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 Fluanxol?
Fluanxol contains the active ingredient flupentixol decanoate. Fluanxol is used for
the long-term treatment of schizophrenia, a mental illness with disturbances in thinking,
emotional reactions and behaviour, and other chronic mental conditions. For more information,
see Section
1. Why am I using Fluanxol? in the full CMI.
2. What should I know before I use Fluanxol?
Do not use if you have ever had an allergic reaction to Fluanxol 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 Fluanxol? in the full CMI.
3. What if I am taking other medicines?
4. How will I be given Fluanxol?
Fluanxol is given by a doctor, nurse or other trained person. Fluanxol is given as
an injection into a large muscle where it is slowly released over time.
5. What should I know while using Fluanxol?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Fluanxol.
Tell your doctor if you notice any soreness of the mouth, gums, throat or other flu-like
symptoms, or if you are thinking or talking about death, suicide, self-harm or harm
to others.
Keep all of your doctor's appointments so that your progress can be checked.
If you are outdoors, wear protective clothing and use a SPF 30+ sunscreen.
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Things you should not do
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Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not take any medicines that cause drowsiness while you are using Fluanxol, unless
recommended by your doctor.
Do not stop using Fluanxol suddenly.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how Fluanxol
affects you.
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Drinking alcohol
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Be careful when drinking alcohol while you are using this medicine.
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Looking after your medicine
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Store Fluanxol below 25°C and keep it in the pack until it is time to use it.
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6. Are there any side effects?
Some of the common side effects include movement disorders (e.g. involuntary muscle
contractions, slowing of movements), restlessness, blurred vision or difficulty focusing,
painful or weak muscles, tiredness, fatigue, difficulty passing urine or other urinary
disorder, difficult or painful breathing, increased salivation or increased sweating,
skin rash and itchy skin. Serious side effects include sudden onset of unusual movements,
blood clots in the veins, serious allergic reaction, convulsions, sudden increase
in body temperature, unusual stiff of the muscles and changes in consciousness.
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):
Flupentixol decanoate (flu-PEN-tic-sol deck-can-OH-ate)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Fluanxol. 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 Fluanxol.
Where to find information in this leaflet:
1. Why am I using Fluanxol?
Fluanxol contains the active ingredient flupentixol decanoate. Fluanxol belongs to a group of medicines called thioxanthene neuroleptics. It helps
to correct chemical imbalances in the brain, which may cause mental illness.
Fluanxol is used for the long-term treatment of schizophrenia, a mental illness with
disturbances in thinking, emotional reactions and behaviour, and other chronic mental
conditions.
Your doctor, however, may prescribe it for another purpose.
Ask your doctor if you have any questions about why it has been prescribed for you.
Fluanxol is not addictive.
2. What should I know before I use Fluanxol?
Warnings
Do not use Fluanxol if:
you are allergic to flupentixol decanoate, to any other similar medicines (such as
thioxanthenes or phenothiazines), to the ingredient fractionated coconut oil, or any
of the ingredients listed at the end of this leaflet.
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, or rash,
itching or hives on the skin.
Always check the ingredients to make sure you can use this medicine.
you have diminished consciousness due to any cause
you collapse due to very low blood pressure
you have brain damage
you have diseases of the blood with a reduced number of red or white blood cells or
platelets
you have phaeochromocytoma, a rare tumour of the adrenal gland which sits near the
kidney.
Do not give Fluanxol to anyone who currently has alcohol poisoning, or poisoning with
medicines used to produce calmness or to help you sleep, or medicines used to treat
epilepsy or strong pain.
Do not give Fluanxol to anyone who is unconscious or in a coma.
Do not give Fluanxol to patients with mental illness who are highly distressed, or
elderly patients who are confused and/or distressed.
Check with your doctor if you:
have allergies to any other substances such as foods, preservatives or dyes.
have, or have had, the following medical conditions:
arteriosclerosis, a disease affecting the arteries
convulsions, fits or seizures
decreased blood supply to the brain
diabetes, a disorder of metabolism in which the amount of sugar in the blood is too
high
glaucoma, a condition in which there is usually a build-up of pressure in the eye
heart and blood vessel problems
kidney problems
liver problems
low potassium and/or low magnesium levels in the blood
organic brain syndrome
parkinsonism, a disease of the brain affecting movement
risk factors for stroke
tardive dyskinesia, a reaction to some medicines with worm-like movements of the tongue,
or other uncontrolled movements of the mouth, tongue, cheeks or jaw which may progress
to the arms and legs
treatment for cancer
you or someone else in your family has a history of blood clots, as medicines like
these have been associated with formation of blood clots
Also tell your doctor if you will be in a hot environment or you do a lot of vigorous
exercise.
