Varenicline tartrate Oral tablet

VARENICLINE (var e NI kleen) helps you quit smoking. It reduces cravings for nicotine, the addictive substance found in tobacco. It is most effective when used in combination with a stop-smoking program.

Take this medication 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 medication more often than directed.

There are 3 ways you can use this medication to help you quit smoking; talk to your care team to decide which plan is right for you:

1) you can choose a quit date and start this medication 1 week before the quit date, or,

2) you can start taking this medication 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 medication and slowly decrease the amount you smoke as directed by your care team 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 medication for reasons other than side effects, or if you returned to smoking after this treatment, speak with your care team about whether another course of this medication 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 care team about the use of this medication in children. This medication is not approved for use in children.

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Seizures

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Drowsiness
• Gas
• Nausea
• Trouble sleeping
• Upset stomach
• Vivid dreams or nightmares
• Vomiting

Keep out of the reach of children and pets.

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

They need to know if you have any of these conditions:

• Heart disease
• Frequently drink alcohol
• Kidney disease
• Mental health condition
• On hemodialysis
• Seizures
• History of stroke
• Suicidal thoughts, plans, or attempt by you or a family member
• An unusual or allergic reaction to varenicline, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

• Alcohol
• Insulin
• Other medications used to help people quit smoking
• Theophylline
• Warfarin

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.

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.