Chantix®(varenicline)

Nicotine withdrawal symptoms include urge to smoke, depressed mood, trouble sleeping, and irritability. Some individuals have experienced suicidal thoughts when attempting to stop smoking.Serious side effects documented include changes in behavior or thinking, aggression, hostility, and suicidal thoughts or actions. These symptoms sometimes emerged after beginning treatment or weeks later.Stop taking CHANTIX and call your healthcare provider right away if you experience these mental health changes. In many people, these symptoms went away after stopping CHANTIX, but in some people symptoms continued.Before starting treatment, tell your healthcare provider if you have a history of depression or mental health problems.

CHANTIX is a prescription medication designed to help you stop smoking. The drug can potentially reduce your risks of lung disease, heart disease, or getting certain types of cancer that are related to smoking.CHANTIX has not demonstrated effectiveness in children 16 years or younger. Its safety and efficacy with other smoking cessation medicines remain unestablished.

Do not take CHANTIX if you have had a serious allergic or skin reaction to varenicline. Signs of a serious reaction include:Swelling of the face, mouth (tongue, lips, gums), throat, or neckTrouble breathingRash with peeling skin

Before taking CHANTIX, tell your healthcare provider about all of your medical conditions, including if you:Are using other smoking cessation treatments (combining with nicotine patches increases nausea risk)Have kidney problems or are on dialysisHave a history of seizuresDrink alcoholHave heart or blood vessel problemsAre pregnant or plan to become pregnantAre breastfeeding or plan to breastfeedTell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

There are three approaches for using CHANTIX:Standard approach: Set a quit date one week ahead, then begin medication. Take for 12 weeks total.Alternative timing: Start medication first, selecting a quit date between days 8-35 of treatment.Gradual reduction: For those unable to quit abruptly, reduce smoking incrementally over 12 weeks while taking CHANTIX, continuing for another 12 weeks (24 weeks total).Dosing schedule:Days 1-3: 0.5 mg once daily (white tablet)Days 4-7: 0.5 mg in the morning and 0.5 mg in the eveningDay 8 to end of treatment: 1 mg in the morning and 1 mg in the evening (blue tablet)Take CHANTIX after eating and with a full glass (8 ounces) of water. If you successfully quit smoking after 12 weeks, your healthcare provider may prescribe an additional 12-week course to help you stay smoke-free.

Use caution when driving or operating machinery until you know how CHANTIX affects you. CHANTIX may make you sleepy, dizzy, or cause trouble concentrating.Reduce the amount of alcohol you drink while taking CHANTIX until you know whether CHANTIX affects your ability to tolerate alcohol.

Serious side effects include:Seizures (often occurring within the first month of treatment)New or worse heart or blood vessel problems, especially in people who already have heart or blood vessel problems. Get emergency help right away if you have symptoms of a heart attack, such as chest discomfort that lasts more than a few minutes, or discomfort in other areas of your upper body, shortness of breath, breaking out in a cold sweat, nausea, or feeling lightheaded.Sleepwalking, which can lead to behavior that can harm yourself or othersAllergic reactions that can be life-threatening, including swelling of the face, mouth, throat, or neck, and skin reactions such as rash with peeling skinCommon side effects include:NauseaSleep problems (trouble sleeping or vivid, unusual, or strange dreams)ConstipationGasVomitingStop taking CHANTIX and get medical help right away if you have swelling of the face, mouth, throat, or neck, or if you develop a rash with peeling skin or blisters in your mouth.

Store CHANTIX at room temperature between 68°F to 77°F (20°C to 25°C).Keep CHANTIX and all medicines out of the reach of children.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not give CHANTIX to other people, even if they have the same symptoms you have. It may harm them.For more information, go to www.CHANTIX.com or call 1-877-242-6849.If you are motivated to quit smoking but did not succeed during prior CHANTIX therapy, or relapsed after treatment, talk to your healthcare provider about whether another course of CHANTIX therapy may be right for you.

Active ingredient: varenicline tartrateInactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry White, Opadry Blue, and Opadry Clear