Risperidone Generichealth Tablets

Risperidone Generichealth Tablets is a brand of medicine containing the active ingredient risperidone.

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

RISPERIDONE GENERICHEALTH


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Risperidone generichealth.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Your doctor and pharmacist have more information.

Keep this leaflet with the medicine. You may need to read it again.

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What Risperidone generichealth is used for

Risperidone generichealth belongs to a group of medicines called antipsychotic agents which improves the symptoms of certain types of illness.

It is used for:

  • treatment of sudden (acute) and long term (chronic) f schizophrenia and other types of related psychoses. These are disorders related to thought, feeling and/or action.
  • 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.
  • 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. Treatment of behavioural symptoms of autism in children and adolescents.

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

Risperidone generichealth 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 generichealth is not addictive.

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Before you use Risperidone generichealth

When you must not use it

Do not use Risperidone generichealth:

  • 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 generichealth should be used with caution in some patients.

Tell your doctor if you have or have ever had any medical conditions, especially the following:

  • heart or blood vessel problems, including low blood pressure. Low blood pressure can results from using Risperidone generichealth together with medications to treat high blood pressure. So, if you need to use both Risperidone generichealth and medications to reduce blood pressure, consult your doctor. Risperidone generichealth 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 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
  • restlessness or difficulty sitting still
  • intraoperative iris syndrome (a complication that may occur during cataract extraction)
  • suicide
  • low blood potassium levels (hypokalaemia)
  • low blood sugar
  • 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)
  • Blood clot
    Tell your doctor if you or someone else in your family has a history of blood clots. Blood clots in the lung and legs have been seen in patients taking risperidone. Blood clot in the lung 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, 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 generichealth.
  • you are breast-feeding. Risperidone generichealth is excreted in breast milk. It is recommended that you do not breast-feed while taking Risperidone generichealth.

Taking other medicines

Risperidone generichealth 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 generichealth 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:

  • 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 generichealth.
  • 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 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 risperidone 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.

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Using Risperidone generichealth

How much to take

Your doctor will decide the dose suitable for you.

Follow your doctor’s instruction carefully and do not change or stop the required dosage without consulting your doctor first.

Important note: never take more tablets than your doctor tell you to take.

The maximum daily dose of Risperidone generichealth is 5 milligrams taken twice daily. Check with your doctor if more than this has been prescribed. The effects of high doses are not yet known.

Risperidone generichealth cannot be recommended for 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 generichealth 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 mg 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 acute mania
The recommended starting dose is 2 mg once a day. This dose can be adjusted by dose increases of 1 mg when needed every 24 hours. Most people feel better with doses between 2 mg and 6 mg a day. Your doctor may decide you should take another drug called a mood stabiliser as well as Risperidone generichealth.

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 generichealth you need.

Risperidone generichealth 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 20 kg or less the usual starting dose is 0.25 mg. On day 4 this dose can be increased to 0.5 mg.

For people weighing more than 20 kg the usual starting dose is 0.5 mg. On day 4 this dose can be increased to 1.0 mg.

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 Risperidone generichealth you need. When trialled, the maximum dose in patients with autism did not exceed 1.5 mg/day in patients <20 kg, 2.5 mg in patients >20 kg or 3.5 mg in patients >45 kg.

When to take it

Risperidone generichealth 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 generichealth either with or between meals.

How to take it

Risperidone generichealth should be swallowed with water or other liquid.

It is very important that you take the correct amount of Risperidone generichealth, but 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.

How long to take it

Continue taking the tablets for as long as your doctor tells you.

Risperidone generichealth helps control your condition, but does not cure it. Therefore you must take Risperidone generichealth every day.

Do not stop taking it unless your doctor tell you to - even if you feel better.

If you forget to take it

  • If you forget to take Risperidone generichealth, take the missed dose as soon as you remember instead of your next dose. Then continue 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 generichealth 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

Immediately telephone your doctor or pharmacist or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Risperidone generichealth. Do this even if there are no signs of discomfort or poisoning.

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

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While you are using Risperidone generichealth

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 generichealth 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 generichealth.

