Neurontin 600 mg film-coated tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Gabapentin

Disponible depuis:

IMED Healthcare Ltd.

Code ATC:

N03AX; N03AX12

DCI (Dénomination commune internationale):

Gabapentin

Dosage:

600 milligram(s)

forme pharmaceutique:

Film-coated tablet

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Other antiepileptics; gabapentin

Statut de autorisation:

Authorised

Date de l'autorisation:

2013-11-08

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
NEURONTIN 600 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, throbbing, shooting, stabbing,
sharp, cramping, aching, ti

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Neurontin 600 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 600 mg film-coated tablet contains 600 mg of gabapentin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from the UK_
Film-coated tablet
Neurontin 600 mg film-coated tablets are 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 PA0822/015/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/015/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Film-coated tablets
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 (hydroxypropylcellulose, talc)
Polishing agent: candelilla wax
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer carton of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C
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6.5 NATURE AND CONTENTS OF CONTAINER
PVC/PE/PVDC/aluminium foil bl