Consumer medicine information

Levetiracetam Medsurge concentrate solution for IV infusion


Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.


1. Why am I using Levetiracetam Medsurge IV?

Levetiracetam IV contains the active ingredient levetiracetam. Levetiracetam IV is used to control epilepsy. Levetiracetam IV may be used alone, or in combination with other medicines, to treat your condition.

For more information, see Section 1. Why am I using Levetiracetam IV? in the full CMI.

2. What should I know before I use Levetiracetam Medsurge IV?

Do not use if you have ever had an allergic reaction to Levetiracetam IV or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Levetiracetam IV? in the full CMI.

3. What if I am taking other medicines?

Some medicines may be affected by Levetiracetam IV or may affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Levetiracetam Medsurge IV?

Your doctor will decide how much Levetiracetam IV you will receive. This depends on your age, your condition and whether or not you are taking any other medicines. More instructions can be found in Section 4. How do I use Levetiracetam IV? in the full CMI.

5. What should I know while using Levetiracetam Medsurge IV?

Things you should 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 being given this medicine.
Things to be careful of
  • 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.
Drinking alcohol
  • Be careful when drinking alcohol while taking this medicine.
  • Combining levetiracetam IV and alcohol can make you more drowsy. Your doctor may suggest you avoid alcohol while you are being treated with Levetiracetam IV.

For more information, see Section 5. What should I know while using Levetiracetam? in the full CMI.

6. Are there any side effects?

Common side effects include dizziness, feeling weak, headache, common cold, upset stomach, diarrhoea, feeling tired, drowsy or sleepy. Serious side effects include mood changes such as depression, nervousness, aggression, anger, anxiety, confusion, hallucination, irritability, feelings of depression, upper respiratory tract infections, recurrent infections, fever, weight loss. Do not be alarmed by this list, you may not experience any of them.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Levetiracetam Medsurge concentrate solution for IV infusion

Active ingredient(s): Levetiracetam


Consumer Medicine Information (CMI)

This leaflet provides important information about using Levetiracetam Concentrate for IV Infusion (Levetiracetam IV). You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Levetiracetam IV.

Where to find information in this leaflet:

1. Why am I using Levetiracetam Medsurge IV?
2. What should I know before I use Levetiracetam Medsurge IV?
3. What if I am taking other medicines?
4. How do I use Levetiracetam Medsurge IV?
5. What should I know while using Levetiracetam Medsurge IV?
6. Are there any side effects?
7. Product details

1. Why am I using Levetiracetam Medsurge IV?

Levetiracetam IV contains the active ingredient, levetiracetam which 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 IV 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.

Levetiracetam IV 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.

Your doctor may have prescribed it for another reason.

There is no evidence that this medicine is addictive.

The safety and effectiveness of Levetiracetam IV has not been established in patients less than 4 years of age.

2. What should I know before I use Levetiracetam Medsurge IV?

Warnings

Do not use Levetiracetam IV if:

  • You are allergic to levetiracetam, the active ingredient, or to any of the other ingredients listed at the end of this leaflet.
  • any other similar medicines.

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.

If you are not sure whether you should be given this medicine, talk to your doctor, nurse or pharmacist.

Before you start to take it

Tell your doctor 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.

Check with your doctor if you:

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

  • kidney problems
  • liver problems
  • blood disorders.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Levetiracetam IV 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 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 IV 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 IV if you are breastfeeding.

If you have not told your doctor about any of the above, tell them before you are given Levetiracetam IV.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Levetiracetam IV does not interact with the oral contraceptive pill.

However, you may be given Levetiracetam IV 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 IV with other antiepileptic medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

4. How do I use Levetiracetam Medsurge IV?

How much to take

Your doctor will decide how much Levetiracetam IV you will receive. This depends on your age, your condition and whether or not you are taking any other medicines.

Follow the instructions provided and use Levetiracetam IV until your doctor tells you to stop.

How to take Levetiracetam IV

  • Levetiracetam IV is diluted and given as an infusion (intravenous drip) into a vein.
  • Levetiracetam IV must only be given by a doctor, nurse or other trained person.

If you take too much Levetiracetam IV

  • As Levetiracetam IV is given to you under the supervision of your doctor, it is very unlikely that you will receive too much.
  • If you think that you have used too much Levetiracetam IV,

you should immediately:

  • phone the Poisons Information Centre (by calling Australia 13 11 26), or
  • contact your doctor, or
  • go to the Accident and Emergency Department at your nearest hospital.

You should 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.

5. What should I know while using Levetiracetam Medsurge IV?

Things you should 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 treat you that you are taking this medicine.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Levetiracetam IV.

Before you have any surgery or emergency treatment, tell your doctor or dentist that you are being given Levetiracetam IV.

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

Your doctor may need to change your medicine.

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 should not do

Do not stop using this medicine suddenly as stopping Levetiracetam IV suddenly may cause unwanted side effects or make your condition worse.

Things to be careful of

Driving or using machines

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 IV 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.

Drinking alcohol

Be careful when drinking alcohol while taking this medicine.

Combining levetiracetam IV and alcohol can make you more drowsy. Your doctor may suggest you avoid alcohol while you are being treated with Levetiracetam IV.

Looking after your medicine

Levetiracetam IV will be stored in the pharmacy or on the ward. The vials are kept in a cool dry place where the temperature stays below 25°C.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

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

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 list of possible 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 IV without first talking to your doctor or pharmacist.

Common side effects

Common side effects What to do
  • dizziness
  • feeling weak
  • headache
  • common cold
  • upset stomach
  • diarrhoea
  • feeling tired, drowsy or sleepy.
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects What to do
  • mood changes such as depression, nervousness, aggression, anger, anxiety, confusion, hallucination, irritability
  • feelings of depression
  • upper respiratory tract infections
  • recurrent infections, fever
  • weight loss.
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Very serious side effects

Very Serious side effects What to do
  • 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.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is only available with a doctor’s prescription.

What Levetiracetam Medsurge IV contains

Active ingredient
(main ingredient)
Levetiracetam
Other ingredients
(inactive ingredients)
sodium acetate trihydrate
sodium chloride
acetic acid – glacial
water for injections.

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Do not take this medicine if you are allergic to any of these ingredients.

What Levetiracetam Medsurge IV looks like

Levetiracetam IV 500 mg/5 ml concentrate solution for IV infusion. Each colourless glass vial with rubber stopper and aluminium cap contains a clear, colourless solution.

(AUST R 334884)

Pack sizes:

Available in pack size of 10 vials.

Who distributes Levetiracetam Medsurge IV

Medsurge Healthcare Pty Limited
Unit 2, 6-7 Gilda Court
MULGRAVE VICTORIA 3170
Tel: 1300 788 261
www.medsurge.com.au

This leaflet was prepared in April 2022

Published by MIMS June 2022