Neurontin 400 mg hard capsules

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Gabapentin

Verfügbar ab:

PCO Manufacturing Ltd.

ATC-Code:

N03AX; N03AX12

INN (Internationale Bezeichnung):

Gabapentin

Dosierung:

400 milligram(s)

Darreichungsform:

Capsule, hard

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

Other antiepileptics; gabapentin

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2003-01-24

Gebrauchsinformation

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEURONTIN
® 300 MG & 400 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, sharp,
crampin

Fachinformation

Health Products Regulatory Authority
06 November 2023
CRN00DWXL
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Neurontin 400 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 400 mg hard capsule contains 400 mg of gabapentin
Excipients with known effect:
Each 400 mg hard capsule contains lactose (as monohydrate).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsule, hard
_Product imported from Greece and Spain_
A two‑piece, orange opaque hard gelatin capsule, imprinted with
'Neurontin 400mg' and the ‘PD’, containing a white to
off‑white powder.
4 CLINICAL PARTICULARS
As per PA23055/004/003
5 PHARMACOLOGICAL PROPERTIES
As per PA23055/004/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Product imported from Greece_
Lactose monohydrate
Maize starch
Talc
Gelatin
Titanium dioxide (E171)
YeIlow iron oxide (E172)
Red iron oxide (E172)
_Product imported from Spain_
Lactose monohydrate
maize starch
Talc
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 package of the product on the market in
the country of origin.
Health Products Regulatory Authority
06 November 2023
CRN00DWXL
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister pack containing 50, 90 or 100 capsules in an outer cardboard
carton.
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
PPA0465/097/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 24 January 2003
Date of last renewal: 24 January 2008
10 DATE OF REVISION OF THE TEXT
November 2023