KETRACCORD levetiracetam 1000 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levetiracetam, Quantity: 1000 mg

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Levetiracetam

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; povidone; magnesium stearate; croscarmellose sodium; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

KETRACCORD Tablets are indicated for: ? Use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation. ? Monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. ? Add-on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy (JME) and, ? Add-on therapy in the treatment of primary generalised tonic-clonic seizures (PGTC) in adults and children from 4 years of age with idiopathic generalised epilepsy (IGE).

Product summary:

Visual Identification: White to off white, oval biconvex, Film coated tablets, debossed " L 67" with breakline on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-04-20

Patient Information leaflet

KETRACCORD TABLETS
CONSUMER MEDICINE INFORMATION
Version 1
2012 Page: 1 of 5
KETRACCORD TABLETS 250 MG/500 MG/1000 MG
(Levetiracetam tablets 250mg/500 mg/1000 mg)
levetiracetam
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Ketraccord tablets.
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
Ketraccord
tablets
against
the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT KETRACCORD
TABLETS ARE USED FOR
Ketraccord
tablets
are
used
to
control epilepsy.
Epilepsy
is
a
condition
where
you have repeated seizures.
There are many different types of
seizures,
ranging
from
mild
to
severe.
Ketraccord
tablets
belong
to
a
group
of
medicines
called
antiepileptics.
These medicines are thought to
work
by
controlling
brain
chemicals which send signals to
nerves
so
that
seizures
do
not
happen.
Ketraccord tablets may be used
alone
or
in
combination
with
other
medicines,
to
treat
your
condition.
Your doctor may have prescribed
Ketraccord tablets in addition to
your current therapy.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
KETRACCORD TABLETS HAVE BEEN
PRESCRIBED FOR YOU.
There
is
no
evidence
that
Ketraccord tablets are addictive.
This medicine is available only
with a doctor’s prescription.
The safety and effectiveness of
Ketraccord tablets has not been
established in patients less than
4 years of age.
BEFORE YOU TAKE
KETRACCORD TABLETS
WHEN YOU MUST NOT TAKE
IT
DO NOT TAKE KETRACCORD TABLETS
IF YOU HAVE AN ALLERGY TO:
• any of the ingredients listed at
the end of this leaflet
Some of the symptoms of an
allergic reaction may include:
• shortness of breath
• wheezing or difficulty
breathing.
• swelling of the face, lips,
tongue or other parts of the
bod

Summary of Product characteristics

Ketraccord Tablets (Levetiracetam tablets 250/500/1000 mg) Version: 1
2012 Page: 1 of 28
PRODUCT INFORMATION
KETRACCORD TABLETS 250 MG/500 MG/1000 MG
(LEVETIRACETAM TABLETS 250/500/1000 MG)
NAME OF THE MEDICINE
Levetiracetam
Structural formula:
Levetiracetam
Chemical name:- (
_S_
)-alpha-ethyl-2-oxo-1-pyrrolidine acetamide.
CAS number: 102767-28-2
Levetiracetam has a molecular formula of C
8
H
14
N
2
O
2
and a molecular weight of 170.21.
DESCRIPTION
Levetiracetam is a white to off white powder with a faint odour and a
bitter taste. It is
very soluble in water (104 g/100 mL). It is freely soluble in
chloroform (65.3 g/l00 mL)
and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL),
sparingly soluble
in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane.
Ketraccord Tablets 250 mg are white to off white, oval biconvex, film
coated tablets,
debossed ‘L 64’ and breakline on one side and plain on the other
side.
Ketraccord Tablets 500 mg are yellow coloured, oval biconvex, film
coated tablets,
debossed ‘L 65’ and breakline on one side and plain on the other
side.
Ketraccord Tablets (Levetiracetam tablets 250/500/1000 mg) Version: 1
2012 Page: 2 of 28
Ketraccord Tablets 1000 mg are white to off white, oval biconvex, film
coated tablets,
debossed ‘L 67’ and breakline on one side and plain on the other
side.
Ketraccord tablets contain the following excipients: croscarmellose
sodium, povidone,
colloidal anhydrous silica and magnesium stearate. Ketraccord tablets
are film-coated.
The coating for each tablet strength contains polyvinyl alcohol,
macrogol, talc and
titanium dioxide. The 500 mg strength also contains iron oxide yellow
(C177492).
PHARMACOLOGY
MECHANISM OF ACTION
The precise mechanism of action by which levetiracetam induces seizure
protection still
remains to be fully elucidated, but appears to be unrelated to the
mechanisms of current
antiepileptic drugs (AEDs).
_In vitro _
and
_in vivo _
experiments suggest that levetiracetam
does not alter basic cell characteristics and