Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Mylan Zopiclone.
HEALTH CANADA ADVISORY
October 30, 2020
Health Canada has issued new restrictions concerning the use of benzodiazepines and benzodiazepine-like prescription drugs. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Alcohol use: The use of zopiclone after consuming alcohol increases the risk of severe side effects such as breathing difficulty and performing activities while not being aware or awake. Alcohol should not be consumed if you are taking zopiclone.
Anxiety or restlessness: An increase in daytime anxiety or restlessness has been observed during treatment with zopiclone.
Bad taste in mouth: Zopiclone may cause you to have a coated tongue, bad breath, or a bitter taste in your mouth. These effects often occur when Mylan Zopiclone is being used.
Behaviour changes: Mylan Zopiclone may worsen symptoms of depression, including thoughts of suicide or wanting to harm others. It may also cause agitated or aggressive behaviour. If you experience these symptoms or any other behaviour change while taking Mylan Zopiclone, contact your doctor immediately.
Family members or caregivers of people who are taking Mylan Zopiclone should contact the person's doctor immediately if they notice unusual behaviour changes.
Breathing: Sedatives can suppress breathing. If you have Asthma, or other lung disease that increases your risk for breathing difficulties, such as sleep apnea, discuss with your doctor how Mylan Zopiclone may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Zopiclone, and whether any special monitoring is needed.
Confusion: Mylan Zopiclone affects mental efficiency (e.g., concentration, attention, and vigilance). The risk of confusion is greater for seniors and those with brain damage.
Depression: Sedative medications have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression or suicidal thoughts, discuss with your doctor how Mylan Zopiclone may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Zopiclone, and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking Mylan Zopiclone contact your doctor as soon as possible.
Drowsiness/reduced alertness: Zopiclone can cause excessive drowsiness and decreased mental alertness. Do not operate heavy machinery or drive after taking Mylan Zopiclone. Wait at least 12 hours after taking Mylan Zopiclone before driving or engaging in other activities that require mental alertness.
Kidney function: Kidney Disease or reduced kidney function may cause Mylan Zopiclone to build up in the body, causing side effects. If you have kidney problems, you may require lower doses of Mylan Zopiclone.
Liver function: Liver disease or reduced liver function may cause Mylan Zopiclone to build up in the body, causing side effects. If you have liver problems, you may require lower doses of Mylan Zopiclone.
Memory disturbance: Amnesia of varying severity has been reported following normal doses of medications like zopiclone. This effect is rare with zopiclone.
Performing activities while not fully awake: People taking zopiclone may perform activities such as sleepwalking, driving, preparing and eating food, and making phone calls while not fully awake and unaware of their actions. The next morning, they may not remember what happened. This may be more likely to occur if you use alcohol or other sedative medications. If you discover this has happened to you, contact your doctor immediately.
Withdrawal: Zopiclone can become habit-forming. Withdrawal symptoms similar to those occurring with related substances, including alcohol, have been observed after stopping the medication suddenly (after having taken it regularly over a period of time). These symptoms include:
- abdominal cramps
- agitation
- confusion
- Diarrhea
- extreme anxiety
- headache
- irritability
- memory impairment
- muscle pain
- nervousness
- restlessness
- sleep problems such as rebound Insomnia
- tension
- tremors
- vomiting
Pregnancy: The safety of using Mylan Zopiclone during pregnancy has not been established. Mylan Zopiclone should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Mylan Zopiclone, contact your doctor immediately.
Breast-feeding: Mylan Zopiclone passes into breast milk. If you are a breast-feeding mother and are taking zopiclone, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of zopiclone have not been established for use by children and adolescents under 18 years of age.
Seniors: People over 65 years of age are more likely to experience dose-related side effects of zopiclone, such as drowsiness, dizziness, or impaired coordination. Using doses that are too high may result in accidents such as falls. Talk to your doctor if you are a senior and are experiencing any of the above side effects.
