Varenicline, Oral

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KEY POINTS

• This medicine is taken by mouth to help you stop smoking. Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• If you have heart disease, this medicine may increase your risk of heart-related side effects.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. When you stop smoking, there may be a change in how certain medicines work for you.

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What are other names for this medicine?

Type of medicine: smoking deterrent

Generic and brand names: varenicline, oral; Chantix

What is this medicine used for?

This product is taken by mouth to help you stop smoking.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Heart or blood vessel problems
• Kidney disease
• Mental disorders such as bipolar disorder, depression, or schizophrenia
• Seizures

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Taking too much may increase the risk of side effects. Do not stop taking this medicine without your healthcare provider's approval. Treatment with this medicine usually lasts for 12 weeks, but may take longer depending on your response.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine is started while you are still smoking because you need to take it for at least 1 week to build an effective level of medicine in your blood. Set a quit date to stop smoking that is between 8 and 35 days after you start taking this medicine.

Do not take nicotine replacement medicines without your healthcare provider's approval. Taking this medicine with nicotine replacement medicines may increase your risk of side effects.

Take this medicine with a full glass of water. Take it after meals to lessen the chance the medicine will upset your stomach.

An instruction sheet is included in the package of this medicine. Read the information carefully. Talk to your healthcare provider or pharmacist if you do not understand all of the instructions.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: fast or irregular heartbeat, vomiting, confusion, restlessness.

What should I watch out for?

Behavior changes may be caused by the medicine or by quitting smoking. Some people have behavior changes when they start taking this medicine, and others after several weeks of treatment, and some people have behavior changes when they stop taking this medicine. Stop taking the medicine and contact your provider right away if you or your family notice any disturbing changes in your thoughts or behavior, such as:

• More outgoing or aggressive behavior than normal
• Hallucinations
• Depression or suicidal thoughts

If you have heart disease, this medicine may increase your risk of heart-related side effects. Contact your healthcare provider if you have new or worsening symptoms such as:

• Shortness of breath or trouble breathing
• Chest pain
• Pain in legs when walking
• Sudden or severe headache; sudden numbness or weakness, especially on one side of your body; problems with vision, speech, or balance.

Your healthcare provider will want to see you regularly while you are taking this medicine. Keep all appointments.

This medicine may increase the effects of alcohol. While you are taking this medicine, limit the amount of alcohol you drink until you know how it affects you.

This medicine may cause dizziness, drowsiness, trouble concentrating, confusion, or weakness. Do not drive or operate machinery unless you are fully alert and know how this medicine affects you.

This medicine may cause nausea and trouble sleeping. These side effects usually go away. If these side effects continue or become worse, contact your healthcare provider. Your healthcare provider may reduce the dose of the medicine.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

When you stop smoking, there may be a change in how certain medicines work for you. Talk to your healthcare provider if you are taking medicine that reduces the chance of blood clots, bronchodilators, or diabetes medicines

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Change in behavior or thoughts; confusion; hallucinations; new or worsening depression, anxiety, or panic attacks; extreme agitation or nervousness; outgoing or aggressive behavior; thoughts of suicide; new or worsening chest pain, shortness of breath, or pain in legs when walking; pain in one or both arms or shoulders, or in your back, neck, jaw, or stomach; severe drowsiness, dizziness, or fainting; seizures; any rash; peeling or blistering sores; mouth sores; nausea or trouble sleeping that doesn’t go away.

Other: Nausea, trouble sleeping, headache, constipation, gas, vomiting, abnormal dreams, drowsiness, dizziness, tiredness, weakness, change in sense of taste, increased appetite, dry mouth.

What products might interact with this medicine?

No significant drug interactions have been reported. Drink less alcohol while you are taking this medicine until you know how it affects you.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.