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 being treated with Hospira Levetiracetam concentrate for IV infusion?
2. What should I know before treatment with Hospira Levetiracetam concentrate for IV
infusion?
Do not start treatment if you have ever had an allergic reaction to Hospira Levetiracetam
concentrate for IV infusion 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 treatment with Hospira Levetiracetam concentrate for
IV infusion? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Hospira Levetiracetam concentrate for IV infusion
and 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 is Hospira Levetiracetam concentrate for IV infusion given?
5. What should I know during treatment with Hospira Levetiracetam concentrate for IV
infusion?
Things you should do
|
Call your doctor straight away if you notice an increase in seizures; have symptoms
of depression or thoughts of harming yourself; or if you become pregnant while being
given this medicine.
Remind any doctor, nurse, dentist or pharmacist who is treating you that you are being
given this medicine.
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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
|
Combining Hospira Levetiracetam concentrate for IV infusion and alcohol can make you
more drowsy.
Your doctor may suggest you avoid alcohol while you are being treated with this medicine.
|
6. Are there any side effects?
Common side effects include dizziness, feeling weak, headache, common cold, stomach
complaints, feeling tired, drowsy or sleepy, difficulty walking and trouble with balance.
Serious side effects include changes in behaviour, thinking or mood (e.g. thoughts
of harming yourself), upper respiratory tract infections, weight loss, muscle pain
and dark red or brown urine or decreased urination, more frequent or more severe seizures,
high fever, fast heartbeat and muscle stiffness, fainting and allergic type reactions.
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.
Active ingredient(s):
Levetiracetam (LEE ve tye RA se tam)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Hospira Levetiracetam concentrate
for IV infusion. 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 Hospira Levetiracetam concentrate
for IV infusion.
Where to find information in this leaflet:
1. Why am I being treated with Hospira Levetiracetam concentrate for IV infusion?
Hospira Levetiracetam concentrate for IV infusion contains the active ingredient levetiracetam.
Hospira Levetiracetam concentrate for IV infusion 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.
Hospira Levetiracetam concentrate for IV infusion 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.
Hospira Levetiracetam concentrate for IV infusion 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.
2. What should I know before treatment with Hospira Levetiracetam concentrate for IV
infusion?
Warnings
You must not be given Hospira Levetiracetam concentrate for IV infusion if:
you are allergic to levetiracetam, or 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.
Always check the ingredients to make sure you can use this medicine.
the expiry date (EXP) printed on the pack has passed.
If you are given this medicine after the expiry date has passed, it may not work as
well.
the packaging is torn or shows signs of tampering.
If you are not sure whether you should be given this medicine, talk to your doctor,
nurse or pharmacist.
Check with your doctor if you:
have any 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.
have or have had any other medical conditions, especially the following:
kidney problems
liver problems
heart problems.
take any medicines for any other condition.
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.
Hospira Levetiracetam concentrate for IV infusion may affect your developing baby
if you are given 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, and help you to decide whether or not you should be given it during
pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
The active ingredient in Hospira Levetiracetam concentrate for IV infusion passes
into breast milk and there is a possibility that your baby may be affected.
It is not recommended for use while breastfeeding.
Your doctor will discuss the risks and benefits of the treatment and the importance
of breastfeeding.
If you have not told your doctor about any of the above, tell them before you are
given Hospira Levetiracetam concentrate for IV infusion.
Use in Children
The safety and effectiveness of Hospira Levetiracetam concentrate for IV infusion
has not been established in patients less than 4 years of age.
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.
Your doctor and pharmacist may have more information on medicines to be careful with
or avoid while you are being given the levetiracetam injection.
Hospira Levetiracetam concentrate for IV infusion does not interact with the oral
contraceptive pill.
However, you may be given Hospira Levetiracetam concentrate for IV infusion 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 are given Hospira Levetiracetam concentrate for IV infusion with other antiepileptic
medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Hospira Levetiracetam concentrate
for IV infusion.
4. How is Hospira Levetiracetam concentrate for IV infusion given?
How much is given
Your doctor will decide how much Hospira Levetiracetam concentrate for IV infusion
you will receive. This depends on your age, your condition and whether or not you
are taking any other medicines.
How it is given
Hospira Levetiracetam concentrate for IV infusion is diluted and given as an infusion
(intravenous drip) into a vein.
Hospira Levetiracetam concentrate for IV infusion must only be given by a doctor,
nurse or other trained person.
