Gabapentin 300 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gabapentin

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N03AX; N03AX12

INN (International Name):

Gabapentin

Dosage:

300 milligram(s)

Pharmaceutical form:

Capsule, hard

Therapeutic area:

Other antiepileptics; gabapentin

Authorization status:

Not 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). The doctor
treating you or your child 6
years of age and older will prescribe Gabapentin for you 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 Gabapentin in addition to the 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 desc

Summary of Product characteristics

Health Products Regulatory Authority
18 July 2022
CRN00CYQF
Page 1 of 12
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.
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.
Epilepsy
Epilepsy typically requires long‑term therapy. Dosage is determined
by the treating physician according to individual tolerance
and efficacy.
Health Products Regulatory Authority
18 July 2022
CRN00CYQF
Page