Patient Medication Information: uses, side effects, how to take - Dom-Zopiclone
Serious Warnings and Precautions
| Addiction, Abuse and Misuse: Even if you take Dom-ZOPICLONE exactly as you were told to, you are at risk for abuse, misuse, addiction, physical dependence and withdrawal. Abuse and misuse can result in overdose or death, especially if you take Dom-ZOPICLONE with: |
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| Your healthcare professional should: |
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Store Dom-ZOPICLONE in a secure place to avoid theft or misuse. Withdrawal: If you suddenly stop taking Dom-ZOPICLONE, lower your dose too fast, or switch to another medication, you can experience severe or life-threatening withdrawal symptoms (see Other warnings you should know about) |
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| Dom-ZOPICLONE with Opioids: Taking Dom-ZOPICLONE with opioid medicines can cause: |
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Complex Sleep Behaviours: Taking Dom-ZOPICLONE can cause complex sleep behaviours. This includes sleepwalking, sleep-driving and doing other activities while you are not fully awake. These behaviours can cause serious injuries, including death. Stop taking Dom-ZOPICLONE right away if you experience any complex sleep behaviours. |
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What is Dom-ZOPICLONE used for?
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How does Dom-ZOPICLONE work?
Dom-ZOPICLONE works by increasing the activity of a chemical in your brain called gamma-aminobutyric acid (GABA). This calms the brain which helps you go to sleep.
What are the ingredients in Dom-ZOPICLONE?
Medicinal ingredients: Zopiclone
Non-medicinal ingredients:
5 mg: Croscarmellose Sodium, Dibasic Calcium Phosphate, Hydroxypropyl Cellulose, Hydroxypropyl Methylcellulose, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Titanium Dioxide.
7.5 mg: Croscarmellose Sodium, Dibasic Calcium Phosphate, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, Hydroxypropyl Methylcellulose, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Pregelatinized Starch, Titanium Dioxide
Dom-ZOPICLONE comes in the following dosage forms:
Tablet: 5 mg and 7.5 mg
Do not use Dom-ZOPICLONE if:
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To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Dom-ZOPICLONE. Talk about any health conditions or problems you may have, including if you:
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Other warnings you should know about:
Complex Sleep Behaviours: Dom-ZOPICLONE can cause dangerous sleeping-related behaviours such as getting out of bed while not fully awake and doing activities that you do not know you are doing. You may not remember doing these activities when you wake up. These unusual behaviours may occur whether or not you drink alcohol or take other medicines that can make you sleepy, such as medicines used to treat depression or anxiety. The activities you may do in these situations can put you and people around you in danger. This can include driving a car (“sleep-driving”), leaving the house, making and eating food, having sex and talking on the phone. These behaviours can cause serious injuries, including death.
You and people close to you should watch out for unusual types of behavior when you are asleep. If you find out that you have done any such activities for which you have no memory, you should stop taking Dom-ZOPICLONE and call your healthcare professional right away.
Driving and Using Machines: Dom-ZOPICLONE may make you feel dizzy, drowsy and affect your coordination. DO NOT drive, use machinery, or do activities that require you to be alert:
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Memory Problems: Dom-ZOPICLONE can cause a type of memory loss known as amnesia. This is characterized by having trouble remembering events that recently occurred, usually several hours after taking the medication. This is not usually a problem if you take Dom-ZOPICLONE before sleeping. However, if you take Dom-ZOPICLONE to help sleep while travelling, such as during an airplane flight, you may wake up to memory lapse caused by the drug. This has been called “traveler's amnesia” and can be a problem.DO NOT take Dom-ZOPICLONE when a full night's sleep is not possible before you need to be active and functional (e.g., an overnight flight of less than 8 hours). Your body needs time to eliminate Dom-ZOPICLONE from your system.
Dependence: Taking Dom-ZOPICLONE can lead to physical dependence. The risk of dependence is greater when Dom-ZOPICLONE is used for longer than 4 weeks and in patients with a history of mental health problems and/or alcohol or drug abuse.
Withdrawal: If you suddenly stop your treatment, lower your dose too fast, or switch to another medication, you can experience withdrawal symptoms that can range from mild symptoms to severe or life threatening.
Your risk of going through withdrawal is higher if you are taking Dom-ZOPICLONE for a long time or at high doses. However, symptoms can still occur if you are taking Dom-ZOPICLONE as directed for a short period of time or slowly reducing the dose.
The symptoms of withdrawal often resemble the condition that you are being treated for. After stopping your treatment, it may be hard to tell if you are experiencing withdrawal or a return of your condition (relapse).
Tell your healthcare professional right away if you experience any symptoms of withdrawal after changing or stopping your treatment.
Severe symptoms of withdrawal include:
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For other symptoms of withdrawal, see the Serious side effects and what to do about them table (below).
