LEVETIRACETAM SCP levetiracetam 250 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

24-08-2020

Summary of Product characteristics (SPC)

17-09-2021

Public Assessment Report (PAR)

29-11-2017

Active ingredient:

levetiracetam, Quantity: 250 mg

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

Levetiracetam

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: maize starch; povidone; purified talc; colloidal anhydrous silica; magnesium stearate; titanium dioxide; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Use in epiletpic 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 genralisation, 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). Add-on therapy in the treatment of Primary Generalised Tonic Clonic (PGTC) seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (IGE).

Product summary:

Visual Identification: Blue, oblong film-coated, biconvex tablets, with central score on both faces, marked with 'Lev 250' on one face; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-04-28

Patient Information leaflet

________________________________________________________________________________
C:Products/Levetir/CMI 8 February 2012
Page
1 of 4
Levetiracetam SCP tablets
_levetiracetam tablets_
CONSUMER MEDICINE INFORMATION
_ _
What is in this leaflet
This leaflet answers some common
questions about this medicine.
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 this medication against the
benefits it is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again
.
What Levetiracetam SCP
is used for
Levetiracetam SCP 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.
Levetiracetam SCP 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.
Levetiracetam SCP may be used alone,
or in combination with other
medicines, to treat your condition.
Your doctor may prescribe
Levetiracetam SCP in addition to your
current therapy.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LEVETIRACETAM
SCP HAS BEEN PRESCRIBED FOR YOU.
There is no evidence that
Levetiracetam SCP is addictive.
This medicine is available only with a
doctor's prescription.
The safety and effectiveness of
Levetiracetam SCP have not been
established in patients less than 4 years
of age.
Before you take
Levetiracetam SCP
_When you must not take it _
DO NOT TAKE LEVETIRACETAM SCP IF
YOU HAVE AN ALLERGY TO:

any of the ingredients listed at the
end of this leaflet
Symptoms of an allergic reaction to
Levetiracetam SCP may include:

shortness of breath, wheezing or
difficulty breathing

swelling of the face, lips, tongue
or other parts of the body
�

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Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
LEVETIRACETAM SCP (LEVETIRACETAM) TABLETS
_ _
1. NAME OF THE MEDICINE
Levetiracetam
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The product, Levetiracetam SCP tablets, contains levetiracetam as the
active ingredient, available in strengths
of 250 mg, 500 mg, 750 mg and 1000 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Tablets - oblong, film coated
•
250 mg -blue, marked Lev 250 on one side with central score on both
faces;
•
500 mg - yellow, marked Lev 500 on one side with central score on both
faces;
•
750 mg
*
orange, marked Lev 750 on one side with central score on both faces;
•
1,000 mg -white, marked Lev 1000 on one side with central score on
both faces.
*
Not currently marketed in Australia
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
FILM COATED TABLETS.
•
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).
•
Add-on therapy in the treatment of Primary Generalised Tonic Clonic
(PGTC) seizures in adults and
children from 4 years of age with idiopathic generalised epilepsy
(IGE).
4.2. DOSE AND METHOD OF ADMINISTRATION
The film coated tablets must be taken orally, swallowed with liquid.
MONOTHERAPY:
The recommended starting dose is 250 mg twice daily which should be
increased to an initial therapeutic dose
of 500 mg twice daily after two weeks. The dose can be further
increased by 250 mg twice daily every two
weeks depending upon the clinical response. The maximum dose is 1,500
mg twice daily.
ADD-ON THERAPY. ADULTS (> 18 YEARS OF AGE) AND ADOLESCENTS (AGED 12 TO
17 YEARS OF AGE) WEIGHING 50 KG

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