Varenicline (Oral)

Varenicline is used along with a support program to help you quit smoking. The program will include counseling and educational materials.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to monitor your or your child's progress at regular visits, especially during the first few weeks of using this medicine. This will help adjust your dose and reduce any side effects. Blood and urine tests may also be needed to check for unwanted effects.

This medicine may increase the risk of having a heart attack, especially in patients with heart or blood vessel disease. Call your doctor immediately if you experience chest pain or discomfort, pain or discomfort in the arms, jaw, back, or neck, pain in your legs when walking, sweating, or trouble breathing.

This medicine may cause some people to feel agitated, irritable, or show other unusual behaviors. It may also lead some individuals to have suicidal thoughts or become more depressed. If you or your caregiver notice any of these side effects, inform your doctor right away.

This medicine may cause serious allergic reactions, including angioedema, which can be life-threatening and requires immediate medical attention. Notify your doctor right away if you experience a rash, itching, large hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, trouble breathing or swallowing, or chest tightness while using this medicine.

Serious skin reactions can occur with this medicine. Contact your doctor immediately if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while using this medicine.

This medicine may cause some people to feel drowsy or dizzy, or have trouble concentrating. Do not drive or engage in any activities that could be dangerous until you understand how this medicine affects you.

Tell your doctor if you have nausea or sleep problems (trouble sleeping or unusual dreams) while using this medicine. Your dose may need to be adjusted.

While using this medicine, be careful to limit the amount of alcohol you consume.

Sleepwalking may occur while using this medicine. This can sometimes lead to harmful behavior to yourself or others, or damage to property. Contact your doctor immediately if you begin sleepwalking.

Do not take any other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other types of allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies to date have not shown any specific problems that would limit the use of varenicline in children older than 16 years. It is not recommended for children 16 years and younger. Safety and effectiveness have not been established.

Geriatric

Studies to date have not indicated any specific problems that would limit the use of varenicline in elderly patients. However, older adults are more likely to have age-related kidney issues, which may require careful monitoring and dose adjustment for those taking varenicline.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if interactions could happen. In those cases, your doctor might adjust the dose or take other precautions. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are selected based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following is usually not recommended, but may be needed in some instances. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Bupropion

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines can also cause interactions. The following interactions are selected based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some situations. If used together, your doctor may adjust the dose or frequency of this medicine, or provide special instructions regarding food, alcohol, or tobacco use.

• Ethanol

Other Medical Problems

Having other medical problems may affect how this medicine works. Make sure to inform your doctor if you have any other medical issues, especially:

• Alcohol abuse or a history of it
• Angina (severe chest pain) or a history of it
• Heart attack or a history of it
• Heart or blood vessel issues
• Stroke or a history of it—May increase the risk of more serious side effects.

• Depression or a history of it
• Mental health issues (e.g., psychosis) or a history of them
• Seizures or a history of them—Use with caution. May worsen these conditions.

• Severe kidney disease—Use with caution. The effects may be stronger because the body removes the medicine more slowly.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Anxiety
• black, tarry stools
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody stools
• blurred vision
• burning feeling in the chest or stomach
• chest pain or discomfort
• chills
• cold hands and feet
• cold sweats
• confusion
• cool, pale skin
• cough
• deep or fast breathing with dizziness
• difficult or labored breathing
• dizziness
• dry mouth
• fainting
• fast, pounding, or irregular heartbeat or pulse
• flushed, dry skin
• fruit-like breath odor
• headache
• headache, severe and throbbing
• increased hunger
• increased thirst
• increased urination
• indigestion
• loss of consciousness
• nausea
• nervousness
• nightmares
• noisy breathing
• nosebleed
• numbness of the feet, hands and around the mouth
• pain or discomfort in the arms, jaw, back, or neck
• pale skin
• pounding in the ears
• rapid weight gain
• seizures
• shakiness
• slow heartbeat
• slurred speech
• stomach pain or upset
• sweating
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tenderness in the stomach area
• tightness in the chest
• tingling of the hands or feet
• tremor
• troubled breathing with exertion
• unexplained weight loss
• unusual bleeding or bruising
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusual weight gain or loss
• vomiting
• vomiting of blood or material that looks like coffee grounds

