Estradiol and norethindrone (transdermal)

Estradiol and norethindrone (transdermal) is a combination medicine used to treat symptoms of menopause, including hot flashes and changes in the vagina. Estradiol and norethindrone (transdermal) is also used before menopause to treat low estrogen levels due to conditions like hypogonadism, primary ovarian failure, or surgical removal of the ovaries.

Estradiol and norethindrone may also be used for other reasons not mentioned in this medication guide.

Using estradiol and norethindrone can raise your chances of getting blood clots, having a stroke, experiencing a heart attack, or developing cancer of the breast, uterus, or ovaries. Estradiol and norethindrone should not be used to stop heart disease, stroke, or dementia.

You should not use this medicine if you are allergic to estradiol or norethindrone, or if you have:

• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease;
• a bleeding disorder;
• a history of heart attack, stroke, or blood clot; or
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

Do not use estradiol and norethindrone if you have had your uterus (womb) removed.

Do not use estradiol and norethindrone if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Using this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Estradiol and norethindrone should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

Tell your doctor if you have ever had:

• heart disease;
• liver problems;
• kidney disease;
• angioedema (swelling of face and tongue);
• lupus;
• asthma;
• diabetes;
• epilepsy or other seizure disorder;
• migraines;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• gallbladder disease;
• endometriosis;
• high levels of calcium levels in your blood;
• a thyroid disorder; or
• if you have any unusual vaginal bleeding.

Using estradiol and norethindrone may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Remove the skin patch and call your doctor right away if you have:

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed;
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• swelling or tenderness in your stomach;
• jaundice (yellowing of the skin or eyes);
• unusual vaginal bleeding, pelvic pain;
• a breast lump;
• memory problems, confusion, unusual behavior; or
• high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects of estradiol and norethindrone may include:

• nausea, vomiting, stomach cramps;
• bloating, swelling, weight gain;
• breast pain;
• light vaginal bleeding or spotting;
• vaginal itching or discharge;
• headache;
• thinning scalp hair; or
• redness or irritation where the patch is worn.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

If you need major surgery or will be on long-term bed rest, you may need to stop using estradiol and norethindrone for a short time. Any doctor who treats you should know that you are using estradiol and norethindrone.

Your doctor should check your progress on a regular basis to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms while using estradiol and norethindrone.

Store estradiol and norethindrone in the refrigerator in the foil pouch, do not freeze. Take the medicine out of the refrigerator and let it reach room temperature before application.

Apply the next patch as soon as you remember, and continue with your usual schedule for changing the patch. Do not apply two patches at the same time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Do not smoke. It can significantly raise your risk of blood clots, stroke, or heart attack while using estradiol and norethindrone.

Grapefruit may interact with estradiol and cause unwanted side effects. Do not use grapefruit products.

Do not use creams, lotions, or powders on the skin where you apply the patch, or it may not stick to your skin.

Sometimes it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medications less effective.

Other drugs may affect estradiol and norethindrone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.