LEVETIRACETAM-AFT

Main information

  • Trade name:
  • LEVETIRACETAM-AFT levetiracetam 100 mg/mL oral solution bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • LEVETIRACETAM-AFT levetiracetam 100 mg/mL oral solution bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218279
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218279

LEVETIRACETAM-AFT levetiracetam 100 mg/mL oral solution bottle

ARTG entry for

Medicine Registered

Sponsor

AFT Pharmaceuticals Pty Ltd

Postal Address

PO Box 748,North Ryde,Sydney, NSW, 1670

Australia

ARTG Start Date

7/11/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. LEVETIRACETAM-AFT levetiracetam 100 mg/mL oral solution bottle

Product Type

Single Medicine Product

Effective date

8/09/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

LEVETIRACETAM-AFT 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 generalized tonic-clonic

seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (IGE).,LEVETIRACETAM-AFT concentrate solution for IV

infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Glass Type III

Coloured

36 Months

Store below 25

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

300mL

(S4) Prescription Only Medicine

Components

1. LEVETIRACETAM-AFT levetiracetam 100 mg/mL oral solution bottle

Dosage Form

Oral Liquid, solution

Route of Administration

Oral

Visual Identification

Clear, colourless solution

Active Ingredients

Levetiracetam

10 % w/v

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 05:11:31 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

Levetiracetam-AFT®

Levetiracetam oral solution

What is in this leaflet

This leaflet answers some common questions about Levetiracetam-AFT.

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 Levetiracetam-

AFT 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 Levetiracetam-AFT is used for

Levetiracetam-AFT 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.

Levetiracetam-AFT 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 Levetiracetam-AFT has not been established in patients less than 4

years of age.

Before you take Levetiracetam-AFT

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When you must not take it

Do not take Levetiracetam-AFT 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.

Levetiracetam-AFT oral solution contains maltitol. Maltitol may cause diarrohea or have a laxative

effect. Do not use this medicine if you have hereditary problems of fructose intolerance.

Do not take this medicine after the expiry date (EXP) printed on the pack.

Do not take this medicine if the solution is not clear or the bottle shows signs of tampering.

If this medicine has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor or pharmacist.

Before you start to take it

Tell your doctor or pharmacist if you have allergies to:

any other medicines, especially barbiturates (such as phenobarbitone) or any other

antiepileptic medicines (such as carbamazepine, lamotrigine or valproate)

any other substances, such as foods, preservatives or dyes.

Tell your doctor if you have or have had any medical conditions, especially the following:

kidney problems

liver problems.

Tell your doctor if you are pregnant or intend to become pregnant.

Levetiracetam-AFT may affect your developing baby if you take it during pregnancy. However, it is

very important to control your seizures while you are pregnant. Your doctor will outline and weigh

up all the risks and benefits of taking Levetiracetam-AFT during pregnancy to help decide whether or

not you should take it.

Tell your doctor if you are breastfeeding or plan to breastfeed.

The active ingredient in Levetiracetam-AFT passes into breast milk and there is a possibility that your

baby may be affected. Your doctor will discuss the risks and benefits of using Levetiracetam-AFT if

you are breastfeeding.

If you have not told your doctor or pharmacist about any of the above, tell them before you start

taking Levetiracetam-AFT.

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Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy

without a prescription from your pharmacy, supermarket or health food shop.

Levetiracetam-AFT does not interact with the oral contraceptive pill.

However, you may be given Levetiracetam-AFT together with other antiepileptic medicines that do

interact and may affect the effectiveness of your contraceptive. Your doctor may advise you to use

an additional method of contraception if you take Levetiracetam-AFT with other antiepileptic

medicines.

How to take Levetiracetam-AFT

How much to take

Follow all directions given to you by your doctor carefully.

They may differ from the information contained in this leaflet.

Your doctor will tell you how much Levetiracetam-AFT you will need to take each day. This may

depend on your age, your condition and whether or not you are taking any other medicines.

For patients 12 years of age and older, the dosage is generally between 1000 mg (10 mL) and 3000

mg (30 mL) each day, taken in two doses.

For children 4 to 11 years of age the doctor will calculate the dosage based on the child's weight and

tell you how much to give. The medicine is to be given twice daily.

Your doctor may start you on a low dose of Levetiracetam-AFT first. Your doctor will slowly increase

the amount of medicine until you are taking enough to control your epilepsy and you are not having

seizures.

If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

How to take it

Use the syringe provided in the cardboard box to measure the exact quantity of oral solution

prescribed by your doctor.

Levetiracetam-AFT oral solution may be diluted in a glass of water or baby's bottle.

Open the bottle, press the cap and turn it anticlockwise (figure 1).

Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3).

Ensure it is firmly attached.

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Take the syringe and put it in the adaptor opening (figure 4). Turn the bottle upside down (figure 5).

Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the

piston upward in order to remove any possible bubble (figure 5B). Pull the piston down to the

graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure

5C).

Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).

Empty the contents of the syringe in a glass of water or baby's bottle by pushing the piston to the

bottom of the syringe (figure 7).

4 | P a g e

Drink the whole contents of the glass/baby's bottle.

Close the bottle with the plastic screw cap.

Wash the syringe with water only (figure 8).

When to take it

Take Levetiracetam-AFT twice a day, once in the morning and once at night. Take it at about the

same time each day.

Taking your medicine at the same time each day will have the best effect. It will also help you

remember when to take it.

It does not matter if you take this medicine before or after food.

