contains the active ingredient risperidone
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some of the common questions about RIXADONE. It does not contain
all of the available information. It does not take the place of talking to your doctor
If you have any concerns about using RIXADONE, ask your doctor or pharmacist.
Your doctor and pharmacist have more information.
Keep this leaflet with your medicine.
You may need to read it again.
What RIXADONE is used for
RIXADONE belongs to a group of medicines called antipsychotic agents which improve
the symptoms of certain types of mental illness.
It is used for:
treatment of sudden (acute) and long-term (chronic) schizophrenia and other types
of related psychoses. These are disorders related to thought, feeling and/or action,
short term treatment of acute mania associated with bipolar 1 disorder. This condition
is characterised by symptoms such as elevated, expansive or irritable mood, inflated
self-esteem, decreased need for sleep, pressured speech, racing thoughts, distractibility
or poor judgement including disruptive or aggressive behaviours,
treatment of behavioural problems in patients with a decline in mental ability (dementia)
caused by Alzheimer's disease. These problems include: aggression through words or
action, morbid suspiciousness, agitation or wandering,
treatment of conduct and other disruptive behaviours such as aggression, impulsiveness
and self-injury in children (over 5 years old), adolescents and adults who are intellectually
treatment of behavioural symptoms of autism in children and adolescent.
RIXADONE helps to correct a chemical imbalance in the brain associated with these
This medicine has been approved for the uses mentioned above. However, your doctor
may prescribe it for another use. It is only available with a doctor's prescription.
If you want more information, ask your doctor.
RIXADONE is not addictive.
Before you take RIXADONE
When you must not take it
Do not use RIXADONE:
if you know you are allergic to any of its ingredients (see the last section of this
leaflet for a list of ingredients)
Signs of allergy include skin rash, itching, shortness of breath, and/or swollen face.
if the packaging is torn or shows signs of being tampered with
if the tablets or the oral solution do not look right
to treat any other complaints unless your doctor says it is safe to do so.
Before you start to take it
RIXADONE should be used with caution in some patients.
Tell your doctor if you have or have ever had any medical conditions, especially the
irregular heart rhythm, abnormalities in electrical activity of the heart, high or
low blood pressure, or you've had a heart attack or stroke in the past.
unusual excessive sweating or diarrhoea, dehydration or problems with your body temperature
kidney or liver problems
you are prone to dizziness when standing up from lying or sitting position
Parkinson's disease (a progressive movement and thinking disorder that tends to affect
dementia or Lewy body dementia. Older people suffering dementia may be at increased
risk of stroke or death with RIXADONE
unusual thirst, tiredness, blurred vision, upset stomach or need to urinate - common
signs of high blood sugar
epilepsy, seizures or fits
continuous and/or painful erections (called 'priapism')
involuntary movements or unusual restlessness or difficulty sitting still
suicidal thoughts or past suicide attempts
low blood potassium levels (hypokalaemia)
cancer of the pituitary gland
Tardive dyskinesia (a reaction to some medicines with uncontrollable twitching or
jerking movements of the tongue, face, mouth, jaw, arms and legs)
Neuroleptic Malignant Syndrome (a serious reaction to some medicines that causes sudden
increase in body temperature, very fast heartbeat, extremely high or low blood pressure
and severe muscle stiffness or fits).
Tell your doctor if you or someone else in your family has a history of blood clots.
Blood clots in the lungs and legs can occur with RIXADONE. Blood clots in the lungs
can result in death.
low white blood cell count
If you have low numbers of some white blood cells, your risk of contracting an infection
or developing a fever is increased with RIXADONE.
Tell your doctor if:
you have any eye surgery planned.
Your doctor will need to assess whether you are at risk of a surgical complication
(called 'Intraoperative Floppy Iris
Syndrome). You may be
recommended to stop your
RIXADONE temporarily prior to
your eye surgery.
you are pregnant or planning to become pregnant.
Your doctor will advise you whether you should take RIXADONE.
Newborn babies of mothers taking RIXADONE in their last trimester may be at risk of
having difficulty feeding or breathing, shaking, muscle stiffness and/or weakness,
sleepiness or agitation.
you are breast-feeding.
As RIXADONE is excreted in breast milk, it is recommended that you do not breast-feed
while taking the medicine.
you will be in a hot environment or do a lot of vigorous exercise.
RIXADONE 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 RIXADONE.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy
without a prescription from your pharmacy, supermarket or health food shop.
