Revised: 12 June 2015

Information for Consumers

Consumer Medicine Information

RIDAL

Risperidone 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, 6 mg film coated tablets

What is in this leaflet

This leaflet will answer some of the common questions about Ridal tablets. It does not contain all of the information available on this medicine and does not take the place of talking to your doctor or pharmacist.

If you have any concerns about using Ridal tablets, ask your doctor or pharmacist. Your doctor and pharmacist have more information.

Keep this leaflet with your Ridal tablets. You may want to read it again.

What are Ridal tablets used for

Ridal is used to treat symptoms of schizophrenia and other types of related psychoses. These are disorders related to thought, feeling and/or action.

This medicine is also used to treat behavioural problems in patients with a decline in mental ability (dementia). These problems include:

  • aggression through words or action
  • agitation
  • morbid suspiciousness
  • wandering

Ridal tablets help to correct a chemical imbalance in the brain associated with these conditions.

This medicine can also 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.

Ridal tablets may be taken for both sudden (acute) and long-lasting (chronic) schizophrenia.

Ridal can also be used for the treatment of autism in children and adolescents.

Ridal 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.

There is no evidence that Ridal tablets are addictive.

Before you use Ridal tablets

When you must not use it

Do not take Ridal tablets:

  • if you are allergic to the active ingredient or any other ingredients listed at the end of this leaflet.(signs of allergy include skin rash, itching, shortness of breath, and/or swollen face)
  • if the packaging is torn or shows signs of being tampered with.
  • if the tablets 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

Ridal tablets should be used with caution in some patients.

  1. Tell your doctor if you have or have ever had:
    • diseases of the heart or blood vessel, including high or low blood pressure
    • dehydration
    • Problems with your kidneys or liver
    • Parkinson's disease
    • Dementia or Lewy body dementia
    • Epilepsy
    • breast cancer
    • Pituitary gland disorders
    • Problems with blood vessels of the brain (including stroke)
    • Neuroleptic Malignant Syndrome (a serious reaction to medicines resulting in high blood pressure, high temperature and severe convulsions)
    • diabetes
    • a condition called tardive dyskinesia characterised by uncontrollable twitching or jerking of the arms or legs.
  2. Tell your doctor if:
    • you are pregnant or are planning to become pregnant
    • you are breast-feeding

    Your doctor will advise you whether or not you should take Ridal tablets.

  3. Other medicines and alcohol

    Do not drink alcohol while taking Ridal tablets.

    Ridal can increase the effects of alcohol and other medicines. This can slow your reactions.

    Tell your doctor if you are also taking any sleeping tablets, tranquillisers, antihistamines or any strong painkillers. Also tell your doctor if you have ever taken medicines for depression, especially paroxetine or fluoxetine. These two medicines may increase the level of risperidone in your blood.

    Also tell your doctor if you are taking medicines for:
    • Parkinson's disease or a tremor
    • epilepsy
    • diuretics, especially frusemide. It is possible that the combination of risperidone and frusemide may be harmful. Frusemide is also known as Lasix, Frusid, Frumil, Diurin or Apo-frusemide.
    • other medicines for your heart or blood pressure.
  4. Elderly People

    Elderly people are recommended to take smaller amounts of Ridal than what is prescribed for other adults (see " How to take it ").
Taking it for the first time

At the start of treatment your blood pressure may fall, making you feel dizzy on standing up. Your heart may also beat faster. These symptoms should go away after a few days. You must tell your doctor if it continues or if it worries you.

Using Ridal

How to take it

Ridal may be taken either 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. The tablets should be swallowed with water or other liquid. Ridal can be taken either with or between meals.

It is very important that you take the correct amount of Ridal, however 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 is 1 mg twice daily. Your doctor will gradually increase to the dose most suitable for you. From then on, the dose can be taken either once a day or twice a day according to your doctor's instructions. For long-term treatment, your doctor will determine the dose that is most suitable for you.

Never take more tablets than your doctor prescribes.

The effects of high doses are not known. You must check with your doctor if your doctor prescribes more than 8 milligrams twice a day.

