Gabapentin 800mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Gabapentin

Disponível em:

Accord-UK Ltd

Código ATC:

N02BF01

DCI (Denominação Comum Internacional):

Gabapentin

Dosagem:

800mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

Schedule 3 (CD No Register Exempt Safe Custody)

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 04080100; GTIN: 5060149319758

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
GABAPENTIN ACCORD 600 MG FILM-COATED TABLETS
GABAPENTIN ACCORD 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 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 or pharmacist or
nurse.This includes any possible side effects
not listed in this leaflet.
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). Your doctor will
prescribe
Gabapentin
Film-coated
tablets
for you to help treat your epilepsy when your current treatment is not
fully controlling your
condition. You should take Gabapentin Film-coated tablets in addition
to your 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 (long lasting pain caused by damage to the nerves).
A variety of different
diseases can

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gabapentin 800mg tablets
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 range was 900 to 3600 mg/day.
Therapy
may be initiated by titrating the dose as described in Table 1 or by
administering 300 mg three times a day (TID) on Day 1. Thereafter,
based on
individual patient response and tolerability, the dose can be further
increased
in 300 mg/day increments every 2-3 days up to a maximum dose of 3600
mg/day. Slower titration of gabapentin dosage may be appropriate for
individual patients. The minimum time to reach a dose of 1800 mg/day
is one
week, to reach 2400 mg/day is a total of 2 weeks, and to reach 3600
mg/day is
a total of 3 weeks. Dosages up to 4800 mg/day have been well tolerated
in
long-term open-label clinical studies. The total daily dose should be
divided
in three single doses, the maximum time interval between the doses
should not
exceed 12 hours to prevent breakthrough convulsions.
_Children aged 6 years and above: _
The starting dose should range from 10 to 15 mg/kg/day and the
effective dose
is reached by upward titration over a period of approximately three
days. The
effective dose of gabapen