
•
have
or
had
depression,
mood
problems
or
suicidal
thoughts
or
behaviour.
•
have kidney problems or get kidney
dialysis
•
have heart 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 (angioedema)
•
are pregnant

Charakterystyka produktu

[DUOPHARMA (M) SDN BHD]
Page 1 of 4
[Revision Date: (09.05.2019)]
PRELICA CAPSULE
COMPOSITION:
Prelica 75mg Capsule : Each capsule contain 75mg Pregabalin
Prelica 150mg Capsule : Each capsule contain 150mg Pregabalin
DECLARATION OF CAPSULE SOURCE: Bovine source.
PRODUCT DESCRIPTION:
Prelica 75mg Capsule : A size #4 capsule, with white body and brown
cap printed with PRE/75, contains white to off white granules
Prelica 150mg Capsule : A size #2 capsule, with opaque white body and
cap printed with PRE/150, contains white to off white granules
PHARMACODYNAMIC / PHARMACOLOGY:
Mechanism of action
Pregabalin binds to an auxiliary subunit (α2-δ protein) of
voltage-gated calcium channels in the central nervous system
PHARMACOKINETIC:
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 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 Cmax by
approximately 25-30% and a delay in tmax to approximately 2.5 hours.
However, administration of pregabalin with food has no clinically
significant effect on the extent of pregabalin absorption.
Distribution
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 to 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