ZYPREXA® IM V9.0
Consumer Medicine Information
What is in this leaflet
This leaflet is designed to provide you with answers to some common questions about this medicine.It does not contain all the available information and does not take the place of talking with your doctor.
The information in this leaflet was last updated on the date shown on the final page. More recent information about this medicine may be available.Make sure you speak to your pharmacist or doctor to obtain the most up to date information on this medicine. You can also download the most up to date leaflet from www.lilly.com.au .The updated leaflet may contain important information about ZYPREXA and its use that you should be aware of.
All medicines have risks and benefits. Your doctor has more information about this medicine than is contained in this leaflet.Also, your doctor has had the benefit of taking a full and detailed history from you and is in the best position to make an expert judgement to meet your individual needs.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with this medicine.
You may need to read it again.
What ZYPREXA is used for
ZYPREXA belongs to a group of medicines called antipsychotics. It helps to correct chemical imbalances in the brain, which may cause mental illness.
ZYPREXA IM injection is used for the rapid control of agitation and disturbed behaviours in patients with schizophrenia and related psychoses and in patients with acute mania associated with Bipolar I Disorder.
Schizophrenia is a mental illness with disturbances in thinking, feelings and behaviour. Bipolar I Disorder is a mental illness with symptoms such as feeling “high”, having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
ZYPREXA IM injection is given when treatment with ZYPREXA tablets is not appropriate. Your doctor will change your treatment to ZYPREXA tablets or ZYPREXA Zydis wafers as soon as practicable.
Your doctor may have prescribed ZYPREXA for another reason.
Ask your doctor if you have any questions about why ZYPREXA has been prescribed for you.
This medicine is available only with a doctor’s prescription.
ZYPREXA is not recommended for use in children under the age of 18 years as there is not enough information on its effects in this age group.
Before you are given ZYPREXA
Tell your doctor if you have any of the following conditions or if you have ever experienced any of these conditions.
When you must not be given it
Do not have it:
if you have had an allergic reaction to any type of ZYPREXA or to any of the ingredients listed at the end of this leaflet (see ‘Product Description’).
Signs of an allergic reaction may include a skin rash, itching, shortness of breath or swelling of the face, lips or tongue.
if the packaging is torn or shows signs of tampering.
if the expiry date on the pack has passed.
If you take this medicine after the expiry date has passed it may not work as well.
If you are not sure whether you should have ZYPREXA, talk to your doctor or pharmacist.
Before you have it
Tell your doctor if you have had an allergic reaction to any medicine which you have taken previously to treat your current condition.
Tell your doctor if you have or have had any medical conditions, especially the following:
tumour of the pituitary gland (a small gland at the base of the brain)
disease of the blood with a reduced number of white or red blood cells
disease of the blood vessels of the brain, including stroke
kidney or liver disease
high blood sugar, diabetes or a family history of diabetes
breast cancer or a family history of breast cancer
paralytic ileus, a condition where the small bowel does not work properly
epilepsy (seizures or fits)
glaucoma, a condition in which there is usually a build up of fluid in the eye
heart disease, including irregular heart rhythm
neuroleptic malignant syndrome, a reaction to some medicines with a sudden increase in body temperature, extremely high blood pressure and severe convulsions
tardive dyskinesia, a reaction to some medicines with uncontrollable twitching or jerking movements of the arms and legs.
Tell your doctor if you are pregnant or intend to become pregnant.
Like most antipsychotic medicines, ZYPREXA is not recommended for use during pregnancy. If there is a need to consider ZYPREXA during your pregnancy, your doctor will discuss with you the benefits and risks of using it.
Tell your doctor if you are breast-feeding or plan to breast-feed.
It is recommended that you do not breast-feed while taking ZYPREXA.
Tell your doctor if you will be in a hot environment or do a lot of vigorous exercise.
ZYPREXA may make you sweat less, causing your body to overheat.
Tell your doctor if you smoke.