In particular, tell your doctor if you are taking:
sleeping tablets, tranquillisers, strong pain-killers, certain allergy medicines called
antihistamines, certain antidepressants and alcohol
medicines that increase the activity of the central nervous system (psychostimulants
such as methylphenidate)
medicines used to treat bacterial infections such as rifampicin
medicines to treat fungal infections such as itraconazole and ketoconazole
medicines to treat HIV/AIDS, such as ritonavir and tipranavir
other medicines to treat mental illness or psychotic conditions
medicines to treat depression, panic disorder, anxiety or obsessive-compulsive disorder,
such as fluoxetine, paroxetine, sertraline and fluvoxamine
medicines for your heart or blood pressure
verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm
frusemide, a medicine used to treat high blood pressure and fluid build-up.
There is an increased risk of side effects or death in older people if frusemide is
also taken with RIXADONE.
medicines to treat epilepsy
carbamazepine, a drug mainly used for epilepsy or trigeminal neuralgia (severe pain
attacks in the face)
medicines to treat Parkinson's disease or a tremor.
Taking it for the first time
At the start of treatment, you may have a fall in blood pressure making you feel dizzy
on standing up, or your heart may beat faster. These should go away after a few days.
Tell your doctor if they continue or worry you.
How to take RIXADONE
How much to take
Your doctor will decide the dose suitable for you.
Follow your doctor's instructions carefully and do not change or stop the required
dosage without consulting your doctor first.
Important note: never take more tablets or solution than your doctor tells you to
RIXADONE cannot be recommended for use in children with schizophrenia under 15 years
at the present time as there is little experience with the product in this group.
For Schizophrenia and Related Psychoses
The usual starting dose of RIXADONE is 1 mg twice a day. This will be gradually increased
by your doctor to suit your needs.
From then on, the dose can be taken once a day or twice a day according to your doctor's
For Elderly Patients with Schizophrenia or Related Psychoses
For older patients a starting dose of 0.5 mg (or 0.5 mL of solution) twice a day (in
the morning and in the evening is usual). This may be gradually increased by your
doctor to suit your needs.
Patients with impaired kidney and liver function.
If you have kidney or liver disease a starting dose of 0.5 mg (or 0.5 mL of solution)
twice a day (in the morning and in the evening) is usual. This may be gradually increased
by your doctor to suit your needs.
For acute mania
The recommended starting dose is 2 mg once a day. This may be gradually increased
by your doctor to suit your needs.
Your doctor may decide you should take another medicine called a mood stabiliser as
well as RIXADONE.
For Behavioural Problems in People with Dementia
The usual starting dose is 0.25 mg twice daily. This may be gradually increased by
your doctor to suit your needs.
For Disruptive Behaviour Disorders in Adults and Children
For people who weigh 50 kg or more, the usual starting dose is 0.5 mg (or 0.5 mL of
solution) once a day. This may be gradually increased by your doctor to suit your
For people who weigh less than 50 kg, the usual starting dose is 0.25 mg once a day.
This may be gradually increased by your doctor to suit your needs.
Your doctor will advise you on how much RIXADONE you need.
RIXADONE cannot be recommended for use in children with disruptive behaviour disorders
under 5 years at the present time as there is little experience with the product in
For Behavioural Disorders Associated with Autism in Children and Adolescents
For people weighing less than 20 kg the usual starting dose is 0.25 mg. This may be
gradually increased by your doctor to suit your needs.
For people weighing 20 kg or more the usual starting dose is 0.5 mg. This may be gradually
increased by your doctor to suit your needs.
Your doctor will advise you on how much RIXADONE you need.
When to take it
RIXADONE may be taken as a single dose, once a day or it may be taken in divided doses
twice a day (in the morning and in the evening). You may take RIXADONE either with
or between meals.
How to take it
Swallow RIXADONE tablets with water or other liquid.
It is very important that you take the correct amount of RIXADONE, but this will vary
from person to person. Your doctor will adjust the number and strength of the tablets
until the desired effect is obtained.
How long to take it for
Continue taking the tablets for as long as your doctor tells you.
RIXADONE helps control your condition but does not cure it. Therefore, you must take
RIXADONE every day.
Do not stop taking it unless your doctor tells you to - even if you feel better.
If you forget to take RIXADONE
If you forget to take RIXADONE, take the missed dose as soon as you remember instead
of your next dose. Then go back to taking it as you would normally.
