Habitrol Canada Support Program - Product Information

How to use Habitrol^®
Transdermal Nicotine Patch

INTRODUCTION

You have chosen Habitrol to relieve the symptoms of nicotine withdrawal. The patch, while it is an effective aid, is only one part of your smoking cessation program. Before attempting to stop, it is important that you are firmly committed to quitting. It is also important that you use the Habitrol System with a behavioural plan to help you stop smoking. The Habitrol System (available by calling 1-888-227-5777) provides you with advice on all the things you should be doing, in addition to using Habitrol, that will increase the chances that you will stop smoking. In addition, the Habitrol Toll-Free Support Information Line is available to answer your questions about Habitrol and smoking cessation.

It is important that your doctor knows you are using Habitrol if you are taking other medications or have other medical conditions. You should stop smoking completely while you are using Habitrol. Do not use Habitrol if you are an occasional smoker. This web page provides you with information on how the patch works, and how to use it safely. PLEASE READ ALL OF IT CAREFULLY, especially the section marked 'PRECAUTIONS', before you start using the patches. If you have any questions about Habitrol after reading this information, or any other time while you are using Habitrol, call our Toll-Free Support Information Line.

Nicotine addiction and smoking

In addition to many other chemicals, cigarette smoke contains nicotine. Although toxic, it does not play an important role in most diseases associated with smoking, such as lung disease and various cancers. It is the nicotine to which smokers are addicted. As you may have experienced when you first started smoking, nicotine produces effects such as: stimulation (especially in a boring situation), calming (during stressful periods), relaxation, enhancement of memory and concentration. In time, dependence develops, so that if nicotine is not made available to the brain, withdrawal symptoms such as irritability, frustration, anger, anxiety, difficulty in concentration, and restlessness appear.

Nicotine addiction may be a product of either a desire to obtain the pleasant effects and/or to avoid the withdrawal symptoms. Unfortunately, nicotine addiction is one of the most difficult drug addictions to break. Habitrol is designed to relieve these symptoms.

HOW THE Habitrol PATCH WORKS

Habitrol is designed to temporarily replace some of the nicotine that cigarettes would normally supply. While the patch is worn, controlled quantities of nicotine pass from the patch into your skin, and then into your bloodstream. Because some nicotine is left in your skin when you take the patch off, the nicotine will continue to pass into your bloodstream for several hours after patch removal.

Which patch size should I use?

Habitrol comes in three patch sizes, which give doses of 21 mg/day (Step 1), 14 mg/day (Step 2) and 7 mg/day (Step 3). Typically, a pack-a-day smoker would wear each size for 3 to 4 weeks, gradually reducing nicotine delivery by going from Step 1 to Step 2 to Step 3.

Starting sizes:

If you smoke 10 or more cigarettes per day:

Start with Step 1 (21 mg), wearing one 21 mg patch daily for 4 weeks before moving on to Step 2.
Next, wear Step 2 (14 mg) for an additional 2 weeks before moving on to Step 3.
Finish by wearing Step 3 (7 mg) for 2 weeks.

If you smoke less than 10 cigarettes per day:

Start at Step 2 (14 mg), wearing one 14 mg patch daily for 6 weeks before moving on to Step 3.
Finish by wearing Step 3 (7 mg) for 2 weeks.

You may have to switch sizes during the first week or two of therapy in order to determine the correct size for you. If you still have withdrawal symptoms or cigarette cravings with 14 mg/day, try 21 mg/day. If you are experiencing side effects, use the next lower dose.

Weaning down: As you move from step to step, you will end up using the smallest patch (last Step 3, 7 mg), and after a while, stop using patches completely. The entire process should not go beyond 8 weeks. However, your stop smoking program does not end when you stop using the patches. If you are to remain successful in quitting, you must continue with all other aspects of your program. Remember, the Habitrol Support Program and the Habitrol Toll-Free Support Information Line will provide you with advice on all the things you should be doing, in addition to using Habitrol, that will increase the chances that you will stop smoking.

Never wear more than one patch at a time as over dosage may occur.

