2. What should I know before I take ZYPINE?
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.
3. What if I am taking other medicines?
Some medicines may interfere with ZYPINE and affect how it works.
4. How do I take ZYPINE?
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.
5. What should I know while taking ZYPINE?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using ZYPINE.
Tell your doctor if you become pregnant while taking ZYPINE.
Keep all of your doctor's appointments so that your progress can be checked.
|
|
Things you should not do
|
Do not stop taking your medicine, or change the dosage, without first checking with
your doctor.
Do not give this medicine to anyone else, even if they have the same condition as
you.
|
|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how ZYPINE
affects you. ZYPINE may cause drowsiness in some people.
|
|
Drinking alcohol
|
Tell your doctor if you drink alcohol. The effects of alcohol could be made worse
while taking ZYPINE.
|
|
Looking after your medicine
|
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Keep this medicine where children cannot reach it.
|
6. Are there any side effects?
Like other medicines, ZYPINE 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.
Active ingredient(s):
Olanzapine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ZYPINE. 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 ZYPINE.
Where to find information in this leaflet:
1. Why am I taking ZYPINE?
ZYPINE contains the active ingredient olanzapine. Olanzapine belongs to a group of medicines called antipsychotics. It helps by correcting
chemical imbalances in the brain, which may cause mental illness.
ZYPINE is used to treat:
Symptoms of schizophrenia and related psychoses
Acute manic episodes associated with Bipolar I Disorder (as a short-term treatment)
with ZYPINE alone or in combination with lithium or valproate.
Mood stabiliser that prevents further occurrences of the disabling high and low (depressed)
extremes of mood 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.
ZYPINE may be used alone, or in combination with other medicines, to treat your condition.
Your doctor may have prescribed ZYPINE for another reason.
Ask your doctor if you have any questions about why ZYPINE has been prescribed for
you.
2. What should I know before I take ZYPINE?
Warnings
Do not take ZYPINE if:
you have an allergy to:
any medicine containing olanzapine
any of the ingredients listed at the end of this leaflet
any other similar medicines (such as medicines of the same class or with a similar
structure, as per PI).
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 printed on the pack has passed or if the packaging is torn or shows
signs of tampering.
If you take this medicine after the expiry date has passed it may not work as well.
If it has expired or is damaged, return it to your pharmacist for disposal.
you are pregnant.
It may affect your developing baby if you take it during pregnancy.
you are breastfeeding.
The active ingredient in Olanzapine passes into breast milk (if applicable) and there
is possibility that your baby maybe affected.
If you are not sure whether you should start taking ZYPINE, 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. ZYPINE may make
you sweat less, causing your body to overheat.
you smoke. Smoking may affect ZYPINE or may affect how it works.
you suffer from lactose intolerance (because ZYPINE tablets contain lactose).
you suffer from phenylketonuria (because ZYPINE ODT contain aspartame).
you have allergies to any medicines, foods, preservatives or dyes.
If you have not told your doctor about any of the above, tell them before you start
taking ZYPINE.
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
Tell your doctor if you are pregnant or plan to become pregnant.
Like most antipsychotic medicines, ZYPINE are not recommended for use during pregnancy.
Newborn babies of mothers taking antipsychotic drugs (including ZYPINE) 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 ZYPINE during your
pregnancy, your doctor will discuss with you the benefits and risks of using it.
Tell your doctor if you are breastfeeding or plan to breastfeed.
It is recommended that you do not breastfeed while taking ZYPINE.
Children
Do not give this medicine to a child under the age of 18 years.
Safety and effectiveness in children younger than 18 years have not been established.
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 ZYPINE 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. Tranquilisers 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 ZYPINE.
You may need different amounts of your medicines, or you may need to take different
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 ZYPINE.
4. How do I take ZYPINE?
How much to take
Your doctor will tell you how much ZYPINE 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
ZYPINE should be taken once a day as advised by your doctor.
Take your prescribed dose at the same time each day.
Taking it at the same time each day will have the best effects. It will also help
you remember when to take it.
ZYPINE can be taken with or without food.
How to take
ZYPINE tablets:
ZYPINE tablets should be swallowed whole with a glass of water.
ZYPINE ODT:
ZYPINE ODT break easily, so you should handle them carefully.
Do not handle the ZYPINE ODT with wet hands as the tablets may breakup.
The ZYPINE ODT can be taken two ways:
Directly into your mouth
In a drink
To take ZYPINE ODT directly into your mouth:
1. 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.
2. Carefully peel off the coloured backing.
3. Gently push the tablet out.
4. Put the tablet 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 tablet 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 colour and possibly become cloudy.
ZYPINE ODT should not be place in cola drinks.
How long to take it
Continue taking your medicine for as long as your doctor tells you to.
This medicine helps to control your condition, but it does not cure it. It is important
to keep taking your medicine even if you feel well.
It is important that you do NOT stop taking ZYPINE unless your doctor tells you.
If you forget to take ZYPINE
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.
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.
If you have taken too much ZYPINE
If you think that you or anyone else has taken too much ZYPINE, urgent medical attention
may be needed.
