This medication can help you quit smoking by replacing the nicotine in cigarettes. The nicotine in tobacco is an important part of cigarette addiction. When you stop smoking, your nicotine levels drop quickly. This drop can cause withdrawal symptoms such as craving tobacco, nervousness, irritability, headache, weight gain, and difficulty concentrating.

Stopping smoking is hard and your chance of success is best when you are ready and have made a commitment to quit. Nicotine replacement products are part of a total stop-smoking program that includes behavior change, counseling, and support. Smoking causes lung disease, cancer, and heart disease. Stopping smoking is one of the most important things you can do to improve your health and live longer.

If you are using the over-the-counter product, read all directions on the product package before using this medication. If your doctor has prescribed this medication, read the Patient Information Leaflet if available from your pharmacist before you start using this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Do not eat or drink anything for 15 minutes before using the lozenge and while the lozenge is in your mouth.

Start this medication on your quit (smoking) day. Suck on a lozenge when you feel the urge to smoke. Place the lozenge in your mouth and allow it to slowly dissolve over 20-30 minutes. You may feel a warm, tingling sensation. Try not to swallow the dissolved medication. Do not chew or swallow the lozenge. Occasionally move the lozenge from one side of your mouth to the other with your tongue.

The best dose for you is the dose that decreases the urge to smoke without side effects from too much nicotine. Your dose will need to be adjusted to your needs, including smoking history and medical condition. During the first 6 weeks, use 1 lozenge every 1-2 hours (at least 9 lozenges a day).

Do not use more than 1 lozenge at a time or continuously use 1 lozenge right after another. Doing so may increase side effects such as hiccups, heartburn, and nausea. Do not use more than 5 lozenges in 6 hours or more than 20 lozenges in a day. You may use this product on a regular schedule as well as at times when you have the urge to smoke.

When you have stopped smoking and you have reached the best dose and schedule for you, continue at that dose. After about 6 weeks, start using fewer lozenges each day as directed in the package or by your doctor until you are no longer smoking and no longer need nicotine replacement. It is important to complete the treatment with this medication (12 weeks). If after the treatment period, you still feel the need to use this medication to prevent you from smoking, talk to your doctor.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as tobacco cravings, nervousness, irritability, headache). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used nicotine for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Some smokers are unsuccessful the first time they try to quit. You may need to stop using this product and try again later. Many people who cannot quit the first time are successful the next time.

Mouth sores, hiccups, nausea, sore throat, headache, heartburn, or dizziness may occur. If any of these effects last or get worse, stop using this medication and tell your doctor or pharmacist promptly.

Common nicotine withdrawal symptoms can occur when you stop smoking and include dizziness, anxiety, depression, or trouble sleeping, among others.

If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Serious side effects are more likely if you continue to smoke while using this product.

Stop using this medication and tell your doctor right away if you have any serious side effects, including:

• severe dizziness
• mental/mood changes (such as irritability, trouble sleeping, vivid dreams)
• numbness/tingling in hands/feet
• swelling hands/ankles/feet

Stop using this medication and get medical help right away if you have any very serious side effects, including:

• chest pain
• confusion
• severe headache
• fast/irregular/pounding heartbeat
• trouble speaking
• weakness on one side of the body

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this product, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as soya found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• blood vessel disease (such as Raynaud's disease, stroke)
• diabetes
• heart disease (such as chest pain, heart attack, irregular heartbeat)
• high blood pressure
• liver disease
• kidney disease
• esophagus problems (such as esophagitis)
• stomach/intestinal sores (peptic ulcers)
• a certain adrenal gland tumor (pheochromocytoma)
• overactive thyroid (hyperthyroidism)
• seizures

This medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet, ask your doctor or pharmacist about using this medication safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Nicotine and smoking may harm an unborn baby. If you are pregnant, try to stop smoking without using a nicotine replacement product if possible. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Nicotine from smoking and from this medication passes into breast milk and could have undesirable effects on a nursing infant. Smoking near an infant can also harm the infant. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Stopping smoking can change the way the liver removes certain drugs from the body (including acetaminophen, caffeine, insulin, oxazepam, pentazocine, propoxyphene, propranolol, theophylline, tricyclic antidepressants such as amitriptyline/imipramine, "water pills"/diuretics such as furosemide). Tell all your doctors and pharmacists that you are quitting smoking.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: confusion, drooling, seizure, slow/shallow breathing, hearing problems.

Do not share this medication with others.

If you are using this on a regular schedule and you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Wrap any partly used lozenge in paper and discard in the trash away from children and pets. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.