Novugab 50mg Capsules

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PREGABALIN

Boleh didapati daripada:

NOVUGEN PHARMA SDN. BHD.

INN (Nama Antarabangsa):

PREGABALIN

Unit dalam pakej:

112 Capsules; 56 Capsules; 14 Capsules; 28 Capsules; 10 Capsules; 30 Capsules; 60 Capsules; 100 Capsules; 120 Capsules

Dikeluarkan oleh:

PHARMANIAGA MANUFACTURING BERHAD

Risalah maklumat

Novugen Confidential
NOVUGAB CAPSULES
Pregabalin (50mg, 75mg, 150mg)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What Novugab is used for
2.
How it works
3.
Before you take Novugab
4.
How to take Novugab
5.
While you are using Novugab
6.
Side Effects
7.
Storage and Disposal of Novugab
8.
Product
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial
Number
WHAT NOVUGAB IS USED FOR
Novugab
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 NOVUGAB WORKS
Novugab helps decrease the number
of nerve signals, and as a result calms
down overly sensitive nerve cells.
BEFORE YOU USE NOVUGAB
_- When you must not use it_
DO NOT START TAKING NOVUGAB IF YOU
ARE ALLERGIC TO PREGABALIN OR ANY OF
THE INGREDIENTS IN NOVUGAB.
See the
end of this leaflet for a complete list
of ingredients in Novugab.
Symptoms of an allergic reaction to
Novugab may include:
-
Serious,
even
life-threatening
allergic reactions
-
Suicidal thoughts or actions
-
Swelling of your hands, legs and
feet
-
Dizziness and sleepiness
-
_Before you start to take 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 in the past
-
have ever had swelling in your face,
mouth,
tongue,
lips, gums, neck
or
throat (angioderma)
-
have
brain
malfunction
(encephalopathy)
-
cases
of
misuse,
abuse
and
depende

Ciri produk

Novugen
Novugab Capsules
Pregabalin
1.
NAME OF THE MEDICINAL PRODUCT
Novugab 50 mg Capsules,
Novugab 75 mg Capsules, and
Novugab 150 mg Capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
50 mg
Each capsule contains 50 mg of pregabalin.
75 mg
Each capsule contains 75 mg of pregabalin.
150 mg
Each capsule contains 150 mg of pregabalin.
3.
PHARMACEUTICAL FORM
50 mg hard capsules
White to off-white powder filled in size ‘4’ hard gelatin capsule,
printed with ‘P 50’ on white body
and ‘N’ on white cap in black ink.
75 mg hard capsules
White to off-white powder filled in size ‘4’ hard gelatin capsule,
printed with ‘P 75’ on white body
and ‘N’ on red cap in black ink.
150 mg hard capsules
White to off-white powder filled in size ‘2’ hard gelatin capsule,
printed with ‘P 150’ on white body
an ‘N’ on white cap in black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
Novugen
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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. Novugab is for oral use
only.
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 after
an interval of 3 to 7 days, and if
needed, to a maximum dose of 600 mg per day after an additional 7-day
interval.
Fibromyalgia
The usual dose range for most patients is 300 to 450 mg per day given
in two divided doses. Some
patients may derive additional benefit at 600 mg per day. Dosing
should