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Consumer Medicine Information

RISPERDAL® Tablets
RISPERDAL QUICKLET® Orally-disintegrating Tablets
RISPERDAL® Oral Solution

Risperidone

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, distractability 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:

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.
    • dehydration
    • kidney or liver problems
    • Parkinson's disease
    • dementia or Lewy body dementia
    • epilepsy
    • breast cancer
    • disease of the pituitary gland
    • diabetes
    • 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 CONSTA 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.
    • diuretics
    • 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 <20kg, 2.5mg in patients ≥20kg or 3.5mg in patients >45kg.

Directions for opening the bottle and using the pipette for RISPERDAL Oral Solution

Step 1:

The bottle comes with a child-proof cap.

To open, push the screw cap down while turning it anti-clockwise. Remove the unscrewed cap.		 Opening the child-proof 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.		 Mark the dose you need.
Step3:

Holding the bottom ring, remove the entire pipette from the bottle.		 Remove the 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 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:

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

Things to be careful of

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:

Although these effects are generally not harmful, contact your doctor if they bother you too much.

The following may occur less often:

The following may occur rarely:

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.

Disposal

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:

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.

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:
Janssen-Cilag Pty Ltd
PO Box 9222
Newmarket
Auckland
New Zealand
Telephone: 0800 800 806

Registration Numbers

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.