Estradiol

ESTRADIOL – VAGINAL TABLETS (ess-truh-DYE-all)

COMMON BRAND NAME(S): Vagifem

WARNING: This drug could increase the chance of womb (endometrial) cancer in women who have been through menopause. This risk appears to depend on the length of time this drug is used and the amount of estrogen per dose. Therefore, the lowest estradiol dose that relieves vaginal symptoms should be used for the shortest period of time, as determined by you and your doctor. If you use this drug for an extended period, your doctor should check you at least every 6 months. If you experience abnormal vaginal bleeding, notify your doctor immediately.

USES: Estradiol is used to treat vaginal symptoms associated with the change of life (menopause). This medication is not indicated for stopping breast milk production after childbirth.

HOW TO USE THIS MEDICATION: Insert the applicator into the vagina as directed and push the plunger to release the medication. Insert one tablet vaginally once daily for the first two weeks and then one tablet twice weekly; or as directed by your doctor. Read and learn the patient instruction leaflet provided by your pharmacist. Consult your pharmacist.

SIDE EFFECTS: Headache or vaginal spotting/discharge may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur:

PRECAUTIONS: Tell your doctor your medical history, especially of: family medical history (e.g., breast cancer), abnormal breast exam, gallbladder or bone disease, heart problems (e.g., coronary artery disease), strokes (cerebral vascular disease), liver or kidney problems, diabetes, asthma, seizures, migraine headaches, history of yellowing of skin or eyes (jaundice) during pregnancy, vaginal infection, high blood pressure, allergies. This medication is not recommended for use if you have the following medical conditions: estrogen-related cancer (e.g., breast, endometrial); abnormal vaginal bleeding; blood disorder (porphyria); a history of blood vessel problems (e.g., thrombophlebitis) or blood clots related to estrogen use; or recent blood clots. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Tell your doctor or pharmacist of all prescription and nonprescription drugs you may use. This product can affect the results of certain laboratory tests (e.g., prothrombin time, thyroid). Make sure laboratory personnel and your doctors know you use this drug. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. This medicine may be harmful if swallowed. Symptoms of overdose may include nausea.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., PAP smears, breast exams) may be performed to monitor your progress. Keep regular medical appointments. Learn the self-breast exam technique and check them monthly.

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 between 59 and 86 degrees F (15 and 30 degrees C) away from light and moisture.