STELAZINE® TABLETS AND LIQUID

Trifluoperazine

WHAT IS IN THIS LEAFLET

This leaflet answers some of the common questions about STELAZINE. It does
not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.

Please read this leaflet before you start taking STELAZINE. If you are
helping someone else take STELAZINE, please read this leaflet before you give
the first dose.

All medicines have risks and benefits. Your doctor has weighed the possible
risks of taking STELAZINE against the benefits they expect it will have for you.

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

Keep this leaflet with the medication. You may want to read it again.

WHAT STELAZINE IS USED FOR

STELAZINE contains trifluoperazine as the active ingredient. STELAZINE
belongs to a group of medicines called phenothiazine neuroleptics. It helps to
correct chemical imbalances in the brain, which may cause mental illness. These
chemicals may also affect the parts of the brain which control nausea and
vomiting.

STELAZINE is used to treat mental illnesses with disturbances in thinking,
feelings and behaviour.

STELAZINE may also be used to treat nausea and vomiting, or used short term
in patients with severe anxiety.

Your doctor may have prescribed STELAZINE for another reason. Ask your doctor
if you have questions about why STELAZINE has been prescribed for you.

There is no evidence that STELAZINE is addictive.

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

BEFORE YOU TAKE STELAZINE

When you must not take it

Do not take STELAZINE if you have an allergy to:

• STELAZINE
• phenothiazines
• any of the ingredients listed at the end of the leaflet

Symptoms of an allergic reaction to STELAZINE may include:

• shortness of breath, wheezing or difficulty in breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin

If you have taken STELAZINE before and became unwell, tell your doctor or
pharmacist before taking the first dose.

STELAZINE must not be given to anyone who is unconscious or in a coma.

Do not take STELAZINE if you have or have had any of the following medical
conditions:

• liver disease
• blood or bone marrow disorder
• phaeochromocytoma, a rare tumour of the adrenal glands which sit near the
  kidneys
• heart and blood vessel disease

Do not give STELAZINE to children less than 3 years old, unless instructed
to by your doctor.

Do not take STELAZINE after the expiry date (EXP) printed on the pack.
If you take this medicine after the expiry date has passed, it may not work as
well.

Do not take STELAZINE if the packaging is torn or shows signs of
tampering.

If you are not sure whether you should start taking STELAZINE, talk to
your doctor or pharmacist.

Before you start taking STELAZINE

Tell your doctor if you have allergies to:

• any other medicines
• any other substances, such as foods, preservatives or dyes

Tell your doctor if you are pregnant or intend to become pregnant.
Like most phenothiazines, STELAZINE is not recommended for use during pregnancy.
However, if you need to take STELAZINE 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 STELAZINE, as it may pass
into the breast milk and may affect the breast-fed baby.

Tell your doctor if you have or have had any medical conditions,
especially the following:

• heart problems, such as angina
• liver problems
• low blood pressure
• breast cancer
• epilepsy, seizures or fits
• blood disorder
• glaucoma, a condition in which there is usually a build-up of fluid in the
  eye
• prostate problems

Tell your doctor if you will be in a hot environment or do a lot of
vigorous exercise. STELAZINE may make you sweat less, causing your body to
overheat.

If you have not told your doctor or pharmacist about any of the above,
tell them before you start taking STELAZINE.

Taking other medicines with STELAZINE

Tell your doctor of pharmacist if you are taking any other medicines,
including any that you buy without a prescription from your pharmacy,
supermarket or health food shop. Some medicines and STELAZINE may interfere
with each other. These include:

• medicines used to control depression
• medicines used to treat anxiety or to help you sleep
• medicines used to treat high blood pressure or treat heart conditions
• anticonvulsants, medicines used to control epilepsy
• medicines used to treat Parkinson's Disease (e.g. levodopa, bromocriptine)
• strong pain killers
• some medicines used to prevent your blood from clotting, including
  warfarin
• thiazide diuretics, medicines used to treat fluid build-up in your body
• atropine, a medicine which may be used in some eye drops or cough and cold
  preparations

These medicines may be affected by STELAZINE, or may affect how well it
works. You may need different amounts of your medicine, or you may need to take
different medicines. Your doctor or pharmacist will advise you.

HOW TO TAKE STELAZINE

Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.

Your doctor or pharmacist will tell you how many tablets you will need to
take each day. This depends on your condition and whether or not you are taking
any other medicines.

