GABAPENTIN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

GABAPENTIN

Available from:

Accord Healthcare Limited

ATC code:

N03AX12

INN (International Name):

GABAPENTIN

Dosage:

300 Milligram

Pharmaceutical form:

Capsules Hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

gabapentin

Authorization status:

Marketed

Authorization date:

2016-10-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
GABAPENTIN 100 MG HARD CAPSULES
GABAPENTIN 300 MG HARD CAPSULES
GABAPENTIN 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 Gabapentin is and what it is used for
2.
What you need to know before you take Gabapentin
3.
How to take Gabapentin
4.
Possible side effects
5.
How to store Gabapentin
6.
Contents of the pack and other information
1.
WHAT GABAPENTIN IS AND WHAT IT IS USED FOR
Gabapentin 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 Gabapentin is gabapentin.
GABAPENTIN 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). Your doctor
will prescribe Gabapentin for
you to help treat your epilepsy when your current treatment is not
fully controlling your
condition. You should take Gabapentin in addition to your current
treatment unless told
otherwise. Gabapentin 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, tin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gabapentin 300 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 300 mg hard capsule contains 300 mg of gabapentin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Opaque yellow/opaque yellow coloured size "1", approximately 18.90 to
19.70 mm in length, hard gelatin capsules
imprinted with "G 300" on cap with blue ink containing white to off
white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Epilepsy
Gabapentin 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).
Gabapentin 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
Gabapentin 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
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.
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.
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
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