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Nicorette Gum (Glaxosmithkline Consumer)



  • Description
  • Indications and Usage
  • Warnings
  • Dosage and Administration
  • How Supplied
  • Patient Package Insert



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  • IF YOU SMOKE LESS THAN 25 CIGARETTES A DAY: Use 2 mg

    IF YOU SMOKE 25 OR MORE CIGARETTES A DAY: Use 4 mg

    Active Ingredient:    Nicotine Polacrilex

    Purpose:    Stop Smoking Aid

    USE

    • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

    WARNINGS

    If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

    DO NOT USE

    • if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products
      ASK YOUR DOCTOR BEFORE USE IF YOU HAVE
    • heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
    • high blood pressure not controlled with medication. Nicotine can increase blood pressure.
    • stomach ulcer or diabetes
      ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    • using a non-nicotine stop smoking drug
    • taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.
      STOP USE AND ASK A DOCTOR IF
    • mouth, teeth or jaw problems occur
    • irregular heartbeat or palpitations occur
    • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat.

    Keep out of reach of children and pets. Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

    DIRECTIONS

    • if you are under 18 years of age, ask doctor before use
    • before using this product, read the enclosed User's Guide for complete directions and other important information
    • stop smoking completely when you begin using the gum
    • if you smoke 25 or more cigarettes a day; use 4 mg nicotine gum
    • if you smoke less than 25 cigarettes a day; use 2 mg nicotine gum

    Use according to the following 12 week schedule:

    Weeks
    1 to 6
    Weeks
    7 to 9
    Weeks
    10 to 12
    1 piece
    every 1
    to 2 hours
    1 piece
    every 2
    to 4 hours
    1 piece
    every 4
    to 8 hours

    • nicotine gum is a medicine and must be used a certain way to get the best results
    • chew the gum slowly until it tingles. Then park it between your cheek & gum. When the tingle is gone, begin chewing again, until the tingle returns.
    • repeat this process until most of the tingle is gone (about 30 minutes)
    • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
    • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
    • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
    • do not use more than 24 pieces a day
    • stop using the nicotine gum at the end of week 12. If you still feel the need for nicotine gum, talk to your doctor.

    OTHER INFORMATION

    • store at 20-25°C (68-77°F)
    • protect from light

    INACTIVE INGREDIENTS

    Original [2 mg] Inactive Ingredients:    flavors, glycerin, gum base, sodium carbonate, sorbitol, sodium bicarbonate

    Original [4 mg] Inactive Ingredients:    flavors, glycerin, gum base, sodium carbonate, sorbitol, D&C yellow #10

    Mint 2 mg Inactive Ingredients:    gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, xylitol

    Mint 4 mg Inactive Ingredients:    gum base, magnesium oxide, menthol, peppermint oil, sodium carbonate, xylitol, D&C yellow #10. Al. Lake

    Orange (2 mg) Inactive Ingredients:    flavor, gum base, magnesium oxide, sodium bicarbonate, sodium carbonate, xylitol

    Orange (4 mg) Inactive Ingredients:    flavor, gum base, magnesium oxide, sodium carbonate, xylitol, D&C yellow #10. Al. Lake

    TO INCREASE YOUR SUCCESS IN QUITTING:

    1. You must be motivated to quit.
    2. Use Enough --Chew at least 9 pieces of Nicorette per day during the first six weeks.
    3. Use long enough --Use Nicorette for the full 12 weeks.
    4. Use with a support program as directed in the enclosed User's Guide. *

    *The American Cancer Society supports the use of a stop smoking aid and counseling as effective tools when quitting smoking but does not endorse any specific product. Glaxosmithkline pays a fee to the American Cancer Society for the use of its logo.

    Blister packaged for your protection. Do not use if individual seals are open or torn.

    • not for sale to those under 18 years of age
    • proof of age required
    • not for sale in vending machines or from any source where proof of age cannot be verified

    HOW SUPPLIED

    Nicorette Original and Mint are available in:

    2 mg or 4 mg Starter kit*--110 pieces

    2 mg or 4 mg Refill--48 pieces, 168 pieces or 192 pieces

    Nicorette Orange is available in:

    2 mg or 4 mg Starter kit*--110 pieces

    2 mg or 4 mg Refill--48 pieces

    *User's Guide and CD included in kit

    Questions or Comments? Call 1-800-419-4766 weekdays.

