Risperidone
Consumer Medicine Information
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 medicine. You may need to read it again.
Risperdal belongs to a group of medicines called antipsychotic agents which improve the symptoms of certain types of mental illness.
It is used for:
Risperdal helps to correct a chemical imbalance in the brain associated with these conditions.
This medicine has been approved for the uses mentioned above. However, your doctor may prescribe it for another use. If you want more information, ask your doctor. It is only available with a doctor's prescription.
Risperdal is not addictive.
Do not use RISPERDAL:
RISPERDAL should be used with caution in some patients.
Tell your doctor if you have or have ever had any medical conditions, especially the following:
Tell your doctor if you are pregnant or intend 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 uses the medicine in the last trimester of her pregnancy
Tell your doctor if you are breast-feeding. RISPERDAL is excreted in breast milk. It is recommended that you do not breast-feed while taking the medicine.
RISPERDAL can increase the effect of other medicines which slow your reactions.
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.
Ask your doctor or pharmacist before taking any other medicines. RISPERDAL can increase the effects of medicines which slow your reactions. These include herbal treatments and those bought in a pharmacy or supermarket.
Tell your doctor if you are taking:
Your doctor will decide the dose suitable for you.
Follow your doctor's instructions carefully and do not change or stop the required dosage without consulting your doctor first.
Important note: never take more tablets or solution than your doctor tells you to take.
The maximum daily dose of RISPERDAL is 5 milligrams taken twice a day. Check with your doctor if more than this has been prescribed. The effects of high doses are not yet known.
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 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.
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 advise 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 advise you on how much RISPERDAL you need. When trialled, the maximum dose in patients with autism did not exceed 1.5mg/day in patients less than 20kg, 2.5mg in patients 20kg or more, or 3.5mg in patients more than 45kg
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). You may take RISPERDAL either with or between meals.
Swallow RISPERDAL tablets with water or other liquid.
Mix RISPERDAL oral solution with a non-alcoholic drink. Mineral water, orange juice, coffee and milk are suitable. Do not use tea.
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.
Directions for opening the bottle and using the pipette for RISPERDAL Oral Solution
Step 1:
The bottle comes with a child-resistant 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.
Step 4:
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.
Step 5:
Rinse and dry the pipette after use and store it in its case. Close the bottle.
Continue taking the tablets for as long as your doctor tells you. RISPERDAL helps control your condition, but does not cure it. Therefore, you must take RISPERDAL every day.
Do not stop taking it unless your doctor tells you to - even if you feel better.
If you have problems remembering when to take your medicine, ask your pharmacist for some hints.
Immediately telephone your doctor or the Poisons Information Centre, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much RISPERDAL. Do this even if there are no signs of discomfort or poisoning.
You can contact the Poisons Information Centre by dialling:
Signs of overdose may include drowsiness, sleepiness, excessive trembling, excessive muscle stiffness, increased heart rate, very low blood pressure causing fainting or unconsciousness.
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.
You should make sure you are not pregnant.
Pre-menopausal women should tell their doctor if they do not have a period for more than six months while taking RISPERDAL.
Tell your doctor immediately if you notice any worm-like movements of the tongue, or other uncontrolled 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 may develop in people taking antipsychotic medicines, including RISPERDAL. This condition is more likely to occur during long term treatment with RISPERDAL, especially in elderly women. In very rare cases, this may be permanent. However, if detected early, these symptoms are usually reversible.
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking RISPERDAL.
Try to drink plenty of water, especially if you are elderly and taking frusemide (a diuretic). This will help decrease your risk of certain side effects.
Do not drink alcohol. RISPERDAL can increase the effects of alcohol.
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.
All medicines can have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.
All medicines can have side effects. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking RISPERDAL
You may need medical treatment if you get some of the side effects.
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 if you notice any of the following and they worry you:
These are mild side effects of RISPERDAL 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:
These may be serious side effects of RISPERDAL. You may need urgent medical attention.
Serious side effects are uncommon.
If any of the following happen, stop taking RISPERDAL and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
These are very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed above may occur in some consumers.
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.
Keep RISPERDAL tablets in a dry place where the temperature stays below 25°C.
Keep RISPERDAL oral solution below 30°C. The oral solution should not be refrigerated.
If your doctor tells you to stop taking RISPERDAL or if it has passed the expiry date, ask your pharmacist what to do with any that are left over.
RISPERDAL Tablets
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:
All strengths come in boxes of 60 tablets, except the 0.5 mg which comes in a box of 20 tablets.
RISPERDAL oral solution
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.
The active ingredient in RISPERDAL is risperidone.
RISPERDAL Tablets
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 oral solution
The RISPERDAL oral solution contains 1 mg/mL of risperidone, as well as tartaric acid, benzoic acid, sodium hydroxide and purified water.
Janssen-Cilag Pty Ltd
1-5 Khartoum Road Macquarie Park NSW 2113
Telephone: 1800 226 334
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
1 mg/mL Oral Solution - AUST R 56444
This leaflet was prepared in December 2016.
sku | 9317376730686 |
---|---|
Tax Class | Taxable Goods |
Refrigeration Required | No |
Manufacturer | Janssen-Cilag |
Poisons Schedule | S4 |
Flammable Goods | No |
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