Nicorette

What is Nicorette?

Nicorette is used to treat nicotine withdrawal. It is used to curb the craving to smoke.

Before taking Nicorette, tell your doctor:

• If you are allergic to Nicorette; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Chest pain or pressure, a heartbeat that does not feel normal, or a recent heart attack.
• If you still smoke, chew tobacco, or use other products that have nicotine while using Nicorette.
• If you have temporomandibular joint (TMJ) disease.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Nicorette with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Nicorette?

• Tell all of your health care providers that you take Nicorette. This includes your doctors, nurses, pharmacists, and dentists.
• Get counseling to help you quit smoking.
• Do not use more than told. Unsafe side effects may happen.
• Tell your doctor if you are taking another drug to help you stop smoking.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Nicorette affects you.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• When you stop smoking, other drugs may be affected. Talk with your doctor.
• Tell your doctor if you have not been able to quit smoking after using Nicorette for as long as it says to use it.
• Gum chewing may cause problems with dental work.
• If you are on a low-sodium or sodium-free diet, talk with your doctor. Some of these products have sodium.
• This medicine may cause harm or be deadly if used or swallowed by children or pets. If a child uses Nicorette or if Nicorette is swallowed by a child or pet, call a doctor or poison control center right away.
• If you are 65 or older, use Nicorette with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Nicorette, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Nicorette best taken?

Use Nicorette as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• The gum comes in 2 doses. If you smoke your first cigarette of the day within 30 minutes of waking use the 4 mg dose. If you smoke your first cigarette of the day more than 30 minutes after waking use the 2 mg dose.
• Use right after opening.
• Do not swallow gum.
• Chew slowly until there is a tingling or peppery taste in the mouth.
• Then place between the cheek and gum.
• After the taste or tingle is gone, chew again slowly.
• Put between the cheek and gum at some other site once the taste or tingle comes back.
• Keep repeating this for about 30 minutes or until the taste or tingle is gone.
• Do not eat or drink within 15 minutes before using the gum or while you are using it.
• If needed, you may use a second piece within the hour. Do not use 1 piece right after the other.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

What are the side effects of Nicorette that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Mood changes.
• Feeling confused.
• Chest pain or pressure, a fast heartbeat, or an abnormal heartbeat.
• A burning, numbness, or tingling feeling that is not normal.
• Dizziness.
• Upset stomach or throwing up.
• Diarrhea.
• Drooling.
• Shakiness.
• Sore throat.
• Jaw pain.
• Feeling tired or weak.
• Cold sweats.
• Blurred eyesight.
• Change in hearing.

What are some other side effects of Nicorette?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Trouble sleeping.
• Bad dreams.
• Feeling nervous and excitable.
• Headache.
• Joint pain.
• Back pain.
• Irritation where Nicorette is used.
• Flu-like signs.
• Gas.
• Mouth tingling.
• Gum changes.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Nicorette?

• Store at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Wrap the gum in paper before you throw it away.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else’s drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Nicorette, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Nicorette or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Nicorette. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

• NDC 0135-0242-05
• Nicorette®
• nicotine polacrilex gum, 4mg • stop smoking aid
• Gum
• Coated
• FOR BOLD FLAVOR
• Fruit Chill®
• 4 mg
• FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.
• If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicorette 2 mg Gum
• 160 PIECES, 4 mg EACH
• 30857XG

SRC: NLM .