IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

ESTRADIOL - NORETHINDRONE ACETATE - TOPICAL PATCH

(ess-truh-DYE-all/nor-ETH-in-drone)

COMMON BRAND NAME(S): Combipatch

USES: This combination product is used for female hormone replacement therapy (HRT) in women who are no longer producing proper amounts (e.g., menopause/change of life). Combination HRT should not be used to prevent heart disease.

HOW TO USE: Use this product as prescribed. Follow the dosing schedule carefully. Dosage is based on your medical condition and response to therapy. Learn all the usage instructions in the product package insert and ask your doctor or pharmacist if you are unclear on any information. This medication should be used for the shortest possible length of time, so you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Consult your doctor or pharmacist for details. Apply the patch to a clean, smooth, dry, non-irritated area of the lower abdomen. Do not place the patch on the breast and 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. To avoid skin irritation, rotate the site of application with each new patch. Each patch may be worn continually as prescribed even while showering or bathing. Do not wear more than one estradiol-norethindrone patch at a time. Do not allow the patch to be exposed to the sun for prolonged periods of time. Ask your pharmacist what to do if a patch starts to fall off.

SIDE EFFECTS: This product may cause nausea, loss of appetite, headache, bloating or skin irritation at the site of application. If these effects persist or worsen, notify your doctor promptly. Report promptly: painful menstrual periods, abnormal vaginal bleeding, vaginal discharge or irritation, breast pain, mental/mood changes (e.g., depression, memory loss). Very unlikely but report promptly: one-sided weakness, vision problems, slurred speech, leg pain, swelling, chest pain, trouble breathing, lumps in breast, stomach pain, joint pain. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: undiagnosed abnormal vaginal bleeding, cancer (e.g., breast or ovary), blood clots, active/recent stroke or heart attack, liver disease. Tell your doctor your medical history (and family history), including: allergies, hysterectomy, gallbladder disease, high blood pressure, high blood levels of fats (triglycerides), asthma, migraine headaches, seizures, heart disease, kidney disease, diabetes, depression. Two-drug combination hormone replacement therapy (estrogen and progestin menopause HRT) can infrequently cause breast cancer, heart disease (CHD/MI), stroke, dementia, and blood clots in the lung (PE) or leg especially if used for a long period of time (greater than one year). Therefore, the risks of use of HRT for a long period of time must be discussed with your doctor . Use of two-drug HRT for short periods of time (less than one year) to relieve menopause symptoms may be considered. Discuss the risks and benefits with your doctor. Blood clots may be more likely to form during very long periods of sitting or if you are bedridden, as well as with certain types of surgery. If this applies to you, ask your doctor whether you should temporarily stop your medication. Cigarette smoking can increase the chance of blood clots, heart attacks, and strokes while using this product (especially in women past the age of 35). This product may cause a patchy, darkening of the skin on the face (melasma). Sunlight may intensify this darkening and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor or pharmacist regarding use of sunscreens and protective clothing. This product should not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. Both the estradiol and norethindrone acetate in this product are excreted into breast milk. Because of the potential risk to the infant, breast-feeding while using this product is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Tell your doctor of all nonprescription and prescription medication you may use, especially of: anti-seizure medications (e.g., barbiturates such as phenobarbital), "blood thinners" (anticoagulants such as heparins or warfarin), rifamycins (e.g., rifampin), corticosteroids (prednisone-like drugs), cholesterol-lowering drugs. This product can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, remove the patch. Contact your local poison control center or emergency room immediately. Symptoms of overdose may include nausea, vomiting, and vaginal bleeding.

NOTES: Do not share this product with others. Laboratory and/or medical tests (e.g., monthly breast self-exams, and yearly breast exams) should be performed to monitor for serious side effects.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not"double-up" the dose to catch up.

STORAGE: Store in the sealed foil pouch at room temperature below 77 degrees F (25 degrees C), away from light and moisture, for up to three months.

Developed by First DataBank, Inc., San Bruno, CA
Copyright 2004 by First DataBank, Inc.