FLUANXOL®

Fluanxol^® Depot 20 mg/mL

Fluanxol^® Concentrated Depot 100 mg/mL

Flupenthixol decanoate

What is in this leaflet

This leaflet contains answers to some common questions about Fluanxol.

It does not contain all the information that is known about Fluanxol. It does
not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of
you using Fluanxol against the benefits he/she expects it will have for you.

If you have any concerns about using this medicine ask your doctor or
pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Fluanxol is used for

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.

Fluanxol belongs to a group of medicines called thioxanthene neuroleptics. It
helps to correct chemical imbalances in the brain, which may cause mental
illness.

Ask your doctor if you have any questions about why this medicine has been
prescribed for you.

Your doctor may have prescribed it for another reason.

Fluanxol is not addictive.

This medicine is available only with a doctor's prescription.

Before you are given Fluanxol

When you must not use it

Do not use Fluanxol if you have an allergy to:

• any medicine containing flupenthixol decanoate.
• fractionated coconut oil.
• any other similar medicines (such as thioxanthenes or phenothiazines).

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, or rash, itching or hives on the skin.

Do not use Fluanxol if you have any of the following medical conditions:

• Collapse due to very low blood pressure
• Depression of the central nervous system due to any cause
• Brain damage
• Diseases of the blood with a reduced number of red or white blood cells or
  platelets
• Phaeochromocytoma, a rare tumour of the adrenal gland which sits near the
  kidney

Do not give Fluanxol to patients with mental illness who are highly
distressed, or elderly patients who are confused and/or distressed.

Do not give Fluanxol to anyone who is unconscious or in a coma.

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 children.

Fluanxol is not recommended for use in children, as safety and effectiveness
have not been established in this age group.

Do not use this medicine after the expiry date printed on the pack or if
the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should be given Fluanxol, talk to your
doctor or pharmacist.

Before you start to use it

Tell your doctor if:

• you have allergies to any other medicines, foods, preservatives or
  dyes.
• have or have had any of the following medical conditions:
  • Liver problems
  • Decreased blood supply to the brain
  • Organic brain syndrome
  • Kidney problems
  • Heart and blood vessel problems
  • Parkinsonism, a disease of the brain affecting movement
  • Arteriosclerosis, a disease affecting the arteries
  • Convulsions, fits or seizures
  • Glaucoma, a condition in which there is usually a build-up of pressure
    in the eye
  • 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
  • Diabetes, a disorder of metabolism in which the amount of sugar in the
    blood is too high
• you are pregnant, or plan to become pregnant.
  
  Like most antipsychotic medicines, Fluanxol is not recommended for use
  during pregnancy, since safety in pregnancy has not been established. However,
  if you need to be given Fluanxol during pregnancy, your doctor can discuss
  with you the benefits and risks involved.
• are breast-feeding or plan to breast-feed.
  
  It is recommended that you do not breast-feed while using Fluanxol. Its
  active ingredient passes into breast milk and therefore there is a possibility
  that your baby may be affected.

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.

If you have not told your doctor or pharmacist about any of the above,
tell them before you are given Fluanxol.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines,
including medicines that you get without a prescription from a pharmacy,
supermarket or health food shop.

Some medicines and Fluanxol may interfere with each other. 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 produce calmness or to help you sleep
• Medicines used to treat strong pain
• 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 relieve stomach cramps or spasms, to prevent travel
  sickness and to treat Parkinson's disease, such as atropine or related
  medicines

These medicines may be affected by Fluanxol, or may affect how well it works.
You may need different amounts of your medicines, or you may need to use
different medicines.

Your doctor and pharmacist have more information on medicines to be careful
with or avoid while using Fluanxol.

How Fluanxol is given

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or
pharmacist for help.

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 dose, 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.

How it is 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.

How often it is given

It is recommended that Fluanxol is given every 2 - 4 weeks, depending on how
your body responds to the medicine.

How many injections you will need

Continue having your injections as long as your doctor tells you to.

Fluanxol helps control your condition, but does not cure it. Therefore, you
will need regular injections.

If you forget to have an injection

If you forget to keep an appointment, contact your doctor as soon as you
remember, so that you can make another one.

Overdose

Immediately telephone your doctor or the Poisons Information Centre (Tel:
13 11 26 for Australia and Tel: 0800 POISON or 0800 764 766 for New Zealand) for
advice, or go to Accident and Emergency at your nearest hospital, if you
experience any side effects after being given Fluanxol.

