Nicotrol NS (nasal, inhalation)

Nicotine is the main ingredient in tobacco products.

Nicotine nasal spray and inhalation are medical products designed to assist you in quitting smoking and to lessen nicotine withdrawal symptoms as you stop smoking.

Nicotine nasal or inhalation may also be used for reasons not mentioned in this medication guide.

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.

You should not use this medicine if you are allergic to nicotine or menthol.

Tell your doctor if you have ever had:

• heart disease, irregular heartbeats;
• high blood pressure;
• chest pain, heart attack or stroke;
• blood circulation problems;
• a blood vessel disorder such as Buerger's disease, Prinzmetal angina, or Raynaud's syndrome;
• insulin-dependent diabetes;
• overactive thyroid;
• asthma or other breathing disorder;
• sinus problems, nasal polyps, allergies that affect your nose;
• liver or kidney disease;
• a stomach ulcer; or
• pheochromocytoma (tumor of the adrenal gland).

Nicotine can harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Smoking cigarettes during pregnancy can cause low birth weight, miscarriage, or stillbirth. Using a nicotine replacement product during pregnancy or while breast-feeding may be safer than smoking. However, you should try to stop smoking without using a nicotine replacement product if you are pregnant or breastfeeding. 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.

Do not give this medicine to a child or teenager without medical advice.

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

This medicine may cause serious side effects. Stop using this medicine and call your doctor right away if you have:

• bronchospasm (wheezing, tightness in your chest, trouble breathing);
• pounding heartbeats or fluttering in your chest;
• severe stinging, burning, or other irritation in your nose, mouth, or throat; or
• blistering, ulcerations, or bleeding in your nose.

Use nicotine nasal regularly during the first week to help you adjust to some of the common side effects, such as irritation in your nose or throat.

Common side effects of Nicotrol NS may include:

• burning or irritation in your nose, mouth, throat, or eyes;
• cough, sore throat, hoarse voice;
• numbness or tingling in your nose, mouth, or head;
• nosebleed;
• runny or stuffy nose, sneezing, watery eyes;
• changes in your sense of taste or smell;
• flushing in your face (sudden warmth, redness, or tingly feeling);
• chest tightness, shortness of breath;
• ear pain, pain in your neck or jaw;
• hiccups, upset stomach, nausea, diarrhea, gas;
• tooth problems; or
• withdrawal symptoms.

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.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed. Tell your doctor if you feel an increased urge to use more of this medicine.

Start using nicotine nasal or inhalation on the same day you stop (quit) smoking or using tobacco products.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Nicotine nasal is generally used for up to 8 weeks, and then gradually reduced over the following 4 to 6 weeks. Nicotine inhalation is generally used for up to 12 weeks, and then gradually reduced over the following 12 weeks. Follow your doctor's instructions for tapering your dose.

Call your doctor if you are unable to stop smoking after using nicotine nasal for 4 weeks, or after using nicotine inhalation for 6 weeks. This medicine may be habit-forming if you use it for too long. Do not use this medicine for longer than 6 months without the advice of your doctor.

Nicotine nasal spray may not work as well if you have a cold or allergy symptoms and a runny nose.

Store at room temperature away from moisture, heat, and light. Protect nicotine inhalation from cold temperatures. Keep the nasal spray bottle tightly closed when not in use. Store inhaler cartridges away from open flame or high heat, such as in a car on a hot day.

Keep this medicine out of the reach of children or pets. Follow all printed instructions about how to safely throw away an empty nasal spray bottle or inhaler cartridge.

As you quit smoking, you may have nicotine withdrawal symptoms, such as: dizziness, drowsiness, trouble concentrating, mood changes (feeling restless, anxious, or irritable), headache, muscle pain, trouble sleeping, increased appetite, constipation, or weight gain.

Since this medicine is used as needed, you may not have a set dosing schedule. If you miss a dose and it's almost time for your next dose, skip the missed dose. Do not use two doses at the same time.

Do not use the nasal spray more than 5 times in one hour or 40 times in a 24-hour period. Do not use more than 16 nicotine inhaler cartridges in one day.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. An overdose of nicotine can be fatal.

Overdose symptoms may include headache, dizziness, vomiting, diarrhea, stomach pain, confusion, problems with hearing or vision, weakness, tremors, rapid heartbeats, pale skin, cold sweat, fainting, seizure (convulsions), or slow breathing (breathing may stop).

The amount of nicotine in a used or unused bottle or cartridge can seriously harm a child who accidentally sucks or chews on it. Seek emergency medical help if this happens.

Avoid getting nicotine nasal in your mouth, eyes, ears, or on your skin or lips. If this occurs, rinse with water.

Ask a doctor before using any other nasal sprays, especially a decongestant spray that contains xylometazoline (such as Triaminic Decongestant).

When you start or stop using nicotine, your doctor may need to change the doses of any other medicines you take regularly.

Tell your doctor about all your other medicines, especially:

• acetaminophen;
• insulin;
• oxazepam;
• pentazocine;
• theophylline;
• an antidepressant such as amitriptyline, imipramine, or nortriptyline;
• cold or cough medicine that contains phenylephrine (a decongestant);
• heart or blood pressure medication;
• ergot medicine--dihydroergotamine, ergotamine, ergonovine, methylergonovine; or
• other smoking cessation medicine--bupropion, varenicline, Chantix, Zyban, Wellbutrin.

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