Neurontin 300 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gabapentin

Available from:

Pfizer Healthcare Ireland

ATC code:

N03AX; N03AX12

INN (International Name):

Gabapentin

Dosage:

300 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antiepileptics; gabapentin

Authorization status:

Marketed

Authorization date:

2006-02-10

Patient Information leaflet

Page 1 of 9
2019-0057090
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 descri

Summary of Product characteristics

Health Products Regulatory Authority
23 February 2021
CRN009TV1
Page 1 of 12
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 with known effect
Each 300 mg hard capsule contains 41 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Neurontin 300 mg hard capsules:A two-piece, yellow opaque hard gelatin
capsule, imprinted with ‘Neurontin 300 mg’ and ‘PD’
and containing a white to off-white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Epilepsy
Neurontin is indicated as adjunctive therapy in the treatment of
partial seizures with and without secondary generalization in
adults and children aged 6 years and above (see section 5.1).
Neurontin is indicated as monotherapy in the treatment of partial
seizures with and without secondary generalization in adults
and adolescents aged 12 years and above.
Treatment of peripheral neuropathic pain
Neurontin is indicated for the treatment of peripheral neuropathic
pain such as painful diabetic neuropathy and post-herpetic
neuralgia in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For all indications a titration scheme for the initiation of therapy
is described in Table 1, which is recommended for adults and
adolescents aged 12 years and above. Dosing instructions for children
under 12 years of age are provided under a separate
sub-heading later in this section.
Table 1
​
DOSING CHART – INITIAL TITRATION
Day 1
Day 2
​Day 3
​
300 mg once a day
300 mg two times a day
​300 mg three times a day
Discontinuation of gabapentin
In accordance with current clinical practice, if gabapentin has to be
discontinued it is recommended this should be done
gradually over a minimum of 1 week independent of the indication.
Health Products Regulatory Authority
23 February 2021
CRN009TV1
Page 2 of 12
Epilepsy
Epilepsy typically requires lon