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

How much to take

The dose your doctor prescribes for you will vary according to your illness.

The starting dose of STELAZINE for adults is 1mg or 2mg twice a day. The
starting dose for children can vary so consult your doctor. If necessary your
doctor may increase or decrease the dose you take each day.

How to take it

Swallow STELAZINE tablets with a glass of water or another liquid.

When to take it

STELAZINE can be taken with or without food. The effects of STELAZINE are not
changed by food.

STELAZINE tablets or liquid are usually taken once or twice daily.

If you forget to take it

Do not take an extra dose. Take the next dose at the normal time it's due.
Do not take a double dose to make up for the dose that you missed. This may
increase the chance of you getting an unwanted side effect.

How long to take it

Continue taking the tablets for as long as your doctor tells you.
STELAZINE helps control your condition, but it does not cure it. For best effect
STELAZINE must be taken every day.

Do not stop taking STELAZINE unless your doctor tells you to - even if you
feel better.

Overdose

Immediately telephone your doctor or Poisons Information Centre (phone
Australia 131 126 or New Zealand 0800 POISON or 0800 764 766) for advice or go
to the Emergency Department at your nearest hospital, if you think that you or
anyone else may have taken too much STELAZINE. Do this even if there are no
signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much STELAZINE, you may feel sleepy, dizzy or agitated. You
may also have a dry mouth, fit or seizure, or muscle spasms.

WHILE YOU ARE USING STELAZINE

Things you must do

Tell any other doctors, dentists, and pharmacists who are treating you
that you are taking STELAZINE.

If you are about to be started on any new medicines, tell your doctor,
dentist or pharmacist that you are taking STELAZINE. This includes medicines
that you buy without a prescription as well as prescribed medicines.

If you plan to have surgery that needs a general anaesthetic, tell your
doctor or dentist that you are taking STELAZINE.

If you become pregnant while taking STELAZINE, tell your doctor.

If you need to have any medical tests while you are taking STELAZINE, tell
your doctor. STELAZINE may affect the results of some tests.

Be sure to keep all of your doctor's appointments so that your progress
can be checked. Your doctor will check your progress and may want to take some
blood/eye/skin tests from time to time. This helps to prevent unwanted side
effects.

Things you must not do

Do not give STELAZINE to anyone else, even if they have the same condition
as you.

Do not take STELAZINE to treat any other complaints unless your doctor or
pharmacist tells you to.

Do not stop taking STELAZINE, or lower the dosage, even if you are feeling
better, without checking with your doctor. If you stop taking STELAZINE
suddenly, your condition may worsen or your chance of getting an unwanted side
effect may increase. To prevent this, your doctor may gradually reduce the
amount of STELAZINE you take each day before stopping completely.

Do not take any medicines that cause drowsiness while you are taking
STELAZINE, unless recommended by your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how STELAZINE
affects you. As with other phenothiazine medicines, STELAZINE may cause
sleepiness, poor co-ordination and blurred vision in some people. Make sure you
know how you react to STELAZINE before you drive a car, operate machinery, or do
anything else that could be dangerous if you are dizzy or light-headed. If this
occurs do not drive. If you drink alcohol, sleepiness or poor co-ordination may
be worse.

If STELAZINE makes you feel light-headed, dizzy or faint, be careful when
getting up from a sitting or lying position. Getting up slowly may help.

Be careful when drinking alcohol while taking STELAZINE. Combining
STELAZINE and alcohol can make you more sleepy, dizzy or light-headed. Your
doctor may suggest you avoid alcohol while you are being treated with STELAZINE.

If outdoors, wear a hat and cover up as much as possible when in direct
sunlight. Use at least SP15+ sunscreen. STELAZINE 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.
STELAZINE may affect the way your body reacts to temperature changes.

Avoid direct contact with insecticides. STELAZINE can make the effect
of insecticides worse on your body. Wear gloves, face mask and cover up as much
as possible when using insecticides.

SIDE EFFECTS

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

Like other medicines, STELAZINE can cause some unwanted side effects.
Sometimes they are serious, most of the time they are not. You may need medical
treatment if you get some of the side effects.