If you forget to take it

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for the dose that you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

How long to take it

Most antiepileptics take time to work, so do not be discouraged if you do not feel better straight

away.

Continue taking your medicine for as long as your doctor tells you to.

This medicine helps control your condition, but does not cure it. Therefore you must take your

medicine every day, even if you feel well.

Do not stop taking Levetiracetam-AFT, or change the dosage, without checking with your doctor.

Do not let yourself run out of medicine over the weekend or on holidays.

Stopping Levetiracetam-AFT suddenly may cause unwanted side effects or make your condition

worse. Your doctor will slowly reduce your dose before you can stop taking it completely.

5 | P a g e

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for

advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone

else may have taken too much Levetiracetam-AFT. Do this even if there are no signs of discomfort

or poisoning.

You may need urgent medical attention.

Symptoms of an overdose may include feeling drowsy.

While you are using Levetiracetam-AFT

Things you must do

Tell your doctor immediately if you notice an increase in seizures.

Tell your doctor immediately if you have symptoms of depression or thoughts of harming yourself.

Tell any other doctors, dentists, and pharmacists who are treating you that you are taking this

medicine.

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that

you are taking Levetiracetam-AFT.

Before you have any surgery or emergency treatment, tell your doctor or dentist that you are

taking Levetiracetam-AFT.

Tell your doctor if you feel Levetiracetam-AFT is not helping your condition.

Your doctor may need to change your medicine.

Tell your doctor if, for any reason, you have not taken this medicine exactly as prescribed.

Otherwise, your doctor may change your treatment unnecessarily.

If you become pregnant while taking this medicine, tell your doctor.

Be sure to keep all of your doctor’s appointments so that your progress can be checked.

Your doctor will check your progress and may want to take some tests from time to time. This helps

to prevent unwanted side effects.

Things you must not do

Do not give Levetiracetam-AFT to anyone else, even if their symptoms seem similar to yours or

they have the same condition as you.

Do not give this medicine to anyone with a fructose intolerance.

It may cause a serious side effect.

Do not take Levetiracetam-AFT to treat any other complaints unless your doctor tells you to.

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Things to be careful of

Be careful driving or operating machinery until you know how this medicine affects you. Children

should be careful doing things like riding bicycles or climbing trees.

As with other antiepileptic medicines, Levetiracetam-AFT may cause dizziness or drowsiness in some

people. This is more frequent at the beginning of treatment or after an increase in the dose.

If you are feeling dizzy or drowsy do not drive, operate machinery, or do anything else that could be

dangerous. Children should not ride a bike, climb trees or do anything else that could be dangerous

if they are feeling dizzy or drowsy.

Be careful when drinking alcohol while taking this medicine.

Combining Levetiracetam-AFT and alcohol can make you more drowsy. Your doctor may suggest you

avoid alcohol while you are being treated with Levetiracetam-AFT.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking

Levetiracetam-AFT.

This medicine helps most people with epilepsy, but it may have unwanted side effects in a few

people. All medicines can have side effects. Sometimes they are serious, most of the time they are

not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following list of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

If you get any side effects, do not stop taking Levetiracetam-AFT without first talking to your

doctor or pharmacist.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

dizziness

feeling weak

headache

common cold

upset stomach

diarrhoea

feeling tired, drowsy or sleepy.

The above list includes the more common side effects of your medicine. They are usually mild and

short-lived.

Tell your doctor as soon as possible if you notice any of the following:

mood changes such as depression, nervousness, aggression, anger, anxiety, confusion,

hallucination, irritability

feelings of depression

upper respiratory tract infections

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weight loss.

The above list includes serious side effects that may require medical attention.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at

your nearest hospital:

thoughts of harming yourself

more frequent or more severe seizures

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, mouth, throat or tongue or other parts of the body

rash, itching or hives on the skin

The above list includes very serious side effects. You may need urgent medical attention or

hospitalisation.

Tell your doctor if you notice anything else that is making you feel unwell.

Other side effects not listed above may happen in some people.

After using Levetiracetam-AFT

Storage

Keep Levetiracetam-AFT oral solution in its original bottle until it is time to take it.

If you take the solution out of the bottle it may not keep well.

Keep your oral solution in a cool place where the temperature stays below 30°C.

After opening the bottle, the oral solution must be used within 7 months.

You should write the date of opening the bottle on the bottle label, and the discard date.

Do not store Levetiracetam-AFT or any other medicine in the bathroom or near a sink. Do not leave

it on a window sill or in the car on hot days.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least oneand-a-half metres above the ground is a good place to store

medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your

pharmacist what to do with any medicine that is left over.

Product description

8 | P a g e

What it looks like

Levetiracetam-AFT oral solution is available in a 100 mg/mL strength and is supplied in an amber

bottle with a child resistant cap. It is also supplied with a measuring syringe for dosing and an

adaptor for the syringe.

Ingredients

Levetiracetam-AFT oral solution contains 100 mg/mL levetiractam as the active ingredient.

Other ingredients in Levetiracetam-AFT oral solution include:

sodium citrate

citric acid monohydrate

methylhydroxybenzoate

parahydroxybenzoate

ammonium glycyrrhizate

glycerol

maltitol solution

acesulfame potassium

grape flavour.

Sponsor

Australia:

AFT Pharmaceuticals Pty Ltd.

Suite 301, 113 Wicks Road

North Ryde

NSW 2113

Levetiracetam-AFT Oral solution: AUST R 218279

Date of preparation:

August 2015

9 | P a g e

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