Generic Name: Estradiol
Evamist Spray should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens have been shown to increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use Evamist Spray. Talk with your doctor if you have questions about the benefits and risks of using Evamist Spray.
Evamist Spray should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Evamist Spray.
Evamist Spray is used for:
Treating certain moderate to severe symptoms of menopause (eg, hot flashes).
Evamist Spray is an estrogen hormone. It works by replacing estrogen in the body when it no longer produces enough on its own.
Do NOT use Evamist Spray if:
- you are allergic to any ingredient in Evamist Spray
- you are pregnant or suspect you may be pregnant
- you have undiagnosed abnormal vaginal bleeding
- you have a history of blood clots (eg, in the lungs, legs, eyes); endometrial, cervical, or vaginal cancer; estrogen-dependent growths; breast cancer; or liver problems
- you have had a heart attack or stroke within the past 12 months
Contact your doctor or health care provider right away if any of these apply to you.
Before using Evamist Spray:
Some medical conditions may interact with Evamist Spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of endometriosis, growths in the uterus, abnormal mammogram, abnormal vaginal bleeding, a lump in the breast, or fibrocystic breast disease, or if a family member has had breast cancer
- if you have dementia or other memory problems, or abnormal blood calcium levels
- if you have a history of asthma, cancer, high blood cholesterol or lipid levels, diabetes, heart problems, high blood pressure, heart attack or stroke, kidney problems, liver tumor, mental or mood problems (eg, depression), underactive thyroid, migraine headaches, gallbladder or pancreas problems, seizures (eg, epilepsy), lupus, chorea, or the blood disease porphyria
- if you smoke, are very overweight, or will be having surgery
- if you have a history of yellowing of the eyes or skin during pregnancy or with past estrogen use
- if a member of your family has a history of blood clots (eg, in the legs, lungs, eyes), diabetes, lupus, or obesity
- if you have had your uterus removed (hysterectomy)
Some MEDICINES MAY INTERACT with Evamist Spray. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Azole antifungals (eg, ketoconazole), HIV protease inhibitors (eg, ritonavir), or macrolide antibiotics (eg, erythromycin) because they may increase the risk of Evamist Spray's side effects
- Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), rifampin, or St. John's wort because they may decrease Evamist Spray's effectiveness
- Thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Evamist Spray
This may not be a complete list of all interactions that may occur. Ask your health care provider if Evamist Spray may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Evamist Spray:
Use Evamist Spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Evamist Spray. Talk to your pharmacist if you have questions about this information.
- Evamist Spray is applied to the inside of the forearm, between the elbow and the wrist. Do not apply Evamist Spray to any other area of the body besides the forearm.
- Apply Evamist Spray to clean, intact skin only. Be sure the area is completely dry before applying Evamist Spray.
- Do not apply Evamist Spray to skin that is irritated or broken. Do not apply it to your face, in or around the vagina, or to your breasts.
- You will need to prime the pump before using it for the first time. To prime the pump, leave the cover on, hold the bottle in an upright position, and press the pump completely down 3 times. The pump is now ready for use.
- Hold the applicator upright and rest the plastic cone flat against the skin of your forearm. Be sure there are no gaps between the cone and your skin. Press the pump firmly and fully 1 time. Do NOT massage or rub the medicine in.
- If you are applying more than 1 spray, move the cone to an area of the skin next to but not touching the previous area. Then press the pump firmly and fully again.
- Replace the protective cover over the pump after use.
- Wash your hands with soap and water after using Evamist Spray.
- Allow the medicine to dry for at least 2 minutes before dressing.
- Do not wash the application area for 30 minutes after you apply Evamist Spray.
- Do not allow others to apply Evamist Spray for you. Do not allow others to come into contact with the application site for at least 30 minutes after you apply Evamist Spray. If someone else comes into contact with Evamist Spray, have them wash the area with soap and water right away.
- This pump contains enough medicine for 56 sprays (not counting the 3 sprays used to prime the pump). Throw away the pump after 56 sprays have been used, even if there is still medicine left in the pump. It may no longer give the correct amount of medicine with each dose.
- Use Evamist Spray at the same time each day.
- If you miss a dose of Evamist Spray, use it as soon as possible. If your next dose is less than 12 hours away, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Evamist Spray.
Important safety information:
- Evamist Spray may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Evamist Spray with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Evamist Spray is for external use only. Do not get it in your eyes, nose, vagina, or mouth. If you get it in any of these areas, rinse right away with warm clean water.
- Check with your doctor before you apply sunscreen to the application site while you are using Evamist Spray.
- Evamist Spray is flammable. Avoid fire, flame, or smoking until the medicine has dried on your skin.
- Eating grapefruit or drinking grapefruit juice may increase the risk of Evamist Spray's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Evamist Spray.
- Tell your doctor or dentist that you take Evamist Spray before you receive any medical or dental care, emergency care, or surgery. If possible, Evamist Spray should be stopped at least 4 to 6 weeks before surgery or any time you might be confined to a bed or chair for a long period of time (such as a long plane flight, car ride, bedrest, or illness).
- Evamist Spray may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or wear protective clothing when exposed to the sun, sunlamps, or tanning booths.
- If you wear contact lenses and you develop problems with them, contact your doctor.
- Diabetes patients - Evamist Spray may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Evamist Spray may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Evamist Spray.
- Lab tests and medical exams, including breast exams, mammograms, Pap tests, physicals, and blood pressure, may be performed while you use Evamist Spray. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Examine your breasts monthly as directed by your doctor. Report any lumps right away.
- Evamist Spray should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Evamist Spray if you are pregnant. If you think you may be pregnant, contact your doctor right away. Evamist Spray is found in breast milk. Do not breast-feed while you are taking Evamist Spray.
Possible side effects of Evamist Spray:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Breast pain or tenderness; headache; mild hair loss; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blurred or double vision, vision loss, or other vision changes; breast lump or discharge; calf or leg pain or swelling; chest pain; confusion; coughing up blood; fainting; memory problems; mental or mood changes (eg, depression); migraine headache; numbness of an arm or leg; one-sided weakness; persistent or recurring abnormal vaginal bleeding; severe or persistent headache or dizziness; severe or persistent stomach pain, nausea, or vomiting; shortness of breath; slurred speech; swelling of the hands, legs, or feet; vaginal discharge, itching, or odor; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include abnormal vaginal bleeding; or severe or persistent nausea or vomiting.Proper storage of Evamist Spray:
Store Evamist Spray at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom or near an open flame. Do not use Evamist Spray after the expiration date. Keep Evamist Spray out of the reach of children and away from pets.
- If you have any questions about Evamist Spray, please talk with your doctor, pharmacist, or other health care provider.
- Evamist Spray is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Evamist Spray. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
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