Neurontin 600 mg film-coated tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Gabapentin

متاح من:

PCO Manufacturing Ltd.

ATC رمز:

N03AX; N03AX12

INN (الاسم الدولي):

Gabapentin

جرعة:

600 milligram(s)

الشكل الصيدلاني:

Film-coated tablet

نوع الوصفة الطبية :

Product subject to prescription which may be renewed (B)

المجال العلاجي:

Other antiepileptics; gabapentin

الوضع إذن:

Authorised

تاريخ الترخيص:

2009-09-18

نشرة المعلومات

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEURONTIN
®
100 MG, 300 MG & 400 MG HARD CAPSULES
600 MG & 800 MG FILM-COATED TABLETS
gabapentin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
–
Keep this leaflet. You may need to read it again.
–
If you have any further questions, ask your doctor or pharmacist.
–
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
–
If you get any side effects talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Neurontin is and what it is used for
2.
What you need to know before you take Neurontin
3.
How to take Neurontin
4.
Possible side effects
5.
How to store Neurontin
6.
Contents of the pack and other information
1.
WHAT NEURONTIN IS AND WHAT IT IS USED FOR
Neurontin belongs to a group of medicines used to treat epilepsy and
peripheral
neuropathic pain (long lasting pain caused by damage to the nerves).
The active substance in Neurontin is gabapentin.
NEURONTIN IS USED TO TREAT:
–
Various forms of epilepsy (seizures that are initially limited to
certain parts of the brain,
whether the seizure spreads to other parts of the brain or not). The
doctor treating you
or your child 6 years of age and older will prescribe Neurontin to
help treat epilepsy
when the current treatment is not fully controlling the condition. You
or your child 6
years of age and older should take Neurontin in addition to the
current treatment
unless told otherwise. Neurontin can also be used on its own to treat
adults and
children over 12 years of age.
–
Peripheral neuropathic pain: (long lasting pain caused by damage to
the nerves). A
variety of different diseases can cause peripheral neuropathic pain
(primarily
occurring in the legs and/or arms), such as diabetes or shingles. Pain
sensations may
be described as hot, burning,

خصائص المنتج

Health Products Regulatory Authority
21 January 2020
CRN009FSS
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Neurontin 600 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 600mg film-coated tablet contains 600mg of gabapentin.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablets
_Product imported from UK & Spain:_
White, elliptical film-coated tablets with a bisecting score on both
sides and debossed with “NT” and “16” on one side. The
tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
As per PA 0822/015/004
5 PHARMACOLOGICAL PROPERTIES
As per PA 0822/015/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Each film-coated tablet contains the following excipients:
Poloxamer 407 (ethylene oxide and propylene oxide)
copovidone
maize starch
magnesium stearate
Film-coating Opadry white YS-1-18111 (hydroxpropylcellulose, talc).
Polishing agent: candelilla wax
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
21 January 2020
CRN009FSS
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25ºC
6.5 NATURE AND CONTENTS OF CONTAINER
PVC/PE/PVDC/aluminium foil blister in overlabelled outer Cartons. Pack
sizes of 90 or 100 film coated tablets.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No Special requirements
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/097/004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 18
th
September 2009
10 DATE OF REVISION OF THE TEXT
January 2020