Gabapentin 600mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Gabapentin

Tillgänglig från:

Accord-UK Ltd

ATC-kod:

N02BF01

INN (International namn):

Gabapentin

Dos:

600mg

Läkemedelsform:

Oral tablet

Administreringssätt:

Oral

Klass:

Schedule 3 (CD No Register Exempt Safe Custody)

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 04080100; GTIN: 5060149319741

Bipacksedel

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

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gabapentin 600mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of gabapentin.
Excipients with known effect:
Each film-coated tablet contains 56 mg hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White, film-coated tablet, oblong, biconvex, scored on both sides. The
tablets can be
divided into equal doses.
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 range was 900 to 3600 mg/day.
Therapy
may be