Section 4.4 (special warnings and precautions for use) had been updated with the following information:

The use of benzodiazepines, including lorazepam, may lead to physical and psychological dependence.

Severe anaphylactic/anaphylactoid reactions have been reported with the use of benzodiazepines. Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of benzodiazepines. Some patients taking benzodiazepines have had additional symptoms such as dyspnoea, throat closing, or nausea and vomiting. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with a benzodiazepine should not be rechallenged with the drug.

Use of benzodiazepines, including lorazepam, may lead to potentially fatal respiratory depression.

Withdrawal symptoms (eg, rebound insomnia) can appear following cessation of recommended doses after as little as one week of therapy.

As with all benzodiazepines, the use of lorazepam may worsen hepatic encephalopathy.