Contains the active ingredient, Risperidone
Consumer Medicine Information
For a copy of a large print leaflet, Ph: 1800 195 055 1800 195 055
What is in this leaflet
Read this leaflet carefully before taking your medicine. Ask your doctor or pharmacist if you do not understand anything or are worried about taking your medicine.
This leaflet answers some common questions about risperidone.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the last page. Some more recent information on your medicine may be available. Speak to your pharmacist or doctor to obtain the most up-to-date information.
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
Keep this leaflet with your medicine. You may want to read it again.
What Risperidone is used for
The name of your medicine is Apo-Risperidone. It contains the active ingredient, risperidone.
It is used to treat:
1.Symptoms of schizophrenia and other types of related psychoses. These are conditions related to thoughts, feelings and/or actions.
Risperidone may be taken for both sudden (acute) and long-lasting (chronic) schizophrenia.
2.Acute mania associated with bipolar 1 disorder (short term treatment). People with this condition may have symptoms such as elevated, expansive or irritable mood, inflated self esteem, decreased need for sleep, pressured speech, racing thoughts, distractibility or poor judgment including disruptive or aggressive behaviours.
3.Behavioural problems in patients with a decline in mental ability (dementia). These problems include: aggression through words or action, morbid suspiciousness, agitation or wandering.
4.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.
5.Behavioural symptoms of autism in children and adolescents.
How it works
Risperidone helps to correct a chemical imbalance in the brain associated with these conditions.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed risperidone for another reason.
This medicine is available only with a doctor's prescription.
There is no evidence that this medicine is addictive.
Before you take Risperidone
When you must not take it
Do not take this medicine if you have had an allergic reaction to risperidone or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; muscle pain or tenderness or joint pain or rash, itching or hives on the skin.
Do not take this medicine 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 this medicine if the packaging is torn, shows signs of tampering or if it does not look quite right.
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 or pharmacist.
Before you start to take it
Tell your doctor if:
1.You have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
2.You have or have had any medical conditions, especially the following:
heart or blood vessel diseases including low blood pressure
kidney or liver problems
Dementia or Lewy body dementia
disease of the pituitary gland
disease of the blood vessels of the brain including stroke
tardive dyskinesia (a reaction to some medicines with uncontrollable twitching or jerking movements of the arms and legs)
Neuroleptic Malignant Syndrome (a serious reaction to some medicines with a sudden increase in body temperature, extremely high blood pressure and severe convulsions).
3.Tell your doctor if:
- you are pregnant or are planning to become pregnant.
Your doctor will advise you whether or not you should take risperidone.
- you are breast feeding or plan to breast feed.
Risperidone is excreted in breast milk. It is recommended that you do not breast-feed while taking risperidone.
If you have not told your doctor about any of the above, tell them before you start taking this medicine.
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.
Some medicines and risperidone may interfere with each other.
sleeping tablets, tranquillisers, pain-killers, antihistamines
medicines to treat Parkinson's disease or a tremor
medicines to treat epilepsy, e.g. carbamazepine
medicines to treat depression, panic disorder, anxiety or obsessive-compulsive disorder. For example fluoxetine and paroxetine may increase the level of risperidone in your blood. So tell your doctor if you start and/or stop taking fluoxetine or paroxetine
Diuretics. In studies in elderly patients with dementia where risperidone was compared with a dummy pill, the death rate was 3.1% with the dummy pill and slightly higher at 4% with risperidone. Taking risperidone with frusemide, a drug which is used to treat high blood pressure, or to treat swelling of parts of the body caused by the build-up of too much fluid, contributed to this difference, so this combination may be harmful. Tell your doctor if you are taking frusemide (e.g. LASIX, UREMIDE, UREX, FRUSID, FRUSEHEXAL)
medicines for your heart or blood pressure. Taking risperidonewith medicines which help heart problems or lower your blood pressure may make your blood pressure even lower
medicines to treat pre-menstrual dysphoric disorder
other medicines to treat mental illness or psychotic conditions
medicines to relieve severe nausea and vomiting
medicines which have an effect on the heart called QT prolongation.
These medicines may be affected by risperidone 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 can tell you if you are taking any of these medicines. They may also have more information on medicines to be careful with or avoid while taking risperidone.
Other interactions not listed above may also occur.
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 this medicine
Follow all directions given to you by your doctor or pharmacist carefully. They may be different to the information in this leaflet.
If you do not understand any written instructions, ask your doctor or pharmacist for help.
How much to take
Your doctor or pharmacist will tell you how many tablets you will need to take. This depends on your condition and whether or not you are taking any other medicines.
Risperidone 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).
It is very important that you take the correct amount of risperidone, 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.
Follow your doctor's instructions carefully and do not change or stop the required dosage without consulting your doctor first.
For Schizophrenia and Related Psychoses:
The usual starting dose of risperidone 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 long-term treatment, 4 to 6 mg per day is usually sufficient but your doctor will determine the dose most suitable for you.
Important note: never take more tablets than your doctor tells you to take.
