Nicotine polacrilex (By mouth)

Introduction

Nicotine Polacrilex (NIK-oh-teen pol-a-KRIL-ex)

Helps you quite smoking. Provides your body with nicotine to replace cigarettes.

Brand Name(s)

Leader Nicotine Polacrilex, Commit, Sunmark Nicotine Lozenge, Rite Aid Nicotine Polacrilex, Nicorelief, Good Sense Nicotine Polacrilex, TopCare Nicotine Polacrilex

When This Medicine Should Not Be Used

How to Use This Medicine

Lozenge

• Your doctor will tell you how much of this medicine to take and how often. Do not take more medicine or take it more often than your doctor tells you to. If you are using this lozenge without a prescription, follow the instructions on the medicine label.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
• Be sure to choose the right kind of lozenges. One kind is for people who smoke their first cigarette less than 30 minutes after they wake up. The other kind is for people who smoke their first cigarette more than 30 minutes after they wake up. Do not change from one kind to the other during treatment.
• Wait at least 15 minutes after you eat or drink before you use a lozenge. Do not eat or drink anything while you have a lozenge in your mouth.
• Do not bite, chew, or swallow the lozenge. It is best to suck on the lozenge and let it melt slowly in your mouth.
• You may feel tingling or a warm feeling in your mouth. This means the nicotine is being released.
• Move the lozenge around sometimes while it is in your mouth. Most people will hold the lozenge inside one cheek, then move it to the other cheek occasionally.
• The lozenge should melt completely in about 20 to 30 minutes.
• When you first start using the Commit? program, use at least the smallest suggested number of lozenges each day. This is important to keep cravings and withdrawal symptoms under control.
• Keep using this medicine for the full treatment time. Do not use more than 20 lozenges in one day. Do not use two lozenges at one time or use one right after another.

How to Store and Dispose of This Medicine

• Store the lozenges at room temperature, away from heat and direct light. If you must throw away a lozenge without using all of it, wrap the used lozenge in paper and throw it away so that children or pets cannot get to it.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using insulin, asthma medicine (such as theophylline, albuterol, Serevent®), medicine for depression (such as amitriptyline), or any other kind of stop-smoking medicine. Tell your doctor about all other medicines you use regularly. Your doses may need to be changed when you quit smoking.
• Do not smoke cigarettes or use any other kind of nicotine at all during the time you are using Commit?. This includes chewing tobacco, nicotine gum, or nicotine patches.

Warnings While Using This Medicine

• If you are pregnant or breastfeeding, you should only use this medicine if your doctor tells you to. Smoking can seriously harm your child. Try to stop smoking without using medicine. This medicine is believed to be safer than smoking. However, the risks to your child from the medicine are not fully known.
• Make sure your doctor knows if you have heart problems or uncontrolled high blood pressure.
• You will probably still want to smoke sometimes. Have a plan for coping with situations where you may be tempted. These lozenges are only part of a complete program to quit smoking.
• Stop using Commit? at the end of week 12. If you still feel the need to smoke after you have finished the Commit? program, talk to your doctor.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fast, slow, pounding, or irregular heartbeat
• Nausea, vomiting, dizziness, weakness, sweating
• Pain, sore, or other problems in your mouth

If you notice these less serious side effects, talk with your doctor:

• Headache
• Mild nausea, heartburn, hiccups
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088