Gabapentin 300 mg capsules

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Gabapentin

Διαθέσιμο από:

Rowex Ltd

Φαρμακολογική κατηγορία (ATC):

N03AX; N03AX12

INN (Διεθνής Όνομα):

Gabapentin

Δοσολογία:

300 milligram(s)

Φαρμακοτεχνική μορφή:

Capsule, hard

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Other antiepileptics; gabapentin

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2007-03-30

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
GABAPENTIN 100 MG, 300 MG & 400 MG CAPSULES
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).
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 (long lasting pain caused by damage to the
nerves). A variety of
different diseases can cause peripheral (primarily occurring in the
legs and/or arms) neuropathic
pain, such as diabetes or shingles. Pain sensations may be described
as hot, burning, throbbing,
shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins
and needles etc.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GABAPENTIN
DO NOT TAKE GABAPENTIN
‐ if you are allergic to

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
19 December 2019
CRN009109
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gabapentin 300 mg capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 300mg gabapentin.
Excipient(s) with known effect: Each capsule contains 67.50mg lactose
anhydrous.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Hard gelatin capsules, size 1 coni-snap, with yellow opaque body and
cap, filled with 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 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
For oral use.
Gabapentin can be given with or without food and should be swallowed
whole with sufficient fluid-intake (e.g. a glass of water).
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
Health Products Regulatory Authority
19 December 2019
CRN009109
Page 2 of 12
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 typ