Estradiol Topical Spray (ESTRADIOL SPRAY - TRANSDERMAL)

Instructions

DO NOT take this medicine by mouth.

The first time you open a new pump, you need to get it ready to use. Leave the cover on the pump and push the pump all the way down three times. The pump is now ready to use. This process is called priming the pump.

Apply the medicine to clean, intact, dry skin on the inside of the forearm between the elbow and the wrist. Do not use the medicine on any other area of the body.

Remove the cover. Hold the pump upright and place the pump flat against the skin.

If your dose is more than 1 spray, do not use the same area. Use the area next to it instead.

Do not rub the medicine into the skin.

Keep the medicine at room temperature. Avoid heat and direct light.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

Avoid getting this medicine inside the vagina.

Use only on normal looking skin. Avoid skin that is red, scraped, or damaged.

Avoid using on face, arm pits, and groin area.

Wash your hands before and after handling this medicine.

Do not touch your eyes, nose or mouth after handling the medicine.

If medicine gets in your eyes, rinse well with cool water.

The area should be covered by clothing.

Allow treated area to completely dry (about 10 minutes) before covering with clothing.

Do not shower, bathe, or swim for at least 1 hour after applying the medicine.

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.

Keep track of how many times you use the pump. Do not use it more than the total number of doses shown on the package.

This medicine is flammable. Do not use it near heaters, open flame or while smoking. Do not crush, puncture, or burn container.

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 for serious blood clots. Speak with your doctor about the benefits and risks from using this medicine.

This medicine is not safe for children. Wash the area where you applied this medication thoroughly before you have skin to skin contact with another person. Keep clothing that has touched the medicine away from children and pets until they can be washed in warm water.

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.

This medicine passes into breast milk. Ask your doctor before breastfeeding.

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

Women who are pregnant or in their childbearing years should not touch or handle this medicine. This medicine can be absorbed through the woman's skin and harm the unborn baby.

If you forget to take a dose on time, take it as soon as you remember. If it is less than 12 hours to the next dose, do not take the dose. Return to your normal dosing schedule. Do not take 2 doses at one time.

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

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

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
• brown colored patches on the face
• 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
• depression or feeling sad
• 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 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.