    (10 a.m.-4:30 p.m. EST).

    Manufactured by Pharmacia AB, Stockholm, Sweden for Glaxosmithkline Consumer Healthcare, L.P. Moon Township, PA 15108

    USER'S GUIDE

    HOW TO USE NICORETTE TO HELP YOU QUIT SMOKING.

    KEYS TO SUCCESS:

    1. You must really want to quit smoking for Nicorette® to help you.
    2. You can greatly increase your chances for success by using at least 9 to 12 pieces every day when you start using Nicorette . See page 11 of User's Guide.
    3. You should continue to use Nicorette as explained in the User's Guide for 12 full weeks.
    4. Nicorette works best when used together with a support program--See page 3 of User's Guide for details.
    5. If you have trouble using Nicorette , ask your doctor or pharmacist or call Glaxosmithkline at 1-800-419-4766 weekdays (10:00am-4:30pm EST).

    SO YOU DECIDED TO QUIT

    Congratulations. Your decision to stop smoking is an important one. That's why you've made the right choice in choosing Nicorette gum. Your own chances of quitting smoking depend on how much you want to quit, how strongly you are addicted to tobacco, and how closely you follow a quitting program like the one that comes with Nicorette .

    QUITTING SMOKING IS HARD!

    If you've tried to quit before and haven't succeeded, don't be discouraged! Quitting isn't easy. It takes time, and most people try a few times before they are successful. The important thing is to try again until you succeed. This User's Guide will give you support as you become a non-smoker. It will answer common questions about Nicorette and give tips to help you stop smoking, and should be referred to often.

    WHERE TO GET HELP

    You are more likely to stop smoking by using Nicorette with a support program that helps you break your smoking habit. There may be support groups in your area for people trying to quit. Call your local chapter of the American Lung Association (1-800-586-4872), American Cancer Society (1-800-227-2345) or American Heart Association (1-800-242-8721) for further information. If you find you cannot stop smoking or if you start smoking again after using Nicorette , remember breaking this addiction doesn't happen overnight. You may want to talk to a health care professional who can help you improve your chances of quitting the next time you try Nicorette or another method.

    LET'S GET ORGANIZED

    Your reason for quitting may be a combination of concerns about health, the effect of smoking on your appearance, and pressure from your family and friends to stop smoking. Or maybe you're concerned about the dangerous effect of second-hand smoke on the people you care about. All of these are good reasons. You probably have others. Decide your most important reasons, and write them down on the wallet card inside the back cover of the User's Guide. Carry this card with you. In difficult moments, when you want to smoke, the card will remind you why you are quitting.

    WHAT YOU'RE UP AGAINST

    Smoking is addictive in two ways. Your need for nicotine has become both physical and mental. You must overcome both addictions to stop smoking. So while Nicorette will lessen your body's physical addition to nicotine, you've got to want to quit smoking to overcome the mental dependence on cigarettes. Once you've decided that you're going to quit, it's time to get started. But first, there are some important warnings you should consider.

    SOME IMPORTANT WARNINGS.

    This product is only for those who want to stop smoking. If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

    Do not use

    • if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products

    Ask a doctor before use if you have

    • heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
    • high blood pressure not controlled with medication. Nicotine can increase your blood pressure.
    • stomach ulcer or diabetes

    Ask a doctor or pharmacist before use if you are

    • using a non-nicotine stop smoking drug
    • taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

    Stop use and ask a doctor if

    • mouth, teeth or jaw problems occur
    • irregular heartbeat or palpitations occur
    • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat

    Keep out of reach of children and pets. Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in trash. In case of overdose, get medical help or contact a Poison Control Center right away.

    LET'S GET STARTED

    Becoming a non-smoker starts today. First, check that you bought the right starting dose. If you smoke 25 or more cigarettes a day, use 4 mg nicotine gum. If you smoke less than 25 cigarettes a day, use 2 mg nicotine gum. Next, read through the entire User's Guide carefully. Then, set your personalized quitting schedule. Take out a calendar that you can use to track your progress, and identify four dates, using the stickers in the User's Guide.

