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CHANTIX- varenicline tartrate kit


  1. When You Try To Quit Smoking, With Or Without Chantix, You May Have Symptoms That May Be Due To Nicotine Withdrawal, Including:
  2. Some People Have Had Serious Side Effects While Taking Chantix To Help Them Quit Smoking, Including:
  3. What Is Chantix?
  4. Do Not Take Chantix If You Have Had A Serious Allergic Or Skin Reaction To Chantix. Symptoms May Include:
  5. What Should I Tell My Healthcare Provider Before Taking Chantix?
  6. If You Are Sure That You Are Not Able Or Willing To Quit Smoking Right Away, Start Taking Chantix And Reduce Smoking During The First 12 Weeks Of Treatment, As Follows:
  7. Decrease The Amount Of Alcoholic Beverages That You Drink During Treatment With Chantix Until You Know If Chantix Affects Your Ability To Tolerate Alcohol. Some People Have Experienced The Following When Drinking Alcohol During Treatment With Chantix:
  8. Serious Side Effects Of Chantix May Include:
  9. Active Ingredient:
  10. Inactive Ingredients:
  11. Patient Information
  12. What Is The Most Important Information I Should Know About Chantix?
  13. There Are 2 Ways That You Can Use Chantix To Help You Quit Smoking. Talk To Your Doctor About The Following 2 Ways To Use Chantix:
  14. What Are The Ingredients In Chantix?
  15. Relabeled By:

When You Try To Quit Smoking, With Or Without Chantix, You May Have Symptoms That May Be Due To Nicotine Withdrawal, Including: 

  • urge to smoke
  • depressed mood
  • trouble sleeping
  • irritability
  • frustration
  • anger
  • feeling anxious
  • difficulty concentrating
  • restlessness
  • decreased heart rate
  • increased appetite
  • weight gain
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 Chantix 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 CHANTIX, and others developed them after several weeks of treatment, or after stopping CHANTIX. These symptoms happened more often in people who had a history of mental health problems before taking CHANTIX, than in people without a history of mental health problems.Stop taking CHANTIX 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 CHANTIX. In many people, these symptoms went away after stopping CHANTIX, but in some people symptoms continued after stopping CHANTIX. It is important for you to follow-up with your healthcare provider until your symptoms go away.Before taking CHANTIX,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 CHANTIX.

What Is Chantix? 

CHANTIX is 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.It is not known if CHANTIX is safe and effective in children.It is not known if CHANTIX is safe and effective when used with other stop smoking medicines.

Do Not Take Chantix If You Have Had A Serious Allergic Or Skin Reaction To Chantix. Symptoms May Include: 

  • swelling of the face, mouth (tongue, lips, gums), throat or neck
  • trouble breathing
  • rash, with peeling skin
  • blisters in your mouth

What Should I Tell My Healthcare Provider Before Taking Chantix? 

  • There are 3 ways that you can use CHANTIX to help you quit smoking. Talk to your healthcare provider about the following 3 ways to use CHANTIX:
    • Choose aquit datewhen you will stop smoking. Start taking CHANTIX 1 week (7 days) before yourquit date. Take CHANTIX for 12 weeks.
      OR
    • Start taking CHANTIX before you choose aquit date.Pick a date to quit smoking that is between days 8 and 35 of treatment. Take CHANTIX for 12 weeks.
      OR

If You Are Sure That You Are Not Able Or Willing To Quit Smoking Right Away, Start Taking Chantix And Reduce Smoking During The First 12 Weeks Of Treatment, As Follows: 

Weeks 1 through 4Reduce 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 8Reduce 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 12Keep 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 CHANTIX for another 12 weeks, for a total of 24 weeks of treatment.Starting CHANTIX before yourquit dategives CHANTIX time to build up in your body. You can keep smoking during this time. Take CHANTIX exactly as prescribed by your healthcare provider.
  • CHANTIX comes as a white tablet (0.5 mg) and a blue tablet (1 mg). You start with the white tablet and then usually go to the blue tablet.
    • Use caution when driving or operating machinery until you know how CHANTIX affects you. CHANTIX may make you feel sleepy, dizzy, or have trouble concentrating, making it hard to drive or perform other activities safely.

Decrease The Amount Of Alcoholic Beverages That You Drink During Treatment With Chantix Until You Know If Chantix Affects Your Ability To Tolerate Alcohol. Some People Have Experienced The Following When Drinking Alcohol During Treatment With Chantix: 

  • increased drunkenness (intoxication)
  • unusual or sometimes aggressive behavior
  • no memory of things that have happened

Serious Side Effects Of Chantix May Include: 

    • Store CHANTIX at room temperature, between 68 F to 77 F (20 C to 25 C).
    • Keep CHANTIX and all medicines out of the reach of children.
    General information about the safe and effective use of CHANTIXMedicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CHANTIX for a condition for which it was not prescribed. Do not give your CHANTIX to other people, even if they have the same symptoms that you have. It 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 CHANTIX that is written for healthcare professionals.For more information about CHANTIX and tips on how to quit smoking, go towww.CHANTIX.comor call 1-877-242-6849.If you are motivated to quit smoking and did not succeed during prior CHANTIX 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 CHANTIX therapy may be right for you.

Active Ingredient: 

varenicline tartrate

Inactive Ingredients: 

microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, OpadryWhite (for 0.5 mg), OpadryBlue (for 1 mg), and OpadryClear.

Logo

December 2016

LAB-0328-15.0

Patient Information 

CHANTIX(CHANT-iks)
(varenicline) Tablets

What Is The Most Important Information I Should Know About Chantix? 

Some people have had serious side effects while using CHANTIX to help them quit smoking, including:

New or worse mental health problems, such as changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions. Some people had these symptoms when they began taking CHANTIX, and others developed them after several weeks of treatment, or after stopping CHANTIX.

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

Stop taking CHANTIX and call your doctor right awayif you, your family, or caregiver notice agitation, hostility, depression or changes in your behavior or thinking that are not typical for you, or you develop any of the following symptoms:

thoughts about suicide or dying, or attempts to commit suicide
new or worse depression, anxiety, or panic attacks
feeling very agitated or restless
acting aggressive, being angry, or violent
acting on dangerous impulses
an extreme increase in activity and talking (mania)
abnormal thoughts or sensations

CHANTIX is 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.

It is not known if CHANTIX is safe and effective in children.

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

There Are 2 Ways That You Can Use Chantix To Help You Quit Smoking. Talk To Your Doctor About The Following 2 Ways To Use Chantix: 

Choose aquit datewhen you will stop smoking. Start taking CHANTIX 1 week (7 days) before yourquit date.
OR
Start taking CHANTIX before you choose aquit date. Pick a date to quit smoking that is between days 8 and 35 of treatment.
Starting CHANTIX before yourquit dategives CHANTIX time to build up in your body. You can keep smoking during this time. Take CHANTIX exactly as prescribed by your doctor.
CHANTIX comes as a white tablet (0.5 mg) and a blue tablet (1 mg). You start with the white tablet and then usually go to the blue tablet.

Use caution when driving or operating machinery until you know how CHANTIX affects you. CHANTIX may make you feel sleepy, dizzy, or have trouble concentrating, making it hard to drive or perform other activities safely.

What Are The Ingredients In Chantix? 

Active ingredient: varenicline tartrate

Relabeled By: 

Proficient Rx LP

Thousand Oaks, CA 91320



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