Habitrol (transdermal)

Habitrol is the main ingredient found in tobacco products.

Habitrol (skin patch) is a medical product designed to help you quit smoking and reduce withdrawal symptoms as you stop smoking.

Habitrol may also be used for other reasons not mentioned in this medication guide.

Follow all instructions on your medicine label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medicines you are using.

Habitrol is not approved for use by anyone younger than 18 years old.

Ask a doctor or pharmacist if Habitrol is safe to use if you have ever had:

• heart disease, irregular heartbeats;
• a heart attack or stroke;
• untreated or uncontrolled high blood pressure;
• blood circulation problems;
• pheochromocytoma (tumor of the adrenal gland);
• diabetes;
• a thyroid disorder;
• a stomach ulcer;
• liver disease; or
• if your skin is sensitive to adhesive tape or bandages.

Do not use Habitrol without medical advice if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Smoking cigarettes during pregnancy can cause low birth weight, miscarriage, or stillbirth. Using a Habitrol replacement product during pregnancy or while breast-feeding may be safer than smoking. However, you should try to stop smoking without using this medicine replacement product if you are pregnant or breast-feeding. Talk with your doctor about the best way for you to stop smoking.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

The Habitrol patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

Get emergency medical help if you notice signs of an allergic reaction: hives; trouble breathing; swelling of your face, lips, tongue, or throat.

Habitrol may cause serious side effects. Stop using Habitrol and call your doctor right away if you experience:

• fast or pounding heartbeats, fluttering in your chest;
• extreme weakness or dizziness;
• severe nausea and vomiting; or
• redness, swelling, or skin rash where a Habitrol patch was worn (especially if these symptoms do not go away within 4 days after the patch was removed).

Common side effects of Habitrol may include:

• dizziness;
• sleep problems (insomnia), unusual dreams;
• dry mouth, upset stomach;
• joint or muscle pain;
• headache; or
• mild skin irritation where the patch is applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Habitrol is only part of a complete program of treatment that may also include counseling, group support, and behavior changes. Your success will depend on your participation in all aspects of your smoking cessation program.

Use exactly as directed on the label, or as prescribed by your doctor. Start using the transdermal patch on the same day you stop (quit) smoking or using tobacco products.

Your patch strength and number of weeks of treatment will depend on how many cigarettes you smoked daily before quitting. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Wash your hands after applying or removing a Habitrol skin patch.

Apply the patch to clean, dry, and hairless skin on your chest or the outer part of your upper arm. Press the patch firmly into place for about 10 seconds to make sure it sticks. You may leave the patch on while bathing, showering, or swimming.

Do not wear more than one Habitrol patch at a time. Never cut a skin patch.

Do not wear a Habitrol patch at night if you have vivid dreams or trouble sleeping.

If a patch falls off, try sticking it back into place. If it does not stick well, put on a new patch.

You may wear a Habitrol patch for 24 hours.

You may wear a Nicoderm CQ patch for 16 or 24 hours (wear for 24 hours if you crave cigarettes when you wake up in the morning).

Remove the skin patch after 24 hours and replace it with a new one. Choose a different place on your body to wear the patch each time you put on a new one. Do not use the same skin area twice within 7 days.

After removing a skin patch fold it in half, sticky side in, and put it back into its pouch.

Do not use Habitrol patches for longer than 8 weeks without the advice of your doctor.

Store at room temperature away from moisture and heat. Keep each patch in its foil pouch until you are ready to use it. Save the pouch so you can use it to throw away any used patches.

Keep both used and unused Habitrol patches out of the reach of children or pets.

The amount of nicotine in a used or unused skin patch can be fatal to a child who accidentally sucks or chews on the patch. Seek emergency medical attention if this happens.

Apply a skin patch as soon as you remember. Do not wear a patch for more than 24 hours. Do not use additional patches to replace the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe dizziness, nausea, vomiting, diarrhea, weakness, and fast heart rate.

Avoid using lotions, oils, or moisturizing soaps on the skin where you plan to wear a Habitrol (transdermal) patch, or it may not stick well.

Other drugs may affect Habitrol, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all your current medicines and any medicine you begin or stop using.