    STEP 1 (Weeks 1-6): Your quit date (and the day you'll start using Nicorette gum). Choose your quit date (it should be soon). This is the day you will quit smoking cigarettes entirely and begin using Nicorette to satisfy your cravings for nicotine. For the first six weeks, you'll use a piece of Nicorette every hour or two. Be sure to follow the directions on pages 9 and 11 of the User's Guide. Place the Step 1 sticker on this date.

    STEP 2 (Weeks 7-9): The day you'll start reducing your use of Nicorette. After six weeks, you'll begin gradually reducing your Nicorette usage to one piece every two to four hours. Place the Step 2 sticker on this date (the first day of week seven).

    STEP 3 (Weeks 10-12): The day you'll further reduce your use of Nicorette. Nine weeks after you begin using Nicorette , you will further reduce your nicotine intake by using one piece every four to eight hours. Place the Step 3 sticker on this date (the first day of week ten). For the next three weeks, you'll use a piece of Nicorette every four to eight hours.

    End of treatment: The day you'll complete Nicorette therapy. Nicorette should not be used for longer than twelve weeks. Identify the date thirteen weeks after the date you chose in Step 1 and place the "EX-Smoker" sticker on your calendar.

    PLAN AHEAD

    Because smoking is an addiction, it is not easy to stop. After you've given up cigarettes, you will still have a strong urge to smoke. Plan ahead NOW for these times, so you're not defeated in a moment of weakness. The following tips may help:

    • Keep the phone numbers of supportive friends and family members handy.
    • Keep a record of your quitting process. Track the number of Nicorette pieces you use each day, and whether you feel a craving for cigarettes. In the event that you slip, immediately stop smoking and resume your quit attempt with the Nicorette program.
    • Put together an Emergency Kit that includes items that will help take your mind off occasional urges to smoke. Include cinnamon gum or lemon drops to suck on, a relaxing cassette tape and something for your hands to play with, like a smooth rock, rubber band or small metal balls.
    • Set aside some small rewards, like a new magazine or a gift certificate from your favorite store, which you'll 'give' yourself after passing difficult hurdles.
    • Think now about the times when you most often want a cigarette, and then plan what else you might do instead of smoking. For instance, you might plan to take your coffee break in a new location, or take a walk right after dinner, so you won't be tempted to smoke.

    HOW NICORETTE GUM WORKS

    Nicorette's sugar-free chewing pieces provide nicotine to your system--they work as a temporary aid to help you quit smoking by reducing nicotine withdrawal symptoms. Nicorette provides a lower level of nicotine to your blood than cigarettes, and allows you to gradually do away with your body's need for nicotine. Because Nicorette does not contain the tar or carbon monoxide of cigarette smoke, it does not have the same health dangers as tobacco. However, it still delivers nicotine, the addictive part of cigarette smoke. Nicotine can cause side effects such as headache, nausea, upset stomach and dizziness.

    HOW TO USE NICORETTE GUM

    If you are under 18 years of age, ask a doctor before use.

    Before you can use Nicorette correctly, you have to practice! That sounds silly, but it isn't.

    Nicorette isn't like ordinary chewing gum. It's a medicine, and must be chewed a certain way to work right. Chewed like ordinary gum, Nicorette won't work well and can cause side effects. An overdose can occur if you chew more than one piece of Nicorette at the same time, or if you chew many pieces one after another. Read all the following instructions before using Nicorette . Refer to them often to make sure you're using Nicorette gum correctly. If you chew too fast, or do not chew correctly, you may get hiccups, heartburn, or other stomach problems. Don't eat or drink for 15 minutes before using Nicorette or while chewing a piece. The effectiveness of Nicorette may be reduced by some foods and drinks, such as coffee, juices, wine or soft drinks.

