Patient Medication Information: uses, side effects, how to take - Risperidone (Meliapharm)

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.

IMPORTANT: PLEASE READ

PART III: CONSUMER INFORMATION

RISPERIDONE

risperidone

This leaflet is part III of a three-part “Product Monograph” published when RISPERIDONE was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about RISPERIDONE. Contact your doctor or pharmacist if you have any questions about the drug.

If you are a caregiver helping someone take RISPERIDONE, read this leaflet before you give the first dose.

ABOUT THIS MEDICATION

What the medication is used for:

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:

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 judgement.

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 (see What the nonmedicinal ingredients are).

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:

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.

What dosage forms it comes in:

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

WARNINGS AND PRECAUTIONS

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 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;
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.

Studies i	n elderly patients with dementia have shown
that risp	eridone ta	ken	by	itse	lf	or	with f	urosemi		de is
associate	d with a higher rate of death (see								Serious
Warnings and Precautions Box

Tell yo	ur doctor	if	you		are		taking	furose			mide.
Furosem	ide is a dr	ug which i			s sometimes			used		to	treat
high blo	od pressu	re, some		h	eart	p	roblem	s,	or	to	treat
swelling	of parts o	f the	body		cause		d by th	e b	uild-up of

too much fluid.

elderl

y patients

with dementia, a sudden change in

mental s

tate or sudden weakness or numbness of the

face, arm

s or legs,

especially o

n one

side, o

r instances

slurred s

peech hav

e been

see

any

these

should

occur, e

ven for a

short period of time, seek medical

attention right awa

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 RISPERIDONE. Inform them if you are taking or 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.

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

Carbamazepine (anticonvulsant) may change the effect of RISPERIDONE. Therefore, inform your doctor if you start or stop taking carbamazepine.

PROZAC^®(fluoxetine) and PAXIL^®(paroxetine) (antidepressants) increase the level of RISPERIDONE in your blood. Therefore, tell your doctor if you start and/or stop taking PROZAC or PAXIL.

Studies

elderly

patients

with

dementia

have

shown that

taking

risperidon

e with

furosemide,

drug

which

sometimes

used t

o treat

high

lood

pressure,

some

heart

problems,

tre

at swelling

parts

the

body

caused

the

build-up

of t

oo much fluid, is associated with an

increased rate of death. Tell your doctor if you are taking

furosemide (see W

ARNINGS AND PRECAUTIONS)

PROPER USE OF THIS MEDICATION

Usual Dose

C It is very important that you take / give

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 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 RISPERIDONE at the same time each day.

C RISPERIDONE tablets should be swallowed with some water or other liquid.

C 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

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, 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 RISPERIDONE include the following: • sleeplessness / sleepiness

anxiety
trembling, decreased motor function or activity such
as slight muscle stiffness

A a feeling of restlessness (akathisia)

A dizziness

A stuffed nose

A constipation

A weight gain

A increased heart rate

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

A trembling, decreased motor function or activity such

as slight muscle stiffness

A a feeling of restlessness (akathisia)

A swelling of the ankles

A stuffed nose

A dizziness, lightheadedness

A difficulty breathing

A 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

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.

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.

In women, medicines of this type may cause changes in the regularity of their monthly period or

leakage o	f milk
from	the br	east even if	they are no	t pregnant. In	some
men,	after	prolonged	treatment, t	here 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 OCCUR AND WHAT TO DO ABOUT THEM
Symptom/effect	Talk with your doctor or pharmacist Only if severe In all cases		Stop taking drug and call your doctor or pharmacist
Symptom/effect			Rare
Symptoms of allergic reaction, such as itching, rash, swelling of the face, lips, or tongue, or shortne of breath.	skin ss	/
Very rare
A state of confusion, redu consciousness, high fever pronounced muscle stiffn	ced , or ess.	/
Marked changes in body temperature (generally as result of several factors together including extrem heat or cold).	a e	/

Seek	medic	al attention	right away i	f the	following	occur
while	you o	r the patien	t you are ca	ring	for are/is taking

RISPERIDONE:

muscle twitching or abnormal movements of the face or tongue.
s

udden

change in m

ental state o

r sudde

n weakness

umbne

ss in the fa

ce, arms

or l

egs,

especially

on one

ide, sl

urred speec

h or vision

prob

lem

s, eve

n for

hort period of tim

continuous erection of the peni

i	f you	have taken	RISPERIDONE			in	the las	t three
months		of your pre	gnancy	and	you	notice th		at your
newborn		baby deve	lops shaking, muscle				stiffn	ess and

difficulty		in		feeding.		These		symptoms	c	an 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 tablets should be stored between 15 - 30 /C. 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.

This document plus the full product monograph, prepared for health professionals can be obtained by post:

MeliaPharm Inc.

6111 Royalmount Ave.

Montreal (QC) H4P 2T4

Last revised: March 8, 2010

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.

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist

Risperidone (Meliapharm): Uses, Side Effects and Dosage