zonnic nicotine polacrilex

Niconovum USA Inc.

Niconovum USA Inc. Nicotine Polacrilex Gum, 4mg (Nicotine) Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each chewing piece)
• Purpose
• zonnic nicotine polacrilex Uses
• Warnings
  • If you are pregnant or breast-feeding,
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • Stop use and ask a doctor if
  • Keep out of reach of children and pets.
• Directions
• zonnic nicotine polacrilex Other information
• Inactive ingredients
• Questions or comments?
• Consumer Information
• Principal Display Panel
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each chewing piece)

Nicotine polacrilex (equal to 4 mg nicotine)

Purpose

Stop smoking aid

zonnic nicotine polacrilex Uses

• •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 a doctor before use if you have

• •a sodium-restricted diet
• •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. (1-800-222-1222)

Directions

• •if you are under 18 years of age, ask a 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 your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg
• •if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg according to the following 12 week schedule:

• •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 and 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
• •it is important to complete treatment. Stop using the nicotine gum at the end of 12 weeks. If you still feel the need to use nicotine gum, talk to your doctor.

Other information

• •each piece contains: calcium 100 mg and sodium 11 mg
• •store at 20-25°C (68-77°F)
• •protect from light

Inactive ingredients

acesulfame potassium, calcium carbonate, carnauba wax, D&C yellow no. 10, flavors, gelatin, gum base, mannitol, sodium bicarbonate, sodium carbonate, sorbitol, talc, titanium dioxide, xylitol

Questions or comments?

call 1-866-677-7858

Consumer Information

:45600 XS J1

KEYS TO SUCCESS.

• 1.You must really want to quit smoking for Zonnic Gum 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 Zonnic Gum. See chart on back side of leaflet.

• 3.You should continue to use Zonnic Gum as explained in this User’s Guide for 12 full weeks.

• 4.Zonnic Gum works best when used together with a support program - See information for instructions on enrollment in the SmokeFreeHabits.com Free & Personalized Support Plan.
• 5.If you have trouble using Zonnic Gum, ask your doctor, pharmacist or health care professional.

• 6.To request a free audio CD containing tips to help make quitting easier, call 1-866-677-7858 (ONE CD PER CUSTOMER).

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 Zonnic 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 Zonnic Gum.

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 nonsmoker. It will answer common questions about Zonnic Gum 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 Zonnic Gum 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, American Cancer Society or American Heart Association for further information. Toll free phone numbers are printed on the Wallet Card on the bottom of this User’s Guide.

If you find you cannot stop smoking or if you start smoking again after using Zonnic Gum, 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 Zonnic Gum 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 secondhand 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 on the back of this 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 Zonnic Gum will lessen your body's physical addiction 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

• •a sodium-restricted diet
• •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 the trash. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

LET'S GET STARTED.

Becoming a nonsmoker starts today. First, check that you bought the right starting dose. If you smoke your first cigarette within 30 minutes of waking up, use Zonnic Gum, 4 mg. If you smoke your first cigarette more than 30 minutes after waking up, use Zonnic Gum, 2 mg. 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 reminders on the back of this leaflet:

STEP 1. (Weeks 1-6).

Your quit date (and the day you'll start using Zonnic Gum).

Choose your quit date (it should be soon). This is the day you will quit smoking cigarettes entirely and begin using Zonnic Gum to satisfy your cravings for nicotine. For the first six weeks, you’ll use a piece of Zonnic Gum every hour or two. Be sure to read the HOW TO USE ZONNIC GUM section. Place the Step 1 reminder on this date.

STEP 2. (Weeks 7-9).

The day you’ll start reducing your use of Zonnic Gum.

After six weeks, you’ll begin gradually reducing your Zonnic Gum usage to one piece every two to four hours. Place the Step 2 reminder on this date (the first day of week seven).

STEP 3. (Weeks 10-12).

The day you’ll further reduce your use of Zonnic Gum.

Nine weeks after you begin using Zonnic Gum, you will further reduce your nicotine intake by using one piece every four to eight hours. Place the Step 3 reminder on this date (the first day of week ten). For the next three weeks, you’ll use a piece of Zonnic Gum every four to eight hours.

End of treatment:

The day you’ll complete Zonnic Gum therapy.

Zonnic Gum 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" reminder 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 Zonnic Gum 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 Zonnic Gum 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 CD, 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 ZONNIC GUM WORKS.

Zonnic Gum’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. Zonnic Gum 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 Zonnic Gum 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 ZONNIC GUM.

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

Before you can use Zonnic Gum correctly, you have to practice! That sounds silly, but it isn’t. Zonnic Gum isn’t like ordinary chewing gum. It’s a medicine, and must be chewed a certain way to work right. Chewed like ordinary gum, Zonnic Gum won’t work well and can cause side effects. An overdose can occur if you chew more than one piece of Zonnic Gum at the same time, or if you chew many pieces one after another. Read all the following instructions before using Zonnic Gum. Refer to them often to make sure you’re using Zonnic 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 Zonnic Gum, or while chewing a piece. The effectiveness of Zonnic Gum may be reduced by some foods and drinks, such as coffee, juices, wine or soft drinks.

• 1.Stop smoking completely before you start using Zonnic Gum.
• 2.To reduce craving and other withdrawal symptoms, use Zonnic Gum according to the dosage schedule on the back of this leaflet.
• 3.Chew each Zonnic Gum 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 Zonnic Gum 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 Zonnic Gum 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 Zonnic Gum piece (usually happens in about half an hour; the peppery taste or tingle won't return.)
• 9.Wrap the used Zonnic Gum piece in paper and throw away in the trash.