IMPORTANT: PLEASE READ

When it should not be used:

Do not use APO-ZOPICLONE if you have:
a muscular disease known as myasthenia
gravis
a severe hepatic insufficiency (liver problems)
severe lung or respiratory disease, including
sleep apnea.
A known allergy to zopiclone or any of the
ingredients APO-ZOPICLONE contains (see
What the nonmedicinal ingredients are)

PART III: CONSUMER INFORMATION

Pr

APO-ZOPICLONE
Zopiclone Tablets

This leaflet is part III of a three-part Product

Monograph published when APO-ZOPICLONE
was approved for sale in Canada and is designed
specifically for Consumers. This leaflet is a summary
and will not tell you everything about APOZOPICLONE. Contact your doctor or pharmacist if
you have any questions about the drug.

What the medicinal ingredient is:

The active ingredient in APO-ZOPICLONE is
zopiclone.

Please read this information before you start to take

your medicine. Keep this leaflet until you have finished
all your tablets, as you may need to read it again. This
leaflet should not replace a discussion between you and
your doctor about the risks and benefits of APOZOPICLONE.

What the important nonmedicinal ingredients are:

The non-medicinal ingredients of APO-ZOPICLONE
5.0 mg are magnesium stearate, lactose monohydrate,
microcrystalline cellulose, hydroxypropyl
methylcellulose, polyethylene glycol, titanium dioxide.

ABOUT THIS MEDICATION

The non-medicinal ingredients of Apo-Zopiclone 7.5

mg are magnesium stearate, lactose monohydrate,
microcrystalline cellulose, hydroxypropyl
methylcellulose, polyethylene glycol, titanium dioxide,
D&C yellow #10, and FD&C blue #1.

What the medication is used for:

APO-ZOPICLONE is a prescription medication
intended to help you sleep if you transient and shortterm insomnia. Symptoms of insomnia may vary: you
may have difficulty in falling asleep, or awaken often
during the night, or awaken early in the morning, or you
may have all three symptoms.

What dosage forms it comes in:

APO-ZOPICLONE is available in 5 mg and 7.5 mg
tablets for oral administration.

Treatment with APO-ZOPICLONE should usually not

go on for more than 7-10 days and should be restricted
for insomnia where disturbed sleep results in impaired
daytime functioning. APO-ZOPICLONE does not treat
the underlying cause of your insomnia.

WARNINGS AND PRECAUTIONS

Complex sleep-related behaviours
There have been reports of people getting out of bed
while not fully awake after taking APO-ZOPICLONE
and doing activities that they did not know they were
doing. The next morning, they did not remember doing
those activities. This unusual behaviour is more likely
to occur when APO-ZOPICLONE is taken with alcohol
or other drugs that can make you sleepy such as those
for the treatment of depression or anxiety. The activities
you may do in these situations can put you and people
around you in danger. Reported activities included
driving a car (sleep-driving), leaving the house,
making and eating food, talking on the phone, etc.

What it does:
APO-ZOPICLONE is one of several prescription
sleeping pills that have generally similar properties such
as a calming effect.
If you are prescribed sleep medication, you should
consider both their benefits and risks. Important risks
and limitations include the following:

you may become dependent on the medication,

the medication may affect your mental
alertness or memory, particularly when not
taken as prescribed.
(see Warnings and Precautions)

Important:
1. Do not take more APO-ZOPICLONE than
prescribed.
2. Do not take APO-ZOPICLONE if you drink alcohol.
3. Talk to your doctor about all of your medicines,
including over-the-counter medicines and herbal
products. Your doctor will tell you if you can take
APO-ZOPICLONE with your other medicines.

IMPORTANT: PLEASE READ

4. You and people close to you should watch for the
type of unusual behaviour described above. If you find
out that you have done any such activities for which
you have no memory you should call your doctor
immediately.

Dependence/Abuse:
All prescription sleeping pills can cause dependence
(addiction) especially when used regularly for more
than a few weeks, or at higher doses. Some people
develop a need to continue taking these drugs, not only
for continued therapeutic effect, but also to avoid
withdrawal symptoms or to achieve non-therapeutic
effects.

Mental Alertness: APO-ZOPICLONE may affect your

ability to be alert. DO NOT DRIVE A CAR or operate
potentially dangerous machinery until you experience
how this drug will affect you.

Individuals who depend, or have depended at any time

in the past, on alcohol or other drugs may be at
particular risk of becoming dependent on drugs of this
class. But all people are at some risk. Consider this
matter before you take these medications beyond a few
weeks.

Memory problems: APO-ZOPICLONE may cause a

special type of memory loss (amnesia); you may not
recall events that occurred during some period of time,
usually several hours, after taking the drug. This lapse
is usually not a problem, because the person taking the
sleeping pill intends to be asleep during this critical
period of time. But it can be a problem if you take the
medication to induce sleep while travelling, such as
during an airplane flight, because you may wake up
before the effect of the drug is gone. This has been
called travellers amnesia. DO NOT TAKE APOZOPICLONE when a full night's sleep is not possible
before you would again need to be active and
functional; e.g., an overnight flight of less than 8 hours.
Memory lapses may occur in such situations. Your
body needs time to eliminate the medication from your
system.

