SUMMARY CMI
ZYPREXA® and ZYPREXA® Zydis®
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 ZYPREXA?
ZYPREXA contain the active ingredient olanzapine. It helps to correct chemical imbalances in the brain, which may cause mental illness.
For more information, see Section 1. Why am I using ZYPREXA? in the full CMI.
2. What should I know before I use ZYPREXA?
Do not use if you have ever had an allergic reaction to olanzapine 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 ZYPREXA? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with ZYPREXA 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 do I use ZYPREXA?
Your doctor will tell you how many tablets you should take. The dose your doctor will prescribe for you will usually be in the range 5 mg to 20 mg per day.
More instructions can be found in Section 4. How do I use ZYPREXA? in the full CMI.
5. What should I know while using ZYPREXA?
Things you should do |
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Things you should not do |
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Driving or using machines |
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Drinking alcohol |
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Looking after your medicine |
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For more information, see Section 5. What should I know while using ZYPREXA? in the full CMI.
6. Are there any side effects?
Like other medicines, ZYPREXA may cause some unwanted side effects. These are likely to vary from patient to patient, although not everybody gets them. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need urgent medical attention.
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.
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.
FULL CMI
ZYPREXA® and ZYPREXA® Zydis®
Active ingredient(s): Olanzapine
Consumer Medicine Information (CMI)
This leaflet provides important information about using ZYPREXA. 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 ZYPREXA.
Where to find information in this leaflet:
1. Why am I using ZYPREXA?
2. What should I know before I use ZYPREXA?
3. What if I am taking other medicines?
4. How do I use ZYPREXA?
5. What should I know while using ZYPREXA?
6. Are there any side effects?
7. Product details
1. Why am I using ZYPREXA?
ZYPREXA contains the active ingredient olanzapine.
Olanzapine belongs to a group of medicines called antipsychotics. It helps to correct chemical imbalances in the brain, which may cause mental illness.
ZYPREXA are used to treat symptoms of schizophrenia and related psychoses. Schizophrenia is a mental illness with disturbances in thinking, feelings and behavior.
ZYPREXA alone, or in combination with lithium or valproate, is used for the short-term treatment of acute manic episodes associated with Bipolar I Disorder.
ZYPREXA is also a mood stabiliser that prevents further occurrences of the disabling high and low (depressed) extremes of mood associated with Bipolar I Disorder.
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.
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.
2. What should I know before I use ZYPREXA?
Warnings
Do not use ZYPREXA if:
- you are allergic to olanzapine, or any of the ingredients listed at the end of this leaflet.
- Always check the ingredients to make sure you can use this medicine.
- Signs of an allergic reaction may include a skin rash, itching, shortness of breath or swelling of the face, lips or tongue.
- the packaging is torn or shows signs of tampering, or the tablets or wafers do not look quite right.
- 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 start taking ZYPREXA, talk to your doctor or pharmacist
Check with your doctor if you:
- have had an allergic reaction to any medicine which you have taken previously to treat your current condition.
- have any other medical conditions, especially the following:
- tumour of the pituitary gland (a small gland at the base of the brain)
- disease of the blood or bone marrow with a reduced number of white or red blood cells
- disease of the blood vessels of the brain, including stroke
- prostate problems
- 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 buildup 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.
- sleep apnoea, a sleep disorder where a person has pauses in breathing or periods of shallow breathing during sleep.
- elderly with dementia-related psychosis
- previously had a stroke or transient ischaemic attack (mini-stroke) or if you have high blood pressure
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.
- you smoke. Smoking may affect ZYPREXA or may affect how it works.
- you suffer from lactose intolerance (because ZYPREXA tablets contain lactose).
- you suffer from phenylketonuria (because ZYPREXA Zydis wafers contain aspartame).
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or intend to become pregnant.
Like most antipsychotic medicines, ZYPREXA are not recommended for use during pregnancy.
