Gabapentin 600 mg Film Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gabapentin

Available from:

Accord Healthcare Limited

ATC code:

N03AX; N03AX12

INN (International Name):

Gabapentin

Dosage:

600 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antiepileptics; gabapentin

Authorization status:

Marketed

Authorization date:

2011-12-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
GABAPENTIN 600 MG
FILM-COATED TABLETS
GABAPENTIN 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 cause periphe

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gabapentin 600 mg Film Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of Gabapentin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Approximately 17.25 mm X 10.15 mm white to off-white, oval shaped,
film coated tablets imprinted G1 on one side
with black ink and plain on other side.
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
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