ALKEM GABAPEN gabapentin 400 mg capsule blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

gabapentin, Quantity: 400 mg

Διαθέσιμο από:

Pharmacor Pty Ltd

INN (Διεθνής Όνομα):

Gabapentin

Φαρμακοτεχνική μορφή:

Capsule, hard

Σύνθεση:

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

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

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

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

ALKEM GABAPEN 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.

Περίληψη προϊόντος:

Visual Identification: orange hard gelatin capsule imprinted "214" 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

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2014-02-06

Φύλλο οδηγιών χρήσης

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

Αρχείο Π.Χ.Π.

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