Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions about RISPERDAL. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.
If you have any concerns about using RISPERDAL, ask your doctor or pharmacist. Your doctor and pharmacist have more information.
Keep this leaflet with your RISPERDAL tablets or solution. You may need to read it again. What RISPERDAL is used for RISPERDAL is used to treat symptoms of schizophrenia and other types of related psychoses. These are disorders related to thought, feeling and/or action. RISPERDAL may be taken for both sudden (acute) and long-lasting (chronic) schizophrenia. RISPERDAL is also used for the 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. RISPERDAL is also used to treat behavioural problems in patients with a decline in mental ability (dementia). These problems include: aggression through words or action, morbid suspiciousness, agitation or wandering RISPERDAL can be used to treat 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. RISPERDAL can also be used to treat behavioural symptoms of autism in children and adolescents RISPERDAL helps to correct a chemical imbalance in the brain associated with these conditions. RISPERDAL has been approved for the uses mentioned above. However, your doctor may prescribe this medicine for another use. If you want more information, ask your doctor. RISPERDAL is not addictive. Before you use RISPERDAL When you must not use it
Do not use RISPERDAL:
if you know you are allergic to any of its ingredients (signs of allergy include skin rash, itching, shortness of breath, and/or swollen face - see the last section of this leaflet for a list of ingredients)
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 use it
RISPERDAL should be used with caution in some patients.
1. Tell your doctor if you have or have ever had:
heart or blood vessel diseases, including low blood pressure.
Low blood pressure can result from using RISPERDAL together with medications to treat high blood pressure. So, if you need to use both RISPERDAL and medications to reduce blood pressure, consult your doctor.
RISPERDAL should be used with caution, and only after consultation with your doctor, if you have heart problems, particularly irregular heart rhythm, abnormalities in electrical activity of the heart, or if using medications that can change the heart's electrical activity.
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).
2. Tell your doctor if:
you are pregnant or are planning to become pregnant. Your doctor will advise you whether or not you should take RISPERDAL.
Shaking, muscle stiffness and difficulty in feeding, all of which are reversible, may occur in newborns, if a mother used RISPERDAL in the last trimester of her pregnancy
you are breast feeding. RISPERDAL is excreted in breast milk. It is recommended that you do not breast-feed while taking RISPERDAL.
3. Other medicines and alcohol
RISPERDAL can increase the effect of alcohol and other medicines which slow your reactions.
You should not drink alcohol while taking RISPERDAL. In studies in elderly patients with dementia where RISPERDAL was compared with a dummy pill, the death rate was 3.1% with the dummy pill and slightly higher at 4% with RISPERDAL. Taking RISPERDAL 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 (trade names LASIX, UREMIDE, UREX, FRUSID, or FRUSEHEXAL). 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, pain-killers, antihistamines
carbamazepine, a drug mainly used for epilepsy or trigeminal neuralgia (severe pain attacks in the face) may decrease the level of RISPERDAL in your blood.
medicines to treat Parkinson's disease or a tremor
medicines to treat epilepsy
medicines to treat depression, panic disorder, anxiety or obsessive-compulsive disorder. For example fluoxetine and paroxetine may increase the level of RISPERDAL in your blood. So tell your doctor if you start and/or stop taking fluoxetine or paroxetine.
medicines for your heart or blood pressure
medicines to treat pre-menstrual dysphoric disorder
other medicines to treat mental illness or psychotic conditions
medicines to relieve severe nausea and vomiting.
4. Elderly People
Elderly people should take less RISPERDAL than is prescribed for other adults (see "How to take it").
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.
Using RISPERDAL How to take it
RISPERDAL 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).
RISPERDAL tablets should be swallowed with water or other liquid. RISPERDAL QUICKLET orally-disintegrating tablets should be placed on the tongue. It begins disintegrating in the mouth within seconds and then can be swallowed with or without water. If you take with food, your mouth should be empty before placing the tablet on the tongue. RISPERDAL oral solution should be mixed with a non-alcoholic drink. Mineral water, orange juice, coffee and milk are suitable. Do not use tea. You may take RISPERDAL either with or between meals. It is very important that you take the correct amount of RISPERDAL, but this will vary from person to person. Your doctor will adjust the number and strength of the tablets or the amount of solution 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 RISPERDAL 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 milligrams per day is usually sufficient but your doctor will determine the dose most suitable for you. Important note:
never take more tablets or solution 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 milligrams twice a day. RISPERDAL 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 (or 0.5 mL of solution) 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 (or 0.5 mL of solution) 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 2mg 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 2mg and 6mg a day. Your doctor may decide you should take another drug called a mood stabiliser as well as RISPERDAL.
