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PRO-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: , 1.2 Geriatrics 01/2023 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 01/2023 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 01/2023 7 WARNINGS AND PRECAUTIONS 01/2023 4 DOSAGE AND ADMINISTRATION, 4.4 Administration 06/2024 7 WARNINGS AND PRECAUTIONS 05/2025 Sections or subsections that are not applicable at the…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 06/2024 7 WARNINGS AND PRECAUTIONS 05/2025 Sections or subsections that are not applicable at the time of authorization are not listed. TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ..................................................................................................................... 1 Pediatrics (< 18 years of age) .......................................................................................
2 Geriatrics (≥ 65 years of age) ...................................................................................... 4 2 CONTRAINDICATIONS ........................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................... 5 4 DOSAGE AND ADMINISTRATION ........................................................................................ 1 Dosing Considerations .................................................................................................
2 Recommended Dose and Dosage Adjustment............................................................. 4 Administration............................................................................................................. 5 Missed Dose ................................................................................................................
7 5 OVERDOSAGE .................................................................................................................... 8
). 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, PRO-ZOPICLONE has CNS-depressant effects. Due to the rapid onset of action, PRO-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 PRO-ZOPICLONE. The risk of next day psychomotor impairment, including impaired driving, is increased if PRO-ZOPICLONE is taken with less than a full night of sleep remaining; if a higher dose than the recommended dose is taken; if coadministered with other CNS depressants or drugs that increase the blood level of zopiclone.
Patients should be cautioned against taking PRO-ZOPICLONE in these circumstances. PRO-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 PRO-ZOPICLONE may be necessary.
Even if PRO-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
4 Administration 06/2024 7 WARNINGS AND PRECAUTIONS 05/2025 Sections or subsections that are not applicable at the time of authorization are not listed. TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ..................................................................................................................... 1 Pediatrics (< 18 years of age) .......................................................................................
2 Geriatrics (≥ 65 years of age) ...................................................................................... 4 2 CONTRAINDICATIONS ........................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................... 5 4 DOSAGE AND ADMINISTRATION ........................................................................................ 1 Dosing Considerations .................................................................................................
2 Recommended Dose and Dosage Adjustment............................................................. 4 Administration............................................................................................................. 5 Missed Dose ................................................................................................................
7 5 OVERDOSAGE .................................................................................................................... 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........................................ 8 7 WARNINGS AND PRECAUTIONS .........................................................................................
PRO-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. PRO-ZOPICLONE (zopiclone tablets) Page 5 of 44
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.
1 Special Populations.................................................................................................... 1 Pregnant Women ......................................................................................................
2 Breast-feeding ........................................................................................................... 3 Pediatrics (< 18 years of age): ....................................................................................
4 Geriatrics (≥ 65 years of age): .................................................................................... 17 8 ADVERSE REACTIONS .......................................................................................................
1 Adverse Reaction Overview ....................................................................................... 2 Clinical Trial Adverse Reactions .................................................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings .................................................................... 5 Post-Market Adverse Reactions.................................................................................
19 9 DRUG INTERACTIONS ....................................................................................................... 1 Serious Drug Interactions ..........................................................................................
2 Drug Interactions Overview ....................................................................................... 3 Drug-Behavioural Interactions ...................................................................................
4 Drug-Drug Interactions .............................................................................................. 5 Drug-Food Interactions..............................................................................................
6 Drug-Herb Interactions .............................................................................................. 7 Drug-Laboratory Test Interactions .............................................................................
22 10 CLINICAL PHARMACOLOGY .............................................................................................. 1 Mechanism of Action.................................................................................................
2 Pharmacodynamics ................................................................................................... 3 Pharmacokinetics ......................................................................................................
24 11 STORAGE, STABILITY AND DISPOSAL ................................................................................ 26 12 SPECIAL HANDLING INSTRUCTIONS ..................................................................................
26 PART II: SCIENTIFIC INFORMATION ........................................................................................ 27 13 PHARMACEUTICAL INFORMATION ...................................................................................
27 14 CLINICAL TRIALS ............................................................................................................... 2 Comparative Bioavailability Study .............................................................................
28 15 MICROBIOLOGY ............................................................................................................... 28 16 NON-CLINICAL TOXICOLOGY ............................................................................................
29 17 […]