PEGASET 150 (Pregabalin Capsules 150 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:

4x7capsule Capsules

Dikeluarkan oleh:

Aurobindo Pharma Limited, Unit-VII (SEZ)

Risalah maklumat

PEGASET
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
Pregabalin Capsules (50 mg, 75 mg and 150 mg)
1
WHAT IS IN THIS LEAFLET
1.
What
_PEGASET _
is used for
2.
How
_PEGASET_
works
3.
Before you use
_PEGASET _
4.
How to use
_PEGASET _
5.
While you are using it
_ _
6.
Side effects
7.
Storage and Disposal of
_PEGASET _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial number
WHAT _PEGASET _IS USED FOR
Pregabalin
belongs
to
a
group
of
medicines called Anti-epileptics.
You
have
been
prescribed
Pregabalin
because:
Pregabalin is used to treat:
_Neuropathic pain _
Pregabalin is indicated for the treatment
of
peripheral
and
central
neuropathic
pain in adults.
_Epilepsy _
Pregabalin
is
indicated
as
adjunctive
therapy
in
adults
with
partial
seizures
with or without secondary generalisation.
_Generalised Anxiety Disorder_
Pregabalin is indicated for the treatment
of Generalised Anxiety Disorder (GAD)
in adults.
_Fibromyalgia_
Pregabalin
is
indicated
for
the
management of fibromyalgia.
HOW _PEGASET_ WORKS
Pregabalin helps decrease the number of
nerve signals, and as a result calms down
overly sensitive nerve cells.
BEFORE YOU USE _PEGASET _
_-When you must not use it _
Do not start taking Pregabalin if you are
allergic
to
Pregabalin
or
any
of
the
Excipients in Pregabalin. See the end of
this
leaflet
for
a
complete
list
of
Excipients in Pregabalin. Symptoms of an
allergic
reaction
to
Pregabalin
may
include:

Serious, even life-threatening allergic
reactions

Suicidal thoughts or actions.

Swelling of your hands, legs and feet.

Faintness and sleepiness
_ _
_-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
behavior.

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 i

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
PEGASET
PREGABALIN CAPSULES 50 MG/75 MG/150 MG
_R_
_x_
_ Only_
NAME OF DRUG PRODUCT
:
Pregabalin Capsules 50 mg
Pregabalin Capsules 75 mg
Pregabalin Capsules 150 mg
(TRADE) NAME OF PRODUCT
:
PEGASET 50
PEGASET 75
PEGASET 150
STRENGTH
:
50 mg, 75 mg & 150 mg
PHARMACEUTICAL DOSAGE FORM
:
Capsule
QUALITATIVE AND QUANTITATIVE COMPOSITIONS:
_Pregabalin Capsules 50 mg_
Each capsule contains Pregabalin 50 mg_ _
_Pregabalin Capsules 75 mg_
Each capsule contains Pregabalin 75 mg_ _
_Pregabalin Capsules 150 mg_
Each capsule contains Pregabalin 150 mg
PHARMACEUTICAL FORM:
_Pregabalin Capsules 50 mg:_ White cap/ white body, size ‘4’ hard
gelatin capsule shells,
imprinting with“Z” on cap and “11” on body with black ink
contains white to off-white
granular powder.
_Pregabalin Capsules 75 mg:_ Orange cap/ white body, size ‘4’ hard
gelatin capsule shells,
imprinting with“Z” on cap and “12” on body with black ink
contains white to off-white
granular powder.
_Pregabalin Capsules 150 mg:_ White cap/ White body, size ‘2’ hard
gelatin capsule shells,
imprinting with“Z” on cap and “14” on body with black ink
contains white to off-white
granular powder.
CLINICAL PARTICULARS:
THERAPEUTIC INDICATIONS
Pregabalin is indicated for the treatment of peripheral and central
neuropathic pain in
adults. Epilepsy Pregabalin is indicated as adjunctive therapy in
adults with partial seizures
with or without secondary generalisation. Generalised Anxiety Disorder
Pregabalin is
indicated for the treatment of Generalised Anxiety Disorder (GAD) in
adults. Fibromyalgia
Pregabalin is indicated for the management of fibromyalgia.
POSOLOGY AND METHOD OF ADMINISTRATION
_Oral_
The dose range is 150 to 600 mg per day given in either two or three
divided doses.
_Pregabalin may be taken with or without food._
Neuropathic pain
Pregabalin treatment can be started at a dose of 150 mg per day. Based
on individual
patient response and tolerability, the dosage may be increased to 300
mg per day afte