Mylan-Zopiclone: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

MYLAN-ZOPICLONE is a prescription medication 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 MYLAN-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. MYLAN-ZOPICLONE does not treat the underlying cause of your insomnia.

What it does:

MYLAN-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 and Precautions)

When it should not be used:

Do not use MYLAN-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

  MYLAN-ZOPICLONE contains (see What the nonmedicinal ingredients are).

What the medicinal ingredient is:

The active ingredient in MYLAN-ZOPICLONE is zopiclone.

What the nonmedicinal ingredients are:

The non-medicinal ingredients of MYLAN-ZOPICLONE 5.0 mg are dibasic calcium phosphate anhydrous, lactose anhydrous, magnesium stearate, maize starch, Opadry white dye (HPMC 2910/Hypermellose 6cP, Titanium Dioxide, Macrogol/PEG 400) and povidone.

The non-medicinal ingredients of MYLAN-ZOPICLONE 7.5 mg are carnauba wax, dibasic calcium phosphate anhydrous, lactose anhydrous, magnesium stearate, maize starch, Opadry blue dye (FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, HPMC 2910/Hypermellose 5 cP, Macrogol/PEG 400 HF, Ponceau 4R Aluminum Lake, Quinoline Yellow Aluminum Lake and Titanium Dioxide) and povidone.

What dosage forms it comes in:

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

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• Taking MYLAN-ZOPICLONE with opioid medicines can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

Complex sleep-related behaviours

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 doing those activities. This unusual behaviour is more likely to occur when 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.

Important:

1. 1. Do not take more MYLAN-ZOPICLONE than prescribed.
2. 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. 3. Do not take MYLAN-ZOPICLONE if you drink alcohol.
4. 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. 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. 6. 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 MYLAN-ZOPICLONE with your other medicines.
7. 7. 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:

MYLAN-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 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: MYLAN-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 “traveller’s amnesia”. DO NOT TAKE MYLAN-ZOPICLONE 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 MYLAN-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.

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 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 disorders and/or alcohol or drug abuse.

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, 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 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 MYLAN-ZOPICLONE, discuss the matter immediately with your doctor.

Worsening of Side Effects:

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

Elderly: An increased risk of falls and fractures has been reported in elderly people who take sleeping pills such as MYLAN-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 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 MYLAN-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 doctor will discuss this with you.

BEFORE you use MYLAN-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 mental disorder.

• 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 opioid medicines or other central nervous system depressants such as sedative or hypnotics (see INTERACTIONS WITH THIS MEDICATION), as well as if you are taking any other medicines, including over-the counter medicines and herbal products.
• You have lactose intolerance.

IACTIONS WITH THIS MEDICATION

INTERACTIONS WITH THIS MEDICATION

Do not use MYLAN-ZOPICLONE if you drink alcohol. Do not use MYLAN-ZOPICLONE along with other medications, over-the counter medicines or herbal

products without first discussing this with your doctor or pharmacist.

MYLAN-ZOPICLONE may produce more pronounced side effects when co- administered with:

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

Other drugs which may interact with MYLAN-ZOPICLONE 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.

P

PROPER USE OF THIS MEDICATION

MYLAN-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.

Usual Adult dose:

MYLAN-ZOPICLONE 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 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 3.75 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 MYLAN-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 MYLAN-ZOPICLONE.

Do not take MYLAN-ZOPICLONE if it is not prescribed for you.

Treatment with MYLAN-ZOPICLONE should usually not exceed 7-10 consecutive days. Do not take MYLAN-ZOPICLONE 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 MYLAN-ZOPICLONE if you drink alcohol.

MYLAN-ZOPICLONE is not indicated for patients under 18 years of age. Do not take MYLAN-ZOPICLONE if you are under 18 years of age. Do not take MYLAN-ZOPICLONE 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 (see WARNINGS AND PRECAUTIONS, Mental Alertness).

Overdose:

Missed Dose:

MYLAN-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.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Common Side Effects:

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

MYLAN-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.

How sleepy you are the day after you use MYLAN-ZOPICLONE 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 (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.

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

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 MYLAN-ZOPICLONE. (see Warnings and Precautions, 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 MYLAN-ZOPICLONE.

Uncommon

This is not a complete list of side effects. For any unexpected effects while taking MYLAN-ZOPICLONE, contact your doctor or pharmacist.

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/adverse-reaction-reporting.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.

HOW TO STORE IT

TO STORE IT

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

Keep in a safe place out of reach and sight of children. M

MORE INFORMATION

E INFORMATION

This document can be found at: www.mylan.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-844-596-9526

Revised on: January 2, 2019

Mylan Pharmaceuticals ULC

Etobicoke, ON M8Z 2S6

1-844-596-9526 www.mylan.ca