Gabapentin Auro100 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gabapentin

Available from:

Aurobindo Pharma (Malta) Limited

ATC code:

N03AX12

INN (International Name):

Gabapentin

Pharmaceutical form:

Capsule, hard

Therapeutic area:

gabapentin

Authorization date:

2022-10-21

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
13 December 2023
CRN00DZ4R
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gabapentin Auro100 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mg hard capsule contains 100 mg of gabapentin.
Each 300 mg hard capsule contains 300 mg of gabapentin.
Each 400 mg hard capsule contains 400 mg of gabapentin.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Hard capsule
White / White size '3' hard gelatin capsules imprinted with 'D' on
white cap and '02' on white body with black edible ink, filled
with 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
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
Health Products Regulatory Authority
13 December 2023
CRN00DZ4R
Page 2 of 12
Epileps