    1. Stop smoking completely before you start using Nicorette .
    2. To reduce craving and other withdrawal symptoms, use Nicorette according to the dosage schedule on page 11 of the User's Guide.
    3. Chew each Nicorette piece very slowly several times.
    4. Stop chewing when you notice a peppery taste, or a slight tingling in your mouth. (This usually happens after about 15 chews, but may vary from person to person.)
    5. "PARK" the Nicorette piece between your cheek and gum and leave it there.
    6. When the peppery taste or tingle is almost gone (in about a minute), start to chew a few times slowly again. When the taste or tingle returns, stop again.
    7. Park the Nicorette piece again (in a different place in your mouth).
    8. Repeat steps 3 to 7 (chew, chew, park) until most of the nicotine is gone from the Nicorette piece (usually happens in about half an hour; the peppery taste or tingle won't return).
    9. Wrap the used Nicorette piece in paper and throw away in the trash.

    See the chart in the "DIRECTIONS" section above for the recommended usage schedule for Nicorette .

    To improve your chances of quitting, use at least 9 pieces of Nicorette a day. If you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another, since this may cause you hiccups, heartburn, nausea, or other side effects.

    HOW TO REDUCE YOUR NICORETTE USAGE

    The goal of using Nicorette is to slowly reduce your dependence on nicotine. The schedule for using Nicorette will help you reduce your nicotine craving gradually. Here are some tips to help you cut back during each step:

    • After a while, start chewing each Nicorette piece for only 10 to 15 minutes, instead of half an hour. Then, gradually begin to reduce the number of pieces used.
    • Or, try chewing each piece for longer than half an hour, but reduce the number of pieces you use each day.
    • Substitute ordinary chewing gum for some of the Nicorette pieces you would normally use. Increase the number of pieces of ordinary gum as you cut back on the Nicorette pieces.

    STOP USING NICORETTE AT THE END OF WEEK 12. If you still feel the need to use Nicorette after Week 12, talk with your doctor.

    TIPS TO MAKE QUITTING EASIER

    Within the first few weeks of giving up smoking, you may be tempted to smoke for pleasure, particularly after completing a difficult task, or at a party or bar. Here are some tips to help get you through the important first stages of becoming a non-smoker:

    On your Quit Date:

    • Ask your family, friends, and co-workers to support you in your efforts to stop smoking.
    • Throw away all your cigarettes, matches, lighters, ashtrays, etc.
    • Keep busy on your quit day. Exercise. Go to a movie. Take a walk. Get together with friends.
    • Figure out how much money you'll save by not smoking. Most ex-smokers can save more than $1,000 a year.
    • Write down what you will do with the money you save.
    • Know your high risk situations and plan ahead how you will deal with them.
    • Keep Nicorette gum near your bed, so you'll be prepared for any nicotine cravings when you wake up in the morning.
    • Visit your dentist and have your teeth cleaned to get rid of the tobacco stains.
      Right after Quitting:
    • During the first few days after you've stopped smoking, spend as much time as possible at places where smoking is not allowed.
    • Drink large quantities of water and fruit juices.
    • Try to avoid alcohol, coffee and other beverages you associate with smoking.
    • Remember that temporary urges to smoke will pass, even if you don't smoke a cigarette.
    • Keep your hands busy with something like a pencil or a paper clip.
    • Find other activities which help you relax without cigarettes.
    • Swim, jog, take a walk, play basketball.
    • Don't worry too much about gaining weight. Watch what you eat, take time for daily exercise, and change your eating habits if you need to.
    • Laughter helps. Watch or read something funny.

    WHAT TO EXPECT

    Your body is now coming back into balance. During the first few days after you stop smoking, you might feel edgy and nervous and have trouble concentrating. You might get headaches, feel dizzy and a little out of sorts, feel sweaty or have stomach upsets. You might even have trouble sleeping at first. These are typical withdrawal symptoms that will go away with time. Your smoker's cough will get worse before it gets better. But don't worry, that's a good sign. Coughing helps clear the tar deposits out of your lungs.

    After a Week or Two.

    By now you should be feeling more confident that you can handle those smoking urges. Many of your withdrawal symptoms have left by now, and you should be noticing some positive signs: less coughing, better breathing and an improved sense of taste and smell, to name a few.

    After a Month.

