Apo-Varenicline Special Precautions

Advise the patient to talk to a doctor or pharmacist before taking APO-VARENICLINE.
There have been reports of depression, suicidal ideation and behaviour and suicide attempts in patients taking APO-VARENICLINE. If the patient is taking APO-VARENICLINE and develop agitation, depressed mood, changes in behaviour that are of concern to him/her or his/her family or if the patient develops suicidal thoughts or behaviours, the patient should stop taking APO-VARENICLINE and be advised to contact the doctor immediately for treatment assessment.
The effects of stopping smoking: The effects of changes in the body resulting from stopping smoking, with or without treatment with APO-VARENICLINE, may alter the way other medicines work. Therefore, in some cases an adjustment of the dose may be necessary. See Interactions for further details.
Psychiatric Symptoms: For some people, stopping smoking with or without treatment has been associated with an increased risk of experiencing changes in thinking or behaviour, feelings of depression and anxiety and can be associated with a worsening of psychiatric disorder. If the patient has a history of psychiatric disorder, advise the patient to discuss this with the doctor.
Serious neuropsychiatric symptoms have occurred in patients being treated with varenicline.
There have been reports of neuropsychiatric symptoms such as depressed mood, agitation, hallucinations, changes in behaviour or thinking, anxiety, psychosis, mood swings, aggressive behaviour, suicidal ideation and suicide in patients attempting to quit smoking while taking varenicline.
Patients and their families should be advised that the patient should stop taking varenicline and contact a health care professional immediately if changes in behaviour or thinking, agitation or depressed mood that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behaviour.
Heart symptoms: New or worse heart or blood vessel (cardiovascular) problems have been reported primarily in people who already have cardiovascular problems. Patients must be advised to inform the doctor if they have any changes in symptoms during treatment with APO-VARENICLINE. Advise patients to get emergency medical help right away if they have symptoms of a heart attack or stroke.
Seizures: Patients must be advised to inform the doctor if they have experienced seizures or have epilepsy before the start of APO-VARENICLINE treatment. Some people have reported seizures while taking APO-VARENICLINE.
In clinical trials and post-marketing experience there have been reports of seizures in patients with or without a history of seizures, treated with varenicline. Varenicline should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Hypersensitivity reactions: Patients must be advised to stop taking APO-VARENICLINE and to inform the doctor immediately if they experience any of the following signs and symptoms that may indicate a serious allergic reaction: swelling of the face, lips, tongue, gums, throat or body and/or difficulty breathing, wheezing.
Skin reactions: Potentially life-threatening skin rashes (Stevens-Johnson syndrome and Erythema Multiforme) have been reported with the use of APO-VARENICLINE. If the patients develops a rash or if the skin starts to peel or blister, advise the patient to stop taking APO-VARENICLINE and to seek emergency medical help.
Driving and using machines: APO-VARENICLINE may be linked with dizziness, sleepiness and transient loss of consciousness. The patient should not drive, operate complex machinery or engage in any other potentially hazardous activities until the patient knows whether this medicine affects the ability to perform these activities.
Use in Children: APO-VARENICLINE is not recommended for use in paediatric patients as efficacy was not demonstrated.