Lybalin 75mg Capsules

Pays: Malaisie

Langue: anglais

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

Ingrédients actifs:

PREGABALIN

Disponible depuis:

MEDISPEC (M) SDN.BHD

DCI (Dénomination commune internationale):

PREGABALIN

Unités en paquet:

8 x 7s Capsules

Fabriqué par:

Biolab Co., Ltd

Notice patient

LYBALIN 75MG CAPSULES
Pregabalin (75mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What LYBALIN is used for
2.
How LYBALIN works
3.
Before you use LYBALIN
4.
How to use LYBALIN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of LYBALIN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT LYBALIN IS USED FOR
LYBALIN is used to treat:
Neuropathic pain
Pregabalin is indicated for the treatment
of
central
and
peripheral
neuropathic
pain in adults.
Epilepsy
Pregabalin
is
indicated
as
adjunctive
therapy
in
adults
with
partial
seizures
with or without secondary generalization.
Generalized Anxiety Disorders (GAD)
Pregabalin is indicated for the treatment
of Generalized Anxiety Disorders (GAD)
in adults.
Fibromyalgia
Pregabalin
is
indicated
for
the
management of fibromyalgia.
HOW LYBALIN WORKS
LYBALIN helps decrease the number of
nerve signals, and as a result calms down
overly sensitive nerve cells.
BEFORE YOU USE LYBALIN
-
_When you must not use it _
_ _
DO NOT START TAKING LYBALIN IF YOU
ARE ALLERGIC TO PREGABALIN OR ANY OF
ITS COMPONENTS
. See the end of this
leaflet
for
the
complete
list
of
ingredients in LYBALIN.
Symptoms of an allergic reaction to
LYBALIN may include:
- Serious, even life-threatening allergic
reactions
- Suicidal thoughts or actions
- Swelling of hands, legs and feet
- Dizziness and sleepiness
_ _
_ _
_Pregnancy and lactation _
It is not known if LYBALIN will harm
your unborn baby. You and your doctor
will have to decide if you should take
LYBALIN while you are pregnant.
LYBALIN passes into breast milk, ut it
is not known if it can harm your baby.
You
and
your
doctor
should
discuss
whether you should take LYBALIN or
breast-feed, but you should not do both.
-
_Before you start to use it _
Tell your doctor about all your medical
conditions including if you:
-
have
or
had
depression,
mood
problems
or
suicidal
thoughts
or
behavior.
-
have
kidney
problems
or
kidney
dialysis
- have heart problems including h

Résumé des caractéristiques du produit

Page 1/11
LYBALIN 75 MG CAPSULES
NAME AND STRENGTH OF ACTIVE INGREDIENT
LYBALIN 75 MG is formulated as a capsule for oral administration.
Each hard capsule contains 75 mg pregabalin.
PRODUCT DESCRIPTION
White to off-white powder filled in white opaque body, red opaque cap,
hard gelatin capsule
No. 4 printed with black ink “BC 75”.
Source of Capsule shells: Bovine gelatin
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC
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.
Evidence from animal models with nerve damage has shown that
pregabalin reduces calcium
dependent
release
of
pronociceptive
neurotransmitters
in
the
spinal
cord
possibly
by
disrupting calcium trafficking and/or reducing calcium currents.
Evidence from other animal
models of nerve damage suggest the antinociceptive activities of
pregabalin may also be
mediated through interactions with the descending noradrenergic and
serotonergic pathways.
Clinical experience
NEUROPATHIC PAIN
Efficacy has been shown in studies in diabetic neuropathy and
post-herpetic neuralgia.
Efficacy has not been studied in other models of neuropathic pain.
Pregabalin has been studied in 9 controlled clinical studies of up to
13 weeks with twice a day
dosing and up to 8 weeks with three times a day dosing. Overall, the
safety and efficacy
profiles for twice a day and three times a day dosing regimens were
similar.
In clinical trials up to 13 weeks, a reduction in pain was seen by
Week 1 and was maintained
throughout the treatment period.
In controlled clinical trials 35% of the pregabalin treated patients
and 18% of the patients on
placebo had a 50% improvement in pain score. For patients not
experiencing somnolence,
such an improvement was observed in 33% of patients treated with
pregabalin and 18% of
patients on placebo. For patients who experienced somnolence the