PHARMAGABAPENTIN gabapentin 100 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gabapentin, Quantity: 100 mg

Available from:

Pharmacor Pty Ltd

INN (International Name):

Gabapentin

Pharmaceutical form:

Capsule, hard

Composition:

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

Administration route:

Oral

Units in package:

One carton contins 100 capsules (10x10's capsules)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

PHARMAGABAPENTIN 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.

Product summary:

Visual Identification: white hard gelatin capsule imprinted "216" 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

Authorization status:

Licence status A

Authorization date:

2014-02-06

Patient Information leaflet

PHARMAGABAPENTIN (
V- 06) PAGE 1 OF 7
PHARMAGABAPENTIN
GABAPENTIN (GAB-A-PEN-TIN)
___________________________________________________________________________________________
_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
PHARMAGABAPENTIN.
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
PHARMAGABAPENTIN
against
the benefits it is expected to have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
PHARMAGABAPENTIN,
ASK
YOUR DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT
PHARMAGABAPENTIN
IS USED FOR
_WHAT _
_PHARMAGABAPENTIN _
_DOES _
PHARMAGABAPENTIN 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.
PHARMAGABAPENTIN
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 _
_PHARMAGABAPENTIN _
_WORKS _
This medicine is thought to work
by
controlling
brain
chemicals
which
send
signals
to
nerves
to
help
control
seizures
or
neuropathic pain.
PHARMAGABAPENTIN also has
pain relieving effects.
Your doctor may have prescribed
PHARMAGABAPENTIN
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
PHARMAGABAPENTIN
for
another reason.
PHARMAGABAPENTIN
may
lead
to
dependence
on
this
medicine.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
PHARMAGABAPENTIN
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 n

Summary of Product characteristics

PHARMAGABAPENTIN (V-06)
Page
1
of
22
AUSTRALIAN PRODUCT INFORMATION -
PHARMAGABAPENTIN
(
GABAPENTIN) CAPSULES
1.
NAME OF THE MEDICINE
Gabapentin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PHARMAGABAPENTIN
contains the active ingredient gabapentin.
PHARMAGABAPENTIN 100 MG CAPSULES
:
Each capsule contains gabapentin 100 mg
PHARMAGABAPENTIN 300 MG CAPSULES:
Each capsule contains gabapentin 300 mg
PHARMAGABAPENTIN 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.
PHARMAGABAPENTIN 100 MG CAPSULES
:
Size "4" white hard gelatin capsule imprinted "216" on body with blue
ink.
PHARMAGABAPENTIN 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).
PHARMAGABAPENTIN (V-06)
Page
2
of
22
PHARMAGABAPENTIN 400 MG CAPSULES:
Size "0" orange hard gelatin capsule imprinted "214" on body with blue
ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PHARMAGABAPENTIN 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.
PHARMAGABAPENTIN 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