Rare

• Agitation
• bleeding gums
• bloating
• blood in the urine or stools
• constipation
• dark urine
• decrease in height
• decreased awareness or responsiveness
• difficulty in swallowing
• eye pain
• feeling of fullness
• fever
• frequent urination
• general feeling of illness
• heartburn
• hostility
• increased sensitivity of the skin to sunlight
• increased volume of pale, dilute urine
• irritability
• itching, skin rash
• loss of appetite
• mood changes
• muscle pain, cramps, or twitching
• numbness or tingling in the hands, feet, or lips
• pain or burning in the throat
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on the skin
• red, scaling, or crusted skin
• redness or other discoloration of the skin
• severe sleepiness
• severe stomach pain
• severe sunburn
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• uncontrolled eye movements
• yellow eyes or skin

Incidence not known

• Anger
• anxiety
• behavior changes
• discouragement
• feeling sad or empty
• feelings of panic
• irregular heartbeat
• loss of interest or pleasure
• mood swings
• restlessness
• seeing, hearing, or feeling things that are not there
• sleepwalking
• thoughts of killing oneself

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abnormal dreams
• absence of menstruation
• change in taste
• diarrhea
• difficulty having a bowel movement
• difficulty in moving
• excess air or gas in the stomach or bowels
• joint pain or swelling
• lack or loss of strength
• loss of taste
• muscle stiffness
• painful menstruation
• passing gas
• toothache
• trouble sleeping

Less common

• Belching
• body aches or pain
• burning, dry, or itching eyes
• continuing ringing or buzzing or other unexplained noise in the ears
• decreased interest in sexual intercourse
• discharge, excessive tearing
• ear congestion
• feeling of constant movement of self or surroundings
• feeling of warmth
• hearing loss
• inability to have or keep an erection
• increased appetite
• increased urge to urinate during the night
• loss in sexual ability, desire, drive, or performance
• loss of voice
• nightmares
• redness in the joints
• redness of the face, neck, arms and occasionally, upper chest
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• sensation of spinning
• sleepiness or unusual drowsiness
• sneezing
• sore throat
• stomach discomfort
• stuffy or runny nose
• transient, mild, pleasant aromatic odor
• trouble concentrating
• waking to urinate at night

Rare

• Change in color vision
• difficulty seeing at night
• increased sensitivity of the eyes to sunlight
• night blindness
• seeing floating dark spots or material before the eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Chantix
• Chantix Starter Pack
• Chantix Starting Month Box
• Chantix Start Month Pak

Available Dosage Forms:

• Tablet

Therapeutic Class: Smoking Cessation Agent

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. It is also important to participate in a stop-smoking program while you use this medicine. This will make it easier for you to quit smoking.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You should set a date to stop smoking. Start using varenicline 1 week before this date.

Your doctor may also tell you to start using this medicine anytime and then to stop smoking between days 8 and 35 of treatment.

You may be told to take this medicine for 12 weeks. Even if you have already stopped smoking by this time, your doctor may tell you to take this medicine for 12 more weeks to help you keep off smoking.

Take this medicine after eating, and with a full glass of water.

If you are motivated to quit smoking and did not succeed treatment with this medicine previously, or if you returned to smoking after using varenicline, talk with your doctor about whether another course of varenicline treatment may be right for you.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):To stop smoking: Adults and children 17 years of age and older— Days 1 to 3: 0.5 milligram (mg) once a day. Days 4 to 7: 0.5 mg 2 times per day. Days 8 to end of treatment: 1 mg 2 times per day. Children 16 years of age and younger—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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