Gabapentin Aurobindo Capsules Hard 300mg

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

GABAPENTIN

Beschikbaar vanaf:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC-code:

N03AX12

INN (Algemene Internationale Benaming):

GABAPENTIN 300 mg

farmaceutische vorm:

HARD CAPSULE

Samenstelling:

GABAPENTIN 300 mg

Prescription-type:

POM

Therapeutisch gebied:

ANTIEPILEPTICS

Autorisatie-status:

Authorised

Autorisatie datum:

2016-10-17

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
GABAPENTIN AUROBINDO 100 MG CAPSULES, HARD
GABAPENTIN AUROBINDO 300 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
diseases can cause peripheral neuropathic pain (primarily occurring in
the l

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gabapentin Aurobindo 100 mg capsules, hard
Gabapentin Aurobindo 300 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 100 mg gabapentin.
Each hard capsule contains 300 mg gabapentin.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsule, hard
Gabapentin Aurobindo 100 mg capsules, hard:
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..
Gabapentin Aurobindo 300 mg capsules, hard:
Yellow / Yellow size ‘1’ hard gelatin capsules imprinted with
‘D’ on yellow cap and ‘03’ on yellow
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 – 300 mg once a day
Day 2 – 300 mg two times a day
Day 3 - 300 mg three times a day
Discontinuation of gabapentin
In accordance with current clinical practice, if gabapentin has to be
discontinued it is rec