Details for: TEVA-RISPERIDONE
Company: TEVA CANADA LIMITED
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02282690 | TEVA-RISPERIDONE | RISPERIDONE | 0.25 MG | TABLET | ORAL |
02264196 | TEVA-RISPERIDONE | RISPERIDONE | 1.0 MG | TABLET | ORAL |
02264218 | TEVA-RISPERIDONE | RISPERIDONE | 2.0 MG | TABLET | ORAL |
02264226 | TEVA-RISPERIDONE | RISPERIDONE | 3.0 MG | TABLET | ORAL |
02264234 | TEVA-RISPERIDONE | RISPERIDONE | 4.0 MG | TABLET | ORAL |
Summary Reports
Summary Safety Review - Atypical antipsychotics - Assessing the Potential Risk of Urinary Retention
Summary Safety Review - Atypical Antipsychotics - Liver failure
Summary Safety Review - Atypical antipsychotics - Assessing the potential risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Risperidone belongs to a group of medicines called antipsychotic drugs.
Use in Schizophrenia
TEVA-RISPERIDONE (risperidone) is 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 Severe Dementia Related to Alzheimers
Disease
TEVA-RISPERIDONE (risperidone) may also be used
for short-term treatment in dementia related to
Alzheimer’s disease, specifically to control aggression
or psychotic symptoms (such as believing things that
are not true or seeing, feeling or hearing things that are
not there) when there is a risk of harm to self or others
Use in Acute Mania Associated with Bipolar Disorder
TEVA-RISPERIDONE (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.
The doctor has prescribed TEVA-RISPERIDONE (risperidone), to help relieve the symptoms that are bothering you/the patient you are caring for. Although TEVA-RISPERIDONE (risperidone) 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.
What it does
Antipsychotic medications affect the chemicals that allow communication between nerve cells (neurotransmitters). These chemicals are called dopamine and serotonin. Exactly how TEVARISPERIDONE (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 TEVA-RISPERIDONE (risperidone) if an allergic reaction to the medicine or any of the nonmedicinal 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.
The safety and efficacy of TEVA-RISPERIDONE in children under the age of 18 have not been established.
What the medicinal ingredient is
Risperidone
What the non-medicinal ingredients are
The following inactive ingredients are common to all tablet strengths: colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide.
Colourants are present in the tablets as follows:
0.25 mg: | Iron Oxide Yellow and Polysorbate 80. |
0.5 mg: | Iron Oxide Red and Iron Oxide Yellow. |
1 mg: | none present |
2 mg: | Iron Oxide Red and Iron Oxide Yellow |
3 mg: | Quinoline Yellow Aluminum Lake. |
4 mg: | FD&C Blue #2, Iron Oxide Yellow and Quinoline Yellow Aluminum Lake. |
What dosage form it comes in
TEVA-RISPERIDONE (risperidone) tablets are available as 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg risperidone.
Warnings and precautions
Serious Warnings and Precautions Increased Risk of Death in Elderly People with Dementia.
Medicines like TEVA-RISPERIDONE can raise the risk of death in elderly people who have dementia..
BEFORE you use TEVA-RISPERIDONE (risperidone), talk to your doctor or pharmacist if you / the patient you are caring for:
- have/has serious allergic reactions to other medications, including paliperidone;
- have/has a history of stroke, mini-strokes, high cholesterol or high blood pressure. Medicines like TEVA-RISPERIDONE can raise the risk of death in elderly people who have dementia;
- have/has neuroleptic malignant syndrome (a disorder that causes you to have high fever and stiffness in your muscles);
- have/has tardive dyskinesia (a disorder that causes you to have uncontrolled and repeated movements of the tongue, face or other body parts)
- have/has or are at risk for diabetes or high blood sugar or a family history of diabetes;
- are/is pregnant, think you may be pregnant or planning to become pregnant;
- are/is breast-feeding or planning to breast-feed;
- have or have had prolonged and/or painful erections;
- 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;
- any problems with the way your heart beats
- are being treated for high blood pressure;
- are taking any medications that affect how your heart beats;
- are/is prone to hypotension (low blood pressure), have or have had a heart disease or heart disease treatment that makes you more likely to have low blood pressure or feeling dizzy or faint when you stand up from lying or sitting positions;
- are at risk for developing blood clots. Risk factors include:
- a family history of blood clots
- being over the age of 65
- smoking,
- being overweight
- having a recent major surgery (such as hip or knee replacement)
- not being able to move due to air travel or other reasons
- taking oral birth control (“The Pill”);
- have had low white blood cell counts in your blood. Let your doctor know right away if you develop a fever or infection while being treated with TEVA-RISPERIDONE;
- have high levels of cholesterol or fats (triglycerides) in your blood
- have, have a history of or are at risk of:
- sleep apnea (a sleep disorder where your breathing is interrupted during sleep)
- sleep walking
- sleep-related eating disorder
- have/has Parkinson's disease;
- are/is taking or planning to take any other medicines (prescription or over-the-counter medicines, or natural health products);
- drink/drinks alcoholic beverages or use/uses drugs;
- have/has or have had/has had breast cancer;
- have/has pituitary tumours;
- suffer/suffers from Alzheimer’s Disease;
- suffer/suffers from Lewy body dementia;
- are/is feeling thirsty and unwell;
- exercise/exercises strenuously. This kind of medication may interfere with your body’s ability to adjust to heat. You should avoid becoming overheated or dehydrated (for example with vigorous exercise or exposure to extreme heat) while taking TEVA-RISPERIDONE;
- are/is planning to have an operation on the eye(s). During surgery to treat the cloudiness of the lens in your eye(s) (known as cataract surgery):
- the pupil (the black circle in the middle of your eye) may not increase in size as needed;
- the iris (the coloured part of the eye) may become floppy during surgery. This may lead to eye damage.
