Infrequently, varenicline may cause serious mental/mood changes, even after stopping the medication. Quitting smoking itself may also cause mental/mood changes. Stop taking varenicline and tell your doctor or pharmacist immediately if you have symptoms such as depression/suicidal thoughts, agitation, aggressiveness, or other unusual thoughts or behavior.

This medication is used in combination with a stop-smoking program (e.g., education materials, support group, counseling) to help you quit smoking. Varenicline works by blocking nicotine's actions in the brain. Quitting smoking decreases your risk of heart and lung disease, as well as cancer.

Read the Medication Guide provided by your pharmacist before you start taking varenicline and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Follow your doctor's directions carefully. Before beginning treatment with this drug, set a date to quit smoking. Begin taking varenicline 1 week before the quit date as follows unless directed otherwise by your doctor. When you first start taking this medication, take one 0.5-milligram tablet once a day for 3 days, then increase to one 0.5-milligram tablet twice a day for 4 days. The dose is slowly increased to lessen the chance of side effects (e.g., nausea, unusual dreams). During this first week, it is okay to smoke. Stop smoking on the quit date and begin taking one 1-milligram tablet twice a day for the rest of the 12-week treatment period. If this medication comes in a dosing package, carefully follow the directions on the dosing package. There are two types of dosing packs, a starting pack and a continuing pack, each containing different strengths of this medication. If this medication comes in a bottle, carefully follow your doctor's directions on the prescription label. If you have any questions about how to take this medication, talk to your doctor or pharmacist.

Take this medication by mouth after food and with a full glass of water.

Dosage is based on your medical condition and response to therapy.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Inform your doctor if you continue to smoke after a few weeks of treatment.

If you are successful and cigarette-free after 12 weeks of treatment, your doctor may recommend another 12 weeks of treatment with varenicline.

Nausea, headache, vomiting, drowsiness, gas, constipation, trouble sleeping, unusual dreams, or changes in taste may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking varenicline, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease (especially kidney dialysis), mental/mood disorders.

This drug may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for nausea and other side effects while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Because this drug may have undesirable effects on a nursing infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: nicotine replacement therapy (e.g., patch, gum, nasal spray).

Smoking can affect the way your body removes certain drugs. When you stop smoking, your doses of these drugs may need to be adjusted by your doctor. Tell your doctor if you take any of the following medications. Some of the drugs that smoking may affect, among others, are: "blood thinners" (e.g., warfarin), insulin, theophylline.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center.

Do not share this medication with others.

Laboratory and/or medical tests (e.g., kidney function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Getting regular exercise and maintaining a nutritious diet, along with using educational materials, receiving counseling, and attending support groups, may help you to successfully quit smoking. Consult your doctor for details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2009 Copyright(c) 2009 First DataBank, Inc.