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JAMP-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: JAMP-Zopiclone Tablets (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…
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 JAMP-Zopiclone Tablets should be avoided, including in geriatric patients.
1 Dosing Considerations). 2 CONTRAINDICATIONS JAMP-Zopiclone Tablets 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, JAMP-Zopiclone Tablets (Zopiclone Tablets) Page 14 of 46 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, JAMP-Zopiclone Tablets has CNS-depressant effects. Due to the rapid onset of action, JAMP- Zopiclone Tablets 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 JAMP-Zopiclone Tablets. The risk of next day psychomotor impairment, including impaired driving, is increased if JAMP-Zopiclone Tablets 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 JAMP-Zopiclone Tablets in these circumstances. JAMP-Zopiclone Tablets 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 JAMP-Zopiclone Tablets may be necessary. Even if JAMP-Zopiclone Tablets 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 JAMP-Zopiclone Tablets 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. JAMP-Zopiclone Tablets (Zopiclone Tablets) Page 5 of 46 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 JAMP-Zopiclone Tablets, 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 JAMP-Zopiclone Tablets, are combined with other medicines, such as opioids, alcohol or illicit drugs. • Assess each patient’s risk prior to prescribing JAMP-Zopiclone Tablets • Monitor all patients regularly for the development of these behaviours or conditions.
• JAMP-Zopiclone Tablets should be stored securely to avoid theft or misuse. Withdrawal Benzodiazepines, or other sedative-hypnotic drugs, such as JAMP-Zopiclone Tablets, can produce severe or life- threatening withdrawal symptoms. • Avoid abrupt discontinuation or rapid dose reduction of JAMP-Zopiclone Tablets.
• Terminate treatment with JAMP-Zopiclone Tablets 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 JAMP-Zopiclone Tablets 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.
JAMP-Zopiclone Tablets 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. JAMP-Zopiclone Tablets (Zopiclone Tablets) Page 5 of 46
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 JAMP-Zopiclone Tablets 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 JAMP-Zopiclone Tablets 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 JAMP-Zopiclone Tablets should be written for short- term use (7-10 days) and it should not be prescribed in quantities exceeding a 1- month supply • JAMP-Zopiclone Tablets should always be prescribed at the lowest effective dose for the shortest duration possible.
• JAMP-Zopiclone Tablets 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 JAMP-Zopiclone Tablets dose, to the previous dosage prior to proceeding with a gradual taper. • Geriatric patients in particular may be more sensitive to JAMP-Zopiclone Tablets (see 7 WARNINGS AND PRECAUTIONS, Falls and Fractures).
• Long-term use of JAMP-Zopiclone Tablets should be avoided, including in geriatric patients. Enhanced monitoring is recommended. 2 Recommended Dose and Dosage Adjustment Use the lowest effective dose of JAMP-Zopiclone Tablets for the patient.
JAMP-Zopiclone Tablets 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, JAMP-Zopiclone Tablets (Zopiclone Tablets) Page 7 of 46 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 […]