Formerly available only by prescription

Available as:

Step 1 - 21 mg/24 hours

Step 2 - 14 mg/24 hours

Step 3 - 7 mg/24 hours

If you smoke:

More than 10 cigarettes per Day: Start with Step 1

10 Cigarettes a Day or Less: Start with Step 2

WHAT IS THE NICODERM CQ PATCH AND HOW IS IT USED?

NicoDerm CQ is a small, nicotine containing patch. When you put on a NicoDerm CQ patch, nicotine passes through the skin and into your body. NicoDerm CQ is very thin and uses special material to control how fast nicotine passes through the skin. Unlike the sudden jolts of nicotine delivered by cigarettes, the amount of nicotine you receive remains relatively smooth throughout the 24 or 16 hour period you wear the NicoDerm CQ patch. This helps to reduce cravings you may have for nicotine.

ACTIVE INGREDIENT

Nicotine

PURPOSE

Stop Smoking Aid

USE

To reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking

WARNINGS

Do Not Use

Ask a doctor before use if you

Stop use and ask a doctor if you have

DIRECTIONS

THE NICODERM CQ PROGRAM
STEP 1 STEP 2 STEP 3
(21 mg) (14 mg) (7 mg)
Initial
Treatment
Period
Weeks 1-6 Weeks 7-8 Weeks 9-10

READ THE LABEL

Read the carton and the User's Guide before using this product. Keep the carton and User's Guide. They contain important information.

INACTIVE INGREDIENTS

Ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between pigmented and clear polyester backings.

Store at 20-25°C (68-77°F)

TO INCREASE YOUR SUCCESS IN QUITTING:

  1. You must be motivated to quit.
  2. Complete the full treatment program, applying a new patch every day.
  3. Use with a support program as described in the Users Guide.

NicoDerm CQ User's Guide

KEYS TO SUCCESS

  1. You must really want to quit smoking for NicoDerm® CQ® to help you.
  2. Complete the full program, applying a new patch every day.
  3. NicoDerm CQ works best when used together with a support program: See page 3 for details.
  4. If you have trouble using NicoDerm CQ , ask your doctor or pharmacist or call GlaxoSmithKline at 1-800-834-5895 weekdays (10:00 am 4:30 pm EST).

SO, YOU'VE DECIDED TO QUIT.

Congratulations. Your decision to stop smoking is one of the most important things you can do to improve your health. Quitting smoking is a two-part process that involves:

  1. overcoming your physical need for nicotine, and
  2. breaking your smoking habit.

NicoDerm CQ helps smokers quit by reducing nicotine withdrawal symptoms.

Many NicoDerm CQ users will be able to stop smoking for a few days but often will start smoking again. Most smokers have to try to quit several times before they completely stop.

Your own chances of quitting smoking depend on how strongly you are addicted to nicotine, how much you want to quit, and how closely you follow a quitting plan like the one that comes with NicoDerm CQ.

QUITTING SMOKING IS HARD!

If you find you cannot stop or if you start smoking again after using NicoDerm CQ please talk to a health care professional who can help you find a program that may work better for you. Breaking this addiction doesn't happen overnight.

Because NicoDerm CQ provides some nicotine, the NicoDerm CQ patch will help you stop smoking by reducing nicotine withdrawal symptoms such as nicotine craving, nervousness and irritability.

This User's Guide will give you support as you become a non-smoker. It will answer common questions about NicoDerm CQ 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 NicoDerm CQ 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 back cover of this User's Guide.

If you find you cannot stop smoking or if you start smoking again after using NicoDerm CQ, 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 NicoDerm CQ 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 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 NicoDerm CQ will lessen your body's craving for 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 cautions 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

When using this product

Stop use and ask a doctor if

Keep out of reach of children and pets. Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a poison control center right away. Dispose of the used patches by folding sticky ends together and inserting in disposal tray in this box.

LET'S GET STARTED.

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

Becoming a non-smoker starts today. Your first step is to read through this entire User's Guide carefully.

First, check that you bought the right starting dose.

If you smoke more than 10 cigarettes a day, begin with Step 1 (21 mg). As the carton indicates, people who smoke 10 or less cigarettes per day should not use Step 1 (21 mg). They should start with Step 2 (14 mg). Throughout this User's Guide we will give specific instructions for people who smoke 10 or less cigarettes per day.

Next, set your personalized quitting schedule.

Take out a calendar that you can use to track your progress. Pick a quit date, and mark this on your calendar using the stickers inside the front cover of this User's Guide, as described below.