To reduce your chances of going through withdrawal:
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Falls and Fractures:
Benzodiazepines or other sedative-hypnotic drugs, such as Dom-ZOPICLONE, can cause you to feel sleepy, dizzy and affect your balance. This increases your risks of falling, which can cause fractures or other fall related-injuries, especially if you:
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Mental and Behavioural Changes: A variety of abnormal thinking and behaviour changes may occur when you take Dom-ZOPICLONE. Some of these changes include aggressiveness and extroversion that seem out of character, delirium (a sudden and severe change in mental state which includes a combination of confused thinking, disorientation and decreased attention), confusion, strange behaviour, anxiety, restlessness, hallucinations, feeling like you are not yourself, worsening insomnia or depression, which may lead to suicidal thinking. If you develop any unusual thoughts or behaviour while using Dom-ZOPICLONE, tell your healthcare professional right away.
Self-harm or Suicide: If you have thoughts of harming or killing yourself at any time, contact your healthcare professional or go to a hospital right away. You may find it helpful to tell a relative or close friend that you are depressed or have other mental illnesses. Ask them to read this leaflet. You might ask them to tell you if they:
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Pregnancy: Do not take Dom-ZOPICLONE if you are pregnant. Dom-ZOPICLONE may harm your unborn baby (e.g., birth defects) if you are pregnant. This risk is higher during the first trimester or last weeks of pregnancy. It may also cause side effects and withdrawal symptoms in your baby after birth. If you are able to get pregnant, want to be or think you are pregnant, there are specific risks you should discuss with your healthcare professional.
Breastfeeding: Dom-ZOPICLONE passes into breast milk. Do not breastfeed while taking Dom-ZOPICLONE. Talk to your healthcare professional about the best way to feed your baby while you are taking Dom-ZOPICLONE.
Blood Tests: Dom-ZOPICLONE can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Dom-ZOPICLONE:
Serious Drug Interactions Taking Dom-ZOPICLONE and opioids may cause: |
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| Tell your healthcare professional if you: |
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How to take Dom-ZOPICLONE:
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Remember: This medication is for YOU. Never give it to others. It may harm them even if their symptoms are the same as yours.
Usual dose:
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Your healthcare professional will slowly decrease your dose and will tell you when to stop taking the medicine. Always follow your doctor’s instructions on how to lower your dose carefully and safely to avoid experiencing withdrawal symptoms.
Overdose:
| If you think you, or a person you are caring for, have taken too much Dom-ZOPICLONE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you missed a dose of this medication, you do not need to make up the missed dose. Skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.
What are possible side effects from using Dom-ZOPICLONE?
These are not all the possible side effects you may have when taking Dom-ZOPICLONE. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
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Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
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| Only if severe | In all cases | ||
| UNCOMMON | |||
| Mental and behavioural changes: excitement, agitation, hyperactivity, delirium, hallucination, worsened insomnia, aggression, irritability, rages, psychoses, and violent behaviour symptom | ✓ | ||
| Severe allergic reactions: swelling of the tongue or throat, trouble breathing, sudden wheeziness, chest pain or tightness, shortness of breath, throat closing, nausea, or vomiting. Other allergic reactions may include rashes, spots on your skin, or itchy skin | ✓ | ||
| RARE | |||
| Amnesia (a type of memory loss): difficulty recalling events that recently happened | ✓ | ||
Complex sleep behaviours: getting out of bed while not fully awake and doing activities you do not remember the day after, including sleep walking, driving, making phone calls, or having sex | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| UNKNOWN | |||
| Overdose: extreme sleepiness, confusion, slurred speech, slow reflexes, slow shallow breathing, coma, loss of balance and coordination, uncontrolled rolling of the eyes, and low blood pressure. | ✓ | ||
| Respiratory Depression: slow, shallow or weak breathing. | ✓ | ||
| Self-harm or Suicide: thoughts or actions about hurting or killing yourself | ✓ | ||
Withdrawal: Severe symptoms include: Delirium: sudden and severe change in mental state that can cause a combination of confusion, disorientation and/or attention deficit Derealization: experiences of unreality or detachment from one’s surroundings Depersonalization: experiences of unreality or detachment from one’s mind, self, or body Hallucinations: seeing or hearing things that are not there Hyperacusis: sensitivity to sounds and noise Convulsions: (seizures – including some that do not stop): loss of consciousness with uncontrollable shaking Other symptoms include: Stomach cramps; trouble remembering or concentrating; diarrhea; feeling uneasy or restless; severe anxiety; headache; sensitivity to light, noise or physical contact; shaking; vomiting; trouble sleeping; feeling irritable; muscle pain or stiffness; a burning or prickling feeling in the hands, arms, legs or feet; | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
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| Only if severe | In all cases | |
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If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
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Storage:
Store in a dry place, between 15°C and 30°C. 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.
If you want more information about Dom-ZOPICLONE:
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