estradiol and norethindrone (transdermal) (Combipatch)

Brand Names: Combipatch

Generic Name: estradiol and norethindrone (transdermal)

• What are estradiol and norethindrone (Combipatch)?
• What are the possible side effects of estradiol and norethindrone (Combipatch)?
• What is the most important information I should know about estradiol and norethindrone (Combipatch)?
• What should I discuss with my healthcare provider before using estradiol and norethindrone (Combipatch)?
• How should I use estradiol and norethindrone (Combipatch)?
• What happens if I miss a dose (Combipatch)?
• What happens if I overdose (Combipatch)?
• What should I avoid while using estradiol and norethindrone (Combipatch)?
• What other drugs will affect estradiol and norethindrone (Combipatch)?
• Where can I get more information (Combipatch)?

Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body.

Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Estradiol and norethindrone transdermal (skin patch) is a combination medicine used to treat menopause symptoms such as hot flashes and vaginal changes (itching, burning, dryness). This medicine is also used before menopause to treat a lack of estrogen caused by conditions such as hypogonadism, primary ovarian failure, or surgical removal of the ovaries.

Estradiol and norethindrone may also be used for purposes not listed in this medication guide.

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 at once 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 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.

You should not use this medicine if you have: undiagnosed vaginal bleeding, liver disease, a bleeding disorder, if you will have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Do not use if you are pregnant.

This medicine may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.

Using this medicine can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries. Estradiol and norethindrone should not be used to prevent 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 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, or jaundice caused by pregnancy or taking hormones;
• kidney disease;
• hereditary angioedema (an immune system disorder);
• lupus;
• asthma;
• epilepsy or other seizure disorder;
• migraines;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• gallbladder disease;
• endometriosis or uterine fibroid tumors;
• a thyroid disorder; or
• high levels of calcium levels in your blood.

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

This medicine lowers the hormone needed to produce breast milk and can slow breast milk production. Tell your doctor if you are breast-feeding.

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

Do not wear more than one patch at a time. Never cut a skin patch.

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

Estradiol and norethindrone may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to help lower this risk. Report any unusual vaginal bleeding right away.

If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon 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 patches at room temperature away from moisture and heat. Keep each patch in its pouch until you are ready to use it.

After removing a skin patch: fold it in half with the sticky side in, and place in a trash container out of the reach of children and pets. Do not flush an estradiol and norethindrone skin patch down a toilet.

QUESTION

Which of the following are methods for contraception? See Answer

Apply the next patch as soon as you remember, and follow your regular schedule for changing the patch. Do not apply two patches at one time.

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

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using estradiol and norethindrone.

Grapefruit may interact with estradiol and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid using 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 at the same time. Some drugs can affect your blood levels of other drugs you take, 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 your current medicines and any medicine you start or stop using.

Your pharmacist can provide more information about estradiol and norethindrone transdermal.

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