DIRECTIONS:   FOR PEOPLE WHO SMOKE OVER 10 CIGARETTES PER DAY

STEP 1.  (Weeks 1-6). Your Quit Date (and the day you'll start using NicoDerm CQ patch).

Choose your quit date (it should be soon).

This is the day you will quit smoking cigarettes entirely and begin using NicoDerm CQ to reduce your cravings for nicotine. Place the Step 1 sticker on this date. For the first six weeks, you'll use the highest-strength (21 mg) NicoDerm CQ patches. Be sure to follow the directions on page 10.

Completing the full program will increase your chances of quitting successfully. This is done by changing over to the Step 2 (14mg) patch for 2 weeks followed by a final 2 weeks with the Step 3 (7mg) patch. The Step 2 and Step 3 treatment periods allow you to gradually reduce the amount of nicotine you get, rather than stopping suddenly, and will increase your chances of quitting.

STEP 2.  (Weeks 7-8). The day you'll start reducing your use of NicoDerm CQ patch.

Switching to Step 2 (14mg) patches after 6 weeks begins to gradually reduce your nicotine usage. Place the Step 2 sticker on this date (the first day of week seven). Use the 14mg patches for two weeks.

STEP 3.   (Weeks 9-10). The day you'll further start reducing your use of NicoDerm CQ patch.

After eight weeks, nicotine intake is further reduced by moving down to Step 3 (7mg) patches. Place the Step 3 sticker on this date (the first day of week nine). Use the 7 mg patches for two weeks.

THE NICODERM CQ PROGRAM
STEP 1 (21 mg) STEP 2 (14 mg) STEP 3 (7 mg)
Initial Treatment
Period
Step Down Treatment Period
Weeks 1-6 Weeks 7-8 Weeks 9-10

STOP USING NicoDerm CQ AT THE END OF WEEK 10.   If you still feel the need to use the patch after Week 10, talk with your doctor or health professional.

DIRECTIONS: For people who smoke 10 or less cigarettes per day .

Do not use Step 1 (21 mg).

Begin with STEP 2 - Initial Treatment Period (Weeks 1-6): 14mg patches.

Choose our quit date (it should be soon). This is the Day you will quit smoking cigarettes entirely and begin using NicoDerm CQ to reduce your cravings for nicotine. Place the Step 2 sticker on this date. For the first six weeks, you'll use the Step 2 (14mg) NicoDerm CQ patches. Be sure to follow the directions on page 10.

Continue with STEP 3 - Step Down Treatment Period (Weeks 7-8): 7mg patches.

Completing the full program will increase your chances of quitting successfully. This is done by changing over to the Step 3 (7mg) patches for 2 weeks. The two week step down treatment period allows you to gradually reduce the amount of nicotine you get, rather than stopping suddenly, and will increase your chances of quitting. Place the Step 3 sticker on the first day of week seven. Use the 7mg patches for two weeks.

People who smoke 10 or less cigarettes per day should not use NicoDerm CQ for longer than 8 weeks. If you still feel the need to use NicoDerm CQ after 8 weeks, talk with your doctor.

PLAN AHEAD.

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

HOW NICODERM CQ WORKS.

NicoDerm CQ patches provide nicotine to your system. They work as a temporary aid to help you quit smoking by reducing nicotine withdrawal symptoms, including nicotine craving. NicoDerm CQ 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 NicoDerm CQ 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 NICODERM CQ PATCHES.

Read all the following instructions, and the instructions on the outer carton, before using NicoDerm CQ. Refer to them often to make sure you're using NicoDerm CQ correctly. Please refer to the compact disc for additional help.

  1. Stop smoking completely before you start using NicoDerm CQ.
  2. To reduce nicotine craving and other withdrawal symptoms, use NicoDerm CQ according to the directions on pages 6-8.
  3. Insert used NicoDerm CQ patches in the child resistant disposal tray provided in the box - safely away from children and pets.

When to apply and remove NicoDerm CQ patches.

Each day apply a new patch to a different place on skin that is dry, clean and hairless. You can wear a NicoDerm CQ patch for either 16 or 24 hours. If you crave cigarettes when you wake up, wear the patch for 24 hours. If you begin to have vivid dreams or other disruptions of your sleep while wearing the patch 24 hours, try taking the patch off at bedtime (after about 16 hours) and putting on a new one when you get up the next day.

PLACE THESE STICKERS ON YOUR CALENDAR

STEP 1
STEP 2
A new 21 mg
A new 14 mg
patch every day
patch every day
AT THE BEGINNING
OF WEEK #1
AT THE BEGINNING
OF WEEK #7
(QUIT DAY)
   

For people who smoke 10 or less cigarettes per day:   Do not use STEP 1 (21 mg). Use STEP 2 (14 mg) at the beginning of week #1 and STEP 3 (7 mg) at the beginning of week #7.

