Neurontin 300 mg Hard Capsules

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:

300 milligram(s)

forme pharmaceutique:

Capsule, hard

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 100 MG HARD CAPSULES
NEURONTIN 300 MG HARD CAPSULES
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,
sh

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Neurontin 300 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 300 mg hard capsule contains 300 mg of gabapentin.
EXCIPIENTS:
Each 300 mg hard capsule contains lactose (as monohydrate).
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
_Product imported from the UK_
Neurontin 300mg hard capsules: A two-piece, yellow opaque hard
capsule, imprinted with 'Neurontin 300mg'
and 'PD'
and containing a white to off-white powder.
4 CLINICAL PARTICULARS
As per PA0822/015/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/015/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Capsule Contents:
Each hard capsule contains the following excipients: lactose
monohydrate, maize starch and talc.
Capsule shell: gelatin, purified water and sodium lauryl sulphate.
The 300 mg hard capsule contain the colourings E171 (titanium dioxide)
and E172 (yellow iron oxide).
The printing ink used on all hard capsules contains shellac, E171
(titanium dioxide) and E132 (indigocarmine).
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.
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6.4 SPECIAL PRECAUTIONS FOR STORA