Gabin 400 mg capsules, hard

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Gabapentin

Dostupné z:

Aurobindo Pharma (Malta) Limited

ATC kód:

N03AX; N03AX12

INN (Medzinárodný Name):

Gabapentin

Dávkovanie:

400 milligram(s)

Forma lieku:

Capsule, hard

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Other antiepileptics; gabapentin

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2011-06-03

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
GABIN 100 MG CAPSULES, HARD
GABIN 300 MG CAPSULES, HARD
GABIN 400 MG CAPSULES, HARD
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 Gabin is and what it is used for
2.
What you need to know before you take Gabin
3.
How to take Gabin
4.
Possible side effects
5.
How to store Gabin
6.
Contents of the pack and other information
1. WHAT GABIN IS AND WHAT IT IS USED FOR
Gabin 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 Gabin is gabapentin.
Gabin 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 Gabin 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 Gabin in addition to the current treatment
unless told otherwise. Gabin 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, tingling, numb

Súhrn charakteristických

Health Products Regulatory Authority
25 August 2023
CRN00DD96
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gabin 400 mg capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 400 mg hard capsule contains 400 mg gabapentin.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsule, hard
Gabin 400 mg capsules, hard, imprinted with ‘D’ on orange cap and
‘04’ on orange body, containing white to off-white
crystalline 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
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 – 300 mg once a day
Day 2 – 300 mg two times a day
Day 3 - 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_
Health Products Regulatory Authority
25 August 2023
CRN00DD96
Page 2 of 12