Estrogens Cream – Vaginal

WARNING: Estrogens, alone or with another hormone (progestin), for replacement therapy after menopause have sometimes caused rare but serious side effects. Discuss the risks and benefits of hormone treatment and your personal health history with your doctor. Estrogens have been reported to increase the chance of endometrial cancer. Taking a progestin with estrogen decreases this risk. Tell your doctor immediately if you have any unusual vaginal bleeding. Estrogens may also increase your risk of ovarian cancer, stroke, dementia, and blood clots in the legs. Estrogen given with progestin can infrequently cause heart disease, stroke, blood clots, dementia, and breast cancer. Some of these risks appear to depend on the length of time this drug is used and the amount of estrogen per dose. Therefore, use this medication for the shortest possible time at the lowest effective dose to reduce the chance of serious side effects. If you need treatment only for vaginal menopause symptoms, products applied directly inside the vagina are preferred. Discuss the details with your doctor and check with him/her regularly to see if you still need to use this medication. Estrogen treatment alone does not appear to increase the risk of breast cancer when used for up to 7 years after menopause. However, talk to your doctor about the risks if you need to take estrogen for a longer period. Products that contain estrogen should not be used to prevent heart disease or dementia. If you use this drug for an extended period, you should have a complete physical exam at regular intervals or as directed by your doctor. See Notes section. USES: This medication contains female estrogen hormones and is usually given to women who no longer produce enough estrogen. It is an effective treatment for reducing vaginal menopause symptoms. HOW TO USE: Use this medication as prescribed. Follow the instructions and dosing schedule carefully. Fill the applicator with the medication according to directions. Insert the applicator high into the vagina and press the plunger to release the medication. Clean the applicator with warm soapy water and rinse well. Do not boil or use hot water to clean the applicator. Read the Patient Information Leaflet available from your pharmacist. Inform your doctor if your symptoms persist or worsen.

SIDE EFFECTS: Vaginal irritation, dizziness, headache, stomach upset, bloating, nausea, weight changes, changes in sex drive, and breast tenderness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these serious side effects occur: mental/mood changes, vision changes, swelling of hands or feet, breast lumps, unusual vaginal bleeding, unusual vaginal discharge/itching/odor, yellowing eyes or skin. Seek immediate medical attention if any of these very serious side effects occur: calf pain/swelling, severe headache, chest pain, trouble breathing, weakness on one side of the body, slurred speech. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it, or if you have any other allergies. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have undiagnosed abnormal vaginal bleeding, certain cancers, current/history of blood clots, or history of stroke or heart attack. Tell your doctor or pharmacist about your medical history, especially of family medical history, asthma, diabetes, seizures, migraine headaches, liver disease, heart disease, kidney disease, low thyroid hormone, hormone problem, abnormal calcium level in the blood, depression, high blood pressure during pregnancy, yellowing eyes or skin during pregnancy, womb problems, cholesterol or lipid problems, gallbladder disease, excessive weight gain, or certain blood disorder. If you will have surgery or will be confined to a chair or bed for a long time, notify your doctor beforehand. Special precautions may need to be taken. This drug may make you dizzy. Do not drive or do any activity that requires alertness until you are sure you can perform safely. Limit alcohol intake. This drug may cause a patchy darkening of the skin on the face. Sun exposure may intensify this darkening. Cigarette smoking can increase the chance of blood clots while using this medication. This medication must not be used during pregnancy. It is unknown if this drug passes into breast milk. Breast-feeding while using this medication is not recommended.

QUESTION

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of possible drug interactions. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use. This product can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medicine may be harmful if swallowed. Symptoms of overdose may include: severe nausea/vomiting or excessive vaginal bleeding. NOTES: Do not share this medication with others. Keep all medical and laboratory appointments. You should have a complete physical examination that includes blood pressure measurements and breast/pelvic examinations at regular intervals or as directed by your doctor. Follow your doctor’s instructions on how to examine your own breasts and report any lumps immediately. You should also be regularly screened for cervical cancer and have periodic mammograms as determined by your doctor. Consult your doctor for more details. To help manage hot flashes, keep a cool body temperature, limiting caffeine and alcohol, exercising regularly, and learning relaxation techniques may also help reduce hot flashes. Vaginal lubricants can help lessen discomfort during intercourse. MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. STORAGE: Store at room temperature below 86 degrees F away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.