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There have been side effects reported in patients taking CHAMPIX. Always consult a doctor before using CHAMPIX to stop smoking.

Do not take Champix if you are allergic to varenicline or any of the other ingredients of this medicine 

Warnings and precautions

Talk to your doctor or pharmacist before taking CHAMPIX.

There have been reports of depression, suicidal ideation and behaviour and suicide attempts in patients taking CHAMPIX. If you are taking CHAMPIX and develop agitation, depressed mood, changes in behaviour that are of concern to you or your family or if you develop suicidal thoughts or behaviours you should stop taking CHAMPIX and contact your doctor immediately for treatment assessment.

The effects of stopping smoking

The effects of changes in your body resulting from stopping smoking, with or without treatment with CHAMPIX, may alter the way other medicines work. Therefore, in some cases an adjustment of the dose may be necessary. See below under ‘Other medicines and CHAMPIX’ for further details. 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 you have a history of psychiatric disorder you should discuss this with your doctor.

Heart symptoms

New or worse heart or blood vessel (cardiovascular) problems have been reported primarily in people who already have cardiovascular problems. Tell your doctor if you have any changes in symptoms during treatment with CHAMPIX. Get emergency medical help right away if you have symptoms of a heart attack or stroke.

Seizures

Tell your doctor if you have experienced seizures or have epilepsy before you start CHAMPIX treatment. Some people have reported seizures while taking CHAMPIX.

Hypersensitivity reactions

Stop taking CHAMPIX and tell your doctor immediately if you 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 CHAMPIX. If you develop a rash or if your skin starts to peel or blister you should stop taking CHAMPIX and seek emergency medical help.

Children and adolescents

CHAMPIX is not recommended for use in children or adolescents below 18 years as safety and efficacy have not yet been established.

Other medicines and CHAMPIX

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In some cases as a result of stopping smoking, with or without CHAMPIX, an adjustment of the dose of other medicines may be necessary. Examples include theophylline (a medicine to treat breathing problems), warfarin (a medicine to reduce blood clotting), and insulin (a medicine to treat diabetes). If in doubt, you should consult your doctor or pharmacist.

If you have severe kidney disease you should avoid taking cimetidine (a medicine used for gastric problems) at the same time as CHAMPIX as this may cause increased blood levels of CHAMPIX.

Use of CHAMPIX with other therapies for smoking cessation

Consult your doctor before using CHAMPIX in combination with other smoking cessation therapies.

CHAMPIX with food and drink

There have been some reports of increased intoxicating effects of alcohol in patients taking CHAMPIX. However, it is not known if CHAMPIX actually increases alcohol intoxication.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is preferable to avoid the use of CHAMPIX while you are pregnant. Talk to your doctor if you are intending to become pregnant.

Although it was not studied, CHAMPIX may pass into breast milk. You should ask your doctor or pharmacist for advice before taking CHAMPIX.

Driving and using machines

CHAMPIX may be linked with dizziness, sleepiness and transient loss of consciousness, You should not drive, operate complex machinery or engage in any other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.

 

PP-CHM-GBR-2491. January 2019.

CHAMPIX important information