GABACOR gabapentin 300 mg capsule blister pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

gabapentin, Quantity: 300 mg

Saatavilla:

Pharmacor Pty Ltd

INN (Kansainvälinen yleisnimi):

Gabapentin

Lääkemuoto:

Capsule, hard

Koostumus:

Excipient Ingredients: lactose; maize starch; purified talc; titanium dioxide; purified water; iron oxide yellow; Gelatin; sodium lauryl sulfate

Antoreitti:

Oral

Kpl paketissa:

one carton contains 20 capsules (2x10 capsules), One carton contins 100 capsules (10x10's capsules), one carton contains 4 capsules (1x4 capsules)

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

GABACOR is indicated for the treatment of,? Partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard anti-epileptic drugs.,? Neuropathic pain.

Tuoteyhteenveto:

Visual Identification: yellow hard gelatin capsule imprinted"215" on body with blue ink; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2014-02-06

Pakkausseloste

GABACOR (
V- 05) PAGE 1 OF 6
GABACOR
GABAPENTIN (GAB-A-PEN-TIN)
___________________________________________________________________________________________
_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about GABACOR.
It does not contain all the available
information.
It does not take the place of talking
to your doctor or pharmacist.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the risks of you taking GABACOR
against the benefits it is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
GABACOR,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT GABACOR IS USED
FOR
_WHAT GABACOR DOES _
GABACOR
is
used
to
control
epilepsy. Epilepsy is a condition
where you have repeated seizures
(fits).
There
are
many
different
types
of
seizures,
ranging
from
mild to severe.
GABACOR is also used to treat
neuropathic pain, a type of pain
caused by damage to the nerves.
This medicine belongs to a group
of
medicines
called
anticonvulsants.
_HOW GABACOR WORKS _
This medicine is thought to work
by
controlling
brain
chemicals
which
send
signals
to
nerves
to
help
control
seizures
or
neuropathic pain.
GABACOR also has pain relieving
effects.
Your doctor may have prescribed
GABACOR
in
addition
to
other
medicines that you may be taking.
This
may
be
necessary
if
your
current
treatment
is
no
longer
working as well.
Your doctor may have prescribed
GABACOR for another reason.
GABACOR
may
lead
to
dependence on this medicine.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY GABACOR
HAS BEEN PRESCRIBED FOR YOU.
This
medicine
is
available
only
with a doctor's prescription.
_USE IN CHILDREN_
_ _
There is not enough information to
recommend
the
use
of
this
medicine in children:

under
the
age
of
3
years
to
control epilepsy, or

under the age of 18 years to
treat neuropathic pain.
BEFORE
YOU
TAKE
GABACOR
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE GABACOR IF YOU
HAVE AN ALLERGY TO:
•
any
medicine
containing
ga

Valmisteyhteenveto

GABACOR (V-06)
Page
1
of
22
AUSTRALIAN PRODUCT INFORMATION - GABACOR
(
GABAPENTIN) CAPSULES
1.
NAME OF THE MEDICINE
Gabapentin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
GABACOR
contains the active ingredient gabapentin.
GABACOR 100 MG CAPSULES
:
Each capsule contains gabapentin 100 mg
GABACOR 300 MG CAPSULES:
Each capsule contains gabapentin 300 mg
GABACOR 400 MG CAPSULES:
Each capsule contains gabapentin 400 mg
EXCIPIENT WITH KNOWN EFFECT:
lactose
For the full list of excipients, see
SECTION 6.1 - LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Capsules, hard.
GABACOR 100 MG CAPSULES
:
Size "4" white hard gelatin capsule imprinted "216" on body with blue
ink.
GABACOR 300 MG CAPSULES:
Size "1" yellow hard gelatin capsule imprinted "215" on body with blue
ink.
WARNINGS
ABUSE POTENTIAL OR DEPENDENCE
Gabapentin is a potential drug of abuse and dependence. Gabapentin
poses risks of abuse
and dependence which can lead to overdose and death especially when
used concomitantly
with opioids and other CNS depressants. Assess the patient’s risk of
abuse or dependence
before prescribing and monitor the patient regularly during treatment,
particularly amongst
patients with current or past abuse or dependence of opioids and/or
benzodiazepines (see
Section 4.4 Special warnings and precautions for use).
GABACOR (V-06)
Page
2
of
22
GABACOR 400 MG CAPSULES:
Size "0" orange hard gelatin capsule imprinted "214" on body with blue
ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
GABACOR is indicated for the treatment of partial seizures, including
secondarily generalized
tonic-clonic seizures, initially as add-on therapy in adults and
children age 3 years and above who
have not achieved adequate control with standard anti-epileptic drugs.
GABACOR is indicated for the treatment of neuropathic pain.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
EPILEPSY DOSAGE FOR ADULTS AND CHILDREN OLDER THAN 12 YEARS OF AGE
Initiation of treatment should be as add-on therapy. Gabapentin can be
given orally with or
without food.
In controlled cl