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BIO-ZOPICLONE is a brand name for Zopiclone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Bio-ZOPICLONE (zopiclone) is indicated for short-term (usually not exceeding 7-10 days) use for: treatment and symptomatic relief of insomnia characterized by difficulty in falling asleep frequent nocturnal awakenings and/or early morning awakenings where disturbed sleep results in impaired daytime functioning…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations). 1 Pediatrics (< 18 years of age) No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics patients ( 65 years of age)). Long-term use of Bio-ZOPICLONE should be avoided, including in geriatric patients.
1 Dosing Considerations). 2 CONTRAINDICATIONS Bio-ZOPICLONE is contraindicated in patients: With known hypersensitivity to the drug or to any component in its formulation. For a complete listing, see
). It is important that the patient should be aware of the possibility of rebound phenomena, thereby minimizing anxiety over such symptoms should they occur while the medicinal product is being discontinued.
Driving and Operating Machinery CNS Depressant Effects and Next-Day Impairment:
Like other sedative/hypnotic drugs, Bio-ZOPICLONE has CNS-depressant effects. Due to the rapid onset of action, Bio-ZOPICLONE should be ingested immediately prior to going to bed. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle after ingesting the drug.
Page 12 of 38 This includes potential impairment of the performance of such activities that may occur the day following ingestion of Bio-ZOPICLONE. The risk of next day psychomotor impairment, including impaired driving, is increased if Bio-ZOPICLONE is taken with less than a full night of sleep remaining; if a higher dose than the recommended dose is taken; if co-administered with other CNS depressants or drugs that increase the blood level of zopiclone.
Patients should be cautioned against taking Bio-ZOPICLONE in these circumstances. Bio-ZOPICLONE is not to be taken with alcohol or other sedative hypnotics (including other zopiclone products) at bedtime or the middle of the night. If concomitant use of another CNS depressant or a drug that increases zopiclone blood levels is clinically warranted, dosage adjustments of Bio-ZOPICLONE may be necessary.
Even if Bio-ZOPICLONE is taken as instructed, some patients may still have zopiclone blood levels in the morning high enough to produce impairment (see 4 DOSAGE AND ADMINISTRATION and
1 Dosing Considerations). 2 CONTRAINDICATIONS Bio-ZOPICLONE is contraindicated in patients: With known hypersensitivity to the drug or to any component in its formulation. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
, significant sleep apnea syndrome). Who have previously experienced complex sleep behaviours after taking any non-benzodiazepine sedative-hypnotic. Page 5 of 38 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Addiction, Abuse and Misuse The use of benzodiazepines, or other sedative-hypnotic drugs, such as Bio-ZOPICLONE, can lead to abuse, misuse, addiction, physical dependence and withdrawal reactions.
Abuse and misuse can result in overdose or death, especially when benzodiazepines, or other sedative-hypnotic drugs, such as Bio-ZOPICLONE, are combined with other medicines, such as opioids, alcohol or illicit drugs. Assess each patient’s risk prior to prescribing Bio-ZOPICLONE Monitor all patients regularly for the development of these behaviours or conditions.
Bio-ZOPICLONE should be stored securely to avoid theft or misuse. Withdrawal Benzodiazepines, or other sedative-hypnotic drugs, such as Bio-ZOPICLONE, can produce severe or life- threatening withdrawal symptoms. Avoid abrupt discontinuation or rapid dose reduction of Bio-ZOPICLONE.
Terminate treatment with Bio-ZOPICLONE by gradually tapering the dosage schedule under close monitoring. (see 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance) Risks from Concomitant Use with Opioids Concomitant use of Bio-ZOPICLONE and opioids may result in profound sedation, respiratory depression, coma and death (see 7 WARNINGS AND PRECAUTIONS, General, Concomitant Use with Opioids).
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are not possible. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Bio-ZOPICLONE is contraindicated in patients: With known hypersensitivity to the drug or to any component in its formulation. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. , significant sleep apnea syndrome).
Who have previously experienced complex sleep behaviours after taking any non-benzodiazepine sedative-hypnotic. Page 5 of 38
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Zopiclone in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Complex sleep behaviours Complex sleep behaviours including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of non-benzodiazepine sedative-hypnotics. Some of these events may result in serious injuries, including death.
Discontinue Bio-ZOPICLONE immediately if a patient experiences a complex sleep behavior. 1 Dosing Considerations Sleep disturbance may be the presenting manifestation of a physical and/or psychiatric disorder. Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the patient has been carefully evaluated.
The use of hypnotics should be restricted for insomnia where disturbed sleep results in impaired daytime functioning. Treatment with Bio-ZOPICLONE should usually not exceed 7-10 consecutive days. Use for more than 2-3 consecutive weeks requires complete re-evaluation of the patient.
Prescriptions for Bio-ZOPICLONE should be written for short-term use (7-10 days) and it should not be prescribed in quantities exceeding a 1-month supply Bio-ZOPICLONE should always be prescribed at the lowest effective dose for the shortest duration possible.
Bio-ZOPICLONE can produce withdrawal signs and symptoms or rebound phenomena following abrupt discontinuation or rapid dose reduction (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Withdrawal; 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance).
Abrupt discontinuation should be avoided and treatment - even if only of short duration - should be terminated by gradually tapering the dosage schedule under close monitoring. Tapering should be tailored to the specific patient. Special attention should be given to patients with a history of seizure (see 7 WARNINGS AND PRECAUTIONS).
If a patient experiences withdrawal signs and symptoms, consider postponing the taper or raising the Bio- ZOPICLONE dose, to the previous dosage prior to proceeding with a gradual taper. Geriatric patients in particular may be more sensitive to Bio-ZOPICLONE (see 7 WARNINGS AND PRECAUTIONS, Falls and Fractures).
Long-term use of Bio-ZOPICLONE should be avoided, including in geriatric patients. Enhanced monitoring is recommended. 2 Recommended Dose and Dosage Adjustment Use the lowest effective dose of Bio-ZOPICLONE for the patient. Bio-ZOPICLONE should be taken in a single intake and not be re-administered during the same night.
The product should be taken just before retiring for the night. 75 mg. 5 mg if clinically indicated. In some patients, the higher doses result in zopiclone blood levels in the morning high enough to produce impairment of driving and other activities that require full alertness (see 7 WARNINGS AND PRECAUTIONS, CNS Depressant Effects and Next-Day Impairment).
5 mg dose should not be exceeded (see 7 WARNINGS AND PRECAUTIONS). 75 mg at bedtime is recommended. The dose may be increased to a maximum of 5 mg if the starting dose does not offer adequate therapeutic effect. 75 mg depending on acceptability and efficacy.
If clinically indicated, a 5 mg may be used with caution in appropriate cases. Page 7 of 38 Bio-ZOPICLONE is contraindicated in patients with severe hepatic insufficiency (see 2 CONTRAINDICATIONS).
Patients with renal insufficiency:
Although no accumulation of zopiclone or of its metabolites has been detected in cases of renal insufficiency, it is recommended that patients with impaired renal function should start treatment with […]