Details for: MINT-ZOPICLONE
Company: MINT PHARMACEUTICALS INC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02391716 | MINT-ZOPICLONE | ZOPICLONE | 5 MG | TABLET | ORAL |
02391724 | MINT-ZOPICLONE | ZOPICLONE | 7.5 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
MINT-ZOPICLONE is a prescription medication
intended to help you sleep if you are over 18 years of
age and have transient and short-term 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.
Treatment with MINT-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. MINT-ZOPICLONE
does not treat the underlying cause of your insomnia.
What it does
MINT-ZOPICLONE is one of several prescription
sleeping pills that have generally similar properties
such as a calming effect.
If you are prescribed sleep medications, 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 andPrecautions)
When it should not be used
Do not use MINT-ZOPICLONEif 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 zopicloneor any of the ingredients MINT-ZOPICLONEcontains (see Whatthe nonmedicinal ingredients are).
- ever experienced complex sleep behaviours including sleep-walking or other unusual behaviour (such as driving, eating, making a phone call or having sex) while not being fully awake after taking MINTZOPICLONE or any other medication to help you sleep.
What the medicinal ingredient is
Zopiclone
What the non-medicinal ingredients are
MINT-ZOPICLONE 5 mg contains: Dibasic Calcium
Phosphate, Croscaramellose Sodium, Microcrystalline
Cellulose, Povidone K-30, Magnesium Stearate,
Opadry II white (Polyvinyl Alcohol, Titanium
Dioxide, Polyethylene glycol, and Talc).
MINT-ZOPICLONE 7.5 mg contains: Dibasic Calcium
Phosphate, Croscaramellose Sodium, Microcrystalline
Cellulose, Povidone K-30, Magnesium Stearate, Opadry
II blue (Polyvinyl Alcohol, Titanium Dioxide,
Polyethylene glycol, Talc, and FD&C Blue #1/Brilliant
blue FCF Aluminum lake).
What dosage form it comes in
Tablets, 5mg and 7.5 mg
Warnings and precautions
Serious Warnings and Precautions
Taking MINT-ZO PICLO NE with opioids:
Taking MINT-ZO PICLO NE with opioid medicines can
cause severe drowsiness, decreased awareness, breathing
problems, coma, and death.
Complex Sleep Behaviours:
Complex sleep behaviours, including sleepwalking,
sleep-driving and doing other activities while you are
not fully awake, can happen after taking medications
to help you sleep, including MINT-ZO PICLO NE.
These behaviours may result in serious injuries,
including death. Stop using MINT-ZO PICLO NE
immediately if you experience any complex sleep
behaviours.
Complex sleepbehaviours
There have been reports of people getting out of bed
while not fully awake after taking zopiclone and doing
activities that they did not know they were doing. The
next morning,they did not remember doingthose
activities. The activities youmay do in these situations
can put you and people aroundyouin danger and can
cause serious injuries or death.Reported activities
ncluded driving a car (“sleep-driving”), leavingthe
house, making and eating food, talking on the phone,
having sex etc. These activities may occur whether or
not you drink alcohol or take other medicines that
make you drowsy with MINT-ZOPICLONE. If you
experience any of the above, stop taking MINTZOPICLONE immediately and contact your doctor or
healthcare professional.
Important:
- Do not take more MINT-ZOPICLONE than prescribed.
- Do not use for longer than recommended by your physician. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.
- Do not take MINT-ZOPICLONEif you drink alcohol.
- Talk to your doctor if you have had episodes of sleepwalking in the past, or if there is a history of sleepwalking in your family.
- Talk to your doctor if you have a condition that affects your sleep,such as Periodic Limb Movement Disorder(involuntary movement of limbs during sleep) or Restless Legs Syndrome (urge to move legs, usually accompanied by uncomfortable and unpleasant sensations,that begins or worsens during periods of inactivity, typically in the evening and night)
- Talk to your doctor about allof yourmedicines, including over-the-countermedicines and herbal products.Your doctor will tell you if you can take MINT-ZOPICLONEwith your other medicines.
- You and people close to you should watch for the complex sleep behaviours describedabove. If you find out that you havedone any such activities forwhich you haveno memory you should callyour doctor immediately.
Mental Alertness:
MINT-ZOPICLONEmay affect your ability to be alert
next day. DO NOT DRIVE A CAR or operate potentially
dangerous machinery:
- If you do not feel fully awake
- If it has not been at least 12 hours since taking the medicine, even if you feel fully awake, especially in elderly patients and in patients who take the 7.5 mg dose
- In all cases, until you experience how the drug affects you next day
Memory problems: MINT-ZOPICLONE may cause a
special typeof memory loss (amnesia); you may not
recall eventsthat occurred duringsome period oftime,
usually severalhours, after taking the drug.This lapse is
usually not a problem, becausethe person taking the
sleeping pill intends to be asleep during this critical
period of time. But it can be a problemif you take the
medication to induce sleep while travelling,suchas
during an airplane flight, becauseyou may wake up
before the effect of the drug is gone. This has been called
“traveller’s amnesia”.DO NOT TAKE MINTZOPICLONE when a full night's sleep is notpossible
before you would again need to beactive and functional;
e.g., an overnight flight of less than 8hours.Memory
lapses may occurin such situations.Your body needs
time to eliminate the medication from your system
Tolerance/Withdrawal Symptoms:
After nightly use, sleeping pills may lose some of their
effectivenessand you may also develop a degree of
dependence.
