Gabapentin Aurobindo 300 mg capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gabapentin

Available from:

Aurobindo Pharma (Malta) Limited

ATC code:

N03AX; N03AX12

INN (International Name):

Gabapentin

Dosage:

300 milligram(s)

Pharmaceutical form:

Capsule, hard

Therapeutic area:

Other antiepileptics; gabapentin

Authorization status:

Marketed

Authorization date:

2005-11-18

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
22 February 2024
CRN00DZ31
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gabapentin Aurobindo 300 mg capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 300 mg gabapentin.
Excipients of known effect: each hard capsule contains 67.5 mg
lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
The 300 mg capsules are yellow in colour and contain a white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Epilepsy
Gabapentin Aurobindo 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 Aurobindo 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 Aurobindo 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