IMPORTANT SAFETY INFORMATION AND INDICATION

When you try to quit smoking, with or without CHANTIX® (varenicline), you may have symptoms that may be due to nicotine withdrawal, including urge to smoke, depressed mood, trouble sleeping, irritability, frustration, anger, feeling anxious, difficulty concentrating, restlessness, decreased heart rate, and increased appetite or weight gain.

Some people have had new or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depressed mood, or suicidal thoughts or actions while taking or after stopping CHANTIX. These symptoms happened more often in people who had a history of mental health problems. Stop taking CHANTIX and call your healthcare provider right away if you, your family, or caregiver notice any of these symptoms. Before starting CHANTIX, tell your healthcare provider if you ever had depression or other mental health problems.

Some people have had seizures during treatment with CHANTIX. Tell your healthcare provider if you have a history of seizures. If you have a seizure, stop taking CHANTIX and contact your healthcare provider right away.

New or worse heart or blood vessel problems can happen with CHANTIX. Tell your healthcare provider if you have heart or blood vessel problems or experience any symptoms during treatment. Get emergency medical help right away if you have symptoms of a heart attack or stroke.

Sleepwalking can happen with CHANTIX, and can sometimes lead to harmful behavior. Stop taking CHANTIX and tell your healthcare provider if you start sleepwalking.

Do not take CHANTIX if you have had a serious allergic or skin reaction to it. These can happen with CHANTIX and can be life-threatening. Stop taking CHANTIX and get medical help right away if you develop swelling of the face, mouth, throat or neck; trouble breathing; rash with peeling skin, or blisters in your mouth.

Use caution when driving or operating machinery until you know how CHANTIX affects you. Decrease the amount of alcohol you drink while taking CHANTIX until you know if CHANTIX affects your ability to tolerate alcohol.

The most common side effects of CHANTIX include nausea (30%), sleep problems (trouble sleeping, vivid, unusual, or strange dreams), constipation, gas and/or vomiting. If you have side effects that bother you or don’t go away, tell your healthcare provider.

What is CHANTIX?
CHANTIX is a prescription medicine to help adults stop smoking.

Please see full Prescribing Information and Medication Guide.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

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