Gabapentin 100 mg capsules, hard

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Gabapentin

Verfügbar ab:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC-Code:

N03AX; N03AX12

INN (Internationale Bezeichnung):

Gabapentin

Dosierung:

100 milligram(s)

Darreichungsform:

Capsule, hard

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

Other antiepileptics; gabapentin

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2005-11-18

Gebrauchsinformation

PAGE 1 OF 10
PACKAGE LEAFLET
PAGE 2 OF 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
GABAPENTIN 100 MG CAPSULES, HARD
GABAPENTIN 300 MG CAPSULES, HARD
GABAPENTIN 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 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.
EPILEPSY:
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). Your doctor will prescribe Gabapentin for you to help treat your
epilepsy when your
current treatment is not fully controlling your condition. You should
take Gabapentin in
addition to your 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:
Gabapentin is used to treat 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 h

Fachinformation

Health Products Regulatory Authority
03 December 2020
CRN009ZQQ
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gabapentin 100 mg capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg gabapentin.
Excipients of known effect: each hard capsule contains 22.5 mg lactose
anhydrous.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
The 100 mg capsules are white in colour and contain a 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 generalisation 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 generalisation 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 day300 mg two times a day300 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
donegraduallyover a minimum of 1 week independent of the indication.
Epilepsy
Epilepsy typically requires long-term therapy. Dosage is determined
bythetreatingphysician according to individual tolerance
and efficacy.
Health Products Regulatory Authority
03 December 2020
CRN009ZQQ
Page 2 of 12
Adults and adolescents:
In clinical tri