Tell your eye doctor you are taking this medicine
Elderly Patients with Dementia
Studies in elderly patients with dementia have shown
that TEVA-RISPERIDONE (risperidone) taken by
itself or with furosemide (a “water pill”) is associated
with a higher rate of death (see Serious Warnings and
Precautions Box).
Tell your doctor if you are taking furosemide. This drug can be used to treat:
- high blood pressure
- some heart problems
- 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
- sudden weakness or numbness of the face, arms or legs, especially on one side of the body
- slurred speech
- vision problems
have been seen
If any of these should occur, even for a short period of time, seek medical attention right away
If you are taking blood pressure medication
Low blood pressure can result from using TEVARISPERIDONE (risperidone) together with
medications used to treat high blood pressure. If you
need to use both TEVA-RISPERIDONE (risperidone)
and medications used to reduce blood pressure, consult
your doctor.
Effects on newborns
You should not take TEVA-RISPERIDONE while you
are pregnant or if you are planning on becoming
pregnant unless you have talked to your doctor about
it.
If you took TEVA-RISPERIDONE at any time while you were pregnant or if you took it before you became pregnant, the following symptoms may happen in your newborn baby:
- shaking
- stiffness in their muscles and/or weakness
- sleepiness
- agitation
- breathing problems
- difficulty feeding
Get medical help right away if your newborn baby has any of these symptoms.
In some cases, babies born to a mother taking risperidone during pregnancy have experienced symptoms that are severe and require the newborn to be hospitalized
Other cautions
Driving and using machines:Do not drive or operate machinery until you know how you respond to TEVARISPERIDONE. Some people experience drowsiness or blurred vision while taking risperidone
Falls: Feeling sleepy, a fall in blood pressure when you stand up from sitting or lying down, vision and speech problems have been reported with the use of antipsychotic drugs. This can lead to falls that may cause fractures or other fall related injuries. Certain medications, diseases or conditions can make this worse.
Weight gain: Weight gain has been seen in patients who are taking antipsychotic drugs. Your doctor may monitor your body weight when you are taking TEVARISPERIDONE.
Blood tests: Your doctor should do blood tests before you start taking TEVA-RISPERIDONE. They will check your blood sugar levels, and for those with certain risk factors, the level of white blood cells in your blood. Your doctor should continue to check your blood for as long as you are being treated with TEVARISPERIDONE.
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.
Interactions with this medication
Inform all doctors, dentists and pharmacists who are treating you that you are taking TEVARISPERIDONE (risperidone).
Inform them if you are taking or are planning on taking any other medicine, including other prescription or over-the-counter medications and natural health products. They will tell you which medicines you can take with TEVA-RISPERIDONE (risperidone).
TEVA-RISPERIDONE (risperidone) can increase the effect of alcohol and medicines that reduce the ability to react (e.g., "tranquillizers", narcotic painkillers, certain antihistamines, certain antidepressants). It is recommended that you DO NOT drink alcohol when you are taking TEVA-RISPERIDONE (risperidone).
You should only take these other medicines when they have been prescribed by your doctor.
Some medicines, when they are taken together with TEVA-RISPERIDONE (risperidone), may increase or decrease the level of TEVA-RISPERIDONE (risperidone) in your blood. Therefore, tell your doctor if you start and/or stop taking any of the below medicines, since your doctor may need to change the dose:
- Dopamine agonists, e.g. levodopa (a drug used to treat Parkinson’s disease), as these may decrease the effect of TEVA-RISPERIDONE (risperidone). Also, TEVA-RISPERIDONE can affect how drugs used to treat Parkinson’s disease work.
