Nicotine (By breathing)

Brand Name(s)

Nicotrol

When This Medicine Should Not Be Used

How to Use This Medicine

Device

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions about using the inhaler.
• The inhaler system comes with a plastic mouthpiece and cartridges (small tubes) of nicotine. These cartridges are inserted into the mouthpiece.
• With the cartridge inserted into the mouthpiece, inhale or puff through the mouthpiece. The nicotine will become a mist that is absorbed through your mouth and throat. There is enough nicotine in one cartridge to last for about 20 minutes of active puffing.
• When you first start using this medicine, use at least the smallest suggested number of cartridges of medicine each day. This is important to keep cravings and withdrawal symptoms under control.
• Do not use more than 16 cartridges in 24 hours. Do not use this medicine for longer than 6 months. Most people begin to slowly lower the dose over the last 12 weeks of treatment.

How to Store and Dispose of This Medicine

• When the cartridge is used up, take it out of the mouthpiece and throw the cartridge away. Always dispose of the cartridges where children and pets cannot reach them.
• Keep the mouthpiece to use later with another cartridge. Wash the mouthpiece regularly with soap and water. Store the mouthpiece in the plastic storage case that came with the medicine.
• Store the cartridges at room temperature in the plastic storage case, away from heat and direct light.
• 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®), or medicine for depression (such as amitriptyline). 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 Nicotrol®. This includes chewing tobacco, nicotine patch, or nicotine gum. Tell your doctor about all other methods you are using to help you quit smoking.

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, diarrhea, dizziness, weakness, sweating
• Seizures
• Severe headache, confusion, fainting, trouble seeing or hearing

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

• Tooth problems, change in your sense of taste
• Coughing, runny nose, sinus problems, hiccups
• Mild nausea, diarrhea

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

Introduction

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

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have heart problems, blood circulation problems, uncontrolled high blood pressure, stomach ulcer, kidney disease, liver disease, thyroid problems, pheochromocytoma (a tumor on the adrenal gland), diabetes, or breathing problems such as asthma.
• This medicine may bother your mouth or throat when you first start using it. Keep using the medicine on a regular basis. These problems should go away within the first week. If you continue to have problems, call your doctor.
• You will probably still want to smoke sometimes. Have a plan for coping with situations where you may be tempted to smoke. This medicine is only part of a complete program to quit smoking.