NOUMED LEVETIRACETAM levetiracetam 250 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levetiracetam

Available from:

AdiraMedica Pty Ltd

Authorization status:

Registered

Patient Information leaflet

NOUMED LEVETIRACETAM
1
NOUMED LEVETIRACETAM
_Levetiracetam tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NOUMED
LEVETIRACETAM 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 NOUMED
LEVETIRACETAM 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 NOUMED
LEVETIRACETAM
TABLETS IS USED FOR
NOUMED LEVETIRACETAM
tablets may be used alone, or in
combination with other medicines, to
treat your condition.
Your doctor may have prescribed this
medicine in addition to your current
therapy.
NOUMED LEVETIRACETAM
tablet is used to treat epilepsy.
Epilepsy is a condition where you
have repeated seizures. There are
many different types of seizures,
ranging from mild to severe.
This medicine belongs 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
There is no evidence that this
medicine is addictive.
This medicine is available only with
a doctor's prescription.
There is not enough information to
recommend the use of this medicine
for children under the age of 4 years.
BEFORE YOU TAKE AMED
LEVETIRACETAM
TABLETS
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE NOUMED
LEVETIRACETAM TABLETS IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
levetiracetam
•
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

Summary of Product characteristics

Date of Effect: 26 Sept 2019
Noumed Levetiracetam Tablets version: 5.0
Page 1 of 32
AUSTRALIAN PRODUCT INFORMATION –NOUMED (LEVETIRACETAM)
1
NAME OF THE MEDICINE
Levetiracetam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Noumed film-coated tablets are available in strengths of 250 mg, 500
mg and 1000 mg
levetiracetam.
Levetiracetam is a white to off-white powder with a faint odor and a
bitter taste. It is very
soluble in water (104 g/100 mL). It is freely soluble in chloroform
(65.3 g/100 mL) and in
methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/ 100mL),
sparingly soluble in acetonitrile
(5.7 g/100 mL) and practically insoluble in n-hexane.
It does not contain any excipient with known affect. For the full list
of excipients, see Section
6.1 List of excipients.
3
PHARMACEUTICAL FORM
Levetiracetam film coated tablets are available in four different
strengths with the following
descriptions:
250 mg: Blue Coloured, ‘Oval’ shaped, film coated tablets,
embossed with “OL” bisect “250”
on one side and plain on other side.
500 mg: Yellow Coloured, ‘Oval’ shaped, film coated tablets,
embossed with “OL” bisect “500”
on one side and plain on other side.
1000 mg: White Coloured, ‘Oval’ shaped, film coated tablets,
embossed with “OL” bisect
“1000” on one side and plain on other side.
*This strength is currently not distributed in Australia
Noumed Levetiracetam Tablets version: 5.0
Page 2 of 32
Date of Effect: 26 Sept 2019
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Levetiracetam is 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