HOW TO APPLY THE Habitrol PATCH

Choose an area of skin on your upper body or the upper outer part of your arm. To ensure that the patch will stick on well, make sure the skin is non-hairy, clean (not oily), dry, and free of creams, lotions, oils or powder. Hair will interfere with the application of Habitrol, and should be clipped away. Do not shave the area as this may irritate the skin. Do not put a Habitrol patch on skin that is inflamed, burned, has broken out, or is irritated in any way, because these conditions may alter the amount of drug absorbed. Women should not apply the patch to their breasts. Be sure to apply the patch to a different area each day. The same area should not be used again for at least one week.
Do not remove the Habitrol patch from the pouch until you are ready to apply it. Using scissors carefully cut open the pouch along the edge. Save the pouch as you will need it when you dispose of the used patch.
Peel the patch you are replacing off your skin, and fold it in half, with the adhesive (sticky) side inward. Place it in the opened foil pouch and DISPOSE OF THE POUCH (WITH THE FOLDED OLD PATCH INSIDE) IN THE GARBAGE, OUT OF THE REACH OF CHILDREN AND PETS. Any adhesive left on your skin may be removed with rubbing alcohol.
A square, shiny protective liner covers the adhesive side of the patch (the side that you will stick onto your skin). Note that there is a pre-cut slit along the length of the liner. It is designed to help you remove the patch from the liner. To remove the patch from the liner, start by removing the strip of liner formed by the pre-cut slit. To do this, hold the liner with the patch facing you, and the slit along the top. Hold a bottom corner of the liner. Now, starting from one edge, pull away the strip from along the top and discard it. To remove the main part of the liner, hold the Habitrol patch at the free edge, (touching the sticky side as little as possible), and peel the liner off of the patch. Discard the liner.
Immediately apply the sticky side of the patch to your skin and firmly press it on with the palm of your hand. Continue pressing firmly for 10-20 seconds. Make sure that it is sticking well, especially around the edges, but do not test the patch by pulling at it once you have stuck it on.
When you have finished applying the patch, wash your hands with water only. Any nicotine on your hands could get into your eyes or nose, and cause stinging, redness or other more serious problems.

When to apply a Habitrol Patch

The patch should be worn for approximately 24 hours and then removed and discarded. Do not leave it on for more than 24 hours because it may irritate your skin, and because it loses strength after that time. You should always replace your patch at the same time each day. This will help you to remember to change it.

What if the patch gets wet?

Water will not usually affect the patch if it is applied correctly. You may bathe, swim, shower, or exercise while wearing the patch. The Habitrol patch should be removed 2 hours before engaging in prolonged strenuous exercise.

What if the patch falls off?

If a patch does fall off, dispose of it and put on a new patch as soon as possible. Be sure the area is non-hairy, clean (not oily), dry, and free of creams, lotions, oils or powder. You should remove this replacement patch at the time you regularly change the patch (the time you would have replaced the other patch if it had not fallen off).

How to store Habitrol

Store your patches at room temperature (below 25°C) away from direct heat and light. Remember that the inside of your car can reach temperatures much higher than this in the summer. Do not store patches outside the pouch. Keep them out of the reach of children and pets.

Always remember

Use Habitrol only as directed. Dispose of used patches only in the manner described in this section (How to Apply the Habitrol Patch), out of the reach of children and pets. If you have any questions, call the Habitrol Toll-Free Support Information Line at: 1-888-227-5777, or ask your doctor or your pharmacist. If you suspect you are experiencing any side effects, remove the patch and call your doctor immediately.

Note: You cannot adjust your dose by cutting a patch, even though the smallest patch contains half the nicotine contained in the next size up. Cutting a patch will cause the nicotine to evaporate rapidly, making all the pieces useless.

QUESTIONS TO ASK BEFORE USING Habitrol (Precautions)

There are immediate beneficial effects on your health when you stop smoking. However, when using Habitrol to assist you, certain precautions must be taken to ensure safe use of the patches.

Do you have any other medical conditions?
In certain medical conditions, Habitrol should not be used at all.

DO NOT use Habitrol if you have had:

a recent heart attack (myocardial infarction).
heart disease:
- unstable or worsening angina (chest pain).
- severely irregular heart beat (arrhythmia).
recent stroke.
skin diseases.
known allergy to the patches or to nicotine.
if you are pregnant or breast-feeding.