The effects of high doses are not yet known. Please double check with your doctor if your doctor prescribes more than 5 mg twice a day.
Risperidone 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 Elderly Patients with Schizophrenia or Related Psychoses: For older patients a starting dose of 0.5 mg (0.5 mg tablet or half a 1 mg tablet) twice a day (in the morning and in the evening is usual). The dose may be increased by 0.5 mg twice daily to 1 to 2 mg twice a day (in the morning and in the evening).
Patients with Impaired Kidney and Liver Function: If you have kidney or liver disease a starting dose of 0.5 mg (0.5 mg tablet or half a 1 mg tablet) twice a day (in the morning and in the evening) is usual. The dose may be increased by 0.5 mg twice daily to 1 to 2 mg twice a day (in the morning and in the evening).
For Acute Mania:
The recommended starting dose is 2 mg once a day. This dose can be adjusted by dose increases of 1mg when needed every 24 hours. Most people feel better with doses between 2 mg and 6 mg a day. Your doctor may also decide you should take another drug called a mood stabiliser as well as risperidone.
For Behavioural Problems in People with Dementia:
The usual starting dose is 0.25 mg (half a 0.5 mg tablet) twice daily. This may 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 long-term treatment, 1 mg daily is the usual dose but your doctor will determine the dose most suitable for you.
For Disruptive Behaviour Disorders in Adults & Children:
For people who weigh 50 kg or more, the usual starting dose is 0.5 mg (0.5 mg tablet or half a 1 mg tablet) once a day. The dose may be increased by 0.5 mg once every two days, to the usual dose of 0.5 to 1.5 mg once a day.
For people who weigh less than 50 kg, the usual starting dose is 0.25 mg (half a 0.5 mg tablet) once a day. The dose may be increased by 0.25 mg once every two days, to the usual dose of 0.25 to 0.75 mg once a day.
Your doctor will advise you on how much risperidone you need.
Risperidone 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 (half a 0.5 mg tablet). On day 4, this dose can be increased to 0.5 mg.
For people weighing 20 kg or more the usual starting dose is 0.5 mg (0.5 mg tablet or half a 1 mg tablet). On day 4, this dose can be increased to 1 mg.
After 14 days, the doctor should check that the tablets are working. The doctor will say whether a bigger dose is needed if the tablets do not seem to be having the desired effect. Your doctor will advise you on how much risperidone you need.
In clinical trials, people with autism weighing less than 20 kg did not need more than 1.5 mg/day. People weighing over 20 kg did not need more than 2.5 mg of risperidone a day, and people weighing over 45 kg did not need more than 3.5 mg a day.
If you feel sleepy, then the doctor may split up your daily dose so that you take half of it in the morning and half in the evening.
How to take it
Swallow risperidone tablets with water or other liquid.
When to take it
Take it at about the same time each day. Taking your medicine at the same time each day will have the best effect. It will also help you remember when to take it.
It does not matter if you take it before, with or after food.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.
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.
If you forget to take risperidone for 5 days or more, tell your doctor before starting your medicine again.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 for Australia) for advice, or go to the Accident and Emergency Department at the nearest hospital, if you think that you or anyone else may have taken too much risperidone.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too much risperidone,you may experience drowsiness, sleepiness, excessive trembling, excessive muscle stiffness, increased heart rate, and/or very low blood pressure causing fainting or unconsciousness.
While you are taking Risperidone
Things you must do
Always follow your doctor's instructions carefully.
Your doctor will be happy to discuss any questions you may have about your treatment.
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking risperidone.
Tell your doctor immediately if you become pregnant.
Go to your doctor regularly for a check-up. Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.
Try to eat a moderate diet.
Risperidone can cause weight gain.
Pre-menopausal women should tell their doctor if they do not have a period for more than six months while taking risperidone.
Ask your doctor before taking any other medicines.
Risperidone can increase the effects of medicines which slow your reactions. Always ask your doctor or pharmacist before taking other medicines. These include herbal treatments and those bought in a pharmacy or supermarket.
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. You may feel light-headed or dizzy when you begin to take risperidone. This is because your blood pressure is falling suddenly. 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 gets worse or continues, talk to your doctor.
Things you must not do
Do not drink alcohol.
Risperidone can increase the effects of alcohol.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not take your medicine to treat any other complaints unless your doctor or pharmacist tells you to.
Do not stop taking your medicine, or change the dosage, without checking with your doctor.
Things to be careful of
Be careful while driving or operating machinery until you know how risperidone affects you.
Risperidone may cause dizziness, drowsiness or light-headedness in some people, especially after the first dose. Make sure you know how you react to risperidone before you drive a car, operate machinery, or do anything else that could be dangerous if you feel drowsy or dizzy.
Avoid excessive eating. There is a possibility of weight gain when taking Risperidone.
Side effects of Risperidone
All medicines may 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.
Risperidone is generally well tolerated and side effects are often hard to distinguish from the disease symptoms. You may need medical treatment if you get some of the side effects.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking risperidone.
