Consumer medicine information

Risperidone-GA

risperidone

Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the common questions about Risperidone-GA. 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 Risperidone-GA, ask your doctor or pharmacist. Your doctor and pharmacist have more information.

Keep this leaflet with your Risperidone-GA tablets. You may need to read it again.

What Risperidone-GA is used for

Risperidone-GA belongs to a group of medicines called antipsychotic agents which improve the symptoms of certain types of mental illness.

It is used for:

  • treatment of sudden (acute) and long-term (chronic) schizophrenia and other types of related psychoses. These are disorders related to thought, feeling and/or action.
  • treatment of behavioural problems in patients with a decline in mental ability (dementia). These problems include: aggression through words or action, morbid suspiciousness, agitation or wandering treatment of 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.

Risperidone-GA helps to correct a chemical imbalance in the brain associated with these conditions.

Risperidone-GA 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. It is only available with a doctor’s prescription.

Risperidone-GA is not addictive.

Before you use Risperidone-GA

When you must not use it

Do not use Risperidone-GA:

  • 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 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

Risperidone-GA should be used with caution in some patients:

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 Risperidone-GA together with medications to treat high blood pressure. So, if you need to use both Risperidone-GA and medications to reduce blood pressure, consult your doctor.

Risperidone-GA 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.

  • disease of the blood vessels of the brain, including stroke
  • dehydration
  • kidney or liver problems
  • Parkinson’s disease
  • dementia or Lewy body dementia
  • Epilepsy, seizures
  • low blood potassium levels (hypokalaemia)
  • low blood sugar
  • breast cancer
  • disease of the pituitary gland
  • diabetes
  • 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)
  • blood clots

Tell your doctor if you or someone else in your family has a history of blood clots. Blood clots in the lungs and legs have been seen in patients taking Risperidone-GA. Blood clots in the lungs can be fatal.

  • low white blood cell count

As dangerously low numbers of certain types of white blood cells needed to fight infection in your blood has been seen very rarely with patients taking Risperidone-GA, your doctor may check your white blood cell counts. Tell your doctor if you know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).

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-GA. 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.
  • You are breast feeding. Risperidone-GA is excreted in breast milk. It is recommended that you do not breast-feed while taking Risperidone-GA.

Taking other medicines

Risperidone-GA 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. Risperidone Watson can increase the effects of medicines which slow your reactions. These include herbal treatments and those bought in a pharmacy or supermarket.

In particular, tell your doctor if you are taking:

  • Diuretics like frusemide (trade names LASIX, UREMIDE, UREX, FRUSID, or FRUSEHEXAL),, a drug used to treat high blood pressure, or to treat swelling of parts of the body caused by the build-up of too much fluid, There is an increased risk of side effects or death in elderly people if frusemide is also taken with Risperidone-GA.
  • 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 Risperidone-GA in your blood.
  • Medicines to treat Parkinson’s disease or a tremor.
  • Medicines to treat epilepsy
  • Medicines to treat depression, panic or anxiety disorders, obsessive-compulsive disorder.

For example fluoxetine and paroxetine may increase the level of Risperidone-GA 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
  • Medicines to relieve severe nausea and vomiting
  • Other medicines to treat mental illness or psychotic conditions

Using Risperidone-GA

How much to take

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 than your doctor tells you to take.

The maximum daily dose of Risperidone-GA 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.

Risperidone-GA 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 Risperidone-GA 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 (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 (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 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 (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 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-GA you need.

Risperidone-GA 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.

When to take it

Risperidone-GA 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 Risperidone-GA either with or between meals.

How to take it

Swallow Risperidone-GA tablets with water or other liquid.

How long to take it

Continue taking the tablets for as long as your doctor tells you. Risperidone-GA helps control your condition, but does not cure it. Therefore you must take Risperidone-GA every day.

Do not stop taking it unless your doctor tells you to – even if you feel better.

If you forget to take Risperidone-GA

If you forget to take Risperidone-GA, 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 Risperidone-GA 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.

If you take too much (Overdose)

If you think you or anybody else has taken too much Risperidone-GA, 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 13 11 26 in Australia 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 Risperidone-GA

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. Risperidone-GA 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 Risperidone-GA.

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 Risperidone-GA. This condition is more likely to occur during long term treatment with Risperidone-GA, 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 Risperidone-GA. 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.

