Patient Medication Information: uses, side effects, how to take - Ratio-Risperidone
ABOUT THIS MEDICATION
What the medication is used for:
The doctor has prescribed ratio-RISPERIDONE, also known as risperidone, to help relieve the symptoms that are bothering you / the patient you are caring for. Although ratio-RISPERIDONE tablets cannot cure the illness, it can keep the symptoms under control and reduce the risk of relapse as you / the patient you are caring for continues treatment.
ratio-RISPERIDONE belongs to a group of medicines called antipsychotic drugs.
What it does:
ratio-RISPERIDONE belongs to a group of medicines called antipsychotic drugs.
Use in Schizophrenia
ratio-RISPERIDONE are used to treat the symptoms of schizophrenia and related psychotic disorders, which may include hallucinations (hearing or seeing things that are not there), delusions, unusual suspiciousness, emotional withdrawal. Patients suffering from schizophrenia may also feel depressed, anxious, or tense.
Use in Inappropriate Behaviour Associated with Severe Dementia ratio-RISPERIDONE may also be used for the short-term symptomatic management of behavioural disturbances such as verbal aggression (e.g., screaming, cursing) or physical aggression (e.g., kicking, hitting, biting, scratching, throwing things), as well as unusual suspiciousness and agitation in patients with severe dementia.
Use in Acute Mania Associated with Bipolar Disorder ratio-RISPERIDONE may be used for the acute treatment of manic episodes associated with bipolar disorder. Signs and symptoms of bipolar mania include but are not limited to: feeling invincible or all powerful, inflated self-esteem, racing thoughts, easily lose your train of thought, overreaction to what you see or hear, misinterpretation of events, speeded-up activity, talking very quickly, talking too loudly, or talking more than usual, decreased need for sleep, and poor judgment.
What it does
Antipsychotic medications affect chemicals that allow communication between nerve cells (neurotransmitters). These chemicals are called dopamine and serotonin. Exactly how risperidone works is unknown. However it seems to readjust the balance of dopamine and serotonin.
When it should not be used:
Do not take / give ratio-RISPERIDONE if an allergic reaction to the medicine or any of the non-medicinal ingredients of the product has occurred.
Symptoms of an allergic reaction may include: itching, skin rash, swelling of the face, lips or tongue, shortness of breath. If you experience any of these symptoms / if these symptoms are experienced by the patient you are caring for, your doctor / the treating physician should be contacted immediately.
What the medicinal ingredient is:
risperidone
What the important nonmedicinal ingredients are: ratio-RISPERIDONE (risperidone) tablets are available in 6 strengths containing 0.25, 0.5, 1, 2, 3 or 4 mg risperidone per tablet.
The following inactive ingredients are common to all tablet strengths: corn starch, lactose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulphate, starch, talc and titanium dioxide.
Colourants are present in the tablets as follows: 0.25 mg: yellow iron oxide
0.5 mg: red iron oxide
1 mg: none present
2 mg: FD&C Yellow #6 Aluminum Lake
3mg: D&C Yellow #10, Aluminum Lake
4mg: D&C Yellow #10, FD & C Blue #2 Aluminum Lake
What dosage forms it comes in:
ratio-RISPERIDONE (risperidone) tablets are available in 6 strengths containing 0.25, 0.5, 1, 2, 3 or 4 mg risperidone per tablet.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Studies with various medicines of the group to which risperidone belongs, when used in elderly patients with dementia, have been associated with an increased rate of death. Some of these studies included treatment with risperidone.
BEFORE you use ratio-RISPERIDONE talk to your doctor or pharmacist if ratio-RISPERIDONE you / the patient you are caring for:
$ have/has a history of stroke, mini-strokes, high cholesterol or high blood pressure;
$ have/has diabetes or a family history of diabetes; $ are /is pregnant or planning to become pregnant; $ are /is breast-feeding
$ have/has ever had blackouts or seizures;
$ have/has a history of kidney or liver problems; $ have/has a history of problems with the heart and/or blood
vessels;
$ are/is prone to hypotension;
$ have/ has Parkinson=s disease;
$ are /is taking or planning to take any other medicines
(prescription or over-the-counter medicines); $ drink/ drinks alcoholic beverages or use/uses drugs; $ have/has or have/has had breast cancer;
$ have/has pituitary tumours;
$ suffer/suffers from Alzheimer’s Disease;
$ are/is dehydrated
$ exercises/exercices strenuously.