Medical conditions other than the above require a doctor's judgment to know if Habitrol can be used safely.

Do not use Habitrol if you are under 18 years of age.

Experience with Habitrol in the elderly is limited.

Consult your doctor first if you have ever had any of the following:

irregular heart beat (arrhythmia).
angina (heart pain).
high blood pressure.
heart failure.
overactive thyroid (hyperthyroidism).
stomach ulcers.
kidney or liver disease.
diabetes requiring insulin.
treatment for poor circulation.
stroke, or treatment for circulation disorders of the brain (cerebral ischemia).
allergies to drugs.
rashes from adhesive tape or bandages.

Are you taking other medicines?

It is important that your doctor knows you are using Habitrol if you are taking other medicines. Smoking may alter the effects of some medicines. Once you have quit, it may be necessary for your doctor to adjust the doses. This is especially important if you are a diabetic, taking medicine for high blood pressure or heart disease, antidepressants, tranquilizers or sleeping pills.

May I use Habitrol if I am pregnant or breast-feeding?

NO. Nicotine, whether it comes from cigarettes or Habitrol, may be harmful to an unborn baby if used during pregnancy. It can also pass into breast milk, and harm a nursing infant. Therefore, if you are pregnant or breast-feeding, do not use Habitrol and do not smoke. If you are already using Habitrol and you think (or know) you have become pregnant, tell your doctor. Stop using Habitrol and do not smoke.

Are there side effects?

You may experience headache, insomnia, dizziness, anxiety, irritability, fatigue, stomach upset, diarrhea, and constipation. Some of these effects may be nicotine withdrawal symptoms or may be caused by nicotine. Therefore, your dose may need to be adjusted. Be sure to tell your doctor if you have any or all of the symptoms listed above.

Remove the nicotine patch and consult your doctor if you experience irregular heart beat, chest pain, palpitations or leg pain or if severe persistent stomach upset (indigestion, heartburn) develops.

Do not continue to smoke, chew nicotine gum or use any other form of tobacco product while using the patch.

If you continue to smoke while using Habitrol, you may be absorbing more nicotine than you body is used to, and this excess could make you feel ill. Therefore, do not continue to smoke, chew nicotine gum or use any other form of tobacco product while using the patch. Signs and symptoms of nicotine overdose include severe headaches, dizziness, upset stomach, drooling, vomiting, diarrhea, cold sweats, blurred vision, difficulty in hearing, mental confusion, weakness, and fainting. If you experience any of these symptoms, tell your doctor immediately.

What If My Skin Reacts to the Patch?

It is normal to experience mild itching, burning or tingling when you first apply a patch, but this should disappear within an hour. After you remove a patch, the skin underneath may be somewhat red, but it should not stay that way for more than 2 days. If the skin under the patch becomes swollen or very red, or if you develop a rash, remove the patch and call your doctor. Do not put on a new patch. It is possible that you may be allergic to one of the components of the patch.

If you become allergic to the nicotine in the patch, you may experience very unpleasant side effects if later you use cigarettes or other nicotine-containing products.

Other important information

The Habitrol patch should be removed 2 hours before engaging in prolonged strenuous exercise.

IMPORTANT SAFETY INFORMATION

KEEP NEW OR USED PATCHES OUT OF THE REACH OF CHILDREN AND PETS. The active ingredient in Habitrol is nicotine. It can be very toxic, and small amounts can cause serious illness in children. Even used patches contain enough nicotine to poison children and pets. Follow the directions given under 'How to Apply a Habitrol Patch', when disposing of used patches, and be sure to dispose of them out of the reach of children and pets. If, in any way, a child comes in contact with a patch that is not in the pouch, take the patch away, and CONTACT A POISON CONTROL CENTRE OR DOCTOR IMMEDIATELY. If the child has touched the sticky (active) side of a patch, you may flush the area WITH WATER ONLY, and dry it. DO NOT USE SOAP, as this will increase the absorption of nicotine.

QUESTIONS?

Contact Habitrol Toll-Free Support Information: 1-888-227-5777