Risperidone (Cobalt Pharmaceuticals): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

RISPERIDONE belongs to a group of medicines called antipsychotic drugs.

Use in Schizophrenia

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 Inappropriate Behaviour Associated with Severe Dementia 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 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 RISPERIDONE, also known as risperidone, to help relieve the symptoms that are bothering you / the patient you are caring for. Although 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

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 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.

The safety and efficacy of RISPERIDONE in children under the age of 18 have not been established.

What the medicinal ingredient is:

Risperidone

What the important nonmedicinal ingredients are: RISPERIDONE tablets: All tablets contain lactose monohydrate, corn starch, microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide.

In addition, all tablet strengths contain talc, titanium dioxide, polyvinyl alcohol and polyethylene glycol.

Colourants are present in the tablets as follows:

• 0.25 mg tablets also contain iron oxide yellow
• 0.5 mg tablets also contain iron oxide red
• 2 mg tablets also contain iron oxide yellow & iron oxide red

• 3 mg tablets also contain D&C Yellow #10 Aluminum

  Lake

• 4 mg tablets also contain D&C Yellow #10, Aluminum

  Lake and FD&C Blue #2.

What dosage forms it comes in:

RISPERIDONE tablets: 0.25 mg, 0.5 mg, 1mg, 2 mg, 3 mg, and 4 mg.

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 RISPERIDONE, talk to your doctor or pharmacist if 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 breastfeeding;

$ 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 had/has breast cancer;

$ have/has pituitary tumours;

$ suffer/suffers from Alzheimer’s Disease; $ suffer/suffers from Lewy body dementia $ are/is dehydrated;

$ exercise/exercises strenuously.

Elderly Patients with Dementia

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.

If you are taking blood pressure medication

Low blood pressure can result from using RISPERIDONE together with medications used to treat high blood pressure. If you need to use both RISPERIDONE and medications used to reduce blood pressure, consult your doctor.

If you may be pregnant

Shaking, muscle stiffness and difficulty in feeding, all of which are reversible, may occur in newborns, if a mother used risperidone in the last trimester of pregnancy.

Other cautions

Very rarely, a state of confusion, reduced consciousness, high fever or stiff muscles might occur. If this should happen, contact a doctor right away and tell him or her that you are receiving RISPERIDONE.

During long-term treatment, RISPERIDONE might cause involuntary twitching in the face. Should this happen, consult your doctor.

Since medications of this type may interfere with the ability of the body to adjust to heat, it is best to avoid becoming overheated or

dehydrated (for example with vigorous exercise or exposure to extreme heat) while taking RISPERIDONE.

RISPERIDONE 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.

Because some people experience drowsiness, you should not drive or operate machinery until you are reasonably certain that RISPERIDONE does not affect your ability to carry out these activities.

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 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 RISPERIDONE.

RISPERIDONE can increase the effect of alcohol and drugs that reduce the ability to react (e.g., “tranquillizers”, narcotic painkillers, certain antihistamines, certain antidepressants). It is recommended that you DO NOT drink alcohol and only take drugs prescribed by your doctor.

Inform your doctor if you start or stop taking any of the following medications:

• Dopamine agonists, e.g. levodopa (antiparkinson agent), may decrease the effect of RISPERIDONE.
• Phenothiazines and some heart medications (e.g., medication for high blood pressure, antiarrhythmics, or β-blockers) as these may interact with RISPERIDONE to cause your blood pressure to drop too low.
• RISPERIDONE should be used with caution when taking medications that may change the electrical activity of the heart, 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 (anticonvulsants) as these may change the effect of RISPERIDONE.

• PROZAC (fluoxetine), and PAXIL (paroxetine)

  (antidepressants) and CLOZARIL (clozapine) increase the level of RISPERIDONE in your blood.

• LASIX* (furosemide): 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 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 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 RISPERIDONE at the same time each day.
• RISPERIDONE should be swallowed with some water or other liquid.
• It is important that you keep taking / giving RISPERIDONE even after your / the symptoms have improved or disappeared. Do not change or stop taking / giving RISPERIDONE without consulting the doctor.

DO NOT give 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 signs may occur in an overdose: reduced consciousness, sleepiness, excessive trembling, excessive muscle stiffness, fast beating heart, dizziness or light-headedness when standing up.

If you take / give too much RISPERIDONE, immediately contact the doctor, regional Poison Control Centre, or go / take the patient to the nearest hospital emergency department. Do this even if there are no signs of discomfort or poisoning. Make sure to bring your medication bottle with you.

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 medications, 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. Should you experience these symptoms, please consult your doctor.

In patients with schizophrenia, the most common side effects of 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 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 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

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 RISPERIDONE.

In addition, the following undesired effects may occur in some cases: agitation, headache, dizziness.

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.

If you have taken 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 RISPERIDONE, contact your doctor or pharmacist.

HOW TO STORE IT

Store RISPERIDONE in its original package.

RISPERIDONE should be stored between 15 - 30EC. Protect from light and moisture.

Keep RISPERIDONE out of the reach of children.

The expiry date for RISPERIDONE is printed on the package. Do not use the medicine in the package after this date.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

---------------------------------------------------------------------------- $ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345

$ Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701C

  Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. 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 the sponsor, Cobalt Pharmaceuticals Inc. at: 1-866-254-6111.

Cobalt Pharmaceuticals Inc. 6500 Kitimat Road Mississauga, Ontario.L5N 2B8 Canada

Last revised: February 4, 2010