Studies in elderly patients with dementia have shown that risperidone taken by itself or with furosemide is associated with a higher rate of death (see Serious Warnings and Precautions Box).
Tell your doctor if you are taking furosemide. Furosemide is a drug which is sometimes used to treat high blood pressure, some heart problems, or to treat swelling of parts of the body caused by the build-up of too much fluid.
In elderly patients with dementia, a sudden change in mental state or sudden weakness or numbness of the face, arms or legs, especially on one side, or instances of slurred speech have been seen. If any of these should occur, even for a short period of time, seek medical attention right away.
Shaking, muscle stiffness and difficulty in feeding, all of which are reversible, have been observed in newborns, if a mother used risperidone in the last trimester of her pregnancy.
It is important for the doctor to have all the above information before prescribing treatment and dosage. This list should be carefully reviewed by you / the caregiver and discussed with the doctor.
The safety and efficacy of risperidone in children under the age of 18 have not been established.
INTERACTIONS WITH THIS MEDICATION
Inform all doctors, dentists and pharmacists who are treating you that you are taking ratio-RISPERIDONE. Inform them if you are taking or are planning on taking any other medicine. They will tell you which medicines you can take with ratio-RISPERIDONE.
ratio-RISPERIDONE can increase the effect of alcohol and drugs that reduce the ability to react (e.g., Atranquillizers@, narcotic painkillers, certain antihistamines, certain antidepressants). It is recommended that you DO NOT drink alcohol and only take drugs prescribed by your doctor.
Dopamine agonists, e.g. levodopa (antiparkinsonian agent) may decrease the effect of ratio-RISPERIDONE.
Carbamazepine and topiramate (anticonvulsants) may change the effect of ratio-RISPERIDONE. Therefore, inform your doctor if you start or stop taking carbamazepine and/or topiramate.
Phenothiazines and some heart medications (e.g., medication for high blood pressure, antiarrhythmics, or β-blockers) may potentially interact with ratio-RISPERIDONE. Therefore, inform your doctor if you start or stop taking any of the above medications.
PROZAC7 (fluoxetine) and, PAXIL7 (paroxetine) (antidepressants) and CLOZARIL7 (clozapine) increase the level of risperidone in your blood. Therefore, tell your doctor if you start and/or stop taking PROZAC or PAXIL or CLOZARIL.
Studies in elderly patients with dementia have shown that taking risperidone with furosemide, a drug which is sometimes used to treat high blood pressure, some heart problems, or to treat swelling of parts of the body caused by the build-up of too much fluid, is associated with an increased rate of death. Tell your doctor if you are taking furosemide (see WARNINGS AND PRECAUTIONS).
PROPER USE OF THIS MEDICATION
Usual dose:
It is very important that you take / give ratio-
RISPERIDONE the way the doctor has prescribed it.
- The doctor has decided on the best dosage for you / the patient you are caring for based on individual needs. Dosage may be increased or decreased depending on the response.
- You may take / give ratio-RISPERIDONE together with meals or between meals. Once a regular dose has been established, the total amount can be taken once a day, or divided into two intakes, one in the morning and one in the evening.
- Try to take /give ratio-RISPERIDONE at the same time each day.
- ratio-RISPERIDONE should be swallowed with some water or other liquid.
It is important that you keep taking / giving ratio-
RISPERIDONE even after your / the symptoms have improved or disappeared. Do not change or stop taking / giving ratio-RISPERIDONE without consulting the doctor.
DO NOT give ratio-RISPERIDONE to anyone else. The doctor has prescribed it for you / the patient you are caring for.
Overdose:
If you take / give too much, immediately contact the doctor or go / take the patient to the nearest hospital emergency department. Do this even if there are no signs of discomfort.
One or more of the following signs may occur in an overdose: reduced consciousness, drowsiness, sleepiness, rapid heartbeat, excessive trembling or excessive muscle stiffness.
In the event of overdosage, contact your doctor, hospital emergency department or regional Poison Control Centre.
Missed Dose:
If you miss a dose, try not to miss any more. DO NOT TAKE / GIVE TWO DOSES AT ONCE.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like other medicines, ratio-RISPERIDONE can cause some side effects. These side effects are most likely to be minor and temporary. However, some may be serious and need medical attention. Many of the side effects are dose related, so it is important not to exceed your prescribed dose.
