Varenicline oral tablets

What is this medicine?

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

How should I use this medicine?

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.

What side effects may I notice from receiving this medicine?

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

What may interact with this medicine?

• alcohol

• insulin

• other medicines used to help people quit smoking

• theophylline

• warfarin

What if I miss a 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.

Where should I keep my medicine?

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.

What should I tell my health care provider before I take this medicine?

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

• heart disease

• if you often drink alcohol

• kidney disease

• mental illness

• on hemodialysis

• seizures

• history of stroke

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• an unusual or allergic reaction to varenicline, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this 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 medicine as directed. Just throw away your cigarettes and get back to your quit plan.

Talk to your health care provider before using other treatments to quit smoking. Using this medicine with other treatments to quit smoking may increase the risk for side effects compared to using a treatment alone.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

Decrease the number of alcoholic beverages that you drink during treatment with this medicine until you know if this medicine 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 medicine.

Sleepwalking can happen during treatment with this medicine, and can sometimes lead to behavior that is harmful to you, other people, or property. Stop taking this medicine and tell your doctor if you start sleepwalking or have other unusual sleep-related activity.

After taking this medicine, you may get up out of bed and do an activity that you do not know you are doing. The next morning, you may have no memory of this. Activities include driving a car ("sleep-driving"), making and eating food, talking on the phone, sexual activity, and sleep-walking. Serious injuries have occurred. Stop the medicine and call your doctor right away if you find out you have done any of these activities. Do not take this medicine if you have used alcohol that evening. Do not take it if you have taken another medicine for sleep. The risk of doing these sleep-related activities is higher.

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 health care professional.

If you have diabetes and you quit smoking, the effects of insulin may be increased and you may need to reduce your insulin dose. Check with your doctor or health care professional about how you should adjust your insulin dose.