APO-LEVETIRACETAM levetiracetam 1000 mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levetiracetam, Quantity: 1000 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: povidone; magnesium stearate; colloidal anhydrous silica; croscarmellose sodium; maize starch; titanium dioxide; hypromellose; macrogol 6000

Administration route:

Oral

Units in package:

60, 10, 100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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 generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (IGE).

Product summary:

Visual Identification: White, capsule shaped, biconvex film coated tablets plain on both sides; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-02-02

Patient Information leaflet

APO-LEVETIRACETAM
_Levetiracetam_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about levetiracetam. 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 using this medicine
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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Levetiracetam 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 in nature.
_HOW IT WORKS_
Levetiracetam belongs to a group of
medicines called antiepileptics. It is
thought to work by controlling brain
chemicals which send signals to
nerves so that seizures do not
happen.
This medicine may be used alone, or
in combination with other medicines,
to treat your condition.
Your doctor may prescribe
levetiracetam in addition to your
current therapy.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine
in children under the age of 4 years.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
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,
throat or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE AFTER T

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
APO-LEVETIRACETAM (LEVETIRACETAM) TABLETS
1
NAME OF THE MEDICINE
Levetiracetam.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg, 500 mg or 1000 mg levetiracetam as the
active ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
250 MG TABLETS:
Light blue, capsule shaped, biconvex, film-coated tablets, plain on
both sides.
500 MG TABLETS:
Yellow, capsule shaped, biconvex, film-coated tablets, plain on both
sides.
1000 MG TABLETS:
White, capsule shaped, biconvex, film-coated tablets, plain on both
sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
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
APO-Levetiracetam tablets are intended for oral administration.
The tablets must be taken orally, swallowed with liquid. It may be
taken with or without food. The
daily dose is administered in two equally divided doses.
Therapy can be initiated with either intravenous or oral
administration. Conversion to or from oral to
intravenous can be done directly without titration. The total daily
dose and frequency of
administration should be maintained.
After oral administration, the bitter taste of levetiracetam may be
experienced.
2
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 we