Estradiol/Norethindrone Transdermal System (ESTRADIOL/NORETHINDRONE ACETATE PATCH - TRANSDERMAL)

Instructions

DO NOT take this medicine by mouth.

Avoid placing the patch near the breast.

Keep this medicine in the refrigerator.

Follow the instructions on the package to use this medicine correctly.

This patch should not be cut.

Wash your hands before and after handling this medicine.

Remove old patch before applying new one. Change the location of the new patch.

Do not use if the pouch containing the medicine is torn or damaged.

Ask your doctor or pharmacist about locations on your body where this patch can be used.

Remove the plastic liner that protects the sticky side of the patch before applying to the skin.

Before applying the patch, clean the skin with water. Gently pat dry. Do not rub the skin. Do not use soap, oils, or alcohol. Do not shave the hair. It irritates the skin. If needed, cut the hair close to the skin with scissors.

Apply the patch to a clean, dry, hairless area. Avoid skin that is red, scraped, or damaged.

Press patch firmly for a few seconds to make sure it sticks. If it does not, talk to your doctor or pharmacist. Do not cover with a bandage or tape unless your doctor or pharmacist says to.

After removing the patch, fold it together and discard it out of reach of children and pets, NOT in the toilet.

Use a patch disposal unit to seal close the used patch before putting it into the trash.

Avoid getting the medicine in the eyes, nose, or mouth. Wash your hands after touching patch.

Put the patch on a different area each time. Wait at least one week before using the same location again.

You can bathe, swim or shower while wearing the patch.

Clothing should be worn over the patch.

This medicine may cause dark patches to appear on your face. Avoid sunlight and use sunscreen lotion to minimize further darkening of these skin patches.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Cautions

This medicine may increase the risk of cancer. Ask your doctor about the benefits and risks.

This medicine is associated with an increased risk of blood clots, heart attack, and stroke. Contact your doctor immediately if you experience leg pain or swelling, difficulty breathing, chest or jaw pain, severe headache, one-sided weakness or slurred speech.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

Avoid smoking while on this medicine. Smoking may increase your risk for stroke, heart attack, blood clots, high blood pressure, and other diseases of the heart and blood vessels.

Ask your doctor how to do a breast self-exam. Check monthly. Report any changes to your doctor.

Talk to your doctor about getting a complete physical exam every year while on this medicine.

Do not breastfeed while on this medicine.

Do not use this medicine if you are pregnant. If you become pregnant, contact your doctor immediately.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Patch should be removed before having an MRI scan to avoid serious burns.

Do not share this medicine with anyone who has not been prescribed this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• bloating
• breast pain or swelling
• headaches
• nausea and vomiting
• skin irritation where medicine is applied
• stomach upset or abdominal pain
• weight gain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• breast lumps
• chest or jaw pain
• changes in memory, mood, or thinking
• swelling of the legs, feet, and hands
• fainting
• severe or persistent headache
• sudden leg pain, swelling, warmth or redness
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• shortness of breath
• symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
• persistent or unusual thirst
• increased urinary frequency
• cramping of the uterus or bleeding from the vagina
• vaginal bleeding or spotting between periods
• vaginal itching or discharge
• severe or persistent vomiting

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.