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MINT-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: MINT-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 MINT-ZOPICLONE should be avoided, including in geriatric patients.
1 Dosing Considerations). 2 CONTRAINDICATIONS MINT-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, MINT-ZOPICLONE has CNS-depressant effects. Due to the rapid onset of action, MINT-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.
This includes potential impairment of the performance of such activities that may occur the day following ingestion of MINT-ZOPICLONE. The risk of next day psychomotor impairment, including impaired driving, is increased if MINT- 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 MINT- ZOPICLONE in these circumstances. MINT-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 MINT-ZOPICLONE may be necessary. Even if MINT-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
, Dependence/Tolerance) Risks from Concomitant Use with Opioids Concomitant use of MINT-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.
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 MINT-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 MINT-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 MINT- ZOPICLONE should be written for short-term use (7-10 days) and it should not be prescribed in quantities exceeding a 1-month supply • MINT-ZOPICLONE should always be prescribed at the lowest effective dose for the shortest duration possible.
• MINT-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).
MINT-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 39 Unclassified / Non classifié
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.
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 MINT-ZOPICLONE dose, to the previous dosage prior to proceeding with a gradual taper. • Geriatric patients in particular may be more sensitive to MINT-ZOPICLONE (see 7 WARNINGS AND PRECAUTIONS, Falls and Fractures).
• Long-term use of MINT-ZOPICLONE should be avoided, including in geriatric patients. Enhanced monitoring is recommended. 2 Recommended Dose and Dosage Adjustment Use the lowest effective dose of MINT-ZOPICLONE for the patient. MINT-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. 5 mg tablet). 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). 5 mg tablet) 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. 5 mg tablet) depending on acceptability and efficacy.
If clinically indicated, a 5 mg may be used with caution in appropriate cases. MINT-ZOPICLONE is contraindicated in patients with severe hepatic insufficiency (see 2 CONTRAINDICATIONS). 5 mg tablet). If clinically indicated, a 5 mg may be used with caution in appropriate cases.
5 mg tablet) depending on acceptability and efficacy. 5 mg may be used with caution in appropriate cases. , significant sleep apnea syndrome (see 2 CONTRAINDICATIONS). 5 mg tablet) at bedtime is recommended (see 9 DRUG INTERACTIONS). If clinically indicated, 5 mg may be used with caution in appropriate cases.
Use with CNS depressants:
Dosage adjustment may be necessary when MINT-ZOPICLONE is combined with other CNS-depressants because of the potentially additive effects (see 9 DRUG INTERACTIONS).
Pediatrics (< 18 years of age):
MINT-ZOPICLONE is not indicated for patients under 18 years of age. 4 Administration Tablets are for oral administration. 75 mg. 5 Missed Dose Patients should be instructed to take MINT-ZOPICLONE at bedtime just before retiring for the night.
Patients who miss a dose should wait to take the next dose at the regular time. The missed dose must be skipped to avoid taking a double dose. 5 OVERDOSAGE Signs and Symptoms: Overdose is usually manifested by varying degrees of central nervous system […]