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.
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 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. 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 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 advice you on how much RISPERDAL you need. RISPERDAL 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 20kg the usual starting dose is 0.25mg. On day 4 this dose can be increased to 0.5mg.
For people weighing 20kg or more the usual starting dose is 0.5mg. On day 4 this dose can be increased to 1.0mg. Response should be assessed at day 14; only in patients not achieving sufficient clinical response should additional dose increases be considered. Your doctor will advice you on how much RISPERDAL you need. When trialled, the maximum dose in patients with autism did not exceed 1.5mg/day in patients weighing less than 20kg, 2.5mg in patients weighing more than or equal to 20kg or 3.5mg in patients weighing more than 45kg. Directions for opening the bottle and using the pipette for RISPERDAL Oral Solution
The bottle comes with a child-proof cap. To open, push the screw cap down while turning it anti-clockwise. Remove the unscrewed cap. Step 2:
Use the pipette from the container. While holding the bottom ring, pull the top ring up to the mark that corresponds to the dose you need. Step 3:
Holding the bottom ring, remove the entire pipette from the bottle. Empty the contents of the pipette into a non-alcoholic drink by sliding the upper ring down. Mineral water, orange juice, coffee and milk are suitable. Do not use tea. Rinse and dry the pipette after use and store it in its case. Close the bottle. Directions for RISPERDAL QUICKLET Orally-disintegrating Tablets
As the tablets are fragile, they should not be pushed through the foil as this will cause damage. Open blister by opening corner fold. After removal from its blister, the RISPERDAL QUICKLET orally-disintegrating tablets should be consumed immediately as it can not be stored once removed. Do not attempt to split the tablet.
If you forget to take RISPERDAL
If you forget to take RISPERDAL, 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 RISPERDAL for 5 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. Overdose
If you think you or anybody else has taken too much RISPERDAL, contact your doctor, pharmacist or the Poisons Information Centre who will advise you what to do.
You can contact the Poisons Information Centre by dialling:
Australia: 13 11 26
New Zealand: 0800 POISON or 0800 764 766.
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 RISPERDAL 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.
Try to eat a moderate diet. RISPERDAL 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 RISPERDAL.
Things to be careful of
Do not drink alcohol.
RISPERDAL can increase the effects of alcohol.
Ask your doctor before taking any other medicines. RISPERDAL 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.
Be careful driving or operating machinery until you know how RISPERDAL affects you. RISPERDAL may cause dizziness or light-headedness in some people, especially after the first dose. Make sure you know how you react to RISPERDAL before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy.
Avoid excessive eating, as there is a possibility of weight gain when taking RISPERDAL.
Side Effects All medicines can have side effects. Sometimes they are serious, but most of the time they are not. RISPERDAL 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 as soon as possible if you do not feel well while you are using RISPERDAL.
Below is a list of possible side effects you could get while taking RISPERDAL:
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.
fast heart rate
Although these effects are generally not harmful, contact your doctor if they bother you too much.
The following may occur less often:
drowsiness, tiredness, difficult in concentrating, somnolence, usually mild and short lasting may occur more often in children than in adults
indigestion, nausea, abdominal pain, constipation
sexual function disturbances
some loss of bladder control
After taking RISPERDAL for a long time, twitching of the tongue, face, mouth and jaws can occur. Should this happen contact your doctor.
In the early stages of treatment, in some people, blood pressure may decrease slightly and the heart beat increase resulting in dizziness. This usually goes away after a few days. (See "Taking it for the first time").
After taking RISPERDAL 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.
The following may occur rarely:
Oversensitivity (allergy). (See "When you must not use it").
In extremely rare cases, significant changes in body temperature may occur. This rise or fall in temperature is caused by a combination of several factors such as extreme cold or heat. Call your doctor if this happens.
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. If any of these should occur, even if for a short period of time, seek medical attention right away.
In very rare cases, high blood sugar has been reported. The symptoms of high blood sugar may be the need to urinate more often or feeling thirsty all the time. Contact your doctor if you experience any of these symptoms
IMPORTANT: If you experience high fever, stiff muscles, fast breathing, abnormal sweating or decreased mental alertness, contact your doctor immediately. Your body may not be reacting properly to the medicine.
Do not hesitate to report any other side effects to your doctor or pharmacist.