- Phenothiazines and some heart medications (e.g., medication for high blood pressure, antiarrhythmics, or beta-blockers), as these may interact with TEVA-RISPERIDONE (risperidone) to cause your blood pressure to drop too low.
- TEVA-RISPERIDONE (risperidone) should be used with caution when taking medications that may change the electrical activity of the heart (QT prolongation), such as but not restricted to: medicines for malaria, heart rhythm disorders, allergies, other antipsychotics, antidepressants, water tablets or other medicines affecting body salts (sodium, potassium, magnesium).
- Carbamazepine and topiramate (drugs used to treat seizures), as these may change the effect of TEVA-RISPERIDONE (risperidone).
- PROZAC® (fluoxetine), PAXIL® (paroxetine) (antidepressants) and CLOZARIL® (clozapine), as these may increase the level of TEVARISPERIDONE (risperidone) in your blood.
- LASIX® (furosemide): Studies in elderly patients with dementia have shown that taking TEVARISPERIDONE (risperidone) with furosemide, a medicine which is sometimes used to treat high blood pressure, some heart problems, or to treat swelling of parts of the body caused by the buildup of too much fluid, is associated with an increased rate of death (see WARNINGS AND PRECAUTIONS).
- Itraconazole and ketoconazole, medicines for treating fungal infections.
- Certain medicines used in the treatment of HIV/AIDS, such as NORVIR® (ritonavir).
- Verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm.
- Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders.
- Rifampicin, a medicine for treating some infections.
- TEVA-RISPERIDONE should be used with caution with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).
Proper use of this medication
Usual Dose
- It is very important that you take / give TEVARISPERIDONE (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 TEVA-RISPERIDONE (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 TEVA-RISPERIDONE (risperidone) at the same time each day.
- TEVA-RISPERIDONE (risperidone) tablets should be swallowed with some water or other liquid.
- It is important that you keep taking/giving TEVARISPERIDONE (risperidone) even after your/the symptoms have improved or disappeared. Do not change or stop taking/giving TEVARISPERIDONE (risperidone) without consulting the doctor.
DO NOT give TEVA-RISPERIDONE (risperidone) to anyone else. The doctor has prescribed it for you/the patient you are caring for.
Overdose
In overdose, one or more of the following may occur:
- feeling sedated
- feeling drowsy or sleepy
- unusual movements of the face, body, arms or legs (such as excessive trembling or muscle stiffness)
- a fast heart rate
- irregular heartbeat or other symptoms of an irregular heartbeat, such as lightheadedness or fainting
- abnormal electrical conduction in the heart (QT prolongation). Symptoms may include lightheadedness or fainting.
- low blood pressure that may include feeling dizzy or lightheaded when standing up.
- low blood sodium levels. Symptoms may include headache or confusion.
- low blood potassium levels. Symptoms may include muscle cramps or feeling weak.
- seizures
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
These are not all the possible side effects you may feel
when taking TEVA-RISPERIDONE. If you experience
any side effects not listed here, contact your healthcare
professional.
Side effects that may occur very commonly are
difficulty falling or staying asleep, trembling,
decreased motor function or activity such as slight
muscle stiffness, increased saliva and/or drooling,
feeling sleepy or less alert, and headache.
Side effects that may occur commonly include: pneumonia, infections of eye, infections of ear, urinary tract infection, feeling like you have the flu, sleep disorder, depression, anxiety, irritability, dizziness, uncontrollable movements of the face or body, rigid muscles, slowness of movement and muscle stiffness or spasm, tremor, a sensation of tingling, prickling, or numbness of skin, blurry vision, faster heart rate, high blood pressure, abdominal pain, nausea/vomiting, constipation, diarrhea, indigestion, dry mouth, muscle spasms, loss of urine, swelling of the body, arms or legs, weakness, and fatigue.
TEVA-RISPERIDONE (risperidone) can raise your levels of a hormone called "prolactin". This is measured with a blood test. Symptoms may include:
- In men
- swelling in the breast
- difficulty in getting or maintaining an erection or other sexual dysfunction
- In women:
- discomfort in the breasts
- leaking of milk from the breasts (even if not pregnant)
- missing your menstrual period or other problems with your cycle
If you have high levels of prolactin and a condition called hypogonadism you may be at an increased risk of breaking a bone due to osteroporosis. This occurs in both men and women.