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:

• drowsiness, fatigue, weakness
• dizziness
• restlessness
• headache
• blurred vision or difficulty focussing
• nausea
• constipation
• increased appetite, weight changes
• dry mouth
• blocked nose
• impaired sexual function in men
• painful, swollen breasts, or breast enlargement in men
• unusual secretion of breast milk
• changes in your menstrual periods
• swelling of your hands, feet and ankles

These side effects are usually mild.

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

• persistent painful erection
• rash, itching or flaking, peeling skin
• symptoms of sunburn (such as redness, itching, swelling or blistering of
  the skin) which occurs more quickly than normal
• yellowing of the skin and/or eyes
• changes in colour vision or difficulty in seeing at night
• fever
• tiredness, headaches, being short of breath when exercising, dizziness and
  looking pale
• bleeding or bruising more easily than normal
• difficulty passing urine
• fast or irregular heart beat
• red or painful eye
• agitation, confusion or nervousness
• mask-like faces, drooling, shaking, rigid muscles, walking stiffly

These may be serious side effects. You may need urgent medical attention.
Serious side effects are rare.

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

• 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 difficulty in breathing
• swelling of the face, lips, mouth, tongue or throat which may cause
  difficulty in swallowing or breathing
• sudden onset of uncontrollable muscle spasms affecting the eyes, head,
  neck and body
• uncontrollable twitching or jerking movements of the arms and legs
• sudden increase in body temperature, sweating, fast heart beat, muscle
  stiffness and fluctuating blood pressure which may lead to coma

These are very serious side effects. You may need urgent medical attention or
hospitalisation. All of these side effects are very rare.

Stop taking STELAZINE and tell your doctor immediately if you notice any
uncontrolled movements of the tongue, face, mouth or jaw, such as puffing of the
cheeks, puckering of the mouth or chewing movements. These are symptoms of a
very rare condition called tardive dyskinesia, which may develop in people
taking phenothiazine medicines, including STELAZINE.

This condition is more likely to occur during long term treatment with
STELAZINE, especially in elderly women. In very rare cases, this may be
permanent. However, if detected early, these symptoms are usually reversible.

Other side effects not listed above may occur in some patients. Tell your
doctor or pharmacist if you notice anything that is making you feel unwell.

You may notice some side effects after you have finished taking STELAZINE.

Do not be alarmed by this list of possible side effects. You may not
experience any of them.

AFTER USING STELAZINE

Storage

Keep your tablets in the bottle until it is time to take them. If you
take the tablets out of the pack they will not keep well.

Keep your tablets in a cool dry place.

Do not store STELAZINE or any other medicines in the bathroom or near a
sink.

Do not leave it in the car on hot days or on window sills. Heat and
dampness can destroy some medicine.

Keep it where children cannot reach it.

Disposal

If your doctor tells you to stop taking STELAZINE, or the tablets have
passed their expiry date, ask your pharmacist what to do with any tablets that
are left over.

PRODUCT DESCRIPTION

What it looks like

STELAZINE comes as:

• a 6.5mm blue round tablet containing 1mg trifluoperazine.
• a 7.3mm blue round tablet containing 2mg trifluoperazine.
• an 8.1mm blue round tablet containing 5mg trifluoperazine.
• a yellow/clear liquid containing 5mg of trifluoperazine in 5mL.

Other ingredients

STELAZINE tablets also contain inactive ingredients, calcium sulfate,
sucrose, maize starch, gelatin, talc, stearic acid, hypromellose, macrogol 400
and the colouring agents titanium dioxide and indigo carmine CI 73015.

STELAZINE liquid also contains inactive ingredients, sodium benzoate,
saccharin sodium, sodium chloride, sodium citrate, citric acid monohydrate,
glycerol, sorbitol, essence of bitter orange, and the colouring agent sunset
yellow FCF CI 15985.

STELAZINE liquid does not contain sugar.

STELAZINE tablets do not contain lactose, gluten, tartrazine.

FURTHER INFORMATION

STELAZINE tablets are only available if prescribed by a doctor.

• STELAZINE 1mg tablets come in packs of 100 tablets (AUST R66873 or AUST
  R71778).
• STELAZINE 2mg tablets come in packs of 100 tablets (AUST R66874 or AUST
  R71779).
• STELAZINE 5mg tablets come in packs of 100 tablets (AUST R66875 or AUST
  R71780).
• STELAZINE 5mg/5mL liquid comes in a bottle of 1L in Australia (AUST
  R13003).