Details for: MINT-ZOPICLONE

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:

1. Do not take more MINT-ZOPICLONE than prescribed.
2. 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.
3. Do not take MINT-ZOPICLONEif you drink alcohol.
4. 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.
5. 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)
6. 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.
7. 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.