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February 10, 2012
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nicotine patch - transdermal, Habitrol, Nicoderm, Nicoderm C (cont.)

SIDE EFFECTS: Mild itching, redness, burning, and stinging at the application site may occur. Stop using this product and tell your doctor if redness caused by the patch does not go away after 4 days. Nausea, dizziness, flushing, or headache may also occur. Common nicotine withdrawal symptoms can occur when you stop smoking and include dizziness, anxiety, depression, or trouble sleeping, among others. If any of these withdrawal symptoms or side effects persist or worsen, tell your doctor or pharmacist promptly.If your doctor has prescribed this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Serious side effects are more likely if you continue to smoke while using this product. Do not smoke while you are using this medication.Stop using this medication and tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., irritability, trouble sleeping, vivid dreams), numbness/tingling in hands/feet, swelling hands/ankles/feet.Stop using this medication and seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, confusion, severe headache, fast/irregular/pounding heartbeat, slurred speech, weakness on one side of the body.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to nicotine; or to adhesive tape; or if you have any other allergies.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled/worsening chest pain, recent heart attack, irregular heartbeat (serious arrhythmias), skin problems (e.g., eczema, contact dermatitis).Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel disease (e.g., Raynaud's disease, stroke), diabetes, heart disease (e.g., chest pain, heart attack), high blood pressure, liver disease, severe kidney disease, stomach/intestinal sores (peptic ulcers), certain adrenal problem (pheochromocytoma), overactive thyroid (hyperthyroidism).If you are going to have an MRI test, notify testing personnel that you are using this patch. Serious burns may occur during MRI tests because of the aluminum contained in these patches. It should be removed just before the MRI test or consult your doctor for specific instructions.Strenuous exercise may raise your skin temperature and increase the amount of nicotine absorbed through the skin. Talk with your doctor about the effects of exercise on this medication.Avoid exposing the skin under the patch to direct heat sources such as heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, or prolonged direct sunlight while wearing you patch. Heat sources may cause more drug to be released into your body, increasing the chance of side effects.Nicotine and smoking may harm an unborn baby. If you are pregnant, try to stop smoking without using a nicotine replacement product if possible. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.Nicotine from smoking and from this medication passes into breast milk and could have undesirable effects on a nursing infant. Smoking near an infant can also harm the infant. Consult your doctor before breast-feeding.



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