PLACE THESE STICKERS ON YOUR CALENDAR

STEP 3
EX-SMOKER
A new 7 mg
patch every day
AT THE BEGINNING
OF WEEK #9
WHEN YOU HAVE COMPLETED YOUR QUITTING PROGRAM

Do not smoke even when you are not wearing the patch.

Remove the used patch and put on a new patch at the same time every day. Applying the patch at about the same time each day (first thing in the morning, for instance) will help you remember when to put on a new patch. Do not leave the same NicoDerm CQ patch on for more than 24 hours because it may irritate your skin and because it loses strength after 24 hours.

Do not use NicoDerm CQ continuously for more than 10 weeks (8 weeks for people who smoke 10 or less cigarettes per day).

How to apply a NicoDerm CQ patch.

  1. Do not remove the NicoDerm CQ patch from its sealed protective pouch until you are ready to use it. NicoDerm CQ patches will lose nicotine to the air if you store them out of the pouch.
  2. Choose a non-hairy, clean, dry area of skin. Do not put a NicoDerm CQ patch on skin that is burned, broken out, cut, or irritated in any way. Make sure your skin is free of lotion and soap before applying a patch.
  3. A clear, protective liner covers the sticky back side of the NicoDerm CQ patch--the side that will be put on your skin. The liner has a slit down the middle to help you remove it from the patch. With the sticky back side facing you, pull half the liner away from the NicoDerm CQ patch starting at the middle slit, as shown in the illustration above. Hold the NicoDerm CQ patch at one of the outside edges (touch the sticky side as little as possible), and pull off the other half of the protective liner.
    Place this liner in the slot in the disposable tray provided in the NicoDerm CQ package where it will be out of reach of children and pets.
  4. Immediately apply the sticky side of the NicoDerm CQ patch to your skin. Press the patch firmly on your skin with the heel of your hand for at least 10 seconds. Make sure it sticks well to your skin, especially around the edges.
  5. Wash your hands when you have finished applying the NicoDerm CQ patch. Nicotine on your hands could get into your eyes and nose, and cause stinging, redness, or more serious problems.
  6. After 24 or 16 hours, remove the patch you have been wearing. Fold the used NicoDerm CQ patch in half with the sticky side together. Carefully dispose of the used patch in the slot of the disposal tray provided in the NicoDerm CQ package where it will be out of the reach of children and pets. Even used patches have enough nicotine to poison children and pets. Wash your hands.
  7. Chose a different place on your skin to apply the next NicoDerm CQ patch and repeat Steps 1 to 6. Do not apply a new patch to a previously used skin site for at least one week.

If your NicoDerm CQ patch gets wet during wearing.

Water will not harm the NicoDerm CQ patch you are wearing if applied properly. You can bathe, swim, or shower for short periods while you are wearing the NicoDerm CQ patch.

If your NicoDerm CQ patch comes off while wearing.

NicoDerm CQ patches generally stick well to most people's skin. However, a patch may occasionally come off. If your NicoDerm CQ patch falls off during the day, put on a new patch, making sure you select a non-hairy, non-irritated area of the skin that is clean and dry.

If the soap you use has lanolin or moisturizers, the patch may not stick well. Using a different soap may help. Body creams, lotions and sunscreens can also cause problems with keeping your patch on. Do not apply creams or lotions to the place on your skin where you will put the patch.

If you have followed the directions and the patch still does not stick to you, try using medical adhesive tape over the patch.

Disposing of NicoDerm CQ patches.

Fold the used patch in half with the sticky side together.

Carefully dispose of the patch in the disposal slot of the tray provided in the NicoDerm CQ package where it will be out of the reach of children and pets. Small amounts of nicotine, even from a used patch, can poison children and pets. Keep all nicotine patches away from children and pets. Wash your hands after disposing of the patch.

If your skin reacts to the NicoDerm CQ patch.

When you first put on a NicoDerm CQ patch, mild itching, burning, or tingling is normal and should go away within an hour. After you remove a NicoDerm CQ patch, the skin under the patch might be somewhat red. Your skin should not stay red for more than a day after removing the patch. Stop use and ask a doctor if skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash. Do not put on a new patch.

Storage Instructions

Keep each NicoDerm CQ patch in its protective pouch, unopened, until you are ready to use it, because the patch will lose nicotine to the air if it's outside the pouch.

Do not store NicoDerm CQ patches at 20-25°C (68-77°F) because they are sensitive to heat. Remember, the inside of your car can reach temperatures much higher than this. A slight yellowing of the sticky side of the patch is normal. Do not use NicoDerm CQ patches stored in pouches that are open or torn.

