Varenicline (var-EN-i-kleen)

Helps you quit smoking. It is used together with a support program that includes counseling and educational materials.

Brand Name(s):

Chantix, Chantix Starting Month Box, Chantix Start Month Pak

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• Set a date when you intend to stop smoking and tell your doctor when this date is. This medicine needs to be started one week before that date.
• Your doctor may also tell you to start taking this medicine anytime and then to stop smoking between days 8 and 35 of treatment.
• You may be told to take this medicine for 12 weeks. Even if you have already stopped smoking by this time, your doctor may tell you to take this medicine for 12 more weeks to help you keep off smoking.
• It is best to take this medicine after eating and with a full glass of water.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using insulin (Humulin®), theophylline (Theolair®), or a blood thinner (such as warfarin, Coumadin®).

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding. Tell your doctor if you have kidney disease, heart or blood vessel problems, or a history of severe chest pain, heart attack, stroke, or depression or mental problems, such as psychosis.
• This medicine may increase your risk of having a heart attack in certain patients with heart or blood vessel disease. Call your doctor right away if you have chest pain or discomfort; pain or discomfort in the arms, jaw, back, or neck; pain in your legs when walking; shortness of breath; sweating; or troubled breathing.
• This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, stop taking this medicine and tell your doctor right away.
• This medicine may cause serious types of allergic reactions, including angioedema. Stop taking this medicine and tell your doctor right away if you have a rash; itching; a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; trouble with breathing; or chest tightness while you are using this medicine.
• Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.
• This medicine may cause some people to become drowsy or dizzy, or to have problems with concentration. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or thinking clearly.
• Tell your doctor if you have nausea or sleep problems (trouble sleeping or unusual dreams) while you are using this medicine. The dose of this medicine may need to be adjusted.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, confusion, depression, restlessness, or mood changes.
• Blistering, peeling, or red skin rash.
• Change in how much or how often you urinate, or trouble urinating.
• Chest pain.
• Fast, pounding, or uneven heartbeat.
• Fever or chills.
• Increased hunger or thirst.
• Lightheadedness, dizziness, drowsiness, or fainting.
• Lumps on your neck, armpit, or groin.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Red or black stools.
• Seeing or hearing things that are not really there.
• Swelling in your hands, ankles, or feet.
• Thoughts of hurting yourself or others.
• Tremors or seizures.
• Trouble breathing or swallowing.
• Unusual bleeding, bruising, or weakness.

If you notice these less serious side effects, talk with your doctor:

• Back pain, joint pain, muscle pain, or muscle cramps.
• Bleeding or swollen gums, or mouth sores.
• Changes in appetite.
• Changes in vision.
• Dry mouth or dry eye.
• Headache.
• Heartburn (burning pain in the chest or throat).
• Increased sweating.
• Mild skin rash or itchiness.
• Nausea, vomiting, diarrhea, constipation, stomach pain, or upset stomach.
• Problems having sex.
• Problems with hearing or balance.
• Runny or stuffy nose, or nosebleeds.
• Tiredness.
• Trouble sleeping, or having unusual dreams.
• Unusual or bad taste in your mouth.
• Warmth or redness in your face, neck, arms, or upper chest.
• Weight gain.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088