NEURONTIN 300MG CAPSULE

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

GABAPENTIN

Mevcut itibaren:

PFIZER (MALAYSIA) SDN. BHD.

INN (International Adı):

GABAPENTIN

Paketteki üniteler:

50Capsule Capsules; 100Capsule Capsules; 100Capsule Capsules

Tarafından üretildi:

PFIZER PHARMACEUTICALS LLC

Bilgilendirme broşürü

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

Ürün özellikleri

P fize r Confide ntia l - 1 -
LP D T it le : G ABAP EN T I N
LPD Date : 172905 MayAugust J anuary 2016782 15 July Mar c h 20165
Country : Malay s ia
Referenc e : CD S version1Ve r s io n 1796.0 dated Dated 01 0716 June J anMar c h 201520167
Reas on :: Sinc e tw o major health authorities (US and EU) have now requested the addition of
“hyponatremia” as an ADR in gabapentin produc t labeling, an RMC review of this safety topic
w as c onduc ted, inc luding disc ussion at PVMAC on 25- Mar-2015. T h e P VMAC
rec ommendation w as to add hyponatremia as an ADR in sec tion 4.8 of the CDS. Consequently
the Gabapentin CDS is being revised to add “hyponatremia” in sec tion 4.8 under the post -
marketing experienc e sec tion. Addition of anaphylaxis w arning (inc luding symptoms of angioedema) in sec tion 4.4 of the
Gabapentin CDS Addition of the ADR anaphylaxis in sec tion 4.8 of the Gabapentin CDS (under the
post -marketing experienc e sec tion) Also, moved the loc ation of the existing DRESS w arning in sec tion 4.4 to be positioned up
higher to reflec t higher c linic al signific anc e of this w arning.
• Addition of mandatory s tatement for Ep ilep t ic s in sec tion 4.4 as per Malays ia D rug
Registration Guidanc e Doc ument - S p ec if ic Lab ellin g Requirement (s ubs tanc e s pecific )
• Addition of anaphylaxis w arning (inc luding symptoms of angioedema) in sec tion 4.4 of the
Gabapentin CDS
• Addition of the ADR anaphylaxis in sec tion 4.8 of the Gabapentin CDS (under the post
marketing experienc e sec tion)
• Also, moved the loc ation of the existing DRES S w arning in sec tion 4.4 to be positioned up
higher to reflec t higher c linic al signific anc e of this w arning.
• Addition of mandatory statement for Epileptic s in sec tion 4.4 as per Malaysia Drug
Registration Guidanc e Doc ument - Spec ific Labelling Requirement (s ubs tanc e specific )
• HA request to update PI ac c ordingly w ith referenc e to PRAC's recommendation on
respiratory depression. EMA has c onc luded gabapentin c an c aus