Nicotine, Lozenge

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KEY POINTS

• This medicine is used in the mouth 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, lozenge; NICOrelief; Nicorette mini Lozenge

What is this medicine used for?

This product is used to help you stop smoking. It provides relief from the symptoms of nicotine withdrawal you feel when you first stop smoking and helps lessen 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 or to soy
• 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)
• Phenylketonuria (PKU). Lozenges may contain phenylalanine.
• 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.

Start 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.

Place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20 to 30 minutes). You may feel a warm or tingling sensation. Occasionally move the lozenge from one side of your mouth to the other until completely dissolved. Do not bite or chew it like a hard candy, and do not swallow the lozenge. Do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause hiccups, heartburn, nausea or other side effects.

Do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day, or as instructed by your healthcare provider.

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

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, 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. If you need to remove the lozenge from your mouth, wrap it in paper and dispose of the medicine safely.

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

• Mouth 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 forming such as warfarin (Coumadin), bronchodilators such as theophylline, or diabetes medicines such as insulin.

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); severe mouth pain or blisters; heartburn that doesn’t go away; severe sore throat.

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.