Ridal 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

The starting dose for older patients is 0.5 mg twice daily in the morning and in the evening. This may be increased by 0.5 mg to 1 to 2 mg twice daily in the morning and in the evening as needed.

Patients with impaired kidney and liver function.

If you have kidney or liver disease, the usual starting dose is 0.5 mg twice daily in the morning and in the evening. This may be increased by 0.5 mg to 1 to 2 mg twice daily in the morning and in the evening as needed.

For Behavioural Problems in People with Dementia

The usual starting dose is 0.25 mg twice daily in the morning and evening. Your doctor may gradually increase this as needed.

From then on the dose can be taken once or twice daily according to your doctor's instructions. For long-term treatment, 1 mg daily is the usual dose however; your doctor will determine the most suitable dose 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 daily. The dose may then be increased by 0.5 mg once every two days, to the usual dose of 0.5 to 1.5 mg daily.

For people who weigh less than 50 kg, the usual starting dose is 0.25 mg( half of a 0.5mg tablet) daily. The dose may be increased by 0.25 mg once every two days, to the usual dose of 0.25 to 0.75 mg daily.

Your doctor will advise you on how much Ridal you need.

Ridal cannot be recommended for use in children under 5 years with disruptive behaviour disorders at the present time, as there is little experience with the product in this group.

If you forget to take Ridal
  • If you forget to take Ridal tablets, 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 missed dose
  • If you forget to take Ridal tablets for 5 days or more, you must 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 have or know anybody else has taken too much Ridal, you must contact your doctor, pharmacist or the Poisons Information Centre, who will advise you what to do.

You can contact the Poisons Information Centre by dialing free phone 0800 POISON or 0800 764 766 in New Zealand .

Signs of overdose may include drowsiness, sleepiness, excessive trembling, excessive muscle stiffness, increased heart rate and/or very low blood pressure causing fainting or unconsciousness.

While you are using Ridal

Things you must do
  • follow your doctor's instructions carefully
  • seek your doctor's advice before change or stop taking this medicine. Your doctor will be happy to discuss any questions you may have with your treatment.
  • It is recommended to eat a moderate diet. Ridal tablets are known to cause weight gain.
  • Pre-menopausal women should tell their doctor if they do not have a period for more than six months while taking Ridal tablets.
Things to be careful of
  • Do not drink alcohol since Ridal can increase the effects of alcohol.
  • Before taking any other medicines, discuss with your doctor or pharmacist. Ridal is known to increase the effects of medicines, which can slow your reactions. These include herbal treatments and those bought in a pharmacy or supermarket.
  • Be careful when driving or operating machinery until you know how Ridal affects you. Ridal can cause dizziness or light-headedness in some people, especially after the first dose. Make sure you know how you react to Ridal tablets 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 Ridal.

Side Effects

Tell your doctor as soon as possible if you do not feel well while you are using Ridal tablets

All medicines can have side effects. Some of these are serious, most of them are not. You may need medical treatment if you get some of the side effects.

Ridal is generally well tolerated and side effects are often hard to distinguish from the disease symptoms.

Below is a list of possible side effects you could get while taking Ridal tablets:

  • agitation
  • feeling anxious
  • trembling
  • unable to sleep
  • headache
  • stiff muscle
  • restless legs
  • excessive saliva
  • fast heart rate
  • fall in blood pressure, particularly on standing. This will be felt by you as light-headedness or dizziness that passes after a few seconds or after sitting down again.

These are the more common side effects seen when taking Ridal tablets and are generally not harmful however do contact your doctor if they bother you too much.