Smoking may affect ZYPREXA or may affect how it works.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may be affected by ZYPREXA or may affect how it works.These include:
medicines used to treat a fast or irregular heart beat (arrhythmia)
medicines taken for anxiety or to help you sleep
medicines taken for depression
carbamazepine, a medicine used for mood stabilisation and to treat epilepsy
other centrally acting medicines (eg. tranquillisers)
ciprofloxacin, a medicine used to treat bacterial infections
medicines that lower blood pressure
medicines used for Parkinson’s disease
medicines that can change the heart’s electrical activity or make it more likely to change.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while havingZYPREXA.
Tell your doctor about these things before you have ZYPREXA.
How you are given ZYPREXA
Follow all directions given to you by your doctor or pharmacist carefully.
These may differ from the information contained in this leaflet.
How much is given
Your doctor will decide how much ZYPREXA you need and how long you need it for.
The dosage you receive will usually be 10 mg in one injection.Up to three injections in 24 hours may be given.
A lower starting dose may be prescribed for elderly patients over the age of 65 years.
How it is given
ZYPREXA is injected into your muscle.Your doctor or nurse will inject ZYPREXA for you.
AS ZYPREXA IM is given to you under the supervision of your doctor, it is unlikely that you will receive too much. However, if you experience any side effects after being given ZYPREXA IM, tell your doctor immediately or go to Accident and Emergency at your nearest hospital
The most common signs of too much ZYPREXA are fast heart beat, agitation/aggression, difficulty speaking, uncontrollable movements and sedation.
While you are having ZYPREXA
Things you must do
Tell all doctors, dentists and pharmacists who are treating you that you are having ZYPREXA.
While you are having ZYPREXA, tell your doctor or pharmacist before you start any new medicine.
If you become pregnant while having ZYPREXA, tell your doctor.
Keep all of your doctor’s appointments so that your progress can be checked.
Your doctor should monitor your weight if you are having ZYPREXA.
Patients with diabetes or who have a higher chance of developing diabetes should have their blood sugar checked often.
If you are over 65, your doctor may measure your blood pressure from time to time.
Tell your doctor if you are female and your monthly periods are absent for six months or more.
Talk to your doctor or mental health professional if you have thoughts or talk about death or suicide; or thoughts or talk about self-harm or harm to others.
These may be signs of changes or worsening in your mental illness.
Things you must not do
Do not stop taking ZYPREXA, or lower the dosage, even if you are feeling better, without checking with your doctor.
Do not give ZYPREXA to anyone else, even if their symptoms seem similar or they have the same condition as you.
Your doctor has prescribed ZYPREXA for you and your condition.
Things to be careful of
Be careful driving or operating machinery until you know how ZYPREXA affects you.
ZYPREXA may cause drowsiness in some people.
Be careful when drinking alcohol while taking ZYPREXA.
The effects of alcohol could be made worse while taking ZYPREXA.
Your doctor may suggest you avoid alcohol while you are being treated with ZYPREXA.
If ZYPREXA makes you feel light-headed, dizzy or faint, be careful when getting up from a sitting or lying position.
Getting up slowly may help.
If outdoors, wear protective clothing and use at least a 30+ sunscreen.
ZYPREXA may cause your skin to be much more sensitive to sunlight than it is normally.
Exposure to sunlight may cause a skin rash, itching, redness, or severe sunburn.
If your skin does appear to be burning, tell your doctor.
Make sure you keep cool in hot weather and keep warm in cool weather.
ZYPREXA may affect the way your body reacts to temperature changes
All medicines may have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.
Like other medicines, ZYPREXA may cause some unwanted side effects. These are likely to vary from patient to patient.Some side effects may be related to the dose of ZYPREXA. Accordingly, it is important that you tell your doctor as soon as possible about any unwanted effects.Your doctor may then decide to adjust the dose of ZYPREXA you are taking.
Tell your doctor if you notice any of the following side effects and they worry you:
unusual tiredness or weakness
restlessness or difficulty sitting still
increased appetite, weight gain
swelling of your hands, feet and ankles
changes to heart rate, such as fast heart beat or slow heart beat
low blood pressure
dizziness, confusion, forgetfulness.
