Brand
name: FLUANXOL
(Depixol, Flupenthixole)®
Fluanxol® Concentrated Depot
Flupenthixol decanoate
Ccommon 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:
o Liver problems
o Decreased blood supply to the brain
o Organic brain syndrome
o Kidney problems
o Heart and blood vessel problems
o Parkinsonism, a disease of the brain affecting movement
o Arteriosclerosis, a disease affecting the arteries
o Convulsions, fits or seizures
o Glaucoma, a condition in which there is usually a build-up of pressure in
the eye
o 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
o 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.
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.