Newborn babies of mothers taking antipsychotic drugs (including ZYPREXA) during the last trimester of pregnancy are at risk of experiencing extrapyramidal neurological disturbances and/or withdrawal symptoms following delivery. These may include, but are not limited to agitation, tremor, muscle stiffness or weakness, drowsiness, feeding problems, and breathing difficulty. If there is a need to consider ZYPREXA during your pregnancy, your doctor will discuss with you the benefits and risks of using it.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is recommended that you do not breast-feed while taking ZYPREXA.
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.
Some medicines may interfere with ZYPREXA and affect how it works. These include:
- medicines used to treat a fast or irregular heartbeat (arrhythmia).
- medicines taken for anxiety or to help you sleep.
- medicines taken for depression
- carbamazepine, a medicine used for mood stabilization and to treat epilepsy
- other centrally acting medicines (eg. Tranquilizers or strong painkillers)
- 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 taking ZYPREXA.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect ZYPREXA.
4. How do I use ZYPREXA?
How much to take
Your doctor will tell you how many ZYPREXA tablets or wafers you should take. The dose your doctor will prescribe for you will usually be in the range 5 mg to 20 mg per day.
Your doctor may increase or decrease your dose to find the appropriate dose for your condition.
A lower starting dose may be prescribed for elderly patients over the age of 65 years.
When to take
ZYPREXA tablets or wafers should be taken once a day as advised by your doctor.
Take your prescribed dose at the same time each day. ZYPREXA tablets or wafers can be taken with or without food.
How to take
ZYPREXA tablets:
ZYPREXA tablets should be swallowed whole with a glass of water.
ZYPREXA Zydis wafers:
Do not handle the wafers with wet hands as the wafers may break up.
ZYPREXA Zydis wafers break easily, so you should handle them carefully.
The wafers can be taken two ways:
- Directly into your mouth
- In a drink
To take a wafer directly into your mouth:
- Hold the blister strip at the edges and separate one blister cell from the rest of the strip by gently tearing along the perforations around it.
- Carefully peel off the coloured backing.
- Gently push the wafer out.
- Put the wafer in your mouth. It will dissolve directly in your mouth, so that it can be easily swallowed.
To take a wafer in a drink:
You can also place the wafer in a full glass or cup of water, orange juice, apple juice, milk or coffee, and stir. Drink it straight away.
With some drinks, the mixture may change color and possibly become cloudy.
Do not place the wafer in cola drinks.
Follow the instructions provided and do not stop taking ZYPREXA just because you feel better. It is important that you do NOT stop taking ZYPREXA unless your doctor tells you.
If you forget to use ZYPREXA
ZYPREXA should be used regularly at the same time each day. If you miss your dose at the usual time, and if it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you use too much ZYPREXA
If you have taken too much ZYPREXA, the most common signs are fast heartbeat, agitation/aggression, difficulty speaking, uncontrollable movements and sleepiness (sedation).
If you think that you have used too much ZYPREXA, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(by calling 13 11 26), or - contact your doctor, 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 while using ZYPREXA?
Things you should do
It is important that you remember to take ZYPREXA daily and at the dose prescribed by your doctor.
Tell all doctors, dentists and pharmacists who are treating you that you are taking ZYPREXA.
If you are about to start on any new medicine, remind your doctor, dentist or pharmacist that you are taking ZYPREXA.
Tell your doctor immediately if you become pregnant while taking ZYPREXA.
Keep all your doctor's appointments so that your progress can be checked.
- Your doctor should monitor your weight while you are taking ZYPREXA.
- Patients with diabetes or who have a higher chance of developing diabetes should have their blood sugar checked often.
- Your doctor may request you have a blood test from time to time to monitor your cholesterol levels.
- 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.
All thoughts of suicide or violence must be taken seriously. 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 doing harm to others.
These may be signs of changes or worsening in your mental illness.
Things you should 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 you should be careful of
If ZYPREXA make 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.