After using RISPERDAL Storage
Keep RISPERDAL tablets in a dry place where the temperature stays below 25 °C.
Keep RISPERDAL QUICKLET orally-disintegrating tablets below 30 °C. Keep RISPERDAL oral solution below 30 °C. The oral solution should not be refrigerated.
Do not store it or any medicines in the bathroom or near a sink. 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 use RISPERDAL 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 RISPERDAL if the appearance of the tablets or oral solution has changed.
Once you have finished using RISPERDAL, ask your pharmacist what to do with any unused medicine.
Product Description What it looks like
You can identify RISPERDAL Tablets by their colour and shape. This is important because there are 5 types of RISPERDAL, each containing a different amount of risperidone:
0.5 mg brownish red, oblong biconvex grooved tablets marked with "Ris 0.5" on the grooved side and "JANSSEN" on the other side.
1 mg white, oblong grooved tablets marked "Ris 1" on the grooved side.
2 mg orange, oblong grooved tablets marked "Ris 2" on the grooved side.
3 mg yellow, oblong grooved tablets marked "Ris 3" on the grooved side.
4 mg green, oblong grooved tablets marked "Ris 4" on the grooved side.
All strengths come in boxes of 60 tablets, except the 0.5 mg which comes in a box of 20 tablets. There are five kinds of RISPERDAL QUICKLET orally-disintegrating tablets containing different amounts of the medically active substance. You can identify the strength as follows.
0.5 mg light coral, round biconvex tablets marked "R0.5" on one side.
1 mg light coral, square biconvex tablets marked "R1" on one side.
2 mg coral, square biconvex tablets marked "R2" on one side.
3 mg coral, round, biconvex tablets marked "R3" on one side.
4 mg coral, round, biconvex tablets marked "R4" on one side.
The RISPEDAL QUICKLET orally-disintegrating tablets come in boxes of 28 tablets. RISPERDAL oral solution is a clear, colourless solution. It is packed in an amber bottle (30 or 100mL) with a pipette which measures the dose in milligrams (mg) and millilitres (mL). One full pipette contains 3 mL (or 3 mg) of oral solution. The smallest amount you can measure with the pipette is 0.25 mL. Ingredients
The active ingredient in RISPERDAL is risperidone.
RISPERDAL tablets contain either 0.5, 1, 2, 3 or 4 mg (milligrams) of risperidone. The tablets also contain lactose, maize starch, microcrystalline cellulose, hypromellose, magnesium stearate, colloidal anhydrous silica, sodium lauryl sulphate, propylene glycol. The 0.5 mg tablets also contain titanium dioxide, purified talc and red iron oxide. The 2 mg tablets also contain titanium dioxide, purified talc and sunset yellow (CI 15985). The 3 mg tablets also contain titanium dioxide, purified talc and quinoline yellow (CI 47005). The 4 mg tablets also contain titanium dioxide, purified talc, quinoline yellow (CI 47005) and indigo carmine (CI 73015). RISPERDAL QUICKLET orally-disintegrating tablets contain either 0.5, 1, 2 mg, 3 mg or 4 mg (milligrams) of risperidone. They also contain polacrillin, gelatin, mannitol, glycine, simethicone, carbomer, sodium hydroxide, aspartame, peppermint oil and red iron oxide. In addition, the 2 mg, 3 mg and 4 mg RISPERDAL QUICKLET orally-disintegrating tablets contain xanthan gum. Phenylketonuric patients should note RISPERDAL QUICKLET orally-disintegrating tablets contain aspartame. The oral solution contains 1 mg/mL of risperidone, as well as tartaric acid, benzoic acid, sodium hydroxide and purified water. Sponsor
Janssen-Cilag Pty Ltd
1-5 Khartoum Road North Ryde NSW 2113
Telephone: 1300 369 949
NZ Office: Auckland, New Zealand
Telephone: 0800 800 806
0.5mg Tablet AUST R 71849
1 mg Tablet AUST R 47008
2 mg Tablet AUST R 48486
3 mg Tablet AUST R 47010
4 mg Tablet AUST R 47011
0.5mg Quicklet® tablet AUST R 94192
1mg Quicklet® tablet AUST R 94193
2mg Quicklet® tablet AUST R 115461
3mg Quicklet® tablet AUST R 115467
4mg Quicklet® tablet AUST R 115469
1 mg/mL Oral Solution AUST R 56444
This leaflet was prepared on 26 November 2007.