Updated product information for varenicline now includes a warning that consuming alcohol may increase the risk of psychiatric symptoms.

The new warning from the TGA stresses that health professionals should discuss the benefits and risks of treatment with varenicline, including potential psychiatric symptoms, before prescribing the medicine.

“Psychiatric symptoms can involve changes in behaviour, thinking or mood and may include depression, anxiety, agitation, aggression, mood swings, self-harm, thoughts of self-harm, or seeing, hearing or sensing things that are not there,” the advisory says.

The information was previously in the production information, but now it has been made more prominent, and an alcohol warning has been added.