Fluanxol may make you sweat less, causing your body to overheat.
Tell your doctor if you are exposed to pesticides that contain phosphorus.
The risk of you experiencing a side effect may be increased.
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.
Fluanxol may affect your fertility. If you are intending to start a family, ask your
doctor for advice.
Like most medicines of this kind, Fluanxol is not recommended for use during pregnancy
unless clearly necessary. The general condition of your baby might be affected by
the use of this medicine.
The following symptoms may occur in newborn babies of mothers who have used Fluanxol
in the last three months of their pregnancy: shaking, muscle stiffness and/or weakness,
sleepiness, agitation, breathing problems and difficulty in feeding. If your baby
develops any of these symptoms you should contact your doctor.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not recommended that you breast-feed while using Fluanxol. Its active ingredient
passes into breast milk and therefore there is a possibility that your baby might
be affected.
Children and adolescents
Do not give Fluanxol to a child or adolescent.
There is no experience with its use in children or adolescents under 18 years old.
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 Fluanxol and affect how it works.
These include:
tricyclic antidepressants, monoamine oxidase (MAO) inhibitors and lithium, medicines
used to treat depression or mood swings
phenobarbitone and carbamazepine, medicines used to treat convulsions and epilepsy
medicines used to treat strong pain
medicines used to produce calmness or to help you sleep
medicines used to treat high blood pressure (hypertension), including debrisoquine,
guanethidine and clonidine
levodopa, a medicine used to treat Parkinson's disease
medicines which stimulate the body, getting it ready for action, such as adrenaline
metoclopramide, a medicine used to relieve nausea and vomiting
piperazine, a medicine used to treat worm infections
medicines used to treat changes in the rhythm or rate of the heart beat, e.g. quinidine,
amiodarone, sotalol and dofetilide
antipsychotics, a class of medicines used to treat certain mental and emotional conditions,
e.g. thioridazine
certain medicines used to treat infections, such as erythromycin, gatifloxacin and
moxifloxacin
medicines used to relieve the symptoms of allergy, including terfenadine and astemizole
cisapride, used to treat stomach problems
medicines that disturb water or salt balance e.g. thiazide diuretics, also called
fluid or water tablets
medicines known to increase the concentration of Fluanxol in your blood
medicines used to relieve stomach cramps or spasms, to prevent travel sickness and
to treat Parkinson's disease, such as atropine or related medicines.
medicines used to treat cancer
These medicines may be affected by Fluanxol or may affect how well it works. You may
need to use different amounts of your medicines or take different medicines. Your
doctor will advise you.
Your doctor or pharmacist has more information on medicines to be careful with or
avoid while using Fluanxol.
4. How will I be given Fluanxol?
How much is given
Your doctor will decide what dose you will receive. This depends on your condition
and other factors, such as your weight and your response to the medicine.
Fluanxol Depot
Generally, the starting dose is 20 to 40 mg (1 to 2 mL). A second dose of 20 to 40
mg (1 to 2 mL) is usually given 4-10 days after the first injection, and further doses
are given every 2 to 4 weeks for the majority of patients.
Fluanxol Concentrated Depot
Patients who require higher doses and/or who have problems with larger injection volumes
may be given Fluanxol Concentrated Depot.
Your doctor may have prescribed a different dose.
Ask your doctor or pharmacist if you are unsure of the correct dose for you. Follow
the instructions they give you.
They will tell you exactly how much you will be given.
How is Fluanxol given
Fluanxol is given as an injection into a large muscle where it is slowly released
over time. The injection should only be given by a doctor, nurse or other trained
person.
When is Fluanxol given
It is recommended that Fluanxol is given every 2-4 weeks, depending on how your body
responds to the medicine.
How many injections will you need
Continue having your injections for as long as your doctor tells you to.
Fluanxol helps control your condition. Therefore, you will need regular injections.
If you forget to have a Fluanxol injection
If you forget to keep an appointment, contact your doctor as soon as you remember,
so that you can make another one.
If you have been given too much Fluanxol (overdose)
As Fluanxol is given to you under the supervision of your doctor, it is very unlikely
that you will be given too much.
However, if you experience any side effects after being given Fluanxol, you should
immediately:
phone the Poisons Information Centre in Australia
(by calling
13 11 26) or the National Poisons Centre in New Zealand (by calling 0800 POISON or 0800 764 766), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You may need urgent medical attention.
Symptoms of an overdose may include sleepiness, coma, extreme agitation, excitement,
confusion, convulsions and extremely high or low body temperature.
