Nicotine Lozenges

WHY is this medicine prescribed?

Nicotine lozenges are used to help people stop smoking. Nicotine lozenges are in a class of medications called smoking cessation aids. They work by providing nicotine to your body to decrease the withdrawal symptoms experienced when smoking is stopped and to reduce the urge to smoke.

Are there OTHER USES for this medicine?

This medication may be used for other conditions; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Nicotine comes as a lozenge to slowly dissolve in the mouth. It is usually used according to the directions on the package, at least 15 minutes after eating or drinking. Follow the directions on your medicine package carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use nicotine lozenges exactly as directed. Do not use more or less of them or use them more often than prescribed by your doctor.

If you smoke your first cigarette within 30 minutes of waking up in the morning, you should use 4-mg nicotine lozenges. If you smoke your first cigarette more than 30 minutes after waking up in the morning, you should use 2 mg-nicotine lozenges.

For weeks 1 to 6 of treatment, you should use one lozenge every 1 to 2 hours. Using at least nine lozenges per day will increase your chance of quitting. For weeks 7 to 9, you should use one lozenge every 2 to 4 hours. For weeks 10 to 12, you should use one lozenge every 4 to 8 hours.

Do not use more than five lozenges in 6 hours or more than 20 lozenges per day. Do not use more than one lozenge at a time or use one lozenge right after another. Using too many lozenges at a time or one after another can cause side effects such as hiccups, heartburn, and nausea.

To use the lozenge, place it in your mouth and allow it to slowly dissolve. Do not chew, crush, or swallow lozenges. Once in a while, use your tongue to move the lozenge from one side of your mouth to the other. It should take 20 to 30 minutes to dissolve. Do not eat while the lozenge is in your mouth.

Stop using nicotine lozenges after 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before using nicotine lozenges,

• tell your doctor and pharmacist if you are allergic to nicotine, any other medications, or any of the ingredients in the nicotine lozenges. Ask your pharmacist for a list of the ingredients.

• do not use nicotine lozenges if you are using any other nicotine smoking cessation aid, such as the nicotine patch, gum, inhaler, or nasal spray.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: non-nicotine smoking cessation aids, such as bupropion (Wellbutrin) or varenicline (Chantix), and medications for depression or asthma. Your doctor may need to change the doses of your medications once you stop smoking.

• tell your doctor if you have recently had a heart attack and if you have or have ever had heart disease, irregular heartbeat, high blood pressure, a stomach ulcer, diabetes, or phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent damage to your brain that can cause severe intellectual disability).

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using nicotine lozenges, call your doctor.

• stop smoking completely. If you continue smoking while using nicotine lozenges, you may have side effects.

• ask your doctor or pharmacist for advice and for written information to help you stop smoking. You are more likely to stop smoking during your treatment with nicotine lozenges if you get information and support from your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Nicotine lozenges may cause side effects. Tell your doctor if either of these symptoms is severe or does not go away:

• heartburn
• sore throat

Some side effects can be serious. If you experience either of these symptoms, call your doctor immediately:

• mouth problems
• irregular or fast heartbeat

Nicotine lozenges may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children and pets. Store it at room temperature and away from excess heat and moisture (not in the bathroom). If you need to remove a lozenge, wrap it in paper and dispose of it in a trash can safely, out of the reach of children and pets.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• nausea
• vomiting
• dizziness
• diarrhea
• weakness
• fast heartbeat

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about nicotine lozenges.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.