Do not take a double dose to make up for the one you missed.
If you forget to take RIXADONE for a number of days or more, tell your doctor before
starting your medicine again.
If you have problems remembering when to take your medicine, ask your pharmacist for
If you take too much
Immediately telephone your doctor or the Poisons Information Centre or go to Accident
and Emergency at your nearest hospital, if you think that you or anyone else may have
taken too much RIXADONE. Do this even if there are no signs of discomfort or poisoning.
You can contact the Poisons Information Centre by dialling: Australia: 13 11 26
Signs of overdose may include drowsiness, sleepiness, excessive trembling, excessive
muscle stiffness, increased heart rate, very low blood pressure causing fainting or
While you are using RIXADONE
Things you must do
Always follow your doctor's instructions carefully and seek your doctor's advice before
changing or stopping treatment.
Your doctor will be happy to discuss any questions you may have with your treatment.
Tell all doctors, dentists, and pharmacists who are treating you that you are taking
You should make sure you are not pregnant. Tell your doctor that you are not pregnant
or if you are planning to become pregnant.
If you are pre-menopausal, tell your doctor if you do not have a period for more than
six months while taking RIXADONE, even if you are not pregnant.
Tell your doctor immediately if you notice any involuntary 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 can develop in
people taking antipsychotic medicines, including RIXADONE. This condition is more
likely to occur during longer term treatment and in older women. In very rare cases,
these symptoms may be permanent. However, if detected early, these symptoms are usually
Be careful during strenuous exercise or exposure to extreme heat. Try to drink plenty
Do not drink alcohol
RIXADONE can increase the effects of alcohol.
Things to be careful of
Ask your doctor or pharmacist before taking any other medicines.
RIXADONE can increase the effects of medicines which slow your reactions. Always ask
your doctor or pharmacist before taking other medicines, including herbal treatments
and medicines that can be bought in a pharmacy or supermarket.
Avoid driving or operating machinery until you are sure RIXADONE does not affect your
RIXADONE may cause dizziness or light-headedness in some people, especially after
the first dose. Make sure you know how you react to RIXADONE before you drive a car,
operate machinery, or do anything else that could be dangerous if you are dizzy.
If the medicine makes you feel light-headed, dizzy or faint, be careful when getting
up from a sitting or lying position.
Getting up slowly may help.
Avoid excessive eating.
There is a possibility of weight gain when taking RIXADONE. Your doctor may monitor
your body weight or recommend strategies to assist with weight management.
All medicines can have some unwanted side effects. Sometimes they are serious, but
most of the time they are not. Your doctor has weighed the risks of using this medicine
against the benefits they expect it will have for you.
All medicines can have side effects. 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 as soon as possible if you do not feel well while you
are taking RIXADONE.
Tell your doctor if you notice any of the following and they worry you:
difficulty thinking or working because of:
trembling, muscle weakness, unsteadiness on your feet, lack of coordination or slow,
shuffling walk (symptoms of Parkinsonism).
lack of energy, drowsiness or excessive sleeping during the day, sleeplessness or
difficulty in concentrating
any problems with confusion or unsteadiness
pains in parts of your body, e.g. in the neck, back, ear, hands or feet
muscle, joint, nerve or movement changes such as:
shaking or trembling
fatigue or weakness
restlessness in the legs or difficulty sitting still
uncontrolled muscle spasms, twitching, jerky or writhing movements
muscle aches or pain
joint swelling or pain
walking abnormally or with difficulty
abnormal posture, such as rigid body movements and persistent abnormal positions of
behavioural changes such as:
irritability or agitation
unusual anxiety or nervousness
other changes such as:
cold or "flu-like" symptoms e.g. cough, blocked or runny nose, sneezing, sore throat
feeling of tension or fullness in the nose, cheeks and behind your eyes, sometimes
with a throbbing ache, fever, stuffy nose and loss of the sense of smell (signs of
tiredness, headaches, being short of breath when exercising, dizziness and looking
pale (signs of decreased red blood cells)
fever, chills, shortness of breath, cough, phlegm and occasionally blood (signs of
discharge with itching of the eyes and crusty eyelids
unexplained weight gain
unexplained increase or decrease in appetite
indigestion, stomach discomfort or pain, diarrhoea or constipation
nausea or vomiting
dry mouth or excessive thirst
rash, red skin or itchy skin
thickening of the skin resulting in warts, corns, calluses
swelling of any part of your body, e.g. hands, ankles or feet
inability to or feeling burning pain when passing urine
some loss of bladder control
frequent daytime urination in children
sexual function disturbances - problems with ejaculation
breast abnormalities - breast discomfort or swelling or unusual secretion of breast
missed or irregular menstrual periods
dizziness on standing up, especially when getting up from a sitting or lying down
shortness of breath
chest pain or discomfort
an increase of CPK (creatine phosphokinase) in your blood, an enzyme which is sometimes
released with muscle breakdown.
