RIXADONE®
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
RIXADONE contains the active ingredient Risperidone. RIXADONE belongs to a group of
medicines called antipsychotic agents which improve the symptoms of certain types
of mental illness.
For more information, see Section 1. Why am I taking RIXADONE? in the full CMI.
Do not take if you have ever had an allergic reaction to risperidone 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 take RIXADONE? in the full CMI.
Some medicines may interfere with RIXADONE and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Swallow RIXADONE tablets with water or other liquid.
More instructions can be found in Section 4. How do I take RIXADONE? in the full CMI.
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking RIXADONE.
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.
Be careful during strenuous exercise or exposure to extreme heat. Try to drink plenty
of water.
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Things you should not do
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Do not take RIXADONE if the appearance of the tablet has changed.
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Driving or using machines
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Avoid driving or operating machinery until you are sure RIXADONE does not affects
your alertness.
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Drinking alcohol
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Do not drink alcohol. RIXADONE can increase the effects of alcohol.
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Looking after your medicine
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Keep your tablets in a cool, dry place where the temperature stays below 25°C.
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For more information, see Section 5. What should I know while taking RIXADONE? in the full CMI.
Like all medicines, RIXADONE can cause side effects. If you do experience any side
effects, most of them are minor and temporary. However, some side effects may need
medical attention and some may require urgent care.
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.
RIXADONE®
Active ingredient(s):
Risperidone
Consumer Medicine Information (CMI)
This leaflet provides important information about taking RIXADONE. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking RIXADONE.
Where to find information in this leaflet:
RIXADONE contains the active ingredient risperidone. RIXADONE belongs to a group of medicines called antipsychotic agents which improve
the symptoms of certain types of mental illness.
RIXADONE is taken for the:
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 disabled,
treatment of behavioural symptoms of autism in children and adolescents.
RIXADONE helps to correct a chemical imbalance in the brain associated with these
conditions.
RIXADONE has been approved for the uses mentioned above. However, your doctor may
prescribe it for another use.
Ask your doctor if you have any questions about why RIXADONE has been prescribed for
you.
RIXADONE is not addictive.
Do not take RIXADONE if:
you have an allergy to:
any medicine containing risperidone
any of the ingredients listed at the end of this leaflet
any other similar medicines
Some of the symptoms of an allergic reaction may include:
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
rash, itching or hives on the skin
Always check the ingredients to make sure you can take this medicine.
the expiry date printed on the pack has passed or 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 start taking RIXADONE, talk to your doctor.
Check with your doctor if you:
have or have had any other medical conditions, especially the following:
heart problems, particularly 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 or heart failure.
unusual excessive sweating or diarrhoea, dehydration or problems with your body temperature
regulation
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
older people)
dementia or Lewy body dementia - older people suffering dementia may be at increased
risk of stroke or death with RIXADONE
sugar diabetes - unusual thirst, tiredness, blurred vision, upset stomach or need
to urinate are common signs of high blood sugars
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)
breast cancer
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).
blood clots - 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.
have any eye surgery planned.
During an operation on the eye for cloudiness of the lens (cataract), the pupil (the
black circle in the middle of your eye) may not increase in size as needed. Also,
the iris (the colored part of the eye) may become floppy during surgery and that may
lead to eye damage. If you are planning to have an operation on your eye, make sure
you tell your eye doctor that you are taking this medicine.
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.
will be in a hot environment or do a lot of vigorous exercise.
RIXADONE may make you sweat less, causing your body to overheat.
take any medicines for any other condition.
RIXADONE should be taken with caution in some patients.
If you have not told your doctor or pharmacist about any of the above, tell them before
you start taking RIXADONE.
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 planning to become pregnant.
Your doctor will advise you whether you should take RIXADONE. Shaking, muscle stiffness
and/or weakness, sleepiness, agitation, breathing problems, or difficulty in feeding
may occur in newborns, if a mother has taken RIXADONE in the last trimester of her
pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
As RIXADONE is excreted in breast milk, it is recommended that you do not breast-feed
while taking the medicine.
Children and adolescents
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.
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
this group.
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.
