Neurontin 100mg capsule

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

GABAPENTIN

Tilgjengelig fra:

PFIZER (MALAYSIA) SDN. BHD.

INN (International Name):

GABAPENTIN

Enheter i pakken:

100Capsule Capsules; 50Capsule Capsules

Produsert av:

PFIZER PHARMACEUTICALS LLC

Informasjon til brukeren

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
NEURONTIN
®
Gabapentin (Capsule: 100 mg, 300 mg, 400 mg & Tablet: 600 mg)
1
PLD TITLE
: NEURONTIN
PLD DATE
: 14 May 2019
COUNTRY
: Malaysia
REFERENCE DOCUMENT
: Malaysia LPD dated 5 January 2018
REASON FOR CHANGE
: To update PRH address
: To add serial number
Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
NEURONTIN
®
Gabapentin (Capsule: 100 mg, 300 mg, 400 mg & Tablet: 600 mg)
2
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
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

Preparatomtale

Pfizer Confidential - 1 -
LPD Title : GABAPENTIN
LPD Date : 05 January 201 8
Country : Malaysia
Reference : CDS Version 1 9.0 Dated 16 March 201 7
Reason :
• Addition of anaphylaxis warning (including symptoms of angioedema) in section 4.4 of the
Gabapentin CDS
• Addition of the ADR anaphylaxis in section 4.8 of the Gabapentin CDS (under the post
marketing experience section)
• Also, moved the location of the existing DRES S warning in section 4.4 to be positioned up
higher to reflect higher clinical significance of this warning.
• Addition of mandatory statement for Epileptics in section 4.4 as per Malaysia Drug
Registration Guidance Document - Specific Labelling Requirement (substance specific)
• HA request to update PI accordingly with reference to PRAC's recommendation on
respiratory depression. EMA has concluded gabapentin can cause respiratory depression
without concomitant opioid use.
• Add "gabapentin crosses the human pla centa" in pregnancy section 4.6 and addition of a
statement in section 4.6 regarding "congenital malformations and adverse developmental
outcomes have been reported with gabapentin use" and "no definitive conclusions can be
made as to whether gabapentin is causally associated with an increased risk of congenital
malformations or other adverse developmental outcomes when taken during pregnancy. The
risk of birth defects is increased by a factor of 2 -3 in the offspring of mothers treated with an
antiepileptic medicinal product; revision of a statement in section 4.6 to state that "studies in
animals have shown reproductive toxicity (see 5.3). The potential risk for humans is
unknown. Gabapentin should be used during pregnancy only if the potential benefit to t he
mother clearly outweighs the potential risk to the fetus.
• Addition of the post -marketing ADR agitation. Minor edit in section 5.3: the word "doses"
was meant to be "does" which means "female rabbits". The labeling team is revising this word
to "female r abbits" for more clarity.
1. NAME OF THE MEDICINAL PRODUCT