VARENICLINE TARTRATE (Generic for CHANTIX)

VARENICLINE (var e NI kleen) is used to help people quit smoking. It is used with a patient support program recommended by your physician.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

Take this medicine by mouth after eating. Take with a full glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed.
 
There are 3 ways you can use this medicine to help you quit smoking; talk to your health care professional to decide which plan is right for you:
1) you can choose a quit date and start this medicine 1 week before the quit date, or,
2) you can start taking this medicine before you choose a quit date, and then pick a quit date between day 8 and 35 days of treatment, or,
3) if you are not sure that you are able or willing to quit smoking right away, start taking this medicine and slowly decrease the amount you smoke as directed by your health care professional with the goal of being cigarette-free by week 12 of treatment.
 
Stick to your plan; ask about support groups or other ways to help you remain cigarette-free. If you are motivated to quit smoking and did not succeed during a previous attempt with this medicine for reasons other than side effects, or if you returned to smoking after this treatment, speak with your health care professional about whether another course of this medicine may be right for you.
 
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
 
Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

-alcohol
-insulin
-other medicines used to help people quit smoking
-theophylline
-warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

It is okay if you do not succeed at your attempt to quit and have a cigarette. You can still continue your quit attempt and keep using this medication as directed. Just throw away your cigarettes and get back to your quit plan.
Talk to your care team before using other treatments to quit smoking. Using this medication with other treatments to quit smoking may increase the risk for side effects compared to using a treatment alone.
This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells.
Decrease the number of alcoholic beverages that you drink during treatment with this medication until you know if this medication affects your ability to tolerate alcohol. Some people have experienced increased drunkenness (intoxication), unusual or sometimes aggressive behavior, or no memory of things that have happened (amnesia) during treatment with this medication.
You may do unusual sleep behaviors or activities you do not remember the day after taking this medication. Activities include driving, making or eating food, talking on the phone, sexual activity, or sleep walking. Stop taking this medication and call your care team right away if you find out you have done activities like this.
Patients and their families should watch out for new or worsening depression or thoughts of suicide. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, call your care team.
If you have diabetes, and you quit smoking, the effects of insulin may be increased. You may need to reduce your insulin dose. Check with your care team about how you should adjust your insulin dose.

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Side effects that you should report to your doctor or health care professional as soon as possible:
-allergic reactions like skin rash, itching or hives, swelling of the face, lips, tongue, or throat
-acting aggressive, being angry or violent, or acting on dangerous impulses
-breathing problems
-changes in emotions or moods
-chest pain or chest tightness
-feeling faint or lightheaded, falls
-hallucination, loss of contact with reality
-mouth sores
-redness, blistering, peeling or loosening of the skin, including inside the mouth
-signs and symptoms of a stroke like changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination
-seizures
-sleepwalking
-suicidal thoughts or other mood changes
 
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
-constipation
-gas
-headache
-nausea, vomiting
-strange dreams
-trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.