These can only be detected by blood tests that your doctor may ask to be done.
These are mild side effects of RIXADONE but may require medical attention.
Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital
if you notice any of the following:
signs of heart or blood pressure problems including:
fainting, blurry vision, light-headedness or dizziness particularly on standing that
persists despite sitting or lying down again
very fast heart rate, slowed heart rate, heart rhythm irregularities
signs of lung problems including:
sudden shortness of breath, trouble breathing, wheezing or gasping when you breathe,
light-headedness or dizziness
signs of high blood sugar or diabetes such as:
unusual thirst, tiredness, upset stomach or need to urinate more often than usual
body temperature changes such as:
unexplained high body temperature, excessive sweating or rapid breathing
severe muscle stiffness or fits
involuntary movements of the tongue, face, mouth, jaw, arms, legs or trunk
rash, itching or hives on the skin; shortness of breath, wheezing or difficulty breathing;
swelling of the face, lips, tongue or other parts of the body.
If you have them, you may have had a serious allergic reaction to RIXADONE.
sudden weakness or numbness of the face, arms, or legs, especially on one side, or
instances of slurred speech (these are called mini-strokes)
These are very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may occur in some patients.
Do not hesitate to report any other side effects to your doctor or pharmacist.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
After taking RIXADONE
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack, they may not keep well.
Keep your tablets in a cool, dry place where the temperature stays below 25°C.
Do not store RIXADONE 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 it 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.
Do not use RIXADONE beyond the date (month and year) printed on the pack after the
letters "EXP", even if it has been stored properly.
Medicines cannot be stored indefinitely
Do not use RIXADONE if the appearance of the tablets has changed.
If your doctor tells you to stop taking RIXADONE or if it has passed the expiry date,
ask your pharmacist what to do with any medicine that is left over.
What it looks like
RIXADONE 0.5 mg: Red-brown, round, biconvex, film coated tablet with break line on
one side and debossed "0.5" on the other side.
RIXADONE 1 mg: White, round, biconvex, film coated tablet with break line on one side
and debossed "1" on the other side.
RIXADONE 2 mg: Orange, round, biconvex, film coated tablet with break line on one
side and debossed "2" on the other side.
RIXADONE 3 mg: Yellow, round, biconvex, film coated tablet with break line on one
side and debossed "3" on the other side.
RIXADONE 4 mg: Green, round, biconvex, film coated tablet with break line on one side
and debossed "4" on the other side.
RIXADONE 0.5 mg tablets are available in blister packs of 20 and 60 tablets.
RIXADONE 1 mg, 2 mg, 3 mg and 4 mg tablets are available in blister packs of 60 tablets.
RIXADONE tablets contain either 0.5 mg, 1 mg, 2 mg, 3 mg or 4 mg (milligrams) of risperidone
as the active ingredient.
The tablets also contain the following inactive ingredients:
pregelatinised maize starch
sodium lauryl sulfate
colloidal anhydrous silica
titanium dioxide (CI 77891)
Additionally, the following tablet strengths also contain the following colouring
RIXADONE 0.5 mg
iron oxide black (CI 77499)
iron oxide red (CI 77491)
RIXADONE 2 mg
sunset yellow FCF (CI 15985)
RIXADONE 3 mg
quinoline yellow (CI 47005)
RIXADONE 4 mg
quinoline yellow (CI 47005)
indigo carmine (CI 73015)
This medicine does not contain sucrose or gluten.
RIXADONE is supplied in Australia by:
Alphapharm Pty Limited
Level 1, 30 The Bond
30 - 34 Hickson Road
Millers Point NSW 2000
Australian registration numbers
RIXADONE 0.5 mg: AUST R 199179
RIXADONE 1 mg: AUST R 199178
RIXADONE 2 mg: AUST R 199180
RIXADONE 3 mg: AUST R 199182
RIXADONE 4 mg: AUST R 199181
This leaflet was prepared in June 2019.