If you are given too much Hospira Levetiracetam concentrate for IV infusion
As Hospira Levetiracetam concentrate for IV infusion is given to you under the supervision
of your doctor, it is very unlikely that you will receive too much.
However, if you think you have been given too much Hospira Levetiracetam concentrate
for IV infusion, or if you experience severe side effects tell your doctor immediately.
You may need urgent medical attention.
Symptoms of an overdose may include feeling drowsy.
You should immediately:
contact your doctor, or
phone the Poisons Information Centre
(by calling
13 11 26), or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know during treatment with Hospira Levetiracetam concentrate for IV
infusion?
Things you should do
Call your doctor straight away if you:
notice an increase in seizures.
have symptoms of depression or thoughts of harming yourself.
feel Hospira Levetiracetam concentrate for IV infusion is not helping your condition.
Your doctor may need to change your medicine.
become pregnant while being given this medicine.
Remind any doctor, nurse, dentist or pharmacist who is treating you that you are being
given Hospira Levetiracetam concentrate for IV infusion. Tell them that you are being
given Hospira Levetiracetam concentrate for IV infusion:
before starting on any new medicine
before any surgery and/or emergency treatment.
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.
Stopping Hospira Levetiracetam concentrate for IV infusion suddenly may cause unwanted
side effects or make your condition worse.
Things to be careful of
Be careful before you drive or use any machines or tools until you know how Hospira
Levetiracetam concentrate for IV infusion affects you. Children should be careful
doing things like riding bicycles or climbing trees.
As with other antiepileptic medicines, Hospira Levetiracetam concentrate for IV infusion
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
Tell your doctor if you drink alcohol.
Combining Hospira Levetiracetam concentrate for IV infusion and alcohol can make you
more drowsy. Your doctor may suggest you avoid alcohol while you are being treated
with Hospira Levetiracetam concentrate for IV infusion.
6. Are there any side effects?
All medicines can have side effects. This medicine helps most people with epilepsy,
but it may have unwanted side effects in a few people. If you do experience any side
effects, most of them are minor and temporary. However, some side effects may need
medical attention.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are treated with Hospira Levetiracetam concentrate for IV infusion.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
If you get any side effects, do not stop the treatment with Hospira Levetiracetam
concentrate for IV infusion without first talking to your doctor or pharmacist.
Common side effects
Common side effects
|
What to do
|
dizziness
feeling weak
headache
common cold
stomach complaints
nausea
vomiting
upset stomach
diarrhoea
feeling tired, drowsy or sleepy
difficulty walking
trouble with balance.
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Speak to your doctor if you have any of these side effects and they worry you.
They are usually mild and short-lived.
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Serious side effects
Serious side effects
|
What to do
|
changes in behaviour, thinking or mood
mood changes such as depression, nervousness, aggression, anger, anxiety, confusion,
hallucination, irritability
feelings of depression
abnormal thoughts, feeling irritable or reacting more aggressively than usual
thoughts of harming yourself
upper respiratory tract infections
weight loss
muscle pain
dark red or brown urine or decreased urination
more frequent or more severe seizures
high fever, fast heartbeat and muscle stiffness
fainting
allergic type reactions
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.
|
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.
You may need urgent medical attention or hospitalisation.
|
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.
Sometimes you may have side effects without experiencing any symptoms. It is important
to keep your routine doctor's appointments so that your condition can be checked.
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.
Always make sure you speak to your doctor or pharmacist before you decide to stop
treatment with any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Hospira Levetiracetam concentrate for IV infusion contains
Active ingredient
(main ingredient)
|
levetiracetam
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Other ingredients
(inactive ingredients)
|
glacial acetic acid
sodium acetate trihydrate
sodium chloride
water for injections
|
Each vial of Hospira Levetiracetam concentrate for IV infusion contains 500 mg/5 mL
levetiracetam.
Do not use this medicine if you are allergic to any of these ingredients.
What Hospira Levetiracetam concentrate for IV infusion looks like
Hospira Levetiracetam concentrate for IV infusion is a clear, colourless solution
(Aust R 211468).
How is Hospira Levetiracetam concentrate for IV infusion stored?
Hospira Levetiracetam concentrate for IV infusion 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.
Who distributes Hospira Levetiracetam concentrate for IV infusion
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free number: 1800 675 229
This leaflet was prepared in October 2021.
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© Pfizer Australia Pty Ltd 2021