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|Nicotine Spray

Nicotine Spray

Nicotine Spray is used for:

Helping you to quit smoking.

Nicotine Spray is a smoking deterrent. It works by providing low levels of nicotine, which may help you to quit smoking by lessening physical signs of withdrawal symptoms.

Do NOT use Nicotine Spray if:

• you are allergic to any ingredient in Nicotine Spray
• you have had a recent heart attack
• you have severe chest pain or a severely irregular heartbeat
• you continue to smoke, chew tobacco, use snuff, or any other nicotine containing products

Contact your doctor or health care provider right away if any of these apply to you.

Before using Nicotine Spray:

Some medical conditions may interact with Nicotine Spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have chest pain, an irregular heartbeat, a history of heart attack, high blood pressure, breathing problems (eg, asthma), an overactive thyroid, an ulcer, a tumor on your adrenal gland, diabetes, kidney or liver problems, or blood vessel problems

Some MEDICINES MAY INTERACT with Nicotine Spray. Tell your health care provider if you are taking any other medicines.

• Asthma medicines (eg, theophylline) or tricyclic antidepressants (eg, amitriptyline) because the side effects of Nicotine Spray may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nicotine Spray may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nicotine Spray:

Use Nicotine Spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Nicotine Spray comes with an additional patient leaflet. Read it carefully and reread it each time you get Nicotine Spray refilled.
• Tilt your head back slightly while using Nicotine Spray.
• Spray Nicotine Spray in your nose whenever you feel the urge to smoke.
• Do not sniff, swallow, or inhale through the nose while the spray is being used
• Do not use more than 1 spray in each nostril for a dose without checking with your doctor.
• Do not exceed 5 doses per hour or 40 doses per day.
• If you miss a dose of this medicine, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Nicotine Spray.

Important safety information:

• Nicotine Spray may cause dizziness, lightheadedness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Nicotine Spray. Using Nicotine Spray alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Nicotine Spray.
• Be careful while opening and closing the container of medicine. The container may break if it is dropped. If this happens, clean the spill up immediately with an absorbent cloth or paper towel. Avoid contact with the skin. Pick up broken glass carefully, using a broom. Wash the area several times. The absorbent material may be thrown away as household waste. If even a small amount of Nicotine Spray contacts your skin, lips, eyes, ears, or the affected area, immediately rinse the area with water only.
• Do not smoke or use tobacco products while using Nicotine Spray.
• Nicotine Spray should be used as part of a larger program to help you stop smoking. If you need help choosing a program, talk with your health care provider.
• Diabetes patients - Nicotine Spray may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• Use Nicotine Spray with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Nicotine Spray may cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Nicotine Spray during pregnancy. Nicotine Spray is excreted in breast milk. If you are or will be breast-feeding while you are using Nicotine Spray, check with your doctor or pharmacist to discuss the risks to your baby.

When used for long periods of time or at high doses, some people develop a need to continue taking Nicotine Spray. This is known as DEPENDENCE or addiction.

Do not suddenly stop taking Nicotine Spray without your doctor"s approval. Stopping Nicotine Spray suddenly may cause serious WITHDRAWAL symptoms including: anxiety, craving, impaired concentration, increased appetite, irritability, nervousness, sleep disturbances, and weight gain.

Possible side effects of Nicotine Spray:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; back pain; burning or irritation of the mouth, nose, or eyes; changes in taste and smell; constipation; cough; earache; flushing of the face; gas; headache; hoarseness; indigestion; irritability; joint pain; mouth sores; nasal ulcers or blisters; nausea; nose bleed; numbness of the mouth; painful menstruation; runny nose; sinus irritation; sneezing; sore throat; stuffy nose; tingling; tooth disorder; watery eyes.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat; lightheadedness; memory loss; severe dizziness or headache; shortness of breath; tightness in the chest; tremor.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include blurred vision; confusion; diarrhea; difficulty breathing; dizziness; excessive saliva; fainting; headache; hearing problems; nausea; rapid, weak, or irregular heartbeat; seizures; stomach pain; sweating; vomiting; weakness.

Store Nicotine Spray at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nicotine Spray out of the reach of children and away from pets.

General information:

• If you have any questions about this medicine, please talk with your doctor, pharmacist, or other health care provider.
• Nicotine Spray is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Nicotine Spray. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.