Antipsychotics have the potential to cause cardiac complications and sudden cardiac death.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ZYPREXA affect you.
ZYPREXA may cause dizziness in some people
Drinking alcohol
Tell your doctor if you drink alcohol.
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.
Looking after your medicine
Keep your tablets and wafers in the blister pack until it is time to take them.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place where the temperature stays below 25°C, away from moisture, heat or sunlight; for example, do not store it:
- in the bathroom or near a sink, or
- in the car or on windowsills.
Keep it where young children cannot reach it. A locked cupboard at least one and a half meters above the ground is a good place to store medicines.
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?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
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.
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.
Less serious side effects
Less serious side effects | What to do |
| 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 |
| Tell your doctor as soon as possible if you notice any of these serious side effects. You may need medical attention. |
Very serious side effects
Very serious side effects | What to do |
| 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 hospitalization. |
The following additional side effects may occur in some groups of people taking ZYPREXA.
Elderly patients with dementia-related psychosis
- unusual manner of walking
- falls
- pneumonia
- involuntary passing of urine
- Stroke
- transient ischemic attack – symptoms maybe, but not limited to, paralysis in face, arm or leg.
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.
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:
- tremors
- speech disorder
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.
Some side effects, such as changes to liver function, blood cell counts, 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. Most of these side effects are very rare. You may not experience any of them. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.
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 affects 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 taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What ZYPREXA tablets contains
Active ingredient (main ingredient) | Olanzapine |
Other ingredients (inactive ingredients) | Lactose monohydrate Hyprolose Crospovidone microcrystalline cellulose magnesium stearate Hypromellose carnauba wax Colour Mixture White YS-1-18027A OPACODE BLUE S-1-10537G Edible Blue Ink |
Potential allergens | Sugars as lactose |
What ZYPREXA Zydis wafers contains
Active ingredient (main ingredient) | Olanzapine |
Other ingredients (inactive ingredients) | Gelatin Mannitol Aspartame sodium methyl hydroxybenzoate sodium propyl hydroxybenzoate |
Potential allergens | Aspartame |
Do not take this medicine if you are allergic to any of these ingredients.
What ZYPREXA tablets and ZYPREXA Zydis wafers looks like
ZYPREXA tablets are white and are available in the following strengths:
- 2.5 mg tablet (AUST R 56603)
- 5 mg tablet (AUST R 56604)
- 7.5 mg tablet (AUST R 56605)
- 10 mg tablet (AUST R 56606)
- 15 mg tablet (AUST R 77388)
- 20 mg tablet (AUST R 77390)
ZYPREXA tablets come in blister packs in the following pack sizes:
- 2.5 mg tablet - 28 tablets
- 5 mg tablet - 7 or 28 tablets
- 7.5 mg tablet - 28 tablets
- 10 mg tablet - 7 or 28 tablets
- 15 mg tablet - 28 tablets
- 20 mg tablet - 28 tablets
Note: ZYPREXA 15 mg and 20 mg tablets are not marketed in Australia.
ZYPREXA Zydis wafers are yellow and are available in the following strengths:
- 5 mg wafer (AUST R 73388)
- 10 mg wafer (AUST R 73389)
- 15 mg wafer (AUST R 73390)
- 20 mg wafer (AUST R 73391)
ZYPREXA Zydis wafers come in blister packs in the following pack sizes:
- 5 mg wafer - 7 or 28 wafers
- 10 mg wafer - 7 or 28 wafers
- 15 mg wafer - 28 wafers
- 20 mg wafer - 28 wafers
Who distributes ZYPREXA and ZYPREXA Zydis
Pharmaco (Australia) Ltd
Level 9, Tower A Zenith Towers
821 Pacific Highway
Chatswood, NSW 2067
Australia
Phone: 1800 201 564
Under license of CHEPLAPHARM Schweiz GmbH, Switzerland
This leaflet was prepared in March 2025.
Published by MIMS May 2025