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

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 generichealth can increase the effects of alcohol.

Things to be careful of

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

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Side effects

All medicines can have side effects. Sometimes they are serious, but most of the time they are not. Your doctor has weighed the risks of using this medicine aginst 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 Risperidone generichealth.

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:

  • 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
    - blockage in the bowel
    - unusual secretion of breast milk
    - breast swelling
    - missed or irregular periods
    - involuntary movements of the tongue, face, mouth, jaw, arms, legs or trunk

These are mild side effect of Risperidone generichealth 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 generichealth. You may need urgent medical attention.

Serious side effects are uncommon.

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

  • rash, itching or hives on the skin; shortness of breath, wheezing or difficult breathing; swelling of the face, lips, tongue or other part of the body. If you have them, you may have serious reaction allergic reaction to Risperidone generichealth
  • sudden weakness or numbness of the face, arms, or legs, especially on one side, or instances of slurred speech (these are called mini-stroke)
  • in elderly patients with dementia, occurrence of the 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.

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After using Risperidone generichealth

Storage

Keep Risperidone generichealth in a dry place where the temperature stays below 25°C.

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 Risperidone generichealth 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 generichealth if the appearance of the tablets has changed.

Disposal

If your doctor tells you to stop taking Risperidone generichealth or if it has passed the expiry date, ask your pharmacist what to do with any that are left over.

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Product description

What it looks like

Risperidone generichealth is available in four different strengths.

  • Risperidone generichealth 1 mg - white, capsule-shaped, biconvex film-coated tablets, debossed with ‘1’ on one side and scoreline on the other side.
  • Risperidone generichealth 2 mg-orange, capsule-shaped, biconvex film-coated tablets, debossed with ‘2’ on one side and scoreline on the other side.
  • Risperidone generichealth 3 mg - dark yellow, capsule-shaped, biconvex film-coated tablets, debossed with ‘3’ on one side and scoreline on the other side.
  • Risperidone generichealth 4 mg - red brown, capsule-shaped, biconvex film-coated tablets, debossed with ‘4’ on one side and scoreline on the other side.

Ingredients

Active Ingredients

  • Risperidone generichealth 1 mg contains 1 mg risperidone
  • Risperidone generichealth 2 mg contains 2 mg risperidone
  • Risperidone generichealth 3 mg contains 3 mg risperidone
  • Risperidone generichealth 4 mg contains 4 mg risperidone

Inactive Ingredients
The 1 mg tablets contain:

  • lactose
  • pregelatinised maize starch
  • microcrystalline cellulose
  • magnesium stearate
  • colloidal anhydrous silica
  • sodium lauryl sulphate
  • purified talc
  • hypromellose(E464)
  • titanium dioxide(E171)
  • propylene glycol(E1520).

The 2 mg tablets contain:

  • lactose
  • pregelatinised maize starch
  • microcrystalline cellulose
  • magnesium stearate
  • colloidal anhydrous silica
  • sodium lauryl sulphate
  • purified talc
  • hypromellose (E464)
  • titanium dioxide (E171)
  • propylene glycol (E1520)
  • FD and C yellow # 6/sunset yellow FCF
  • Aluminum lake (E110).

The 3 mg tablets contain:

  • lactose
  • pregelatinised maize starch
  • microcrystalline cellulose
  • magnesium stearate
  • colloidal anhydrous silica
  • sodium lauryl sulphate
  • purified talc
  • hypromellose (E464)
  • iron oxide yellow (E172)
  • titanium dioxide (E171)
  • propylene glycol (E1520).

The 4 mg tablets contain:

  • lactose
  • pregelatinised maize starch
  • microcrystalline cellulose
  • magnesium stearate
  • colloidal anhydrous silica
  • sodium lauryl sulphate
  • purified talc
  • hypromellose (E464)
  • titanium dioxide(E171)
  • propylene glycol (E1520)
  • iron oxide red (E172)

Risperidone generichealth does not contain gluten, sucrose, tartrazine or any other azo dyes.

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CMI provided by MIMS Australia, October 2014  

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