APO-Levetiracetam Oral levetiracetam 100 mg/mL amber glass bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levetiracetam, Quantity: 100 mg/mL

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

Levetiracetam

Pharmaceutical form:

Solution

Composition:

Excipient Ingredients: propyl hydroxybenzoate; maltitol; purified water; sodium citrate dihydrate; glycerol; ammonium glycyrrhizinate; methyl hydroxybenzoate; acesulfame potassium; citric acid monohydrate; Flavour

Administration route:

Oral

Units in package:

300 mL amber glass bottle

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

APO-Levitiracetam Oral Solution 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),,? add-on therapy in the treatment of Primary Generalized Tonic Clonic (PGTC) seizures in adults and,children from 4 years of age with idiopathic generalized epilepsy (IGE).

Product summary:

Visual Identification: Clear and colourless solution; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-04-08

Patient Information leaflet

APO-LEVETIRACETAM oral solution
1
APO-LEVETIRACETAM
ORAL SOLUTION
_Contains the active ingredient 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
APO-LEVETIRACETAM oral
solution.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking
APO-LEVETIRACETAM oral
solution against the benefits they
expect it will have for you.
If you have any concerns about
taking this medicine, talk to your
doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
APO-LEVETIRACETAM oral
solution 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.
APO-LEVETIRACETAM oral
solution 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.
APO-LEVETIRACETAM oral
solution may be used alone, or in
combination with other medicines, to
treat your condition.
Your doctor may have prescribed
APO-LEVETIRACETAM oral
solution in addition to your current
therapy.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
APO-LEVETIRACETAM ORAL
SOLUTION HAS BEEN PRESCRIBED FOR
YOU.
The safety and effectiveness of
APO-LEVETIRACETAM oral
solution have not been established in
patients less than 4 years of age.
APO-LEVETIRACETAM oral
solution is available only with a
doctor's prescription.
There is no evidence that
APO-LEVETIRACETAM oral
solution is addictive.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
Do not take
APO-LEVETIRACETAM oral
solution if you have an allergy to
levetiracetam or any of the
ingredients listed at the end of this
leaflet.
Symptoms of an allergic react

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-LEVETIRACETAM (LEVETIRACETAM) ORAL
SOLUTION
1
NAME OF THE MEDICINE
Levetiracetam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APO-Levetiracetam Oral Solution contains 100 mg/mL levetiracetam, as
the active ingredient.
Each bottle of APO-Levetiracetam oral solution contains 100 mg/mL of
levetiracetam, as the
active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Propyl hydroxybenzoate, methyl hydroxybenzoate, and maltitol.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Clear and colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
APO-LEVETIRACETAM ORAL SOLUTION 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).
•
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).
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Levetiracetam oral solution is intended for oral administration.
DOSAGE
Levetiracetam 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.
The oral solution may be diluted in a glass of water and maybe taken
with or without food.
After oral administration the bitter taste of levetiracetam may be
experienced. The daily dose
is administered in two equally divided doses.
*Levetiracetam solution for injection is available in various brands.
MONOTHERAPY
The recommended starting dose is 250 mg tw