When takingMINT-ZOPICLONE, you may get
awakened during the last third ofthe night or feel
anxious or nervous duringthe day.If this occurs, tell
your doctor.
You may also experience “withdrawal effects” when
you stop the medication aftertaking it for only a week
or two.But usually, these withdrawal effects are more
common and severe afterlong periods of continuous
use. For instance, on thefirst few nights afterstopping
the medication, you may find that insomnia is worse
than before takingthe sleeping pills.This typeof
withdrawal symptomis known as “rebound
insomnia”.
Otherwithdrawal effectsfollowing abrupt stopping of
sleeping pills may range fromunpleasant 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.
Dependence/Abuse:
All prescription sleeping pills can cause dependence
(addiction) especially when used regularly for more
than a fewweeks, or at higher doses.Some people
develop a needto continue taking these drugs, not
only for continuedtherapeutic effect, but also to avoid
withdrawal symptoms or to achievenon-therapeutic
effects.
Individuals who depend, or have dependedat any time
in the past, on alcoholor other drugsmay be at
particularrisk of becoming dependenton drugs of this
class. But all people are at some risk. Consider this
matter before you take these medications beyond the
recommended 7-10 days, because longer treatment
times increase the risk of dependence. The risk of
dependence is also greater in patients with a history of
mental health problems and/or alcohol or drug abuse.
Mental and Behavioural Changes:
A variety of abnormal thinkingand behavioural
changesmay occurwhen you useprescription
sleeping pills. Some of these changesinclude
aggressiveness andextroversion which seemout of
character. Other changes, although rare, can be more
unusual and extreme. These include confusion,strange
behaviour, restlessness, agitation,irritability,
nightmares, hallucinations, delusion (a false belief or
wrong judgment, held with conviction despite
evidence to the contrary), feeling like you are not
yourself, and feeling more depressed, which may lead
to suicidal thinking.
It is rarely clearwhethersuch symptoms are causedby
the medication, or by an illness that was present
before the medication was used, or are simply
spontaneous happenings.If you developany unusual
disturbing thoughts or behaviour while using MINTZOPICLONE, discussthe matterimmediately with
your doctor.
Worsening ofSide Effects:
DO NOT CONSUME ALCOHOL WHILE TAKING
MINT-ZOPICLONE. Some medicines may also
worsen side effects that some patients experience with
zopiclone (see Interactions with this medication).
Elderly: An increased risk offalls and fractures has
been reported in elderly people who take sleeping pills
such as zopiclone.
Effects on Pregnancy:
Certain sleeping pills have been linked to birth defects
when taken duringthe early months of pregnancy.It is
not yet known if MINT-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 MINT-ZOPICLONE
at anytime during pregnancy,it may affect the
developing baby.
Use in Nursing Mothers: Zopiclonepassesinto breast
milk. Therefore, if you are breast feeding,this medicine
should be avoided.Your doctor will discuss this with
you.
BEFORE you use MINT-ZOPICLONE talk to your
doctor or pharmacist if you:
- have a lung disease or breathing problems. have liver or kidney condition.
- have ever had mental health problems or have abused or been dependent on alcohol or drugs. The risk of dependence is greater when MINTZOPICLONE is used for longer than 4 weeks, and in patients with a history of mental health problems and/or alcohol or drug abuse.
- have a historyof depressionand/orsuicide thoughts or attempts.
- have had unexpected reactionsto alcohol or sedative medications in the past, such as irritability, aggression, hallucinations, etc.
- are planning to become pregnant,if you are pregnant, or if you become pregnantwhile taking this medication.
- are breastfeeding.
- consume alcohol.
- are taking opioid medicines or other central nervous system depressants such as sedative or hypnotics (see NTERACTIONS WITH THIS MEDICATIONS), as well as if you are taking any othermedicines, including over-the- counter medicines and herbalproducts.
Interactions with this medication
Do not use MINT-ZOPICLONEif you drinkalcohol.
Do not use MINT-ZOPICLONE along with other
medications, over-thecounter medicines or herbal
products without first discussingthis with your doctor
or pharmacist.
MINT-ZOPICLONE may producemore pronounced
side effects when co-administered with:
- Alcohol
- Other tranquilizers or sleeping pills
- Sedative antihistamines
- Anticonvulsants (medicines used tocontrolor prevent convulsions)
- Narcotic analgesics(opioids) (see Serious Warnings and Precautions box)
- Antipsychotics, antidepressants and other psychotropic medications(moodaltering drugs) which themselves can make you sleepy.
Other drugs which may interact with MINTZOPICLONE by affecting the way thedrug is metabolized by the enzyme CYP3A4 in the liver include:
- CYP3A4 inhibitors,suchas erythromycin, clarithromycin, ketoconazole,itraconazole, and ritonavir;
- CYP3A4 inducers, such asrifampicin or rifampin, carbamazepine, phenobarbital, phenytoin, and St. John’s wort.
