Risperdal (Janssen, 5 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

RISPERDAL^® belongs to a group of medicines called antipsychotic drugs.

Use in Schizophrenia

RISPERDAL^® 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

RISPERDAL^® 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 RISPERDAL^® 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 RISPERDAL^® to help relieve the symptoms that are bothering you/the patient you are caring for. Although RISPERDAL^® 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 RISPERDAL^® works is unknown. However it seems to readjust the balance of dopamine and serotonin.

When it should not be used:

Do not take/give RISPERDAL^® 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 RISPERDAL^® in children under the age of 18 have not been established.

What the medicinal ingredient is:

risperidone

What the nonmedicinal ingredients are:

RISPERDAL^® tablets: All tablets contain the following nonmedicinal ingredients: lactose, cornstarch, microcrystalline cellulose, hydroxypropyl methylcellulose, magnesium stearate, colloidal silicon dioxide, sodium lauryl sulphate and propylene glycol. In addition, all tablet strengths except the 1 mg contain talc and titanium dioxide. The 0.25 mg tablets also contain yellow ferric oxide. The 0.5 mg tablets also contain red ferric oxide. The 2 mg tablets also contain FD & C Yellow #6 Aluminum Lake. The 3 mg tablets also contain D & C Yellow #10. The 4 mg tablets also contain D & C Yellow #10, FD & C Blue #2 Aluminum Lake.

RISPERDAL^® oral solution: tartaric acid, benzoic acid, sodium hydroxide and purified water.

RISPERDAL^® M-TAB^® orally disintegrating tablets: All tablets contain the following nonmedicinal ingredients: polacrilex resin, gelatin, mannitol, glycine, simethicone, carbomer 934P, sodium hydroxide, aspartame, red ferric oxide and peppermint oil. The 2 mg tablets manufactured from 2006 onwards and the 3 and 4 mg tablets also contain xanthan gum.

Phenylketonurics: RISPERDAL^® M-TAB^® contains aspartame, which may not be suitable for those who cannot have phenylalanine (see WARNINGS AND

PRECAUTIONS).

What dosage forms it comes in:

RISPERDAL^® tablets: 0.25, 0.5, 1, 2, 3 and 4 mg. RISPERDAL^® oral solution: 1 mg/mL.

RISPERDAL^® M-TAB^® orally disintegrating tablets: 0.5, 1, 2, 3 and 4 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Studies with various medicines of the group to which RISPERDAL^® belongs, when used in elderly patients with dementia, have been associated with an increased rate of death. Some of these studies included treatment with RISPERDAL^®.

BEFORE you use RISPERDAL^®, 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 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;

• cannot take phenylalanine because RISPERDAL^® M-

  TAB^® tablets contain aspartame, a source of phenylalanine;

• 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 dehydrated;
• exercise/exercises strenuously.

Elderly Patients with Dementia

Studies in elderly patients with dementia have shown that RISPERDAL^® 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 RISPERDAL^® together with medications used to treat high blood pressure. If you need to use both RISPERDAL^® and medications used to reduce blood pressure, consult your doctor.

Effects on newborns

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. Sometimes, the symptoms may resolve on their own. Be prepared to seek immediate emergency medical attention for your newborn if they have difficulty breathing, are overly sleepy, have muscle stiffness, or floppy muscles (like a rag doll), are shaking, or are having difficulty feeding.

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 RISPERDAL^®.

During long-term treatment, RISPERDAL^® 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 RISPERDAL^®.

RISPERDAL^® 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 RISPERDAL^® 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 RISPERDAL^®.

Inform them if you are taking or are planning on taking any other medicine. They will tell you which medicines you can take with RISPERDAL^®.

RISPERDAL^® 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 (antiparkinsonian agent), as these may decrease the effect of RISPERDAL^®.

• Phenothiazines and some heart medications (e.g.,

  medication for high blood pressure, antiarrhythmics, or β-blockers), as these may interact with RISPERDAL^® to cause your blood pressure to drop too low.

• RISPERDAL^® 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 RISPERDAL^®.

• PROZAC^® (fluoxetine), PAXIL⁷ (paroxetine)

  (antidepressants) and CLOZARIL^® (clozapine), as these may increase the level of RISPERDAL^® in your blood.

• LASIX^® (furosemide): Studies in elderly patients with

  dementia have shown that taking RISPERDAL^® 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 (see WARNINGS AND PRECAUTIONS).

RISPERDAL^® oral solution is not compatible with cola or tea.

PROPER USE OF THIS MEDICATION

Usual dose:

• It is very important that you take/give RISPERDAL^® 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 RISPERDAL^® 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 RISPERDAL^® at the same time each day.