Things you must not do

Do not drink alcohol. Risperidone-GA can increase the effects of alcohol.

Things to be careful of

Be careful driving or operating machinery until you know how Risperidone-GA affects you. Risperidone-GA may cause dizziness or light-headedness in some people, especially after the first dose.

Make sure you know how you react to Risperidone-GA 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 Risperidone-GA.

Side Effects

All medicines can have side effects. Sometimes they are serious, but most of the time they are not. Risperidone-GA 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.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor as soon as possible if you do not feel well while you are using Risperidone-GA.

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:

Difficulty thinking or working because of:

  • sleeplessness
  • headache
  • trembling
  • drowsiness, tiredness, difficulty in concentrating

Behavioural changes such as:

  • agitation
  • anxiety

Joint or movement changes such as:

  • muscle stiffness
  • restlessness in the legs

Other changes such as:

  • weight gain
  • indigestion, nausea, abdominal pain, constipation
  • excessive thirst
  • frequent urination
  • unusual secretion of breast milk
  • breast swelling missed or irregular menstrual periods
  • involuntary movements of the tongue, face, mouth, jaws, arms, legs or trunk

These are mild side effects of Risperidone-GA 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:

Heart or blood pressure problems such as:

  • 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
  • faster heart rate, slowed heart rate, heart beat irregularities

Body temperature changes such as:

  • fever
  • abnormally high body temperature

These may be serious side effects of Risperidone-GA. You may need urgent medical attention.

Serious side effects are uncommon.

If any of the following happen, stop taking Risperidone-GA and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • rash, itching or hives on the skin; shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body. If you have them, you may have had a serious allergic reaction to Risperidone-GA.
  • sudden weakness or numbness of the face, arms, or legs, especially on one side, or instances of slurred speech (these are called mini-strokes)
  • in elderly patients with dementia, occurrence of following even for a short period time: sudden weakness or numbness of the face, arms or legs, especially on one side, instances of slurred speech and stroke

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.

After using Risperidone-GA

Storage

Keep Risperidone-GA tablets in a dry place where the temperature stays below 25°C.

Do not store Risperidone-GA tablets or any medicines in the bathroom or near a sink. Heat and dampness can destroy some medicines.

Keep the tablets where young children cannot reach them. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Do not use Risperidone-GA 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 Risperidone-GA if the appearance of the tablets has changed.

Disposal

Once you have finished using Risperidone-GA, ask your pharmacist what to do with any unused medicine.

Product Description

What it looks like

You can identify Risperidone-GA tablets by their colour and shape. This is important because there are 5 marketed strengths of Risperidone-GA, each containing a different amount of risperidone:

  • 0.5 red, round tablets marked “R” on one side and scored on the other.
  • 1 mg white, oblong scored tablets marked “R” “1” on the scored side.
  • 2 mg orange, oblong scored tablets marked “R” “2” on the scored side.
  • 3 mg yellow, oblong scored tablets marked “R” “3” on the scored side.
  • 4 mg green, oblong scored tablets marked “R” “4” on the scored side.

Ingredients

Active ingredient:

  • Risperidone

Excipients:

  • Lactose
  • Cellulose – microcrystalline
  • Starch – maize
  • Silica – colloidal anhydrous
  • Magnesium stearate
  • Hypromellose
  • Titanium dioxide
  • Macrogol 400
  • Iron oxide red (CI77491) – 0.5mg, 2mg
  • Quinoline yellow (CI47005) – 2mg, 3mg, 4mg
  • Indigotin CI73015 – 4mg

Risperidone-GA tablets are available in blister and bottle packs of 60 tablets.

Supplier

www.ascentpharma.com.au

Ascent Pharma Pty Ltd
151-153 Clarendon St
South Melbourne Vic 3205

For further information call 1800 554 414

Australian registration numbers
Blister packs:
0.5 mg AUST R 127764
1 mg AUST R 127770
2 mg AUST R 127779
3 mg AUST R 127787
4 mg AUST R 127862
*6mg AUST R 127875

Bottle packs:
0.5 mg AUST R 127769
1 mg AUST R 127775
*2 mg AUST R 127786
*3 mg AUST R 127788
*4 mg AUST R 127863
*6mg AUST R 127879

* Not marketed.

This leaflet was prepared in July 2013.

Published by MIMS October 2013