When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to estradiol, or if you have liver disease, breast cancer, or certain other types of cancer. Do not use it if you have a history of blood clotting problems, or if you had a heart attack or stroke. Do not use this medicine if you may be pregnant, or if you have unusual vaginal bleeding that has not been checked by your doctor.

How to Use This Medicine:
Liquid Mixture, Gel/Jelly, Spray

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. This medicine is usually applied once a day, at the same time each day.
• Use this medicine only on your skin. Rinse it off right away if it gets on a cut or scrape. Do not get the medicine in your eyes, nose, or mouth.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Wash your hands with soap and water before and after you use this medicine.
• To use the emulsion:
  
  • Apply the emulsion to your legs. The usual daily dose is 2 foil pouches, 1 for each leg.
  • Cut or tear open the first pouch at the notches near the top. Squeeze out all of the medicine from the pouch onto the top of your left thigh. Rub the medicine thoroughly into your thigh and calf, for about 3 minutes. Repeat these steps to apply the medicine in the second pouch to the right thigh and calf.
  • Allow the medicine to dry completely before you get dressed. Wait at least 25 minutes before you put on sunscreen.
• To use the gel:
  
  • Gel pump: You get the correct dose of estradiol each time you press the pump. You may need to prime the pump by pumping 3 times (EstroGel®) or 10 times (Elestrin™) the first time you use it. Follow the patient instructions for the container you use. After you prime the pump, do not press the pump more than 1 time each time you use it.
  • Apply the gel to clean, dry, and unbroken skin. Spread the gel as thinly as possible over the entire area on the inside and outside of 1 arm from your wrist to your shoulder. Do not apply the medicine directly to your breasts or in or around your vagina.
  • Do not allow others to come in contact with the area of skin where you applied the gel for at least 1 hour after you use the medicine. Do not allow others to apply the gel for you. Allow the medicine to dry for at least 5 minutes before you get dressed.
  • Apply sunscreen at least 25 minutes after using Elestrin™ gel. Avoid applying sunscreen on the same application site for 7 days or more.
  • Gel packet: Cut or tear the Divigel® packet. Squeeze the packet contents onto your upper thigh. Gently spread the gel over your upper thigh, covering a space about the size of 2 palm prints. You do not need to massage or rub in the gel. Allow the gel to dry completely before you put on clothes. Alternate between your right and left upper thigh each day.
  • Do not allow others to come in contact with the area of skin where you applied the gel for at least 1 to 2 hours after you use the medicine. Do not allow others to apply the gel for you.
• To use the spray:
  
  • The spray form comes in an applicator that delivers the same amount of estradiol with each spray. You need to prime the pump of a new spray applicator before you use it. Hold the spray upright and pump it 3 times. You only need to prime the pump the first time you use a new spray applicator.
  • Apply the medicine to clean, dry, and unbroken skin on the inside of your forearm between the elbow and the wrist. Do not apply the medicine directly to your breasts or in or around the vagina.
  • Allow the medicine to dry for at least 2 minutes before you get dressed. Wait at least 1 hour before you wash your skin.
  • If your doctor tells you to increase your dose, move the applicator to an area of the skin next to your previous application site before you apply the next dose. Do this for each spray.
  • Do not rub Evamist® spray into your skin.
  • Always place the protective cover back on the applicator.
  • Do not use the applicator for more than 56 sprays.
  • Apply sunscreen at least 1 hour before you apply Evamist®.
• The estradiol gel and spray are flammable. Do not use these medicines near an open flame or while smoking.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how estradiol works. Tell your doctor if you are using St John's wort, carbamazepine, clarithromycin, erythromycin, itraconazole, ketoconazole, phenobarbital, rifampin, ritonavir, thyroid medicine, or a blood thinner (such as warfarin).
• Do not put cosmetics or skin care products on the treated skin.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Pregnancy after menopause is not likely, but if you think you could be pregnant, tell your doctor. This medicine could harm an unborn baby.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, asthma, diabetes, edema (body swelling), endometriosis, epilepsy, migraine headaches, porphyria, lupus, thyroid problems, heart disease, high blood pressure, high cholesterol or triglycerides, inherited angioedema, or a history of cancer. Tell your doctor if you had liver problems caused by pregnancy or estrogen.
• This medicine may cause the following problems:
  
  • Higher risk of heart attack, stroke, or blood clots
  • Higher risk of endometrial cancer, breast cancer, or uterine cancer
  • Gallbladder disease
  • Higher risk of dementia
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results. You may need to stop using this medicine before you have surgery or if you need to stay in bed for a long time.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments. You should have regular exams and mammograms as directed by your doctor.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.
• Do not allow children or pets to touch the skin where you applied the medicine. If this happens, wash the child or pet's skin with soap and water.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Breast lumps
• Chest pain, trouble breathing, or coughing up blood
• Loss of vision, double vision, or other vision changes
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Sudden and severe stomach pain, with or without nausea, vomiting, fever, and lightheadedness
• Swelling in your hands, ankles, or feet
• Unusual vaginal bleeding or heavy bleeding

If you notice these less serious side effects, talk with your doctor:

• Changes in weight or hair growth
• Headache
• Nausea, vomiting, or stomach cramps
• Runny or stuffy nose, sore throat, or fever
• Skin redness or itching where the medicine is applied
• Swollen or tender breasts

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088