In patients with schizophrenia, the most common side effects of ratio-RISPERIDONE include the following:
- sleeplessness / sleepiness
- anxiety
trembling, decreased motor function or activity such as slight
muscle stiffness
- a feeling of restlessness (akathisia)
- dizziness
- headache
- runny nose
- constipation
- weight gain
- increased heart rate
In severely demented patients, the most common side effects of ratio-RISPERIDONE include the following:
- sleepiness
trembling, decreased motor function or activity such as slight
muscle stiffness
- a feeling of restlessness (akathisia)
- swelling of the ankles
- runny nose
- dizziness, lightheadedness
- difficulty breathing
- increased heart rate
In patients with bipolar disorder, the most common side effects of ratio-RISPERIDONE were:
- sleeplessness / sleepiness
trembling, decreased motor function or activity such as slight
muscle stiffness
- dizziness
- headache
- constipation
- anxiety
- weight gain
- nausea
heartburn
- increased salivation
ratio-RISPERIDONE may cause sudden dizziness or lightheadedness (symptoms of postural hypotension). You / the patient you are caring for should not rise rapidly after having been sitting or lying for prolonged periods, especially when you start taking ratio-RISPERIDONE.
In addition, the following undesired effects may occur in some cases: agitation, headache, dizziness.
Because some people experience drowsiness, you should not drive or operate machinery until you are reasonably certain that ratio-RISPERIDONE does not affect your ability to carry out these activities.
In women, medicines of this type may cause changes in the regularity of their monthly period or leakage of milk from the breast even if they are not pregnant. In some men, after prolonged treatment, there may be some diminished sexual function and breast enlargement may be experienced.
In rare cases, the following may happen: tiredness, concentration difficulties, blurred vision, indigestion, nausea, vomiting, abdominal pain, some loss of urine.
In very rare cases, high blood sugar has been reported. See your doctor if you experience symptoms, such as excessive thirst or urination.
Do not be alarmed by this list of possible side effects. You may not experience any of them. If any of these side effects are experienced, they are usually mild and temporary. However, do not hesitate to report any undesired side effects to your doctor.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | |||||
| HAPPEN AND WHAT TO DO ABOUT THEM | |||||
| Symptom / effect | Call your doctor right away | Stop taking drug and call your doctor or pharmacist | |||
Only if severe | In all cases | ||||
| Rare | |||||
| Symptoms of allergic reaction, such as itching, skin rash, swelling of the face, lips, or tongue, or shortness of breath. | T | ||||
| Very Rare | |||||
| A state of confusion, reduced consciousness, high fever, or pronounced muscle stiffness. | T | ||||
| Marked changes in body temperature (generally as a result of several factors together including extreme heat or cold). | T | ||||
Seek medical attention right away if the following occur while you or the patient you are caring for are/ is taking ratio-RISPERIDONE:
muscle twitching or abnormal movements of the face or
tongue
sudden change in mental state or sudden weakness or
numbness in the face, arms or legs, especially on one side, slurred speech or vision problems, even for a short period of time
- continuous erection of the penis
if you have taken ratio-RISPERIDONE in the last three
months of your pregnancy and you notice that your newborn baby develops shaking, muscle stiffness and difficulty in feeding. These symptoms can be reversible. Contact your doctor immediately.
This is not a complete list of side effects. For any unexpected effects while taking ratio-RISPERIDONE, contact your doctor or pharmacist.
HOW TO STORE IT
Store ratio-RISPERIDONE in its original package.
ratio-RISPERIDONE should be stored between 15 - 30 °C. Protect from light and moisture.
Keep ratio-RISPERIDONE out of the reach of children.
The expiry date for ratio-RISPERIDONE Tablets is printed on the package. Do not use the medicine in the package after this date.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
By toll-free telephone: 866-234-2345
By toll-free fax: 866-678-6789
Online: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness Information Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Tunney’s Pasture A.L. 0701C
Ottawa, ON K1A 0K9
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document provides you with the most current information at the time of printing.
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor,
ratiopharm inc.
17 800 Lapointe, Mirabel
Quebec, Canada, J7J 1P3
1-800-337-2584