Nicotine, Oral

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KEY POINTS

• This medicine is a chewing gum used to help you stop smoking. Use it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: smoking deterrent

Generic and brand names: nicotine polacrilex, gum; NICOrelief; Nicorette Gum

What is this medicine used for?

This medicine is a chewing gum used to help you stop smoking. The nicotine in the gum is absorbed into the body through skin in the mouth and lessens the urge to smoke.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Asthma or other breathing problems that you take medicine to control
• Dental problems, especially with your gums or jaws
• Depression that you take medicine to control
• Diabetes
• Gastric reflux disease (GERD)
• Heart disease or a recent heart attack
• High blood pressure
• Liver or kidney disease
• Pheochromocytoma (tumor of the adrenal gland)
• Seizures
• Thyroid problems
• Ulcers

Tell your healthcare provider if you continue to smoke, chew tobacco, use snuff, or use other products that contain nicotine. Also, tell your healthcare provider if you are on a low-sodium diet.

Females of childbearing age: Tell your healthcare provider if you are pregnant or breast-feeding. Nicotine from any source can harm the baby. Do not become pregnant while using this medicine. If you become pregnant, contact your healthcare provider. This treatment is not recommended during pregnancy or while breast-feeding. If you are pregnant or breast-feeding, do not use this medicine unless your healthcare provider approves. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine.

How do I use it?

If you have tried to stop smoking using another form of nicotine replacement therapy and have not had any success, ask your healthcare provider if this medicine is right for you. Take this medicine exactly as your healthcare provider prescribes. If your healthcare provider has not given you specific instructions, follow the directions that come with the medicine package. Do not take more or take it longer than prescribed. Ask your healthcare provider or pharmacist about anything you do not understand.

Begin using this medicine on your quit day. Check the label on the medicine for directions about your specific dose. This medicine comes in 2 strengths. The dose is based upon how soon you would normally smoke after waking up in the morning.

Check with your healthcare provider before using this medicine in children under age 18.

When you feel like smoking, chew 1 piece of gum slowly until you feel a slight tingling sensation or peppery taste in your mouth. Stop chewing and place the gum between your teeth and cheek until the tingling is gone. Then chew the gum again until the tingling comes back. Start and stop in this way for about 30 minutes, until most of the tingling is gone. You must chew slowly to get the full benefit from this medicine. If you still feel a craving to smoke even after chewing a piece of gum, you may chew a second piece within the hour. Do not chew more than 2 pieces in a row, since this may cause more side effects such as hiccups, heartburn, nausea, or other side effects.

Do not use more than 24 pieces of gum in 1 day, or as instructed by your healthcare provider.

Do not eat or drink for 15 minutes before using the gum, or while you are chewing it. Food and drink can keep the nicotine from being absorbed.

If the gum sticks to your dentures, ask your healthcare provider or dentist what to do.

If you get blisters in your mouth, stop using the medicine and contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, diarrhea, stomach pain, cold sweat, headache, dizziness, trouble seeing or hearing, confusion, restlessness, fast or irregular heartbeat, chest pain, drooling, seizures, coma.

What should I watch out for?

Caution: Nicotine can poison children and pets. Keep used and unused nicotine in a safe place out of the reach of children. Wrap used pieces of gum in paper and dispose of the medicine safely.

Stop using this medicine and contact your healthcare provider if you have:

• Mouth, teeth or jaw problems
• Fast or irregular heartbeat
• Symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness, and fast heartbeat

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

When you stop smoking, there may be a change in how certain medicines work for you. Talk to your healthcare provider if you are taking medicine that reduces the chance of blood clots, bronchodilators, or diabetes medicines.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Signs of nicotine overdose (pale skin, cold sweats, nausea, increased saliva, vomiting, diarrhea, severe headache, dizziness, confusion, weakness, very slow or very fast heartbeat, irregular heartbeat, trouble breathing, trouble seeing or hearing, severe nervousness, seizures); jaw or tooth pain, severe mouth pain or irritation; mouth blisters.

Other: Sore mouth or throat, change in sense of taste, belching, gas, mild headache, trouble sleeping, hiccups.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Also, when you stop smoking and start using any nicotine replacement products, the dosage of some medicines you may have been taking may need adjustment. Talk to your healthcare provider if you are taking:

• Adenosine (Adenocard)
• Alpha blockers such as doxazosin (Cardura), prazosin (Minipress), and terazosin
• Antianxiety medicines such as chlordiazepoxide, diazepam (Valium), and oxazepam
• Antiarrhythmic medicines (to treat irregular heartbeat) such as flecainide and mexiletine
• Antidepressants such as amitriptyline, desipramine (Norpramin), fluvoxamine (Luvox), imipramine (Tofranil), and nortriptyline (Pamelor)
• Antipsychotic medicines such as clozapine (Clozaril, FazaClo) and olanzapine (Zyprexa)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Caffeine in food, drinks, or medicines
• Cancer medicines such as erlotinib (Tarceva) and irinotecan (Camptosar)
• Cimetidine (Tagamet)
• Decongestants such as oxymetazoline (Afrin, Dristan), phenylephrine (Neo-Synephrine, Sudafed PE), and pseudoephedrine (Sudafed)
• Doxepin (Silenor)
• Furosemide (Lasix)
• Insulin
• Medicines to treat breathing or lung problems such as aminophylline and theophylline
• Migraine medicines such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar), and methylergonovine
• Other medicines or products to help you stop smoking
• Pentazocine (Talwin)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Varenicline (Chantix)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.