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February 10, 2012
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estradiol/norethindrone acetate patch - transdermal, Combipatch (cont.)

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist.This medication is for use on the skin only. Follow the dosing schedule carefully. Dosage is based on your medical condition and response to therapy.Apply the patch to a clean, smooth, dry, non-irritated area of the lower abdomen. Do not place the patch on the breast. Avoid the waistline since tight clothing may rub the patch off. Press firmly on the patch for at least 10 seconds to make sure it stays in place.Replace the patch with a new one, usually twice weekly (every 3 or 4 days) or as directed by your doctor. Be sure to remove the old patch. Do not wear more than one patch at a time. To avoid skin irritation, change to a different area on the lower abdomen with each new patch and do not apply to the same area for at least a week.The patch should be worn continuously, even while bathing. Do not expose the patch to the sun for long periods. If a patch falls off, you may reapply it to a different area on the lower abdomen. If the patch does not stick any longer, use a new one and continue your usual dosing schedule.Use this medication regularly to get the most benefit from it. To help you remember, change the patch on the same days each week. It may help to mark your calendar as a reminder.Inform your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Dizziness, lightheadedness, headache, stomach upset, bloating, irritability, changes in sleep patterns, nausea, weight changes, increased/decreased interest in sex, change in vaginal discharge, or breast tenderness may occur. If any of these persist or worsen, tell your doctor promptly.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: mental/mood changes (e.g., depression, memory loss), breast lumps, nipple discharge, swelling of the hands/feet, painful menstrual periods, unusual vaginal bleeding (e.g., spotting, breakthrough bleeding, prolonged/returning bleeding), yellowing eyes/skin, stomach/abdominal pain, worsening of seizures, signs of worsening diabetes control (e.g., increased thirst and urination).This medication may rarely cause very serious problems such as heart attacks, stroke, and blood clots. Seek immediate medical attention if you experience any of the following: chest/jaw/left arm pain, sudden severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (e.g., double vision, loss of vision), pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch, trouble breathing, coughing up blood, sudden dizziness/fainting.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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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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