IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. NICOTINE GUM - BUCCAL (NIK-oh-teen) COMMON BRAND NAME(S): Nicorette USES: This medication can help you quit smoking by replacing the nicotine in cigarettes. The nicotine in tobacco is an important part of cigarette addiction. When you stop smoking, your nicotine levels drop quickly. This drop can cause withdrawal symptoms such as craving tobacco, nervousness, irritability, headache, weight gain, and difficulty concentrating. Stopping smoking is hard and your chance of success is best when you are ready and have made a commitment to quit. Nicotine replacement products are part of a total stop-smoking program that includes behavior change, counseling, and support. Smoking causes lung disease, cancer, and heart disease. Stopping smoking is one of the most important things you can do to improve your health and live longer. HOW TO USE: If you are using the over-the-counter product, read all directions on the product package before using this medication. If your doctor has prescribed this medication, read the Patient Information Leaflet if provided by your pharmacist before you start using this product and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Do not eat or drink anything for 15 minutes before or during use of the gum. Do not use if the individual wrapper is open or damaged. Start this medication on your quit (smoking) day. Chew a piece of gum when you feel the urge to smoke. Chew the gum very slowly until it tingles, then move it to the space between your cheek and gum. Keep it there until it stops tingling. When the tingle is gone, begin chewing again until the tingle returns. Most of the nicotine will be gone after 30 minutes. Do not use more than 1 piece of gum at a time. You may also use this product on a regular schedule as well as at times when you have the urge to smoke. The best dose for you is the dose that decreases the urge to smoke without side effects from too much nicotine. Your dose will need to be adjusted to your needs, including your smoking history and medical condition. For the first 6 weeks, use at least 9 pieces each day. If you still have a strong urge to smoke, you can use a second piece of gum within 1 hour. Do not continuously use 1 piece right after another. Doing so will increase side effects such as hiccups, nausea, or heartburn. Most people use about 9 to 12 pieces of gum per day during the first month of treatment. Do not chew more than 24 pieces of gum a day. After you have stopped smoking and you have reached the best dose and schedule for you, continue at that dose. Start to lower your dose after 6 weeks or as directed by your doctor until you are no longer smoking and no longer need nicotine replacement. It is important to complete the treatment with this medication (12 weeks). If after the treatment period, you still feel the need to use this medication to prevent you from smoking, talk to your doctor. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as tobacco cravings, nervousness, irritability, headache) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately. Some smokers are unsuccessful the first time they try to quit. You may need to stop using this product and try again later. Many people who cannot quit the first time are successful the next time. SIDE EFFECTS: Mouth/teeth/jaw problems, headache, heartburn, sweating, or diarrhea may occur. If any of these side effects persist or worsen, stop using this medication and tell your doctor or pharmacist promptly. Common nicotine withdrawal symptoms can occur when you stop smoking and include dizziness, anxiety, depression, or trouble sleeping, among others. Chewing the gum too fast can cause lightheadedness, dizziness, hiccups, nausea, vomiting, or trouble sleeping. If these effects occur, chew the gum more slowly. If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Serious side effects are more likely if you continue to smoke while using this product. Stop using this medication and tell your doctor right away if you have any serious side effects, including: severe dizziness, mental/mood changes (e.g., irritability, trouble sleeping, vivid dreams), numbness/tingling in hands/feet, swelling hands/ankles/feet. Stop using this medication and get medical help right away if you have any very serious side effects, including: chest pain, confusion, severe headache, fast/irregular/pounding heartbeat, slurred speech, weakness on one side of the body. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to nicotine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel disease (e.g., Raynaud's disease, stroke), dental/jaw problems (e.g., bridges, temporal mandibular joint disease-TMJ), diabetes, heart disease (e.g., chest pain, heart attack, irregular heartbeat), high blood pressure, liver disease, severe kidney disease, stomach/intestinal sores (peptic ulcers), certain adrenal problem (pheochromocytoma), overactive thyroid (hyperthyroidism). Nicotine and smoking may harm an unborn baby. If you are pregnant, try to stop smoking without using a nicotine replacement product if possible. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Nicotine from smoking and from this medication passes into breast milk and could have undesirable effects on a nursing infant. Smoking near an infant can also harm the infant. Consult your doctor before breast-feeding. DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: medications for high blood pressure (e.g., beta blockers such as labetalol, prazosin), bronchodilators/decongestants (e.g., isoproterenol, phenylephrine). Stopping smoking can change the way the liver removes certain drugs from the body (e.g., acetaminophen, caffeine, insulin, oxazepam, pentazocine, propoxyphene, propranolol, theophylline, tricyclic antidepressants such as amitriptyline/imipramine, "water pills"/diuretics such as furosemide). Tell all your doctors and pharmacists that you are quitting smoking. OVERDOSE: This product may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: confusion, drooling, seizure, slow/shallow breathing, hearing problems. NOTES: Do not share this medication with others. MISSED DOSE: If you are using this on a regular schedule and you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Wrap the used piece of gum in a piece of paper and discard in the trash away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. Information last revised February 2014. Copyright(c) 2014 First Databank, Inc.