NEURONTIN 300MG CAPSULE

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

GABAPENTIN

Boleh didapati daripada:

VIATRIS SDN. BHD.

INN (Nama Antarabangsa):

GABAPENTIN

Unit dalam pakej:

50Capsule Capsules; 100Capsule Capsules; 100Capsule Capsules

Dikeluarkan oleh:

PFIZER PHARMACEUTICALS LLC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
NEURONTIN
®
CAPSULES
Gabapentin (Capsule: 100 mg, 300 mg & Tablet: 600 mg)
1
WHAT IS IN THIS LEAFLET
1.
What NEURONTIN is used for
2.
How NEURONTIN works
3.
Before you use NEURONTIN
4.
How to use NEURONTIN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
NEURONTIN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT NEURONTIN IS USED FOR
NEURONTIN is used to treat epilepsy
(seizures that are initially limited to
certain parts of the brain, whether the
seizure spreads to other parts of the
brain or not) and peripheral
neuropathic pain (long lasting pain
caused by damage to the nerves).
HOW NEURONTIN WORKS
NEURONTIN belongs to a group of
medicines used to treat epilepsy and
peripheral neuropathic pain (long
lasting pain caused by damage to the
nerves).
BEFORE YOU USE NEURONTIN
_-_
_When you must not use it_
Do not take NEURONTIN:
- If you are allergic (hypersensitive)
to gabapentin or any of the other
ingredients of NEURONTIN
_Pregnancy and lactation_
Tell your doctor if you are pregnant or
intend to become pregnant.
NEURONTIN should not be taken
during pregnancy, unless you are told
otherwise by your doctor. Effective
contraception must be used by women
of child-bearing potential.
Contact your doctor immediately if
you become pregnant, think you might
be pregnant or are planning to become
pregnant while taking NEURONTIN.
Do not suddenly discontinue taking
this medicine as this may lead to a
breakthrough seizure, which could
have serious consequences for you and
your baby.
Gabapentin, the active substance of
NEURONTIN, is passed through
human milk. As the effect on the baby
is unknown, caution should be
exercised when gabapentin is
administered to a nursing mother.
Gabapentin should be used in nursing
mothers only if the benefits clearly
outweigh the risks.
_-_
_Before you start to use it_
Inform your doctor if you have the
following:
-If you are about to take any
prescription or non-

Ciri produk

CLD Title
: Gabapentin (Neurontin)
CLD Date
: 9 March 2023
Country
: Malaysia
Reference Document
: CDS Version 22.0 Dated 20 January 2023
Reason for change
: To update section 4.4 to add a paragraph on withdrawal syndrome and
woman of childbearing potential/contraception
: To update section 4.6 to add a paragraph on neonatal withdrawal
syndrome,
pregnancy study outcome and replacement of current wording
: To update section 4.8 by replacing the current withdrawal symptoms
statement with the PRAC statement
1
1. NAME OF THE MEDICINAL PRODUCT
NEURONTIN
®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Gabapentin is supplied as capsules containing 100 mg, and 300 mg of
active drug substance for oral
administration.
Gabapentin is also supplied as 600 mg tablets.
Gabapentin is a white to off-white crystalline solid. It is freely
soluble in water and both basic and acidic
aqueous solutions.
3. PHARMACEUTICAL FORM
_CAPSULE _
Gabapentin 100 mg is a hard gelatin capsule with a white opaque cap,
blue printed “Neurontin 100 mg”
and white opaque body, blue printed “PD”.
Gabapentin 300 mg is a hard gelatin capsule with a light yellow opaque
cap, grey printed with
“Neurontin 300 mg” and light yellow opaque body, grey printed
“PD”.
_TABLET _
Gabapentin 600 mg is a white elliptical shaped, film-coated tablets
with a bisecting score on both sides
and debossed with ‘NT’ and ‘16’ on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
_EPILEPSY _
Gabapentin is indicated as adjunctive therapy in the treatment of
partial seizures with and without
secondary generalization in adults and children aged 3 years and
older. Safety and effectiveness for
adjunctive therapy in pediatric patients younger than 3 years have not
been established (see Section 4.2
POSOLOGY AND METHOD OF ADMINISTRATION: _EPILEPSY_
:
_Pediatric patients aged 3 to 12 years_
).
_NEUROPATHIC PAIN _
Gabapentin is indicated for the treatment of neuropathic pain which
includes diabetic neuropathy, post-
herpetic neuralgia and trigeminal neuralgia