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.

While you are using Fluanxol

Things you must do

If you are about to be started on any new medicine, remind your doctor and
pharmacist that you are using Fluanxol.

Tell any other doctors, dentists and pharmacists who treat you that you
are using this medicine.

If you become pregnant while using Fluanxol, tell your doctor immediately.

Tell your doctor immediately if you 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.

Also tell your doctor if you notice any soreness of the mouth, gums,
throat or other flu-like symptoms.

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.

Things you must 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, but does not cure it. Therefore, you
will need regular injections.

Things to be careful of

Be careful driving or operating machinery until you know how Fluanxol
affects you.

This medicine 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 might be dangerous.

Be careful when drinking alcohol while you are using this medicine.


If you drink alcohol, drowsiness or sleepiness may be worse.

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.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are using Fluanxol.

Fluanxol helps most people with mental illness, but it may have unwanted
side effects in some people. All medicines can have side effects.

Sometimes they are serious, most of the time they are not. You may need medical
attention if you get some of the side effects.

If you are over 65 years of age you may have an increased chance of getting
side effects.

Do not be alarmed by the following lists of side effects. You may not
experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they
worry you:

• Restlessness
• Difficulty sleeping
• Headache
• Drowsiness
• Tiredness, sleepiness
• Dry mouth
• Constipation
• Nausea
• Weight changes
• Breast enlargement in men
• Impaired sexual function
• Unusual secretion of breast milk
• Change in your menstrual periods

The above list includes the more common side effects of Fluanxol. They are
usually mild and short-lived.

Tell your doctor immediately if you notice any of the following:

• Worm-like movements of the tongue or other uncontrolled movements of the
  mouth, tongue, cheeks or jaws, which may progress to the arms and legs
• Sudden onset of unusual movements, including trembling and shaking of the
  hands and fingers, twisting movements of the body, or shuffling walk and
  stiffness of the arms and legs
• Difficulty passing urine
• Changes in heart rate and blood pressure
• Fainting
• Yellowing of the skin and/or eyes, also called jaundice
• Severe pain in the stomach with bloating, gut cramps and vomiting
• High pressure in the eye
• Blurred vision or difficulty focussing
• Tiredness, headaches, dizziness, being short of breath when exercising and
  looking pale
• Frequent infections such as fever, severe chills, sore throat or mouth
  ulcers
• Bleeding or bruising more easily than normal, nosebleeds

The above list includes serious side effects that may require medical
attention.

If any of the following happen tell your doctor immediately or go to
Accident and Emergency at your nearest hospital:

• Sudden increase in body temperature, extremely high blood pressure and
  severe convulsions
• Sudden signs of allergy such as rash, itching or hives on the skin,
  swelling of the face, lips, tongue or other parts of the body, shortness of
  breath, wheezing or trouble breathing

The above list includes very serious side effects. You may need urgent
medical attention or hospitalisation.

Tell your doctor or pharmacist if you notice anything that is making you
feel unwell.

Other side effects not listed above may also occur in some people.

After using Fluanxol

Storage

Keep Fluanxol in the pack until it is time to use it.

If you take Fluanxol out of the pack it may not keep well.

Keep Fluanxol in a cool dry place where the temperature stays below 25°C.

Keep Fluanxol away from sunlight.

Do not store Fluanxol or any other medicine in the bathroom or near a
sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep Fluanxol where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good
place to store medicines.

Disposal

If your doctor stops giving you this medicine or the expiry date has
passed, ask your pharmacist what to do with any medicine that is left over.

Fluanxol description

What it looks like

Fluanxol Depot ampoules contain a clear, colourless to slightly yellowish
oily solution. It is available in packs of 5 x 1 mL and 5 x 2 mL glass ampoules.

Fluanxol Concentrated Depot ampoules contain a clear, colourless to
slightly yellowish oily solution. It is available in packs of 5 x 1 mL glass
ampoules.

Ingredients

Active ingredient(s)

Fluanxol Depot contains 20 mg flupenthixol decanoate per 1 mL or 40 mg
flupenthixol decanoate per 2 mL as the active ingredient.

Fluanxol Concentrated Depot contains 100 mg flupenthixol decanoate per 1 mL
as the active ingredient.

Other ingredients

Fluanxol Depot and Concentrated Depot also contain coconut oil ?
fractionated.