Brand Combipatch

This medication is used to reduce menopause symptoms. It helps reduce episodes of flushing and sweating of the upper body and face, commonly called hot flashes. It also helps treat dryness, itching, and burning around the vagina. These symptoms occur when a woman's body no longer makes the usual amount of female hormone (estrogen) such as in women after menopause and in young women who have had their ovaries removed or who have a condition called primary ovarian failure. This medication is a combination of 2 female hormones: an estrogen (estradiol) and a progestin (norethindrone). A progestin is added to estrogen replacement therapy to reduce the risk of cancer of the uterus. A woman who has had her uterus removed does not need progestin and should not be treated with this combination medication. If you need treatment only for vaginal menopause symptoms (e.g., vaginal dryness), products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected.

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.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; 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: vaginal bleeding of unknown cause, certain types of cancer (breast, ovary, uterus), current/history of blood clots, history of stroke or heart attack, liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: family medical history (including blood clots, breast lumps/cancer), asthma, diabetes, seizures, migraine headaches, heart disease (e.g., high blood pressure, congestive heart failure), kidney disease, underactive thyroid (hypothyroidism), a certain hormone problem (hypoparathyroidism), abnormal calcium level in the blood, mental/mood disorders (e.g., depression, memory loss), high blood pressure during pregnancy (toxemia), yellowing eyes/skin (cholestatic jaundice) during pregnancy or with past estrogen use, uterus problems (e.g., uterine fibroids, endometriosis), high blood cholesterol/fat (triglyceride) levels, gallbladder disease, obesity, certain blood disorder (porphyria), lupus. This drug may make you dizzy or lightheaded. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Consult your eye doctor if these problems occur. This drug may cause a patchy darkening of the skin on the face (melasma). Sunlight may worsen this darkening. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors. Do not smoke cigarettes or use tobacco. Smoking/using tobacco while using this medication further increases your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35. If you will be having surgery or will be confined to a chair or bed for a long time (such as on a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are using this drug because of the increased risk for blood clots. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. This medication is not effective for preventing a miscarriage and should not be used for this purpose. Small amounts of this medication pass into breast milk. This drug may reduce the quality and amount of breast milk. Consult your doctor before breast-feeding.

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 the dose to catch up.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. This drug should not be used with the following medications because very serious interactions may occur: anastrozole, exemestane. If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting estradiol/norethindrone. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: corticosteroids (e.g., prednisone), raloxifene, tamoxifen, warfarin, drugs affecting liver enzymes that remove estrogens from your body (such as azole antifungals including itraconazole, macrolide antibiotics including erythromycin, rifamycins including rifabutin, St. John's wort, certain anti-seizure medications including carbamazepine, phenobarbital, phenytoin). This product can affect the results of certain lab tests. Make sure laboratory personnel and all your doctors know you use this drug. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

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.

Store the US product in the sealed foil pouch at room temperature below 77 degrees F (25 degrees C) away from light, heat, and moisture. Do not store in the bathroom. Do not use if the expiration date on the prescription label has passed. The Canadian product may be stored in the sealed foil pouch at room temperature between 68-77 degrees F (20-25 degrees C) away from light, heat, and moisture. The patches should be used within 6 months or before the expiration date, whichever comes first. If the patches are stored in the refrigerator, they should be used before the expiration date and should be allowed to reach room temperature before applying so the patch will stick properly. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.