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 RIXADONE and affect how it works. These include:
RIXADONE can enhance the effects of alcohol and medicines that reduce the ability
to react (e.g., sleeping tablets, "tranquillisers", strong painkillers, certain antihistamines,
certain antidepressants). So don’t drink alcohol and only take such medicines if your
doctor prescribes them.
Some medicines for treating Parkinson's disease or a tremor (dopamine agonists, e.g.
levodopa) may counteract RIXADONE.
medicines that increase the activity of the central nervous system (psychostimulants
such as methylphenidate).
other medicines to treat mental illness or psychotic conditions
if you are taking medicines for high blood pressure, consult your doctor, as taking
these medicines together with RIXADONE may cause the blood pressure to drop too low.
RIXADONE should be taken with caution when taking medications that may change the
electrical activity of the heart, such as but not restricted to: medicines for malaria,
heart rhythm disorders, allergies, other antipsychotics, antidepressants, water tablets
or other medicines affecting body salts (sodium, potassium, magnesium).
Taking RIXADONE with furosemide (frusemide), a medicine taken to treat conditions
such as heart failure, high blood pressure and fluid build-up. There is an increased
risk of side effects or death in older people if furosemide (frusemide) is also taken
with RIXADONE.
medicines to treat epilepsy.
Some medicines, when they are taken together with RIXADONE, may increase or decrease
the level of RIXADONE in your blood. Therefore, tell your doctor if you start and/or
stop taking any of the below medicines, since your doctor may need to change the dose.
Medicines that may
increase
the effect of RIXADONE include:
medicines to treat depression, panic disorder, anxiety or obsessive-compulsive disorder,
such as fluoxetine and paroxetine, sertraline and fluvoxamine;
medicines to treat fungal infections such as itraconazole and ketoconazole;
certain medicines taken in the treatment of HIV/AIDS, such as ritonavir and tipranavir;
verapamil, a medicine taken to treat high blood pressure and/or abnormal heart rhythm;
Medicines that may
reduce
the effect of RIXADONE include:
carbamazepine, a medicine mainly used for epilepsy or trigeminal neuralgia (severe
pain attacks in the face);
rifampicin, a medicine for treatment bacterial infections.
These medicines may be affected by RIXADONE or may affect how well it works. You may
need different amounts of your medicines, or you may need to take different medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect RIXADONE.
How much to take
Your doctor will decide the dose suitable for you. Do not change or stop the required
dosage without consulting your doctor first.
Important note: never take more tablets than your doctor tells you to take.
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
instructions.
For Elderly Patients with Schizophrenia or Related Psychoses
For older patients a starting dose of 0.5 mg twice a day is usual (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 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 once a day.
This may be gradually increased by your doctor to suit your needs.
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.
For Behavioural Disorders Associated with Autism in Children and Adolescents
For people weighing less than 20 kg the usual starting dose is 0.25mg. This may be
gradually increased by your doctor to suit your needs.
For people weighing 20 kg or more the usual starting dose is 0.5mg. This may be gradually
increased by your doctor to suit your needs.
Your doctor will advise you on how much RIXADONE you need.
Patients with impaired kidney and liver function
If you have kidney or liver disease a starting dose of 0.5 mg twice a day (in the
morning and in the evening) is usual. This may be gradually increased by your doctor
to suit your needs.
When to take RIXADONE
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.
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
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
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
if your next dose. Then go back to taking it as you would normally.
Do not take a double dose to make up for the dose 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
some hints.
If you take too much RIXADONE
If you think that you have or anyone else has taken too much RIXADONE, urgent medical
attention maybe needed.
You should immediately:
phone the Poisons Information Centre
(in Australia telephone 13 11 26), or
(in Australia telephone 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
Signs of overdose may include drowsiness, sleepiness, excessive trembling, excessive
muscle stiffness, increased heart rate, very low blood pressure causing fainting or
unconsciousness.
You should do this even if there are no signs of discomfort or poisoning.
Things you should do
Follow your doctor's instructions carefully and seek your doctor's advice before changing
or stopping treatment.
Be careful during strenuous exercise or exposure to extreme heat. Try to drink plenty
of water.
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.
Tell all doctors, dentists and pharmacists who are treating you that you are taking
RIXADONE.
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.
Call your doctor straight away if you:
notice any involuntary movements of the tongue, mouth, cheeks or jaw which may progress
to the arms and legs.