Some people may feel dizzy in the early stages of treatment, especially when getting up from a lying or sitting position.This side effect usually passes after taking ZYPREXA for a few days.
Tell your doctor if you notice any of the above side effects and they worry you.
These are the more common side effects of ZYPREXA or ZYPREXA IM.
Tell your doctor as soon as possible if you notice any of the following side effects:
symptoms of sunburn (such as redness, itching, swelling or blistering of the skin) which occur more quickly than normal
rash or allergic reaction
slow heart beat
changes in sexual functioning or sex drive in men or women
prolonged and/or painful erection
unusual secretion of breast milk
breast enlargement in men or women
symptoms of high sugar levels in the blood (including passing large amounts of urine, excessive thirst, having a dry mouth and skin and weakness).These may indicate the onset or worsening of diabetes
reaction following abrupt discontinuation (profuse sweating, nausea or vomiting)
absence of menstrual periods and changes in the regularity of menstrual periods
involuntary passing of urine or difficulty in initiating urination
unusual hair loss or thinning. These side effects are uncommon but may require medical attention.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:
Sudden signs of an allergic reaction such as a skin rash, itching, shortness of breath or swelling of the face, lips or tongue.
frequent infections such as fever, severe chills, sore throat or mouth ulcers
bleeding or bruising more easily than normal
seizures, fits or convulsions
yellowing of the skin and/or eyes
nausea, vomiting, loss of appetite, generally feeling unwell, fever, itching, yellowing of the skin and/or eyes
severe upper stomach pain often with nausea and vomiting (inflammation of the pancreas)
worm-like movements of the tongue, or other uncontrolled movements of the tongue, mouth, cheeks, or jaw which may progress to the arms and legs
sudden increase in body temperature, sweating, fast heart beat, muscle stiffness, high blood pressure and convulsions
sharp chest pain, coughing of blood, or sudden shortness of breath
pain/tenderness in the calf muscle area
muscle pain, muscle weakness and brown urine
heart palpitations and dizziness, which may lead to collapse.
These are very serious side effects.You may need urgent medical attention or hospitalisation.
All of these side effects are very rare.
The following additional side effects may occur in some groups of people taking ZYPREXA:
Elderly patients with dementia-related psychosis
Elderly patients with dementia-related psychosis may notice the following side effects:
unusual manner of walking
involuntary passing of urine.
Parkinson’s disease psychosis
Some patients with Parkinson’s disease may hallucinate (see, feel or hear things that are not there) or develop worsening symptoms of Parkinson’s disease.
Zyprexa in combination with lithium or valproate
Patients with bipolar mania taking ZYPREXA in combination with lithium or valproate may notice the following additional side effects:
Tell your doctor if you notice anything unusual or if you are concerned about any aspect of your health, even if you think the problems are not connected with this medicine and are not referred to in this leaflet.
Also, some side effects, such as changes to liver function, cholesterol or triglycerides can occur.These can only be found when your doctor does tests from time to time to check your progress.
Do not be alarmed by this list of side effects.
You may not experience any of them.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.
After having ZYPREXA
ZYPREXA IM Injection vials should be stored below 25° C.
The vials are usually stored in the hospital ward or in the pharmacy.
All medicines should be kept where young children cannot reach them.
There will be an expiry date (month, year) on your ZYPREXA container.
The medicine should not be taken after this date because it may have lost some of its strength.
If your doctor tells you to stop taking ZYPREXA or you find that the tablets or wafers have passed their expiry date, please return any left over tablets or wafers to your pharmacist.
What it looks like
ZYPREXA IM Injection comes as a yellow powder in a clear glass vial.A vial of ZYPREXA IM Injection can provide you with 10 mg of olanzapine.
Active Ingredient – 10 mg olanzapine.
Inactive Ingredients :
ZYPREXA is a product of:
Eli Lilly Australia Pty Limited
112 Wharf Road
WEST RYDE, NSW 2114
ZYPREXA is distributed in New Zealand by:
Eli Lilly and Company (NZ) Ltd.
PO Box 107 197 Newmarket,
®= Registered Trademark
Australian Registration Number
AUST R 76867
This leaflet was revised in