Varenicline is a smoking cessation medicine. It is used together with behavior modification and counseling support to help you stop smoking.

Varenicline may also be used for purposes not listed in this medication guide.

When you stop smoking, you may have nicotine withdrawal symptoms with or without using medication such as varenicline. This includes feeling restless, depressed, angry, frustrated, or irritated.

Stop taking varenicline and call your doctor if you have if you feel depressed, agitated, hostile, aggressive, or have thoughts about suicide or hurting yourself.

Do not drink large amounts alcohol. Varenicline can increase the effects of alcohol or change the way you react to it.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

When you first start taking varenicline, you will take a low dose and then gradually increase it over the first several days of treatment. Take varenicline regularly to get the most benefit.

You may choose from 3 ways to use varenicline. Ask your doctor which method is best for you:

• Set a date to quit smoking and start taking varenicline 1 week before that date. Make sure to quit smoking on your planned quit date. Take varenicline for a total of 12 weeks.

• Start taking varenicline before you set a planned quit date, and choose a quit date that is between 8 and 35 days after you start treatment. Take varenicline for a total of 12 weeks.

• Start taking varenicline and gradually reduce the number of cigarettes you smoke each day over a 12-week period, until you no longer smoke at all. Then take varenicline for another 12 weeks, for a total of 24 weeks.

Take varenicline after eating. Take the medicine with a full glass of water.

When you stop smoking, you may have nicotine withdrawal symptoms with or without using medication such as varenicline. Withdrawal symptoms include: increased appetite, weight gain, trouble sleeping, slower heart rate, feeling anxious or restless, and having the urge to smoke.

Smoking cessation may also cause new or worsening mental health problems, such as depression.

Stop taking varenicline and call your doctor if you have if you feel depressed, agitated, hostile, aggressive, or have thoughts about suicide or hurting yourself.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Smoking Cessation:

Days 1 to 3: 0.5 mg orally once a day
Days 4 to 7: 0.5 mg orally 2 times a day
Days 8 to end of treatment: 1 mg orally 2 times a day
Duration of therapy: 12 weeks

Comments:
-The patient should set a date to stop smoking. Dosing should start 1 to 2 weeks before this date OR the patient may begin treatment and quit smoking between Days 8 and 35.
-Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided with additional advice and support.
-In smoking cessation therapy, risk for relapse to smoking is elevated in the period immediately following the end of treatment.

Use: As an aid to smoking cessation treatment

You should not use varenicline if you used it in the past and had:

• a serious allergic reaction--trouble breathing, swelling in your face (lips, tongue, throat) or neck; or

• a serious skin reaction--blisters in your mouth, peeling skin rash.

Tell your doctor if you have ever had:

• depression or mental illness;

• a seizure;

• kidney disease (or if you are on dialysis);

• heart or blood vessel problems; or

• if you drink alcohol.

Tell your doctor if you are pregnant. It is not known whether varenicline will harm an unborn baby if you use the medicine during pregnancy. However, smoking while you are pregnant can harm the unborn baby or cause birth defects.

If you breast-feed while using varenicline, your baby may spit up or vomit more than normal, and may have a seizure.

Varenicline is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Do not drink large amounts alcohol while taking varenicline. Varenicline can increase the effects of alcohol or change the way you react to it. Some people taking varenicline have had unusual or aggressive behavior or forgetfulness while drinking alcohol.

Do not use other medicines to quit smoking, unless your doctor tells you to. Using varenicline while wearing a nicotine patch can cause unpleasant side effects.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Varenicline may cause serious side effects. Stop using varenicline and call your doctor at once if you have:

• a seizure (convulsions);

• thoughts about suicide or hurting yourself;

• strange dreams, sleepwalking, trouble sleeping;

• new or worsening mental health problems--mood or behavior changes, depression, agitation, hostility, aggression;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; o

• stroke symptoms--sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance.

Your family or other caregivers should also be alert to changes in your mood or behavior.

Common side effects of varenicline may include:

• nausea (may persist for several months), vomiting;

• constipation, gas;

• sleep problems (insomnia); or

• unusual dreams.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

After you stop smoking, your doctor may need to adjust the doses of certain medicines you take on a regular basis.

Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.