Mental and Behavioural Changes:

A variety of abnormal thinking and behavioural
changes may occur when you use prescription sleeping
pills. Some of these changes include aggressiveness and
extroversion which seem out of character. Other
changes, although rare, can be more unusual and
extreme. These include confusion, strange behaviour,
restlessness, irritability, illusions, nightmares,
hallucinations, feeling like you are not yourself, and
feeling more depressed, which may lead to suicidal
thinking.
It is rarely clear whether such symptoms are caused by
the medication, or by an illness that was present before
the medication was used, or are simply spontaneous
happenings. If you develop any unusual disturbing
thoughts or behaviour while using
APO-ZOPICLONE, discuss the matter immediately
with your doctor.

Tolerance/Withdrawal Symptoms:
After nightly use, sleeping pills may lose some of their
effectiveness and you may also develop a degree of
dependence.
When taking APO-ZOPICLONE, you may get
awakened during the last third of the night or feel
anxious or nervous during the day. If this occurs, tell
your doctor.

Worsening of Side Effects

DO NOT CONSUME ALCOHOL WHILE TAKING
APO-ZOPICLONE.
Some medicines may also worsen side effects that some
patients experience with APO-ZOPICLONE (see
Interactions with this medication).

You may also experience withdrawal effects when

you stop the medication after taking it for only a week
or two. But usually, these withdrawal effects are more
common and severe after long periods of continuous
use. For instance, on the first few nights after stopping
the medication, you may find that insomnia is worse
than before taking the sleeping pills. This type of
withdrawal symptom is known as rebound insomnia.

Elderly: An increased risk of falls and fractures has

been reported in elderly people who take sleeping pills
such as APO-ZOPICLONE.
Effects on Pregnancy:
Certain sleeping pills have been linked to birth defects
when taken during the early months of pregnancy. It is
not yet known if APO-ZOPICLONE could cause
similar effects. In addition, sleeping pills taken during
the last weeks of pregnancy have been known to sedate
the baby and may also cause withdrawal symptoms
after birth. Therefore, DO NOT TAKE APO-

Other withdrawal effects following abrupt stopping of

sleeping pills may range from unpleasant feelings to a
major withdrawal syndrome that may include
abdominal and muscle cramps, vomiting, sweating,
tremor, and rarely, convulsions. The severe symptoms
are uncommon. If you have been taking sleeping pills
for a long time, discuss with your physician when and
how it would be best for you to stop.
2

IMPORTANT: PLEASE READ

ZOPICLONE at anytime during pregnancy, it may
affect the developing baby.

CYP3A4 inducers, such as rifampicin or rifampin,

carbamazepine, phenobarbital, phenytoin, and St.
Johns wort.

Use in Nursing Mothers: APO-ZOPICLONE passes

into breast milk. Therefore, if you are breast feeding,
this medicine should be avoided. Your doctor will
discuss this with you.

PROPER USE OF THIS MEDICATION

APO-ZOPICLONE is an effective medication and is
relatively free of serious problems when used for the
short-term management of insomnia. Sleeplessness may
last only for a short time and may respond to brief
treatment. The risks and benefits of prolonged use
should be discussed with your doctor.

BEFORE you use APO-ZOPICLONE talk to your

doctor or pharmacist if:
You have a lung disease or breathing problems.
You have liver or kidney condition.
You have a history of depression and/or suicide
thoughts or attempts.
You have had unexpected reactions to alcohol or
sedative medications in the past, such as irritability,
aggression, hallucinations, etc.
You have a history of drug or alcohol abuse or
addiction.
You are planning to become pregnant, if you are
pregnant, or if you become pregnant while taking this
medication.
You are breastfeeding.
You consume alcohol.
You are taking any other medicines, including overthe counter medicines and herbal products.
You have lactose intolerance.

Usual dose:
APO-ZOPICLONE should be taken at bedtime just
before retiring for the night.
Adults: The usual adult dose is 5.0 mg to 7.5 mg.
Special population: Elderly (65 years of age or more),
debilitated patients and/or patients with liver, kidney, or
chronic respiratory problems should start with 3.75 mg
(one-half of a 7.5 mg tablet) at bedtime just before
retiring.
Follow your doctors advice about how to take APOZOPICLONE, when to take it, and how long to take it.
The lowest effective dose should be used.
Do not increase the prescribed dose of APOZOPICLONE.

INTERACTIONS WITH THIS MEDICATION

Do not use APO-ZOPICLONE if you drink alcohol. Do
not use APO-ZOPICLONE along with other
medications, over-the counter medicines or herbal
products without first discussing this with your doctor
or pharmacist.

Do not take APO-ZOPICLONE if it is not prescribed

for you.
Treatment with APO-ZOPICLONE should usually not
exceed 7-10 consecutive days. Do not take APOZOPICLONE for more than 7-10 days without first
consulting your doctor. If you still have problems
sleeping after you finish your capsules, contact your
doctor again.

