Nicoderm

In the U.S.

• Habitrol
• Nicoderm CQ
• Nicotrol

In Canada

• Nicoderm

Available Dosage Forms:

• Patch, Extended Release

Therapeutic Class: Smoking Cessation Agent

Pharmacologic Class: Cholinergic

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of nicotine skin patches in the pediatric population. Safety and efficacy have not been established. Small amounts of nicotine can cause serious unwanted effects in children, and patches contain enough nicotine to cause problems, including used patches.

Geriatric

No information is available on the relationship of age to the effects of nicotine skin patches in geriatric patients.

Pregnancy

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Tegafur

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart or blood vessel disease or
• Hypertension (high blood pressure), uncontrolled—Use with caution. May make these conditions worse.

This section provides information on the proper use of a number of products that contain nicotine. It may not be specific to Nicoderm. Please read with care.

Use the patches exactly as directed in the dosing section on the label. Ask your doctor or pharmacist if you have any questions.

This medicine comes with a patient instruction booklet. Read and follow these instructions carefully.

It is also important to use a stop-smoking program that may include education, counseling, and psychological support. This may make it easier for you to stop smoking.

For most patches, the strength of the patch will be decreased over a few weeks until use is stopped. If you use a patch that is only available in one strength, use is stopped after the treatment period indicated on the label.

NicoDerm® CQ patch:

• This is a 3-step program. If you smoke more than 10 cigarettes per day, start with Step 1 followed by Step 2 and Step 3. If you smoke 10 or less cigarettes per day, start with Step 2 followed by Step 3.
• Begin using the patch on the morning of your "quit" day, even if you are not able to stop smoking immediately.
• Leave the patch in its sealed storage pouch until you are ready to put it on. Carefully open the pouch. Never cut the pouch or patch with scissors. Do not use a patch that has been cut by accident.
• Save the original storage pouch. It will be used to dispose of the used patch.
• Apply the patch at about the same time every day to clean, dry skin and in an area with little hair.
• When putting on a new patch, choose a different body area. Be sure to remove the old patch before applying a new one.
• Do not put the patch on burned, cut, or irritated skin. Do not use creams or lotions, including sunscreen, on the skin where you apply the patch because it may not stick well.
• Wash your hands after applying or removing a patch.
• Apply a new patch to a different body area if one falls off.
• Remove the patch after 16 or 24 hours. It will not work as well after 24 hours and may irritate your skin.
• If you have vivid dreams or sleep problems, remove the patch at bedtime and apply a new one in the morning.
• Water will not harm the patch. You may bathe, shower, or swim for short periods while wearing the patch.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For transdermal dosage form (patch):
  • To help you stop smoking:
    • Adults and teenagers 18 years or older—The dose will be provided on the label and is based on the number of cigarettes you smoke per day. The amount of nicotine is decreased over time until treatment ends. If you need to use the patch for a longer period of time than recommended on the label, talk to your doctor.
    • Children—Use is not recommended.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

After removing a used patch, fold it in half with the sticky sides together. Place the used patch in its storage pouch and throw it away. Make sure it is out of the reach of children and pets.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blurred vision
• dizziness
• headache
• nervousness
• pounding in the ears

• Fast or irregular heartbeat
• hives, itching, rash, redness, or swelling of the skin

Get emergency help immediately if any of the following symptoms of overdose occur:

• Dizziness
• fast heartbeat
• nausea or vomiting
• weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache
• redness, itching, or burning at the application site

• Dizziness or lightheadedness
• irritability or nervousness
• nausea or vomiting
• trouble sleeping or unusual dreams

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.