Gabapentin 600 mg film-coated tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Gabapentin

Disponível em:

Accord Healthcare Ireland Ltd.

Código ATC:

N03AX; N03AX12

DCI (Denominação Comum Internacional):

Gabapentin

Dosagem:

600 milligram(s)

Forma farmacêutica:

Film-coated tablet

Área terapêutica:

Other antiepileptics; gabapentin

Status de autorização:

Not marketed

Data de autorização:

2011-12-05

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
GABAPENTIN 600 MG FILM-COATED TABLETS_ _
GABAPENTIN 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 , pharmacist or
nurse.
•
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 , pharmacist or
nurse.This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Gabapentin Film-coated tablets
are and what they are used for
2. What you need to know before you take Gabapentin Film-coated
tablets
3. How to take Gabapentin Film-coated tablets
4. Possible side effects
5. How to store Gabapentin Film-coated tablets
6. Content of the pack and other information
1. WHAT GABAPENTIN FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
Gabapentin Film-coated tablets
belong to a group of medicines used to treat epilepsy and peripheral
neuropathic
pain (long lasting pain caused by damage to the nerves).
The active ingredient in Gabapentin Film-coated tablets
is gabapentin.
Gabapentin Film-coated tablets
are 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 Film-coated tablets 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 Film-coated tablets in addition to the current treatment
unless told otherwise. Gabapentin
Film-coated tablets can also be used on its own to treat adults and
children over 12 years of age.
•
Peripheral neuropathic pain

Características técnicas

Health Products Regulatory Authority
25 July 2023
CRN00DQSD
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gabapentin 600 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of Gabapentin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Approximately 17.25 mm X 10.15 mm white to off-white, oval shaped,
film coated tablets imprinted G1 on one side with black
ink and plain on other side.
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
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.
Epilepsy
Epilepsy typically requires long-term therapy. Dosage is determined by
the treating physician according to individual tolerance
and efficacy.
_ _
_Adults and adolescents:_
In clinical trials, the effective dosing r