APO-ZOPICLONE may produce more pronounced side

effects when coadministered with:
Alcohol
Other tranquilizers or sleeping pills
Sedative antihistamines
Anticonvulsants (medicines used to control or prevent
convulsions)
Narcotic analgesics
Antipsychotics, antidepressants and other
psychotropic medications (mood altering drugs) which
themselves can make you sleepy.
Other drugs which may interact with APOZOPICLONE by affecting the way the drug is
metabolized by the enzyme CYP3A4 in the liver
include:
CYP3A4 inhibitors, such as erythromycin,
clarithromycin, ketoconazole, itraconazole, and
ritonavir;

Do not take APO-ZOPICLONE if you drink alcohol.

APO-ZOPICLONE is not indicated for patients under
18 years of age. Do not take APO-ZOPICLONE if
you are under 18 years of age.
Do not take APO-ZOPICLONE when a full nights
sleep is not possible before you would again need to be
active and functional.
Do not drive a car or operate potentially dangerous
machinery until you experience how this drug will
affect you the next day.

IMPORTANT: PLEASE READ

Do not drink alcohol while using APO-ZOPICLONE.
Do not use sleeping pills along with other medications
without first discussing this with your doctor.

Overdose:
Contact your doctor, regional Poison Control Centre or
pharmacist immediately if you suspect you have taken
an overdose or someone else accidentally takes your
APO-ZOPICLONE. If you are unable to contact them,
go to a hospital emergency department for medical
help, even though you may not feel sick. Show your
doctor your bottle of tablets.

Allergic reactions:
Rare cases of severe allergic reactions have been
reported.
Symptoms may include:
swelling of the tongue or throat, trouble breathing,
nausea and vomiting. Get emergency medical help if
you get these symptoms after taking APOZOPICLONE.

In case of drug overdose, contact a health care

practitioner, hospital emergency department or regional
Poison Control Centre immediately, even if there are no
symptoms.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY

HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect
Talk with your
Stop taking
doctor or
drug and
pharmacist
call your
doctor or
Only if
In all
pharmacist
severe
cases

Uncommon
Unexpected

Missed Dose:
APO-ZOPICLONE should be taken at bedtime just
before retiring for the night. If you miss a dose, wait
and take your next dose at your regular time. Do not
take 2 doses at the same time. Do not make up for a
missed dose

reactions
such as
excitement,
agitation,
hyperactivity,
hallucination,
worsened
insomnia,
aggressiveness,
irritability,
rages,
psychoses, and
violent
behaviour

SIDE EFFECTS AND WHAT TO DO ABOUT

THEM
Common Side Effects:
The most common adverse reaction seen with APOZOPICLONE is taste alteration (bitter taste).
APO-ZOPICLONE may cause drowsiness, dizziness,
lightheadedness, and difficulty with coordination. Users
must be cautious about engaging in hazardous activities
requiring complete mental alertness, e.g., operating
machinery or driving a motor vehicle.
This risk is increased by concomitant intake of alcohol.

Depressed
Mood

How sleepy you are the day after you use one of these
sleeping pills depends on your individual response and
on how quickly your body gets rid of the medication.
The larger the dose, the more likely that you will
experience drowsiness, etc., the next day. It is important
that you comply with the dose your physician has
prescribed. Prescription sleeping pills which are
eliminated rapidly, tend to cause less drowsiness the
next day, but may cause withdrawal problems the day
after use (see below).

Severe allergic
reactions
(swelling of
the tongue or
throat,
trouble
breathing,
nausea and
vomiting)
Trouble
breathing
Withdrawal
effects
(abdominal and
muscle
cramps,
vomiting,
sweating,
tremor, and
rarely,
convulsions)

Withdrawal-related side effects: You may experience an

increase in sleep difficulties (rebound insomnia) and/or
increased daytime anxiety (rebound anxiety) for one
or two days after discontinuing
APO-ZOPICLONE (see Warnings and Precautions,
Tolerance/Withdrawal Symptoms).
Elderly patients are especially susceptible to side
effects. Excessive drowsiness in the elderly may result
in falls and fractures.
4

IMPORTANT: PLEASE READ

Somnambulism
(sleepwalking)

getting out of
bed
while not fully
awake
and do
activities you
do not
remember the
day after

Rare

Very Rare

thoughts of
death or
suicide

Keep in a safe place out of reach of children.

MORE INFORMATION
For more information, please contact your doctor,
pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared
for health professionals, can be obtained by contacting
DISpedia, Apotex's Drug Information Service at:

1-800-667-4708
This leaflet can also be found at:
http://www.apotex.ca/products

This is not a complete list of side effects. For any

unexpected effects while taking APO-ZOPICLONE,
contact your doctor or pharmacist.

This leaflet was prepared by Apotex Inc., Toronto,

Ontario,
M9L 1T9.
Last revised:

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
Address Locator: 0701C
Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form

and the adverse reaction reporting guidelines are
available on the MedEffectTM Canada Web site at
www.healthcnada.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.
HOW TO STORE IT
Store in a dry place, at room temperature (15 - 30C).
Protect from light. Do not exceed the expiry date
indicated on the container.

May 31, 2010