KEPPRA levetiracetam 100 mg/mL oral solution bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levetiracetam, Quantity: 100 mg/mL

Available from:

UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia

INN (International Name):

Levetiracetam

Pharmaceutical form:

Oral Liquid, solution

Composition:

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

Administration route:

Oral

Units in package:

300 mL bottle

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Keppra (film coated tablets and 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), and - Add on therapy in the treatment of primary generalised tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (IGE). Keppra concentrate solution for IV infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.

Product summary:

Visual Identification: Clear liquid; Container Type: Bottle; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2006-09-07

Patient Information leaflet

1
KEPPRA
®
_ _oral solution
(pronounced “KEPP-ruh”)
_ _
_Contains the active ingredient levetiracetam (pronounced "LEE ve tye
RA se tam") _
_ _
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Keppra.
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 Keppra
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 KEPPRA IS USED
FOR
Keppra is 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.
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.
Keppra 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
There is no evidence that this
medicine is addictive.
This medicine is available only with
a doctor’s prescription.
The safety and effectiveness of
Keppra has not been established in
patients less than 4 years of age.
BEFORE YOU TAKE KEPPRA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE KEPPRA 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 body
•
rash, itching or hives on the
skin.
KEPPRA ORAL SOLUTION CONTAINS
MALTITOL. DO NOT USE THIS
MEDICINE IF YOU HAVE HEREDITARY
PROBLEMS OF FR

Summary of Product characteristics

KEPPRA Tablets and Oral Solution PI
Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION
KEPPRA (LEVETIRACETAM)
FILM-COATED TABLETS AND ORAL SOLUTION
1
NAME OF THE MEDICINE
Levetiracetam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Keppra film-coated tablets are available in strengths of 250 mg, 500
mg, 750 mg and 1000 mg
levetiracetam. Keppra oral solution is available as 100 mg/mL
strength.
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/100
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.
Keppra oral solution contains the following excipients:
Methylhydroxybenzoate,
propylhydroxybenzoate, and maltitol solution. For the full list of
excipients, see Section 6.1 List of
Excipients.
3
PHARMACEUTICAL FORM
Keppra film-coated tablets:
_250 mg._
Blue, oblong, scored film-coated tablet debossed with the code ucb and
250 on one side.
_500 mg._
Yellow, oblong, scored film-coated tablet debossed with the code ucb
and 500 on one side.
_750 mg*._
Orange, oblong, scored film-coated tablet debossed with the code ucb
and 750 on one side.
_1000 mg._
White, oblong, scored film-coated tablet debossed with the code ucb
and 1000 on one side.
_*not currently distributed in Australia._
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Keppra (film-coated tablets and 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); and
KEPPRA Tablets and Oral Solution PI
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