Ask your doctor or pharmacist to answer any questions you may have.
Following is a list of possible side effects. Do not be alarmed by this list. You may not experience any of them.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
fever, chest or throat infection
increased or decreased appetite
restlessness in the legs
fall in blood pressure, particularly on standing. This will be apparent to you as light-headedness or dizziness that passes after a few seconds or after sitting down again.
hair loss, rash or other skin disorders
blocked nose, sinusitis, nose bleed
fast heart rate.
The above list includes the more common side effects. Most of these are mild.
The following may occur less often:
drowsiness, tiredness, listlessness, difficulty in concentrating, sleepiness, usually mild and short lasting may occur more often in children than in adults
breathing problems, cough
muscle or joint pain, swelling, stiffness or weakness
ear pain or ringing in the ears (tinnitus)
infections of the chest, ears, nail or urinary tract
indigestion, nausea, abdominal pain, constipation
sexual function disturbances
some loss of bladder control
dry, swollen or cracked lips
In the early stages of the treatment or when taking certain other medicines, in some people, blood pressure may decrease slightly and the heart beat increase causing dizziness. This usually goes away after a few days (see "Taking it for the first time").
After taking risperidone for a long time, some women may experience breast enlargement or get a discharge from the breasts. They may also experience irregular or heavy periods or absence of their periods. In men, breasts may enlarge slightly.
Tell your doctor as soon as possible if you notice any of the following:
significant changes in body temperature. This rise or fall in temperature is caused by a combination of several factors such as extreme cold or heat. It is very rare.
high blood sugar.
The symptoms of high blood sugar may be the need to urinate more often or feeling thirsty all the time.
twitching of the tongue, face, mouth and jaws. This may happen after taking risperidone for a long time
dark coloured urine
swelling of the ankles, feet or legs due to fluid build up
liver problems, yellow skin or eyes
These may be serious side effects. You may need medical attention. Most of these side effects are rare.
If any of the following happen, stop taking your medicine and either tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
high fever, stiff muscles, fast breathing, abnormal sweating or decreased mental alertness. Your body may not be reacting properly to the medicine
fast or irregular heart beat
loss of consciousness
in elderly patients with dementia, sudden weakness or numbness of the face, arms or legs, especially on one side, instances of slurred speech and stroke have been seen
over sensitivity (allergy). Symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; muscle pain or tenderness or joint pain or rash, itching or hives on the skin
in men, a prolonged and painful erection.
These are 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 may occur in some patients.
After taking this medicine
Keep your medicine in its original packaging until it is time to take them. If you take the tablets out of their original packaging they may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25 degrees C.
Do not store your medicine, 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.
If your doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, ask your pharmacist what to do with any medicine that is left over.
Where to go for further information
Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.
What Apo-Risperidone looks like
Apo-Risperidone 0.5 mg tablets:
Brownish-red, capsule-shaped film-coated tablets. Engraved "APO" on one side, "RI" score ".5" on the other side.
Blister pack of 20 tablets.
Apo-Risperidone 1 mg tablets:
White, capsule-shaped film-coated tablets. Engraved "APO" on oneside, "RI" score "1" on the other side.
Blister pack of 60 tablets.
Apo-Risperidone 2 mg tablets:
Light orange, capsule-shaped film-coated tablets. Engraved "APO" on one side, "RI" score "2" on the other side.
Blister pack of 60 tablets.
Apo-Risperidone 3 mg tablets:
Beige, capsule-shaped film-coated tablets. Engraved "APO" on oneside, "RI" score "3" on the other side.
Blister pack of 60 tablets.
Apo-Risperidone 4 mg tablets:
Light green, capsule-shaped film-coated tablets. Engraved "APO" on one side, "RI" score "4" on the other side.
Blister pack of 60 tablets.
Apo-Risperidone Tablets are intended for oral administration.
Each tablet contains 0.5 mg, 1 mg, 2 mg, 3 mg or 4 mg of risperidone.
It also contains the following inactive ingredients:
iron oxide red (0.5 mg)
sunset yellow FCF aluminium lake (2 mg)
iron oxide yellow (3 mg and 4 mg)
indigo carmine aluminium lake (4 mg).
This medicine is gluten-free, sucrose-free, tartrazine-free and other azo dyes-free.
Australian Registration Numbers
Apo-Risperidone 0.5 mg tablets (blister pack): AUST R 127606.
Apo-Risperidone 1 mg tablets (blister pack): AUST R 127608.
Apo-Risperidone 2 mg tablets (blister pack): AUST R 127610.
Apo-Risperidone 3 mg tablets (blister pack): AUST R 127612.
Apo-Risperidone 4 mg tablets (blister pack): AUST R 127615.
Apotex Pty Ltd
ABN 52 096 916 148
66 Waterloo Road
North Ryde NSW 2113
Apotex Pty Ltd is the licensee of the registered trade marks APO and APOTEX from the registered proprietor, Apotex Inc.
This leaflet was prepared in:
Published by MIMS/myDr March 2009
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