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. Hear are some tips to help get you through the important first stages of becoming a nonsmoker:

On Your Quit Date:

Right after Quitting:

WHAT TO EXPECT.

The First Few Days.

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 nicotine 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 nicotine 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 should not spoil your efforts! Throw away your cigarettes, forgive yourself and continue with the program. Listen to the Audio Tape again and re-read the User's Guide to ensure that you're using NicoDerm CQ correctly and following the other important tips for dealing with the mental and social dependence on nicotine. Your doctor, pharmacist or other health professional can also provide useful counseling on the importance of stopping smoking. You should consider them partners in your quit attempt.

What To Do About Relapse After a Successful Quit Attempt.

If you have taken up regular smoking again, don't be discouraged. Research shows that the best thing you can do is try again, since several quitting attempts may be needed before you're successful. And your chances of quitting successfully increase with each quit attempt.

The important thing is to learn from your last attempt.

WHEN THE STRUGGLE IS OVER.

Once you've stopped smoking, take a second and pat yourself on your 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 NicoDerm CQ?
    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 or four days. Understand that any of the following is possible:

    NicoDerm CQ reduces nicotine withdrawal symptoms such as irritability and nervousness, as well as the craving for nicotine you used to satisfy by having a cigarette.
  2. Is NicoDerm CQ just substituting one form of nicotine for another?
    NicoDerm CQ does contain nicotine. The purpose of NicoDerm CQ is to provide you with enough nicotine to reduce the physical withdrawal symptoms so you can deal with the mental aspects of quitting.
  3. Can I be hurt by using NicoDerm CQ?
    For most adults, the amount of nicotine delivered from the patch is less than from smoking. If you believe you may be sensitive to even this amount of nicotine, you should not use this product without advice from your doctor. There are also some important warnings in this User's Guide (See page 4).
  4. Will I gain weight?
    Many people do tend to gain a few pounds 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. Drink lots of water. This is good for your body and skin, and also helps to reduce the amount you eat.
  5. Is NicoDerm CQ more expensive than smoking?
    The total cost of NicoDerm CQ program is similar 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 NicoDerm CQ is only a short-term cost, while the cost of smoking is a long-term cost, including 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!

WALLET CARD

My most important reasons to quit smoking are:

WALLET CARD

Where to call for Help:

American Lung
Association
American Cancer
Society
American Heart
Association
800-586-4872 800-227-2345 800-242-8721

For people who smoke more than 10 cigarettes per day:

STEP 1 STEP 2 STEP 3
Use one 21 mg
patch/day
Use one 14 mg
patch/day
Use one 7 mg
patch/day
Weeks 1-6 Weeks 7-8 Weeks 9-10

People who smoke 10 or less cigarettes per day.    Do not use STEP 1 (21 mg). Use STEP 2 (14 mg) for six weeks and STEP 3 (7 mg) for two weeks and then stop.

Copyright © 2003 GlaxoSmithKline Consumer Healthcare, L.P.

For your family's protection, NicoDerm CQ patches are supplied in child resistant pouches. Do not use if individual pouch is open or torn.

Manufactured by ALZA Corporation, Mountain View, CA 94043 for GlaxoSmithKline Consumer Healthcare, L.P.

Comments or Questions? Call 1-800-834-5895 Weekdays. (10 a.m.-4:30 p.m. EST).

Available as

NicoDerm CQ Step 1 (21 mg/24 hours)-7 Patches*

NicoDerm CQ Step 1 (21 mg/24 hours)-14 Patches*

Clear NicoDerm CQ Step 1 (21 mg/24 hours)-7 Patches*

Clear NicoDerm CQ Step 1 (21 mg/24 hours)-14 Patches*

Clear NicoDerm CQ Step 1 (21 mg/24 hours)-21 Patches*

NicoDerm CQ Step 2 (14 mg/24 hours)-7 Patches*

NicoDerm CQ Step 2 (14 mg/24 hours)-14 Patches*

Clear NicoDerm CQ Step 2 (14 mg/24 hours)-14 Patches*

NicoDerm CQ Step 3 (7 mg/24 hours)-7 Patches**

NicoDerm CQ Step 3 (7 mg/24 hours)-14 Patches**

Clear NicoDerm CQ Step 3 (7 mg/24 hours)-14 Patches**


*User's Guide, Compact Disk & Child Resistant Disposal Tray

**User's Guide, & Child Resistant Disposal Tray

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis.

images/pills/n05504d3.jpg



Copyright© 2006 Thomson PDR