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doxepin cream - topical, Zonalon (cont.)

HOW TO USE: Before applying the medication, clean the affected area with mild soap and water, rinse well, and pat dry. Gently rub a small amount of the medication into the affected area in a thin layer, usually 4 times a day. Wait at least 3-4 hours between applications, or use as directed by your doctor. How often the medication is applied and for how long depends on your condition and response to treatment. Usually, this medication is for short-term use only (up to 8 days).Wash hands immediately after use unless the area being treated includes the hands. This medication is for use on the skin only. Avoid getting the product in your eyes, nose, ears, mouth, or vaginal/anal area. If the medication gets in these areas, rinse immediately with clean water.Do not cover the area with plastic or waterproof bandages. Covering the treated area may increase the absorption of the medication through the skin and increase the risk of side effects.Do not use more of this product, use it more often, or keep using it longer than prescribed by your doctor. Your condition will not improve faster and the risk for side effects will increase. Side effects may increase when you use the cream on a larger area of skin (e.g., more than 10 percent of your body surface). Tell your doctor if you have severe drowsiness while using this product. It may be a sign that you are absorbing too much of the medication. Your doctor may tell you to decrease how often you apply the medication, the amount of medication used, or how much skin to spread the medication over. Follow your doctor's directions carefully.Tell your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Burning/stinging at the application site, drowsiness, dizziness, dry mouth, blurred vision, or changes in taste may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.Remember that your doctor has prescribed this medication because 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.Tell your doctor immediately if any of these unlikely but serious side effects occur: severe constipation, loss of coordination, ringing in the ears, persistent heartburn, mental/mood changes (e.g., agitation, confusion, depression), muscle weakness/spasms, numbness/tingling of the hands/feet, restlessness, decreased sexual ability/interest, trouble urinating, swelling of the hands/feet, weight gain.Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, persistent nausea/vomiting, signs of infection (e.g., fever, persistent sore throat), pain/redness/swelling of arms or legs, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.Seek immediate medical attention if any of these rare but very serious side effects occur: slurred speech, fast/irregular heartbeat, vision changes, fainting, weakness on one side of the body, seizures.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.



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