These may be 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
reversible.
Things you should not do
Do not take RIXADONE if the appearance of the tablets has changed. Driving or using
machines
Avoid driving or operating machinery until you are sure RIXADONE does not affect your
alertness.
RIXADONE may cause dizziness 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.
Looking after your medicine
Keep your tablets in the pack until it is time take them.
If you take the tablets out of the pack, they may not keep well.
Keep your tablets where the temperature stays below 25°C.
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.
Heat and dampness can destroy some medicines.
Keep it where young 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 take 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 take RIXADONE if the appearance of the tablets has changed.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
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.
Less serious side effects
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Less serious side effects
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What to do
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difficulty thinking, working or carrying out your usual daily activities because of:
headache
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
difficulty speaking
blurred vision
fainting
dizziness
any problems with confusion or unsteadiness
pains in parts of your body, e.g. in the neck, back, ear, hands or feet
falling
muscle, joint, nerve or movement changes such as:
shaking or trembling
fatigue or weakness
muscle stiffness
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
the body
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
sinusitis)
fever, chills, shortness of breath, cough, phlegm and occasionally blood (signs of
pneumonia)
nosebleeds
tiredness, headaches, being short of breath when exercising, dizziness and looking
pale (signs of decreased red blood cells)
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
drooling
difficulty swallowing
acne
dry skin
dandruff
rash, red skin or itchy skin
thickening of the skin resulting in warts, corns, calluses
skin infection
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
bedwetting
frequent daytime urination in children
sexual function disturbances - problems with ejaculation
breast abnormalities - breast discomfort or swelling or unusual secretion of breast
milk
missed or irregular menstrual periods
dizziness on standing up, especially when getting up from a sitting or lying down
position
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.
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Tell your doctor if you notice any of these less serious side effects and they worry
you.
These are mild side effects.
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Serious side effects
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Serious side effects
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What to do
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Hypersensitivity Reactions
severe or life-threatening rash with blisters and peeling skin that may start in and
around the mouth, nose, eyes, and genitals and spread to other areas of the body (Stevens-Johnson
syndrome or toxic epidermal necrolysis)
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 a serious allergic reaction to RIXADONE.
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:
fever
unexplained high body temperature, excessive sweating or rapid breathing
severe muscle stiffness or fits
Tardive dyskinesia
(uncontrollable twitching or jerking movements of the tongue, face, mouth, jaw, arms
and legs)
Other
sudden weakness or numbness of the face, arms, or legs, especially on one side, or
instances of slurred speech (these are called mini-strokes).
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Tell your doctor immediately, or go to the Emergency Department at your nearest hospital
if you notice any of these serious side effects.
These are very serious side effects.
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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.
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.
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 . 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.
This medicine is only available with a doctor's prescription.
What RIXADONE contains
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Active ingredient
(main ingredient)
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risperidone (0.5 mg, 1 mg, 3 mg, 3 mg and 4mg) per tablet
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Other ingredients
(inactive ingredients)
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lactose monohydrate
microcrystalline cellulose
pregelatinised maize starch
sodium lauryl sulfate
colloidal anhydrous silica
magnesium stearate
purified talc
hypromellose
propylene glycol
titanium dioxide
Additionally, the following tablet strengths also contain the following colouring
agents:
RIXADONE 0.5 mg
iron oxide black
iron oxide red
RIXADONE 2 mg
sunset yellow FCF aluminium
lake
RIXADONE 3 mg
quinoline yellow aluminium lake
RIXADONE 4 mg
quinoline yellow aluminium lake
indigo carmine aluminium lake
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Potential allergens
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egg products
sugars as lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What RIXADONE 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 (AUST R 199179).
RIXADONE 1 mg: White, round, biconvex, film coated tablet with break line on one side and debossed
"1" on the other side (AUST R 199178).
RIXADONE 2 mg: Orange, round, biconvex, film coated tablet with break line on one side and debossed
"2" on the other side (AUST R 199180).
RIXADONE 3 mg: Yellow, round, biconvex, film coated tablet with break line on one side and debossed
"3" on the other side (AUST R 199182).
RIXADONE 4 mg: Green, round, biconvex, film coated tablet with break line on one side and debossed
"4" on the other side (AUST R 199181).
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.
