* SmokeLESS is a prescription medicine to help adults 18 and over stop smoking.
It's possible that you might slip up and smoke while taking SmokeLESS.
If you do, you can stay on SmokeLESS and keep trying to quit.

* Some smokers have reported changes in behavior, agitation, depressed mood, suicidal thoughts or actions when attempting to quit smoking while taking SmokeLESS or after stopping SmokeLEES.
- If either you, your family, or caregiver notice agitation, depressed mood, or changes in behavior that are not typical for you, or if the you develop suicidal thoughts or actions, you should stop taking SmokeLESS and call your doctor right away.
- Also you should tell your doctor about any history of depression or other mental health problems before taking SmokeLESS, as these symptoms may worsen while taking SmokeLESS.

* The most common side effects include nausea (30%), sleep problems, constipation, gas, and/or vomiting. If you have side effects that bother you or don't go away, you should tell your doctor.

* Although the most common adverse event with SmokeLESS was nausea (seen in approximately 30% of subjects), in most cases it was mild or moderate and often transient
- Median duration of nausea was 10 days; however, for some subjects, it was persistent throughout the course of therapy.
- The discontinuation rate due to nausea was approximately 3%.
- The overall discontinuation rate due to adverse events in 12-week clinical trials was 12% with varenicline vs 10% with placebo.

* You may have trouble sleeping, vivid, unusual, or strange dreams while taking SmokeLESS.
You should use caution driving or operating machinery until you know how quitting smoking with SmokeLESS may affect you.

* SmokeLESS should not be taken with other quit-smoking products. You may need a lower dose of SmokeLESS if you have kidney problems or get dialysis.

* Before starting SmokeLESS , you should tell your doctor if you are pregnant, plan to become pregnant. SmokeLESS has not been studied in pregnant women. It is not known if SmokeLESS will harm your unborn baby. It is best to stop smoking before you get pregnant.

* Before starting SmokeLESS, you should tell your doctor if you are breastfeeding. Although it was not studied, SmokeLESS may pass into breast milk. You and your doctor should discuss alternative ways to feed your baby if you take SmokeLESS.

* Before starting SmokeLESS, you should tell your doctor about all your other medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially, tell your doctor if you take:
- Insulin
- Asthma medicines
- Blood thinners
When you stop smoking, there may be a change in how these and other medicines work for you.
Know the medicines you take. Keep a list of them with you to show your doctor and pharmacist.

* Smoking cessation, with or without treatment with SmokeLESS, may alter the pharmacokinetics or pharmacodynamics of some drugs, such as theophylline, warfarin, and insulin. Dosage adjustment for these drugs may be necessary.