Nicoderm CQ (Transdermal)

Nicotine skin patches are used to help you quit smoking. Nicotine is absorbed from the patch on your skin and enters your bloodstream. This replaces the nicotine you would get from smoking and makes the withdrawal symptoms from not smoking less intense. The amount of nicotine is gradually reduced over time until you stop using it.

This medicine is available without a prescription, but you need to show proof of age (18 years or older).

It is important to complete the NicoDerm® CQ 3-step program fully. If you need to use the patch for a longer time, talk to your doctor.

Pregnant women should only use this medicine as directed by a doctor. Cigarette smoke can seriously harm your child. Try to stop smoking without using medicine. Although this medicine is believed to be safer than smoking, the risks to your child from this medicine are not fully known.

Nicotine products must be kept out of the reach of children and pets. Small amounts of nicotine can cause serious unwanted effects in children, and used patches may have enough nicotine to cause problems. If a patch is swallowed, contact your doctor or poison control center immediately.

Mild itching, burning, or tingling may happen when the patch is first applied. This should go away within 24 hours. Call your doctor if you have a rash or if your skin is swollen or red. Do not put on a new patch.

The opaque NicoDerm® CQ patch may cause skin burns when used during a magnetic resonance imaging (MRI) scan. You must remove the patch before an MRI procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will consider the risks of taking the medicine against the benefits it may provide. Here are some important points to think about:

Allergies

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

Pediatric

There have been no appropriate studies on how nicotine skin patches affect children. Safety and effectiveness have not been established. Even small amounts of nicotine can cause serious side effects in children, and patches have enough nicotine to cause problems, even if they have been used.

Geriatric

There is no information available on how nicotine skin patches affect older adults.

Breast Feeding

Studies on breastfeeding women have shown harmful effects on infants. You should be prescribed an alternative to this medication or stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be taken together even if an interaction could happen. In these situations, your doctor might adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions are significant but may not be a complete list.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Tegafur

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at mealtime or with specific foods due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how you can use this medicine. Be sure to tell your doctor about any other medical problems you have, especially:

• Heart or blood vessel disease or
• Uncontrolled hypertension (high blood pressure)—Use with caution. May worsen these conditions.

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:

Less common

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

Rare

• 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:

Symptoms of overdose

• 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:

More common

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

Less common or rare

• 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.

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 System

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.

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