Lygaba Capsule 75mg

Country: Malaysia

Language: English

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

Active ingredient:

PREGABALIN

Available from:

MEDISPEC (M) SDN.BHD

INN (International Name):

PREGABALIN

Units in package:

4 x 14'scapsule Capsules

Manufactured by:

2ND PLANT STANDARD CHEM & PHARM CO LTD

Patient Information leaflet

LYGABA CAPSULE 75MG
®
Pregabalin 75mg
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Lygaba _
is used for
2.
How
_Lygaba _
works
3.
Before you use
_Lygaba_
4.
How to use
_Lygaba_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Lygaba_
8.
Product Description
9.
Manufacturer and Product
Registration
Holder
10. Date of revision
WHAT _Lygaba _IS USED FOR
Pregabalin
belongs to a group of medicines used to
treat epilepsy, neuropathic pain,
fibromyalgia and Generalised Anxiety
Disorder (GAD) in adults.
HOW _Lygaba _WORKS
Pregabalin helps decrease the number of
nerve signals, and as a result calms down
overly sensitive nerve cells.
BEFORE YOU USE _Lygaba_
_When you must not use it_
You should not use this medication if
you are allergic to pregabalin or to any of
the excipients of Lygaba.
-
_ Before you start to 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 or plan to become
pregnant. It is not known if
_Lygaba _
will
harm your unborn baby. You and your
healthcare provider will have to decide if
you should take
_Lygaba _
while you are
pregnant.
• are breast-feeding. Pregabalin is
excreted into human milk. The effect of
pregabalin on new-borns/infants is
unknown. You and your healthcare
provider should discuss whether you
should take
_Lygaba _
or breast-feed, but
you should not do both.
_Pregnancy and lactation_
Do not take
_Lygaba _
if you are pregnant,
trying to get pregnant or think you may
be pregnant.
Do not take
_Lygaba _
if you are breast-
feeding.
_Taking other medicines_
Tell your healthcare provider about all
the medicines you take including
prescrip

Summary of Product characteristics

PROPOSED PACKAGE INSERT
PRODUCT NAME
:Lygaba Capsule 75mg
NAME AND STREGTH OF ACTIVE INGREDIENT
: PREGABALIN 75MG
PRODUCT DESCRIPTION
Lygaba Capsule 75mg, is available a dark red cap and white body No.4
capsule, imprinted blue "STD"
on cap and LGB 571 on body, contains a white to cream-white powder.
PHARMACODYNAMICS
_PHARMACODYNAMICS:_
_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.
_Clinical Experience: 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.
Pregabalin has been studied in either twice-daily or thrice-daily
dosing. Overall, the safety and
efficacy profiles for twice-daily and thrice-daily dosing regimens
were similar.
_Epilepsy: _Pregabalin has been studied in either twice-daily or
thrice-daily dosing. Overall, the safety
and efficacy profiles for twice-daily and thrice-daily dosing regimens
were similar.
A redction in seizure frequency was observed.
_Generalised Anxiety Disorder:_
Relief of the symptoms of GAD as reflected by the Hamilton Anxiety
Rating Scale (HAM-A) was
observed. In controlled clinical trials , pregabalin-treated patients
had shown improvement in HAM-A
total score from baseline to endpoint.
PHARMACOKINETICS
Pregabalin steady-state pharmacokinetics are 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 hr 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 24-48 hrs. The rate of
pregabalin absorption is
decreased when given with food resulting in a decrease in C
max
by