PHL-Risperidone: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

The doctor has prescribed phl-RISPERIDONE, also known as risperidone, to help relieve the symptoms that are bothering you / the patient you are caring for. Although phl-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:

phl-RISPERIDONE belongs to a group of medicines called antipsychotic drugs.

Use in Schizophrenia

phl-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

phl-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 phl-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 judgement.

What it does:

Antipsychotic medications affect the chemicals that allow communication between nerve cells (neurotransmitters). These chemicals are called dopamine and serotonin. Exactly how phl-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 phl-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 nonmedicinal ingredients are:

phl-RISPERIDONE tablets: All tablets contain the following nonmedicinal ingredients: colloidal silicon dioxide, cornstarch, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and sodium lauryl sulphate. The 0.25 mg tablets also contain polyvinyl alcohol, titanium dioxide and yellow ferric oxide. The 0.5 mg tablets also contain polyvinyl alcohol, talc, titanium dioxide and red ferric oxide. The 1 mg tablets also contain hydroxypropylmethylcellulose, polydextrose, titanium dioxide and triethyl citrate. The 2 mg tablets also contain polyvinyl alcohol, talc, titanium dioxide and FD & C Yellow #6 Aluminum Lake. The 3 mg tablets also contain polyvinyl alcohol, talc, titanium dioxide and D & C Yellow #10. The 4 mg tablets also contain polyvinyl alcohol, talc, D & C Yellow #10 Aluminum Lake and FD & C Blue #2 Aluminum Lake.

phl-RISPERIDONE oral solution: benzoic acid, purified water, sodium hydroxide, sorbitol solution and tartaric acid.

phl-RISPERIDONE ODT (orally disintegrating tablets): aspartame, colloidal silicon dioxide, crospovidone, gum arabic, mannitol, peppermint natural flavor, polyethylene glycol, red iron oxide, sodium stearyl fumarate and sorbitol.

Phenylketonurics: phl-RISPERIDONE ODT contains aspartame, which may not be suitable for those who cannot have phenylalanine (see WARNINGS AND PRECAUTIONS).

What dosage forms it comes in:

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

phl-RISPERIDONE Oral solution: 1 mg/mL

phl-RISPERIDONE ODT orally disintegrating tablets: 0.5, 1 and 2 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Studies with various medicines of the group to which phl-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 phl-RISPERIDONE.

BEFORE you use phl-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 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 your heart

  and/or blood vessels;

C are/is prone to hypotension;

• have/has Parkinson's disease;

• are 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 phl-

  RISPERIDONE ODT tablets contain aspartame, a source of phenylalanine.

C have/has or have had/has breast cancer; C have/has pituitary tumours;

C suffer/suffers from Alzheimer’s Disease; C are/is dehydrated;

C exercise/exercises strenously.

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 swelling of parts of the body caused by the builed-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 phl-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 phl-RISPERIDONE. Inform them if you are taking or planning on taking any other medicine. They will tell you which medicines you can take with phl-RISPERIDONE.

phl-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.

Dopamine agonists, e.g. levodopa (antiparkinson agent) may decrease the effect of phl-RISPERIDONE.

Carbamazepine (anticonvulsant) may change the effect of phl-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 $-blockers) may potentially interact with phl-RISPERIDONE. Therefore inform your doctor if you start or stop taking any of the above medications.

PROZAC^® (fluoxetine) and PAXIL^® (paroxetine) (antidepressants) and CLOZARIL^® (clozapine) increase the level of phl-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 phl-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 WARNING AND PRECAUTIONS).

phl-RISPERIDONE oral solution is not compatible with cola or tea.

PROPER USE OF THIS MEDICATION

Usual Dose

C It is very important that you take / give phl-

RISPERIDONE the way the doctor has prescribed it.

C 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.

C You may take / give phl-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.

C Try to take / give phl-RISPERIDONE at the same

time each day.

C phl-RISPERIDONE tablets should be swallowed

with some water or other liquid.

C Before taking/giving phl-RISPERIDONE oral

solution, read the “Directions for Use of phl-RISPERIDONE oral solution”. Be sure to mix the exact dose of phl-Risperidone 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. C It is important that you keep taking / giving phl-

RISPERIDONE even after your / the symptoms have improved or disappeared. Do not change or stop taking / giving phl-RISPERIDONE without

consulting the doctor.

• Before taking / giving phl-RISPERIDONE ODT tablets, read the "Directions for Use of phl-RISPERIDONE Orally Disintegrating Tablets " for opening the blister and handling the tablet.

DO NOT give phl-RISPERIDONE to anyone else. The doctor has prescribed it for you / the patient you are caring for.

Directions for Use of phl-RISPERIDONE 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. 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 phl-RISPERIDONE Oral Solution

To open the bottle and use the

syringe:

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.

Fig. 2: Insert the syringe 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 syringe from

the bottle. Empty the syringe

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.

phl-RISPERIDONE 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 syringe with some water. 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.

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, phl-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 phl-RISPERIDONE include the following: • sleeplessness / sleepiness

• anxiety

• trembling, decreased motor function or activity

  such as slight muscle stiffness

• a feeling of restlessness (akathisia)

C dizziness

C headache

C runny nose

C constipation

C weight gain

C increased heart rate

In severely demented patients, the most common side effects of phl-RISPERIDONE include the following: C sleepiness

C trembling, decreased motor function or activity

such as slight muscle stiffness

C a feeling of restlessness (akathisia)

C swelling of the ankles

C runny nose

C dizziness, lightheadedness

C difficulty breathing

C increased heart rate

In patients with bipolar disorder, the most common side effects of phl-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

phl-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 phl-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 phl-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 the milk from 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.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected 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 Division

Marketed Health Products Directorate Health Products and Food Branch

Health Canada

Tunney's Pasture, AL 0701C

Ottawa ON K1A OK9

Seek medical attention right if the following occur while you or the patient you are caring for are/is taking phl-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

C continuous erection of the penis

C if you have taken phl-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. If you have any unexpected effects while taking phl-RISPERIDONE, contact your doctor or pharmacist.

phl-RISPERIDONE tablets and phl-RISPERIDONE ODT orally disintegrating tablets should be stored between 15 -30 /C. Protect from light and moisture.

phl-RISPERIDONE oral solution should be stored between 15-30 /C. Protect from light and freezing.

Keep phl-RISPERIDONE out of the reach of children.

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

HOW TO STORE IT

Store phl-RISPERIDONE in its original package. MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting Pharmel Inc., at 1-888-550-6060.

Pharmel Inc.

Montréal, Québec H4P 2T4

Last revised: April 29, 2008

PROZAC^® is a registered trademark of Eli Lilly and Company.

PAXIL^® is a registered trademark of GlaxoSmithKline Inc. CLOZARIL is a registered trademark of Novartis Pharmaceuticals Inc.

* All trademark rights used under license