Nicotine Gum

Nicotine Gum is used for:

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Helping you to quit smoking.

Nicotine Gum is a smoking deterrent. It works by providing low levels of nicotine, which may help you to quit smoking by lessening physical signs of withdrawal symptoms.

Do NOT use Nicotine Gum if:

• you are allergic to any ingredient in Nicotine Gum
• you have had a recent heart attack
• you have severe chest pain or a severely irregular heartbeat
• you continue to smoke, chew tobacco, use snuff, or nay other nicotine containing products

Contact your doctor or health care provider right away if any of these apply to you.

Before using Nicotine Gum:

Some medical conditions may interact with Nicotine Gum. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have chest pain, an irregular heartbeat, a history of heart attack, high blood pressure, an overactive thyroid, an ulcer, a tumor on your adrenal gland, diabetes, a jaw problem (temporomandibular joint disorder [TMJ]), or blood vessel problems

Some MEDICINES MAY INTERACT with Nicotine Gum. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Asthma medicines (eg, theophylline) or tricyclic antidepressants (eg, amitriptyline) because the side effects of Nicotine Gum may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nicotine Gum may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nicotine Gum:

Use Nicotine Gum as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Do not eat or drink for 15 minutes before using Nicotine Gum or while chewing a piece of Nicotine Gum.
• Do not swallow the gum.
• Carry this gum with you at all times. Whenever you have the urge to smoke, chew 1 piece of gum. Chew the gum slowly. Bite 1 or 2 times, then keep the gum between your cheek and gum. Wait about 1 minute and then repeat. Continue until you have used the same piece of gum for about 30 minutes.
• Continue using the gum until your urge to smoke fades or until 1 to 2 pieces of gum per day satisfies your craving.
• If you miss a dose of Nicotine Gum, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Nicotine Gum.

Important safety information:

• Nicotine Gum may cause dizziness, lightheadedness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Nicotine Gum. Using Nicotine Gum alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Nicotine Gum.
• This gum may stick to dental work and damage it. If this occurs, stop using the gum and contact your dentist.
• Dispose of used pieces by wrapping and placing in the trash out of the reach of children and away from pets.
• Do not smoke or use tobacco products while using Nicotine Gum.
• Do not chew more than 24 pieces of gum a day unless advised to do so by your doctor.
• Nicotine Gum should be used as part of a larger program to help you stop smoking. If you need help choosing a program, talk with your health care provider.
• Use Nicotine Gum with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Nicotine Gum may cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Nicotine Gum during pregnancy. Nicotine Gum is excreted in breast milk. If you are or will be breast-feeding while you are using Nicotine Gum, check with your doctor or pharmacist to discuss the risks to your baby.

When used for long periods of time or at high doses, some people develop a need to continue taking Nicotine Gum. This is known as DEPENDENCE or addiction.

Do not suddenly stop taking Nicotine Gum without your doctor's approval. Stopping Nicotine Gum suddenly may cause serious WITHDRAWAL symptoms including: anxiety, craving, impaired concentration, increased appetite, irritability, nervousness, sleep disturbances, and weight gain.

Possible side effects of Nicotine Gum:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal dreams; diarrhea; difficulty sleeping; dry mouth; joint pain; muscle pain; nervousness; redness, itching, or burning at the application site; sweating; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); pounding in the chest.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include blurred vision; confusion; diarrhea; difficulty breathing; dizziness; excessive saliva; fainting; headache; hearing problems; nausea; rapid, weak, or irregular heartbeat; seizures; stomach pain; sweating; vomiting; weakness.

Store Nicotine Gum at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Store Nicotine Gum in the original blister pack. Once removed from the blister, use immediately. Do not store in the bathroom. Keep Nicotine Gum out of the reach of children and away from pets.

General information:

• If you have any questions about Nicotine Gum, please talk with your doctor, pharmacist, or other health care provider.
• Nicotine Gum is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Nicotine Gum. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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