The following symptoms may occur less often:

  • excessive thirst
  • weight gain
  • some loss of bladder control
  • drowsiness, tiredness, difficult in concentrating
  • somnolence, usually mild and short lasting may occur more often in children than in adults
  • blurred vision
  • dizziness
  • indigestion, nausea, abdominal pain, constipation
  • changes in sexual function
  • blocked nose
  • twitching of the tongue, face, mouth and jaws can occur if you have been on a long treatment, (you must contact your doctor if you experience this)
  • After taking Ridal 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:

  • allergic reaction (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. If this happens, you must contact your doctor.
  • In elderly patients with dementia, sudden weakness or numbness of the face, arms or legs, especially on one side as well as 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. Symptoms may be the need to urinate more often or feeling thirsty all the time. If you experience any of these symptoms, you must contact your doctor

IMPORTANT: If you experience high fever, stiff muscles, fast breathing, abnormal sweating or decreased mental alertness, you must 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.

Storage Conditions

Keep your tablets in the original container until it is time to take them. If you leave the tablets out of the original container, they will not keep well.

Keep Ridal tablets in a dry place where the temperature stays below 25°C.

  • Do not store Ridal tablets or any other medicine in the bathroom or near a sink. Do not leave it in the car or on a windowsill.
    Heat and dampness can destroy medicines.
  • Always keep the tablets out of reach of young children.
    A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Do not use Ridal tablets beyond the expiry date even if it has been stored properly .

Medicines cannot be stored indefinitely.

  • Do not use Ridal if the appearance of the tablets has changed.
Disposal

If your doctor tells you to stop taking this medicine or if the tablets have passed the expiry date, ask your pharmacist what to do with any that are left over.

Product Description

What it looks like

You can identify Ridal Tablets by their colour and shape. This is important because there are 6 types of tablet, each containing a different amount of risperidone:

  • 0.5 mg - Red, round tablets engraved with "R" on one face and a breakline on the other.
  • 1 mg - White, oblong scored tablets engraved with "R", a breakline and "1" on one face and plain on the other.
  • 2 mg - Orange, oblong tablets engraved with "R", a breakline and "2" on one face and plain on the other.
  • 3 mg - Yellow, oblong tablets engraved with "R", a breakline and "3" on one face and plain on the other.
  • 4 mg - Green, oblong tablets engraved with "R", a breakline and "4" on one face and plain on the other.
  • 6 mg - Yellow, oblong tablets engraved with "R", a breakline and "6" on one face and plain on the other.
Ingredients

The active ingredient in Ridal is risperidone.

The tablets contain 0.5, 1, 2, 3, 4 or 6 mg (milligrams) of risperidone.

The 0.5 mg tablets also contain lactose, cellulose-microcrystalline, starch-maize, silica- colloidal anhydrous, magnesium stearate, water-purified, hypromellose, titanium dioxide, Macrogol 400, and iron oxide red CI77491.

The 1 mg tablets also contain lactose, cellulose-microcrystalline, starch-maize, silica- colloidal anhydrous, magnesium stearate, water-purified, hypromellose, titanium dioxide, and Macrogol 400.

The 2 mg tablets also contain lactose, cellulose-microcrystalline, starch-maize, silica- colloidal anhydrous, magnesium stearate, water-purified, hypromellose, titanium dioxide, Macrogol 400, iron oxide red CI77491, and quinoline yellow CI47005.

The 3 mg tablets also contain lactose, cellulose-microcrystalline, starch-maize, silica- colloidal anhydrous, magnesium stearate, water-purified, hypromellose, titanium dioxide, Macrogol 400, and quinoline yellow CI47005.

The 4 mg tablets also contain lactose, cellulose-microcrystalline, starch-maize, silica- colloidal anhydrous, magnesium stearate, water-purified, hypromellose, titanium dioxide, Macrogol 400, quinoline yellow CI47005 and eurolake indigo carmine CI73015.

The 6 mg tablets also contain lactose, cellulose-microcrystalline, starch-maize, silica- colloidal anhydrous, magnesium stearate, water-purified, hypromellose, titanium dioxide, Macrogol 400, and quinoline yellow CI47005.

If you want to know more

Should you have any questions regarding this product, please contact your doctor or pharmacist

Supplier

Douglas Pharmaceuticals Limited,
P O Box 45 027,
Lincoln,
Auckland 0651

Telephone: (09) 835 0660

Date of information
4 December 2006

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