Uncommon side effects may include: anemia, increased cholesterol in your blood, weight loss, loss of appetite resulting in malnutrition and low body weight, mania, a restless urge to move parts of your body, concentration difficulties, nightmares, itching, flushing, a sensation of tingling, pricking, or numbness of skin, muscle weakness, thirst, infection of the breathing passages, bladder infection, infection of the skin, fungal infection of the nails, crackly lung sounds, wheezing, breathing passage disorder, chills, vaginal discharge, joint swelling or stiffness, ringing in your ears, sensation of spinning (vertigo), being unresponsive to what is going on around you, difficulty with your voice, changes in taste, difficult or painful urination, bowel incontinence, gas, stomach or intestinal infection, low blood pressure, heartbeat irregularities, changes in body temperature, and increased liver transaminases in your blood.
High blood sugar, diabetes mellitus or worsening of diabetes have been reported. See your doctor if you experience symptoms such as excessive thirst or urination.
TEVA-RISPERIDONE (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 TEVA-RISPERIDONE (risperidone).
In rare cases, the following may happen: sugar in the urine, high blood triglycerides (a fat), chapped lips, eye rolling, glaucoma (increased pressure within the eyeball), eyelid margin crusting, swollen tongue, coldness in arms and legs, and low blood sugar.
Lack of bowel muscle movement that causes blockage may occur very rarely.
Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
---|---|---|---|
Common | |||
Skin rash on its own | ✔ | ||
Dystonia: twisting movements that you cannot control, and can affect posture or the face, including eyes, mouth, tongue or jaw | ✔ | ||
Uncommon | |||
Seizure (i.e., loss of consciousness with uncontrollable shaking) | ✔ | ||
Decreased White Blood Cells: infections, fatigue, fever, aches, pains and flu -like symptoms | ✔ | ||
Tardive Dyskinesia: Muscle twitching or abnormal movements of the face or tongue or other parts of your body | ✔ | ||
Severe Allergic Reaction: Fever, itching, skin rash, hives, swelling of the mouth, face, lips, throat or tongue, difficulty swallowing or breathing, shortness of breath and sometimes a drop in blood pressure (amounting to an “anaphylactic reaction”) | ✔ | ||
Strokes and Transient Ischemic Attacks: Sudden change in mental state or sudden weakness or numbness of the face, arms or legs, especially on one side, slurred speech or vision problems, even for a short period of time | ✔ | ||
Dysphagia: difficulty swallowing that can cause food or liquid to get into your lungs | ✔ | ||
Rare | |||
Rhabdomyolysis: Very dark (“tea coloured”) urine, muscle tenderness and/or aching | ✔ | ||
Blood clots: Swelling, pain and redness in an arm or leg that can be warm to touch. You may develop sudden chest pain, difficulty breathing and heart palpitations | ✔ | ||
A state of confusion, reduced consciousness, high fever, or pronounced muscle stiffness | ✔ | ||
Inflammation of the pancreas: Severe abdominal pain, fever, nausea, vomiting | ✔ | ||
Jaundice: Yellowing of the skin and eyes, dark urine | ✔ | ||
Very rare | |||
Life -threatening complications of uncontrolled diabetes, such as shortness of breath, confusion and loss of consciousness | ✔ | ||
Marked changes in body temperature (generally as a result of several factors together including extreme heat or cold). | ✔ | ||
Priapism: Long - lasting (greater than 4 hours in duration) and painful erection of the penis | ✔ | ||
Serious Allergic reactions even if you have previously tolerated oral risperidone or oral paliperidone; symptoms include rash, swelling of your throat, itching or problems breathing. These may be signs of a serious allergic reaction | ✔ | ||
Catatonia: unable to move or respond while awake | ✔ |
This is not a complete list of side effects. For any unexpected effects while taking TEVA-RISPERIDONE (risperidone), contact your doctor or pharmacist.
How to store
Store TEVA-RISPERIDONE (risperidone) in its original package
TEVA-RISPERIDONE (risperidone) tablets should be
stored as follows:
0.25 mg tablets stored between 15 - 30°C. Protect from
light and moisture.
0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg tablets stored
between 15 - 25°C. Protect from light and moisture.
Keep TEVA-RISPERIDONE (risperidone) out of the sight and reach of children.
The expiry date for TEVA-RISPERIDONE (risperidone) is printed on the package. Do not use the medicine in the package after this date.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-healthproducts/medeffect-canada/adverse-reactionreporting.html) for information on how to report online, by mail or by fax; or
- Call toll-free at 1-866-234-2345
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full Product Monograph prepared for health professionals can be found by contacting Teva Canada Limited by: Phone: 1-800-268-4127 ext. 3; Email: druginfo@tevacanada.com; or Fax: 1-416-335-4472
This leaflet was prepared by: Teva Canada Limited 30 Novopharm Court Toronto, Ontario Canada, M1B 2K9
www.tevacanada.com
Last revised: January 16, 2019