Champix – MIMS Publication

Notice type: 3rd Party Publications

Date: 05/01/2009


Product name or type:
Champix (varenicline)

MIMS Publication January 2009

Active Substance:

Problem Or Issue:
Champix (varenicline) is a medicinal product authorised for use throughout the European Union for the treatment of smoking cessation in adults. It is a non-nicotine aid which can help relieve the cravings and withdrawal symptoms associated with stopping smoking. The recommended dose of varenicline is 1mg twice daily following a 1-week titration (i.e. 0.5mg daily for the first three days [days 1-3], then 0.5mg twice daily for the next three days [days 4-7], increasing to 1mg twice daily thereafter [day 8 onwards]). However, for patients who cannot tolerate the adverse effects of varenicline, the dose may be lowered temporarily or for the duration of treatment, to 0.5mg twice daily. The patient should set a date to stop smoking and varenicline dosing should start 1-2 weeks before this date. Patients should be treated with varenicline for 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with varenicline at 1 mg twice daily may be considered. 

Varenicline has been marketed in Ireland since December 2006 and since that time the IMB, in conjunction with the European Medicines Agency (EMEA), has closely monitored its safety. Frequently reported adverse reactions notified in association with varenicline include gastrointestinal disorders such as increased appetite, nausea, vomiting and taste disturbance, general effects such as fatigue and CNS effects, including headache, somnolence, dizziness and sleep disorders. It is important to note that these suspected reactions may not necessarily have been caused by varenicline and may relate to other factors including nicotine withdrawal. 

Following concerns about reports of depression, suicidal ideation and suicidal behaviour associated with use of varenicline, the available data were reviewed at EU level. This review concluded that smoking cessation, with or without treatment may be associated with symptoms of anxiety and depression 
including exacerbation of underlying psychiatric illnesses. As a result, the product information for varenicline was updated to include additional warnings about the risk of depression, associated with its use and as a symptom of nicotine withdrawal. It was also recommended that patients should be advised of this risk. 

Depression and suicidal ideation have been reported in patients treated with Champix in the postmarketing experience. Clinicians should be aware of the possible emergence of significant depressive symptomology in patients undergoing a smoking cessation attempt and should advise patients accordingly. Champix should be discontinued immediately if agitation, depressed mood or changes in behaviour that are of concern for the doctor, the patient, family or caregivers are observed, or if the patient develops suicidal ideation or suicidal behaviour. 

The safety and efficacy of Champix in patients with serious psychiatric illness such as schizophrenia, bipolar disorder and major depressive disorder has not been established. Care should be taken with patients with a history of psychiatric illness, alternative therapeutic options should be considered and patients should be advised of the risk of neuropsychiatric events. 

The IMB is continuing to closely monitor experience of use of Champix in Ireland, particularly in relation to cases of neuropsychiatric symptoms that have been reported. Healthcare professionals are reminded to adhere to the approved recommendations for use of varenicline and to closely monitor patients during use, advising them to report any symptoms associated with their treatment to their doctor. All suspected adverse reactions associated with use of varenicline should be notified to the IMB in the usual way.

Background Information Or Related Documents:
Champix – MIMS Publication Document

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