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As this preparation contains Benzyl Alcohol, its use should be avoided in children under 2 years of age. Not to be used in neonates.
Anaphlaxis (severe allergic reaction) and angiodema (severe facial swelling) which can occur as early as the first time the product is taken.
Complex sleep: related behaviours which may include sleep driving, making phone calls, preparing and eating food while sleeping.
When used intravenously, the following procedures should be undertaken to reduce the possibility of venous thrombosis, phlebitis, local irritation, swelling, and rarely, vascular impairment: the solution should be injected slowly, taking at least 1 minute for each 5 mg (1 mL) given; do not use small veins, such as those on the dorsum of the hand or wrist; extreme care should be taken to avoid intra-arterial administration or extravasation.
Do not mix or dilute Zopam with other solutions or drugs in syringe or infusion flask. If it is not feasible to administer Zopam directly IV, it may be injected slowly through the infusion tubing as close as possible to the vein insertion.
Profound sedation, respiratory depression coma, and death may result from the concomitant use of Zopam with benzodiazepines. Observational studies have demonstrated that concomitant use of opioids and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
If the decision is made to newly prescribe a benzodiazepine and an opioid together, prescribe the lowest effective dosages and minimum duration of concomitant use.
If the decision is made to prescribe a benzodiazepine in a patient already receiving an opioid, prescribe a lower initial dose of the benzodiazepine than indicated in the absence of an opioid, and titrate based on clinical response.
If the decision is made to prescribe a lower initial dose of the opioid, and titrate based on clinical response.
Follow patients closely for signs and symptoms of respiratory depression and sedation. Advice both patients and caregivers about the risks of respiratory depression and sedation when Zopam is used with benzodiazepines. Advice patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of benzodiazepines (see Interactions).