• RISPERDAL^® tablets should be swallowed with some

  water or other liquid.

• Before taking/giving RISPERDAL^® oral solution, read

  the “Directions for Use of RISPERDAL^® Oral Solution”. Be sure to mix the exact dose of RISPERDAL^® oral solution that the doctor has prescribed in 100 mL of one of the following beverages: water, coffee, orange juice or low-fat milk; DO NOT MIX it in cola or tea.

• It is important that you keep taking/giving RISPERDAL^®

  even after your/the symptoms have improved or disappeared. Do not change or stop taking/giving RISPERDAL^® without consulting the doctor.

• Before taking/giving RISPERDAL^® M-TAB^® tablets,

  read the “Directions for Use of RISPERDAL^® M-TAB^®

  Orally Disintegrating Tablets” for opening the blister and handling the tablet.

  DO NOT give RISPERDAL^® to anyone else. The doctor has prescribed it for you / the patient you are caring for.

  Directions for Use of RISPERDAL^® M-TAB^® Orally Disintegrating Tablets

  1. 1. Do not open the blister until ready to administer. Peel open the blister to expose the tablet. Do not push the tablet through the foil because it is fragile and may break. Remove the tablet from the blister with dry hands. Do not break or divide the tablets.
  2. 2. Immediately place the tablet on your tongue. The tablet will begin disintegrating within seconds and can then be swallowed. Water may be used if desired.

Directions for Use of RISPERDAL^® Oral Solution

To open the bottle and use the pipette:

Fig. 1: The bottle comes with a

child-proof cap, and should be

opened as follows: push the plastic

screw cap down while turning it

counter-clockwise. Remove the

unscrewed cap.

Fig. 2: Insert the pipette into the

bottle. While holding the bottom

ring, pull the top ring up to the

mark that corresponds to the

number of millilitres or milligrams

you need to give.

Fig. 3: Holding the bottom ring,

remove the entire pipette from the

bottle. Empty the pipette into at

least 100 mL (3–4 ounces) of any

non-alcoholic drink (see list

below), by sliding the upper ring

down. Stir the mixture thoroughly

before consuming.

RISPERDAL^® oral solution is compatible with the following beverages: water, coffee, orange juice and low-fat milk. However, it is NOT compatible with cola or tea. Close the bottle and rinse the pipette with some water.

Overdose:

In overdose, one or more of the following signs may occur: reduced consciousness, sleepiness, excessive trembling , excessive muscle stiffness, fast beating heart, dizziness or light-headedness when standing up.

If you take/give too much RISPERDAL^®, 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, RISPERDAL^® can cause some side effects. Some side effects are 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 RISPERDAL^® 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 RISPERDAL^® 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 RISPERDAL^® were:

• sleeplessness/sleepiness

• trembling, decreased motor function or activity such as

  slight muscle stiffness

• dizziness
• headache
• constipation
• anxiety
• weight gain
• nausea
• heartburn
• increased salivation

RISPERDAL^® 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 RISPERDAL^®.

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, and low blood sugar.

High blood sugar, diabetes mellitus and sugar in the urine have been reported. See your doctor if you experience symptoms such as excessive thirst or urination.

Your doctor may check your body weight before starting RISPERDAL^® and during treatment.

Your doctor may take blood tests before starting RISPERDAL^® and during treatment, and may monitor blood sugar, and the number of infection fighting white blood cells.

If you have high levels of prolactin (measured with a blood test) and a condition called hypogonadism you may be at an increased risk of breaking a bone due to osteoporosis. This occurs in both men and women.

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 RISPERDAL^® in the last three months of your pregnancy and you notice that your newborn baby develops shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding, seek immediate emergency medical attention.

This is not a complete list of side effects. For any unexpected effects while taking RISPERDAL^®, contact your doctor or pharmacist.

HOW TO STORE IT

Store RISPERDAL^® in its original package.

RISPERDAL^® tablets and RISPERDAL^® M-TAB^® orally disintegrating tablets should be stored between 15 – 30°C. Protect from light and moisture.

RISPERDAL^® oral solution should be stored between 15 – 30°C. Protect from light and freezing.

Keep RISPERDAL^® out of the reach of children.

The expiry date for RISPERDAL^® 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:

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$ 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 0701E

  Ottawa, Ontario

  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 at:

http://www.janssen.ca

or by contacting the sponsor, Janssen Inc., at:

1-800-567-3331 or 1-800-387-8781.

Janssen Inc.

Toronto, Ontario M3C 1L9

Last revised: January 30, 2013

All listed brand names are trademarks of their respective manufacturers.