Uncontrollable movements may develop, and collapse due to very low blood pressure
or difficulty breathing may occur. Changes in the rhythm or rate of the heart beat
have been seen in Fluanxol overdose when medicines known to affect the heart have
also been taken.
5. What should I know while using Fluanxol?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are using Fluanxol.
Remind any doctor, dentist or pharmacist you visit that you are using Fluanxol.
Tell your doctor if you notice any soreness of the mouth, gums, throat or other flu-like
symptoms.
Talk to your doctor or mental health professional if you are thinking or talking about
death, suicide, self-harm or harm to others.
These may be signs of changes or worsening in your mental illness.
If you are going to have surgery, tell the surgeon or anaesthetist that you are using
this medicine.
Fluanxol 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.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may do some blood and liver tests from time to time, particularly during
the first months of therapy, to make sure the medicine is working and to prevent unwanted
side effects.
Protect your skin when you are in the sun, especially between 10am and 3pm.
If you are outdoors, wear protective clothing and use a SPF 30+ sunscreen.
If your skin appears to be burning, tell your doctor.
Fluanxol may cause your skin to be much more sensitive to sunlight than it is normally.
This could cause skin rash, itching, redness, or severe sunburn.
Call your doctor straight away if you:
become pregnant while using Fluanxol.
notice any 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.
These are symptoms of a condition called tardive dyskinesia, which may develop in
people taking similar medicines, including Fluanxol.
This condition is more likely to occur during long-term treatment with Fluanxol, especially
in elderly women. In very rare cases, this may be permanent. However, if detected
early, these symptoms are usually reversible.
Things you should not do
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not take any medicines that cause drowsiness while you are using Fluanxol, unless
recommended by your doctor.
Do not miss any injections, even if you feel better.
Fluanxol helps control your condition. Therefore, you will need regular injections.
Do not stop using Fluanxol suddenly.
If Fluanxol is stopped suddenly, you may experience symptoms such as nausea, vomiting,
loss of appetite, diarrhoea, runny nose, sweating, aching muscles, pins and needles,
sleeplessness, restlessness, anxiety, or agitation.
Your doctor may want to gradually reduce the amount you are given before stopping
completely.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Fluanxol
affects you.
It may cause drowsiness, tiredness, sleepiness or blurred vision in some people. If
you have any of these symptoms, do not drive, operate machinery, or do anything else
that could be dangerous.
Drinking alcohol
Tell your doctor if you drink alcohol.
Be careful when drinking alcohol while you are using this medicine.
If you drink alcohol, drowsiness or sleepiness may be worse.
Feeling light-headed, dizzy or faint
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.
Standing up slowly 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.
Looking after your medicine
Store Fluanxol below 25°C and keep it in the pack until it is time to use it.
If you take the ampoules out of the box they may not keep well.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place 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.
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, or if the packaging is torn or shows
signs of tampering. If you use it after the expiry date has passed, it may not work
as well.
The expiry date refers to the last day of the month.
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.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are using Fluanxol.
It helps most people with mental illness, but it may have unwanted side effects in
a few people.
If you are over 65 years of age you may have an increased chance of getting side effects.
Less serious side effects
Serious side effects
These may be serious side effects of Fluanxol. You may need urgent medical attention.
Very serious side effects
These are very serious side effects. You may need urgent medical attention or hospitalisation.
These side effects are generally rare.
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 or in New Zealand at https://pophealth.my.site.com/carmreportnz/s/. 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 Fluanxol contains
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Active ingredient
(main ingredient)
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Fluanxol 20 mg/mL injection
20 mg/mL flupentixol decanoate or 40 mg/2 mL flupentixol decanoate
Fluanxol 100 mg/mL injection
100 mg/mL flupentixol decanoate.
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Other ingredients
(inactive ingredients)
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fractionated coconut oil
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Do not take this medicine if you are allergic to any of these ingredients.
What Fluanxol looks like
Fluanxol comes in two types of injections:
Fluanxol Depot 20 mg/mL solution for injection - clear, colourless to slightly yellowish
oil (AUST R 47109 or AUST R 47247).
Fluanxol Concentrated Depot 100 mg/mL concentrated injection - clear, yellow to yellowish
oil (AUST R 47107).
A box contains 5 ampoules.
Who distributes Fluanxol
Distributed in Australia by:
Lundbeck Australia Pty Ltd
1 Innovation Rd
North Ryde NSW 2113
Ph: +61 2 8669 1000
Distributed in New Zealand by:
Pharmacy Retailing t/a
Healthcare Logistics
58 Richard Pearse Drive
Mangere
Auckland 2022
Ph: 0800 540 555
This leaflet was prepared in June 2025.
"Fluanxol" is the registered trademark of H. Lundbeck A/S.