Leader Nicotine Polacrilex (gum, lozenge)

Leader Nicotine Polacrilex is the main ingredient in tobacco products.

Leader Nicotine Polacrilex gum and lozenges are medical products designed to help adults stop smoking. Taking a controlled amount of Leader Nicotine Polacrilex can lessen withdrawal symptoms when you quit smoking.

Leader Nicotine Polacrilex may also be used for reasons not mentioned in this medication guide.

This medicine is only part of a complete treatment program that may also include counseling, group support, and behavior changes. Your success will depend on your participation in all parts of your smoking cessation program.

Use exactly as directed on the label, or as prescribed by your doctor. Start using Leader Nicotine Polacrilex gum or lozenges on the same day you stop (quit) smoking or using tobacco products.

Your dose will depend on how many cigarettes you smoked daily before quitting. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

After removing the gum or lozenge, wrap it in paper and throw it away in a place where children and pets cannot reach it.

Do not use this medicine for longer than 12 weeks without the advice of your doctor.

Do not use more than one lozenge or piece of gum at a time. Do not use the gum and lozenges together at the same time.

Store at room temperature away from moisture, heat, and light.

Keep both used and unused gum and lozenges out of the reach of children or pets.

Follow all instructions on your medicine label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medicines you are taking.

Ask a doctor or pharmacist if Leader Nicotine Polacrilex is safe to use if you have ever had:

• heart disease, irregular heartbeats;
• a heart attack or stroke;
• untreated or uncontrolled high blood pressure;
• diabetes;
• stomach ulcer;
• a seizure; or
• if you are on a low salt diet.

Do not use this medicine if you are pregnant unless your doctor has told you to. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Smoking cigarettes during pregnancy can cause low birth weight, miscarriage, or stillbirth. Using a Leader Nicotine Polacrilex replacement product during pregnancy or while breast-feeding may be safer than smoking. However, you should try to stop smoking without using a Leader Nicotine Polacrilex replacement product if you are pregnant or breast-feeding. Talk with your doctor about the best way for you to stop smoking.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Leader Nicotine Polacrilex lozenges may contain phenylalanine. Check the medication label if you have phenylketonuria (PKU).

Do not give this medicine to anyone under 18 years old without medical advice.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Leader Nicotine Polacrilex may cause serious side effects. Stop using Leader Nicotine Polacrilex and call your doctor right away if you have:

• fast or pounding heartbeats, fluttering in your chest;
• blisters inside your mouth;
• problems with your teeth or jaw; or
• wheezing, tightness in your chest, trouble breathing.

Common side effects of Leader Nicotine Polacrilex may include:

• dizziness;
• dry mouth, upset stomach, burping, or hiccups;
• mouth or throat soreness;
• changes in taste; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Since Leader Nicotine Polacrilex is taken as needed, you are unlikely to miss a dose. Do not use more than 20 lozenges or 24 pieces of gum each day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. The amount of Leader Nicotine Polacrilex in a used or unused lozenge or piece of gum can be fatal to a child who accidentally sucks or chews on it. Seek emergency medical attention if this happens.

Overdose symptoms may include severe dizziness, nausea, vomiting, diarrhea, weakness, and fast heart rate.

Do not eat or drink anything within 15 minutes before using the gum or lozenge or while the medicine is in your mouth.

Ask a doctor or pharmacist before using Leader Nicotine Polacrilex gum or lozenges with any other medications, especially:

• an antidepressant;
• asthma medication; or
• any other smoking cessation medicine (bupropion, varenicline, Chantix, Zyban, Wellbutrin).

This list is not complete. Other drugs may affect Leader Nicotine Polacrilex, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.