    You probably have the urge to smoke much less often now. But urges may still occur, and when they do, they are likely to be powerful ones that come out of nowhere. Don't let them catch you off guard. Plan ahead for these difficult times. Concentrate on the ways non-smokers are more attractive than smokers. Their skin is less likely to wrinkle. Their teeth are whiter, cleaner. Their breath is fresher. Their hair and clothes smell better. That cough that seems to make even a laugh sound more like a rattle is a thing of the past. Their children and others around them are healthier, too.

    What To Do About Relapse.

    What should you do if you slip and start smoking again? The answer is simple. A lapse of one or two or even a few cigarettes has not spoiled your efforts! Discard your cigarettes, forgive yourself and try again. If you start smoking again, keep your box of Nicorette for your next quit attempt. If you have taken up regular smoking again, don't be discouraged. Research shows that the best thing you can do is to try again. The important thing is to learn from your last attempt.

    • Admit that you've slipped, but don't treat yourself as a failure.
    • Try to identify the `trigger' that caused you to slip, and prepare a better plan for dealing with this problem next time.
    • Talk positively to yourself--tell yourself that you have learned something from this experience.
    • Make sure you used Nicorette gum correctly over the full 12 weeks to reduce your craving for nicotine.
    • Remember that it takes practice to do anything, and quitting smoking is no exception.

    WHEN THE STRUGGLE IS OVER

    Once you've stopped smoking, take a second and pat yourself on the back. Now do it again. You deserve it. Remember now why you decided to stop smoking in the first place. Look at your list of reasons. Read them again. And smile. Now think about all the money you are saving and what you'll do with it. All the non-smoking places you can go, and what you might do there. All those years you may have added to your life, and what you'll do with them. Remember that temptation may not be gone forever. However, the hard part is behind you, so look forward with a positive attitude, and enjoy your new life as a non-smoker.

    QUESTIONS & ANSWERS

    1. How will I feel when I stop smoking and start using Nicorette? You'll need to prepare yourself for some nicotine withdrawal symptoms. These begin almost immediately after you stop smoking, and are usually at their worst during the first three to four days. Understand that any of the following is possible:
      • craving for cigarettes
      • anxiety, irritability, restlessness, mood changes, nervousness
      • drowsiness
      • trouble concentrating
      • increased appetite and weight gain
      • headaches, muscular pain, constipation, fatigue.
        Nicorette can help provide relief from withdrawal symptoms such as irritability and nervousness, as well as the craving for nicotine you used to satisfy by having a cigarette.
    2. Is Nicorette just substuting one form of nicotine for another? Nicorette does contain nicotine. The purpose of Nicorette is to provide you with enough nicotine to help control the physical withdrawal symptoms so you can deal with the mental aspects of quitting. During the 12 week program, you will gradually reduce your nicotine intake by switching to fewer pieces each day. Remember, don't use Nicorette together with nicotine patches or other nicotine containing products.
    3. Can I be hurt by using Nicorette? For most adults, the amount of nicotine in the gum is less than from smoking. Some people will be sensitive to even this amount of nicotine and should not use this product without advice from their doctor. (See page 4 of User's Guide). Because Nicorette is a gum-based product, chewing it can cause dental fillings to loosen and aggravate other mouth, tooth and jaw problems. Nicorette can also cause hiccups, heartburn and other stomach problems especially if chewed too quickly or not chewed correctly.
    4. Will I gain weight? Many people do tend to gain a few pounds in the first 8-10 weeks after they stop smoking. This is a very small price to pay for the enormous gains that you will make in your overall health and attractiveness. If you continue to gain weight after the first two months, try to analyze what you're doing differently. Reduce your fat intake, choose healthy snacks, and increase your physical activity to burn off the extra calories.
    5. Is Nicorette more expensive than smoking? The total cost of Nicorette for the twelve week program is about equal to what a person who smokes one and a half packs of cigarettes a day would spend on cigarettes for the same period of time. Also, use of Nicorette is only a short-term cost, while the cost of smoking is a long-term cost, because of the health problems smoking causes.
    6. What if I slip up? Discard your cigarettes, forgive yourself and then get back on track. Don't consider yourself a failure or punish yourself. In fact, people who have already tried to quit are more likely to be successful the next time. GOOD LUCK!
      [End User's Guide]
      Copyright © 2001 Glaxosmithkline Consumer Healthcare, L.P.








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