VARENICLINE- varenicline tartrate tablet, film coated 
American Health Packaging

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MEDICATION GUIDE

8464821/1221

Varenicline Tablets
(var EN i kleen)

What is the most important information I should know about varenicline tablets?
When you try to quit smoking, with or without varenicline tablets, you may have symptoms that may be due to nicotine withdrawal, including:

Some people have even experienced suicidal thoughts when trying to quit smoking without medication. Sometimes quitting smoking can lead to worsening of mental health problems that you already have, such as depression.

Some people have had serious side effects while taking varenicline tablets to help them quit smoking, including:

New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depressed mood, or suicidal thoughts or actions. Some people had these symptoms when they began taking varenicline tablets, and others developed them after several weeks of treatment, or after stopping varenicline tablets. These symptoms happened more often in people who had a history of mental health problems before taking varenicline tablets, than in people without a history of mental health problems.

Stop taking varenicline tablets and call your healthcare provider right away if you, your family, or caregiver notice any of these symptoms. Work with your healthcare provider to decide whether you should continue to take varenicline tablets. In many people, these symptoms went away after stopping varenicline tablets, but in some people symptoms continued after stopping varenicline tablets. It is important for you to follow-up with your healthcare provider until your symptoms go away.

Before taking varenicline tablets, tell your healthcare provider if you have ever had depression or other mental health problems. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without varenicline tablets.

What are varenicline tablets?
Varenicline tablets are a prescription medicine to help people stop smoking.

Quitting smoking can lower your chances of having lung disease, heart disease or getting certain types of cancer that are related to smoking.

Varenicline tablets have not been shown to be effective in children 16 years of age and under. Varenicline tablets should not be used in children 16 years of age and under.

It is not known if varenicline tablets are safe and effective when used with other stop smoking medicines.

Who should not take varenicline tablets?
Do not take varenicline tablets if you have had a serious allergic or skin reaction to varenicline tablets. Symptoms may include:

What should I tell my healthcare provider before taking varenicline tablets?
See “What is the most important information I should know about varenicline tablets?”

Before you take varenicline tablets, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Your healthcare provider may need to change the dose of some of your medicines when you stop smoking.

You should not use varenicline tablets while using other medicines to quit smoking. Tell your healthcare provider if you use other treatments to quit smoking.

Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist when you get a new medicine.

How should I take varenicline tablets?

Weeks 1 through 4

Reduce your smoking to reach one-half of your starting daily number of cigarettes.

Example: If you usually smoke 20 cigarettes each day, reduce your smoking to 10 cigarettes each day during weeks 1 through 4.

Weeks 5 through 8

Reduce your smoking to reach one-quarter of your starting daily number of cigarettes.

Example: If you usually smoked 20 cigarettes each day, reduce your smoking to 5 cigarettes each day during weeks 5 through 8.

Weeks 9 through 12

Keep reducing your smoking until you are no longer smoking (you reach zero cigarettes each day).

Aim to quit by the end of the 12th week of treatment, or sooner if you feel ready. Continue to take varenicline tablets for another 12 weeks, for a total of 24 weeks of treatment.

Starting varenicline tablets before your quit date gives varenicline tablets time to build up in your body. You can keep smoking during this time. Take varenicline tablets exactly as prescribed by your healthcare provider.

Day 1 to Day 3

  • White to off-white tablet (0.5 mg)
  • Take 1 tablet each day

Day 4 to Day 7

  • White to off-white tablet (0.5 mg)
  • Take 1 in the morning and 1 in the evening

Day 8 to end of treatment

  • Light blue tablet (1 mg)
  • Take 1 in the morning and 1 in the evening

What should I avoid while taking varenicline tablets?

What are the possible side effects of varenicline tablets?
Serious side effects of varenicline tablets may include:

The most common side effects of varenicline tablets include:

Tell your healthcare provider about side effects that bother you or that do not go away.

These are not all the side effects of varenicline tablets. Ask your healthcare provider or pharmacist for more information.

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

How should I store varenicline tablets?

Keep varenicline tablets and all medicines out of the reach of children.

General information about the safe and effective use of varenicline tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use varenicline tablets for a condition for which it was not prescribed. Do not give your varenicline tablets to other people, even if they have the same symptoms that you have. They may harm them. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about varenicline tablets that is written for healthcare professionals.

For more information about varenicline tablets and tips on how to quit smoking, go to www.parpharm.com or call Par Pharmaceutical at 1-800-828-9393.
For more information about the packaging or labeling, call American Health Packaging at 1-800-707-4621.

If you are motivated to quit smoking and did not succeed during prior varenicline tablets treatment for reasons other than side effects, or if you returned to smoking after treatment, speak with your healthcare provider about whether another course of varenicline tablets therapy may be right for you.

What are the ingredients in varenicline tablets?
Active ingredient:
varenicline tartrate
Inactive ingredients: croscarmellose sodium, maltodextrin, microcrystalline cellulose, stearic acid. The tablets are film-coated with a coating material containing hydroxypropyl cellulose, hypromellose, talc, and titanium dioxide. In addition to these, the 1 mg tablet film coating includes FD&C blue #2/indigo carmine aluminum lake and iron oxide yellow.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed By:
American Health Packaging
Columbus, OH 43217

8464821/1221

Revised: 1/2022
American Health Packaging