NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
RIXADONE
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 or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking RIXADONE against the benefits they expect it will have for you.
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 disabled,
treatment of behavioural symptoms of autism in children and adolescent.
RIXADONE helps to correct a chemical imbalance in the brain associated with these conditions.
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.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
This medicine has been approved for the uses mentioned above. However, your doctor may prescribe it for another use.
RIXADONE is not addictive.
It is only available with a doctor’s prescription.
Before you take RIXADONE
When you must not take it
Do not use 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:
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
Do not take 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 start taking this medicine, talk to your doctor.
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 following:
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 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 – 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)
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.
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 or pharmacist 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
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 such as verapamil
Furosemide (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 furosemide (frusemide) is also taken with RIXADONE.
Medicines to treat epilepsy such as 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.
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.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
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
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/bottle, ask your doctor or pharmacist for help.
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 (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 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.
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.
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.
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 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 some hints.
If you take too much
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much [Medicine name]. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Signs of overdose may include drowsiness, sleepiness, excessive trembling, excessive muscle stiffness, increased heart rate, very low blood pressure causing fainting or unconsciousness.
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 RIXADONE.
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.
Tell your doctor 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 reversible.
Be careful during strenuous exercise or exposure to extreme heat. Try to drink plenty of water.
Do not drink alcohol
RIXADONE can increase the effects of alcohol.
Things to be careful of
Avoid driving or operating machinery until you are sure RIXADONE does not affect your alertness.
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.
Side effects
All medicines can have some unwanted side effects. Sometimes they are serious, but 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 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:
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)
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 pneumonia)
nosebleeds
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
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.
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:
fever
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
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 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 or pharmacist if you notice anything else that is making you feel unwell.
Other side effects not listed above 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.
After taking RIXADONE
Storage
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.
Disposal
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.
Product description
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.
Ingredients
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:
lactose monohydrate
microcrystalline cellulose
pregelatinised maize starch
sodium lauryl sulfate
colloidal anhydrous silica
magnesium stearate
purified talc
hypromellose
propylene glycol
titanium dioxide (CI 77891)
Additionally, the following tablet strengths also contain the following colouring agents:
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.
Sponsor
RIXADONE is supplied in Australia by:
Alphapharm Pty Ltd
Level 1, 30 The Bond
30 – 34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au
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 November 2020.
Rixadone_cmi\Nov20/00
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