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Champix® (varenicline tartrate) Prescribing Information.  Adverse event reporting information can be found at the bottom of the page.

Champix warnings and precautions

  • Clinicians should be aware of the possible emergence of serious neuropsychiatric symptoms in patients attempting to quit smoking with or without treatment.
  • If serious neuropsychiatric symptoms occur whilst on varenicline treatment, patients should discontinue varenicline immediately and contact a healthcare professional for re-evaluation of treatment.
  • Care should be taken with patients with a history of psychiatric illness and patients should be advised accordingly.
  • CHAMPIX should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
  • Treatment discontinuation was associated with an increase in irritability, urge to smoke, depression, and/or insomnia in up to 3% of patients. The prescriber should inform the patient accordingly and discuss or consider the need for dose tapering.
  • Patients taking CHAMPIX should be instructed to notify their doctor of new or worsening cardiovascular symptoms and to seek immediate medical attention if they experience signs and symptoms of myocardial infarction or stroke.
  • There have been post-marketing reports of hypersensitivity reactions including angioedema. Patients experiencing symptoms should discontinue treatment and contact a health care provider immediately.
  • There have also been post-marketing reports of rare but severe cutaneous reactions, including Stevens-Johnson Syndrome and Erythema Multiforme. Patients should discontinue treatment at the first sign of rash or skin reaction and contact a healthcare provider immediately.
  • Champix may have minor or moderate influence on the ability to drive and use machines.
  • Champix may cause dizziness, somnolence and transient loss of consciousness, and therefore may influence the ability to drive and use machines. Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medicinal product affects their ability to perform these activities.

​​​​​​Please refer to the summary of product characteristics for further information on the safety profile of Champix.


PP-CHM-GBR-3363. June 2021

Champix efficacy vs NRT

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Champix efficacy data

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PP-PFE-GBR-2688. December 2020

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