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IMOVANE (ZOPICLONE): PATIENT AND CONSUMER INFORMATION

ABOUT IMOVANE (ZOPICLONE)

What Imovane (Zopiclone) is used for?

Imovane is a prescription medicine intended to help you sleep if you 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 Zopiclone (Imovane) 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. This medication does not treat the underlying cause of your insomnia.

What it does?

Imovane (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.

    When Zopiclone (Imovane) tablets should not be used?

    Do not use this drug if you have:

  • a severe hepatic insufficiency (liver problems)
  • a muscular disease known as myasthenia gravis
  • severe lung or respiratory disease, including sleep apnea.
  • a known allergy to zopiclone or any of the ingredients Imovane tablets contain.

    What the medicinal ingredient is in Imovane?

    The active ingredient in Imovane tablets is Zopiclone.

    What the nonmedicinal ingredients are?

    The non-medicinal ingredients of Zopiclone (Imovane) tablets 5 mg are dicalcium phosphate, corn starch, hydroxypropyl-methylcellulose, magnesium stearate, lactose, sodium carboxymethyl starch and titanium dioxide.

    The non-medicinal ingredients of Imovane (Zopiclone) tablets 7.5 mg are croscarmellose sodium, carnauba wax, calcium phosphate dihydrate dibasic, magnesium stearate, polyethylene glycol, microcrystalline cellulose, Opadry II White, and FD&C Blue #1.

    What dosage forms this medicine comes in?

    Imovane (Zopiclone) is available in 5 mg and 7.5 mg tablets for oral administration.


    WARNINGS AND PRECAUTIONS

    Complex sleep-related behaviours

    There have been reports of people getting out of bed while not fully awake after taking Imovane (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 Zopiclone (Imovane) 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.

    Important

  • Do not take more Imovane (Zopiclone) tablets than prescribed.
  • Do not take This medication if you drink alcohol.
  • Talk to your doctor, pharmacist, or other healthcare professional if you have had episodes of sleepwalking in the past, or if there is a history of sleepwalking in your family.
  • Talk to your healthcare provider 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 or pharmacist about all of your medicines, including OTC medicines and herbal products. Your physician will tell you if you can take Zopiclone (Imovane) tablets with your other medicines.
  • 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.

    Mental Alertness

    Imovane (Zopiclone) may 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 Zopiclone (Imovane), 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 younext day

    Memory problems

    Imovane (Zopiclone) tablets 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 "traveller's amnesia". Do not take Zopiclone (Imovane) tablets 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.

    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 Imovane, 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.

    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".

    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.

    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.

    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.

    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 strange behaviour, confusion, restlessness, irritability, agitation, nightmares, delusion (a false belief or wrong judgment, held with conviction despite evidence to the contrary), 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 Imovane (Zopiclone) was used, or are simply spontaneous happenings. If you develop any unusual disturbing thoughts or behaviour while using Zopiclone (Imovane), discuss the matter immediately with your healthcare provider.

    Worsening of Side Effects

    Do not take alcohol while you have the therapy with Imovane (Zopiclone) tablets. Some medicines may also worsen side effects that some patients experience with this drug.

    Elderly

    An increased risk of falls and fractures has been reported in elderly people who take sleeping pills such as Imovane (Zopiclone) tablets.

    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 Zopiclone (Imovane) tablets 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, d o not take Imovane (Zopiclone) at anytime during pregnancy, it may affect the developing baby.

    Use in Nursing Mothers

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

    Before you use Imovane (Zopiclone) talk to your doctor, pharmacist, or other healthcare professional if:

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


    DRUG INTERACTIONS

    Do not use Imovane (Zopiclone) tablets if you drink alcohol. Do not use this medicine along with other medications, OTC preparations or herbal products without first discussing this with your physician or pharmacist.

    Zopiclone (Imovane) may produce more pronounced side effects when co-administered with:

  • Other tranquilizers or sleeping pills
  • Alcohol
  • Sedative antihistamines
  • Narcotic analgesics
  • Antipsychotics, antidepressants and other psychotropic medications (mood altering drugs) which themselves can make you sleepy.
  • Anticonvulsants (medicines used to control or prevent convulsions)

    Other drugs which may interact with Zopiclone (Imovane) tablets 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;
  • CYP3A4 inducers, such as rifampicin or rifampin, carbamazepine, phenobarbital, phenytoin, and St. John's wort.


    PROPER USE OF IMOVANE (ZOPICLONE)

    Imovane 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.

    Usual Adult dose

    Imovane (Zopiclone) tablets should be taken at bedtime just before retiring for the 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 healthcare provider.

    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. 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 how to take Imovane (Zopiclone), when to take it, and how long to take it.

    The lowest effective dose should be used.

    Do not increase the prescribed dose of Zopiclone (Imovane) tablets.

    Do not take this medication if it is not prescribed for you.

    Treatment with Imovane (Zopiclone) should usually not exceed 7-10 consecutive days. Do not take this drug for more than 7-10 days without first consulting your doctor. If you still have problems sleeping after you finish your tablets, contact your doctor again.

    Do not take Zopiclone (Imovane) if you drink alcohol.

    This medicine is not indicated for patients under 18 years of age. Do not take Imovane (Zopiclone) tablets if you are under 18 years of age.

    Do not take this medication when a full night's 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.

    Overdose

    In case of drug overdose, contact a health care practitioner, hospital emergency department or local Poison Control Centre immediately, even if there are no symptoms. Show the doctor, pharmacist, or other healthcare professional your bottle of tablets.

    Missed Dose

    Zopiclone (Imovane) tablets 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.


    SIDE EFFECTS AND WHAT TO DO ABOUT THEM

    Common Side Effects

    The most common adverse reaction seen with Imovane (Zopiclone) is taste alteration (bitter taste).

    This drug may cause dizziness, drowsiness, 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.

    How sleepy you are the day after you use Zopiclone (Imovane) 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. 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.

    Elderly patients are especially susceptible to side effects. Excessive drowsiness in the elderly may result in falls and fractures.

    Do not drink alcohol while using Imovane (Zopiclone) tablets. Do not use sleeping pills along with other medications without first discussing this with your physician.

    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 Zopiclone (Imovane) tablets.

    Allergic reactions

    Rare cases of severe allergic reactions have been reported.

    Symptoms may include:

  • swelling of the trouble breathing, tongue or throat, nausea and vomiting. Get emergency medical help if you get these symptoms after taking Imovane (Zopiclone).


    HOW TO STORE IMOVANE (ZOPICLONE) TABLETS

    Store in a dry place, at room temperature (15°C - 30°C). Protect from light. Do not exceed the expiry date indicated on the container.

    Keep Zopiclone (Imovane) in a safe place out of reach and sight of children.

    Manufactured and distributed by Sanofi-Aventis pharmaceutical company and its divisions.

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