Proper use of this medication
MINT-ZOPICLONE is an effective medicationand is relatively free of serious problems when used forthe short-termmanagement 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.
Usual Dose:
MINT-ZOPICLONE should be taken at bedtime just
before retiring forthe night.
Adults:The recommended starting dose is 3.75 mg
(one-half of a 7.5 mg tablet). This can be increased to
5 mg or 7.5 mg if advised by your doctor.
Special population: Elderly (65 years of age or more),
debilitated patients and/or patients with liver, kidney, or
chronic respiratory problems should start with 3.75mg
(one-half of a 7.5 mg tablet) at bedtime just before
retiring.The dose in elderly, debilitated patients and/or
patients with liver or kidney problems is not to exceed 5
mg.
Follow your doctor’s advice about howto take MINTZOPICLONE, when to take it, and how long to take it.
The lowest effective dose shouldbe used.
Do not increase the prescribed dose of MINTZOPICLONE.
Do not take MINT-ZOPICLONEif it is not prescribed
for you.
Treatment with MINT-ZOPICLONEshould usually not
exceed 7-10 consecutive days. Do not take MINTZOPICLONE formore than 7-10 days without first
consultingyour doctor. If you still have problems
sleeping after you finish yourtablets, contact your
doctor again.
Do not take MINT-ZOPICLONE if you drink alcohol.
MINT-ZOPICLONE is not indicated for patients under
18 years of age.Do not take MINT-ZOPICLONE if
you are under 18 years of age.
Do not take MINT-ZOPICLONE when a full night’s
sleep is not possible beforeyou would again needto be
active and functional.
Do not drive a car or operate potentially dangerous
machinery until you experience how this drugwill
affect you the next day (see WARNINGS AND PRECAUTIONS, Mental Alertness).
Overdose:
If you think you, or a person you are caring for, have taken too much MINT-ZOPICLONE, contact a healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose
MINT-ZOPICLONE should be takenat bedtime just before retiring for the night.If you miss a dose,wait and take your next doseat your regular time. Do not take 2 doses at thesame time. Do not make up for a missed dose.
Side effects and what to do about them
Common Side Effects:
The most common adverse reactionseen with
zopiclone is taste alteration (bitter taste).
MINT-ZOPICLONE may cause drowsiness, dizziness,
lightheadedness, and difficulty with coordination.
Users must be cautious about engaging in hazardous
activities requiringcompletemental alertness, e.g.,
operating machinery or driving a motor vehicle. This
risk is increased by concomitant intake of alcohol.
Howsleepy youare the day after you use MINTZOPICLONE depends onyour individual response
and on how quickly your bodygets rid ofthe
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.If you experience excessive
drowsiness the next day that affects your ability to
perform tasks in the morning contact your physician
as your dose may need to be reduced (see Warnings
and Precautions, Mental Alertness).
Elderly patients are especially susceptible to side
effects. Excessive drowsiness in the elderly may result
in falls and fractures.
MINT-ZOPICLONE may cause sleep walking or
other unusual behaviour (such as driving, eating,
making a phone call, or having sex) while not being
fully awake, some of which have been associated with
serious injuries and death.
Do not drink alcohol while using MINTZOPICLONE. Do not use sleeping pills along with
other medications without first discussing this with
your doctor.
Withdrawal-related sideeffects: You may experience
an increase in sleep difficulties (reboundinsomnia)
and/or “increased daytime anxiety” (reboundanxiety)
for one ortwo days after discontinuing MINTZOPICLONE (see Warnings andPrecautions,
Tolerance/Withdrawal Symptoms).
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 MINT-ZOPICLONE
Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
---|---|---|---|
Uncommon | |||
Unexpected reactions such as excitement, agitation, hyperactivity, hallucination, worsened insomnia, aggression irritability, rages, psychoses, and violent behaviour | ✔ | ||
Depressed Mood | ✔ | ||
Severe allergic reactions(swelling of the tongue or throat, trouble breathing, nausea and vomiting) | ✔ | ||
Withdrawal effects (abdominal and muscle cramps, vomiting, sweating, tremor, and very rare cases of convulsions) | ✔ | ||
Rare | |||
Complex sleep behaviours (sleep walking, sleep driving, eating, making phone calls, having sex) | ✔ | ||
Very Rare | |||
Thoughts of death or suicide | ✔ | ||
UnKnown | |||
Trouble breathing | ✔ |
How to store
Store in a dry place, at room temperature (15ºC30ºC). Protect from light. Do not exceed the expiry date indicated on the container. Keep in a safe place out of reach and sightof children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about MINTZOPICLONE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html ; Mint Pharmaceuticals website http://www.mintpharmaceuticals.com/, or by calling 1-877-398-9696.
This leaflet was prepared by:
Mint Pharmaceuticals Inc.
6575 Davand Drive Mississauga, Ontario
Canada L5T 2M3
Last Revised: July 30, 2021