If you have taken too much ZYPINE, 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 ZYPINE, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, 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 taking ZYPINE?
Things you should do
It is important that you remember to take ZYPINE daily and at the dose prescribed
by your doctor.
Tell all doctors, dentists and pharmacists who are treating you that you are taking
ZYPINE.
While you are taking ZYPINE, tell your doctor or pharmacist before you start any new
medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
It may affect other medicines used during surgery.
If you are about to have any blood tests, tell your doctor that you are taking this
medicine.
It may interfere with the results of some tests.
Tell your doctor immediately if you become pregnant while taking ZYPINE.
Keep all your doctor's appointments so that your progress can be checked.
Your doctor should monitor your weight while you are taking ZYPINE.
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.
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 ZYPINE, or lower the dosage, even if you are feeling better, without
checking with your doctor.
Do not give ZYPINE to anyone else, even if their symptoms seem similar or they have
the same condition as you. Your doctor has prescribed ZYPINE for you and your condition.
Things you should be careful of
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.
Standing up slowly, especially when you get up from bed or chairs, will help your
body get used to the change in position and blood pressure. If this problem continues
or gets worse, talk to your doctor.
If outdoors, wear protective clothing and use at least a 30+ sunscreen.
ZYPINE 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.
ZYPINE 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 ZYPINE
affects you.
ZYPINE 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 ZYPINE.
Your doctor may suggest you avoid alcohol while you are being treated with ZYPINE.
Looking after your medicine
Keep your tablets 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 window sills.
Heat and dampness can destroy some medicines.
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, ZYPINE 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 ZYPINE.
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 ZYPINE 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
ZYPINE for a few days.
Less serious side effects
Serious side effects
Very serious side effects
The following additional side effects may occur in some groups of people taking ZYPINE.
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 ZYPINE 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.
Also, some side effects, such as changes to liver function, blood cell counts, cholesterol,triglycerides,
glucose and glycosuria 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.
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.
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 ZYPINE tablet contains
|
Active ingredient
(main ingredient)
|
olanzapine
|
|
Other ingredients
(inactive ingredients)
|
crospovidone
lactose monohydrate
magnesium stearate
maize starch
OPADRY AMB OY-B-28920 (ID: 10274)
pregelatinised maize starch
|
|
Potential allergens
|
sugars as lactose
sulfites
|
Each ZYPINE 2.5 mg tablet contains 2.5 mg of olanzapine.
Each ZYPINE 5 mg tablet contains 5 mg of olanzapine.
Each ZYPINE 7.5 mg tablet contains 7.5 mg of olanzapine.
Each ZYPINE 10 mg tablet contains 10 mg of olanzapine.
What ZYPINE ODT contains
|
Active ingredient
(main ingredient)
|
olanzapine
|
|
Other ingredients
(inactive ingredients)
|
mannitol
microcrystalline cellulose
guar gum
crospovidone
magnesium stearate
colloidal anhydrous silica
aspartame
sodium lauryl sulfate
|
|
Potential allergens
|
aspartame
phenylalanine
sulfites
gluten
|
Each ZYPINE ODT 5 mg orally disintegrating tablet contains 5 mg of olanzapine.
Each ZYPINE ODT 10 mg orally disintegrating tablet contains 10 mg of olanzapine.
Each ZYPINE ODT 15 mg orally disintegrating tablet contains 15 mg of olanzapine.
Each ZYPINE ODT 20 mg orally disintegrating tablet contains 20 mg of olanzapine.
Do not take this medicine if you are allergic to any of these ingredients.
What ZYPINE tablets looks like
2.5 mg - approximately 7.0 mm normal convex, white film coated tablets debossed "OZ" over
"2.5" on one side and "G" on the other side (AUST R 154620).
5 mg - approximately 8.0 mm normal convex, white film coated tablets debossed "OZ" over
"5" on one side and "G" on the other side (AUST R 154624).
7.5 mg - approximately 9.0 mm normal convex, white film coated tablets debossed "OZ" over
"7.5" on one side and "G" on the other side (AUST R 154621).
10 mg - approximately 10.2 mm normal convex, white film coated tablets debossed "OZ" over
"10" on one side and "G" on the other side (AUST R 154617).
Each blister pack contains 28 tablets.
What ZYPINE ODT looks like
5 mg - Light yellow to yellow coloured, plain to mottled, round, flat faced, bevelled edged
tablets debossed with "M" on one side and "OE1" on other side (AUST R 175773).
10 mg - Light yellow to yellow coloured, plain to mottled, round, flat faced, bevelled edged
tablets debossed with "M" on one side and "OE2" on other side (AUST R 175775).
15 mg - Light yellow to yellow coloured, plain to mottled, round, flat faced, bevelled edged
tablets debossed with "M" on one side and "OE3" on other side (AUST R 189670).
20 mg - Light yellow to yellow coloured, plain to mottled, round, flat faced, bevelled edged
tablets debossed with "M" on one side and "OE4" on other side (AUST R 189673).
Each blister pack contains 28 orally disintegrating tablets.
Who distributes ZYPINE
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in November 2025.
ZYPINE® is a Viatris company trade mark
ZYPINE_cmi\Nov25/00