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FEMRING
ESTRADIOL ACETATE - VAGINAL RING

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

ESTRADIOL ACETATE - VAGINAL RING

(ess-truh-DYE-all as-IH-tate)

COMMON BRAND NAME(S): Femring

WARNING: Estrogens have been reported to increase the chance of womb (endometrial) cancer in women who have been through menopause, especially in women with a uterus who receive estrogen-only hormone therapy. Estrogens may also increase the risk of cancer of the ovary or breast. Estrogen-containing products should not be used to prevent heart disease. Estrogen given in combination with another hormone (progestin) for replacement therapy can infrequently cause heart disease (e.g., heart attacks), stroke, dementia, serious blood clots (pulmonary embolism and deep venous thrombosis), and cancer of the breast. These risks appear to depend on the length of time this drug is used and the amount of estrogen per dose. Therefore, this medication should be used for the shortest possible length of time at the lowest effective dose, so you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Consult your doctor or pharmacist for details. If you use this drug for an extended period, you should be evaluated at least once a year. See Notes section. This medication is not effective in preventing or treating a tendency toward miscarriages (natural habitual abortion) nor the threat of miscarriage. This drug must not be used during pregnancy because its use may result in birth defects or cancer later in the child's life. See Precautions section.

Uses

This medication is a female hormone and is usually given to women who no longer produce the proper amount. It is used to reduce menopause symptoms (e.g., hot flashes, vaginal dryness). If you are only being treated for vaginal menopause symptoms, other products such as vaginal creams or tablets should be considered before this medication.

How To Use

Wash your hands before and after inserting the ring. Insert the ring into the upper third of the vagina as directed. Generally, the ring is left in place for 3 months and then removed and replaced with a new ring if therapy is continued. Do not leave a ring in place for longer than 3 months. Follow the dosing schedule carefully. Read the Patient Information Leaflet available from your pharmacist and learn all usage instructions in the product package. Ask your doctor or pharmacist if you are unclear about any of the information. When the ring is placed properly, you should not feel it and it will not interfere with sexual intercourse. If the ring moves into the lower part of your vagina, push it back into place with your finger. If the ring falls out of the vagina, rinse the ring with lukewarm water and re-insert. The ring is removed by hooking your finger through the ring and gently pulling it out. Discard the used ring in the trash container. Do not flush it down the toilet.

Side Effects

Dizziness, lightheadedness, headache, stomach upset, bloating, nausea, weight changes, increased/decreased interest in sex, and breast tenderness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. You may develop a vaginal yeast infection while using this medication. If this occurs, consult your doctor or pharmacist for treatment options. You may leave the ring in place if you are treating the vaginal infection locally or topically. Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., severe depression, memory loss), calf pain/swelling, sudden severe headache, chest pain, trouble breathing, one-sided weakness, slurred speech, vision changes (e.g., change in contact lens fit, loss of vision), breast lumps, swelling of hands or feet, changes in vaginal bleeding (e.g., spotting, breakthrough bleeding or prolonged bleeding), yellowing of eyes or skin, severe stomach pain or cramping. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

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 (e.g., breast cancer, especially non-metastatic type), blood clots, active/recent stroke, heart attack. Before using this medication, tell your doctor or pharmacist your medical history, especially of: family medical history (especially breast lumps and cancer), asthma, diabetes, seizures, migraine headaches, liver disease, heart disease (e.g., high blood pressure, heart attacks, congestive heart failure), kidney disease, low thyroid hormone (hypothyroidism), abnormal calcium level in the blood, depression, high blood pressure during pregnancy (toxemia), yellowing of eyes and skin (cholestatic jaundice) during pregnancy or with past estrogen use, womb problems (e.g., uterine fibroids, endometriosis), vaginal conditions (e.g., recurring vaginal infections, prolapse, stenosis), cholesterol or lipid problems, gallbladder disease, excessive weight gain, certain blood disorder (porphyria), any allergies. If you will be having surgery or will be confined to a chair or bed for a long period of time (e.g., a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are using this drug. This drug may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. This drug may cause a patchy darkening of the skin on the face (melasma). Sunlight may intensify this darkening and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding use of sunscreens and protective clothing. Cigarette smoking can increase the chance of blood clots while taking this medication (especially in women over the age of 35). This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This medication may pass into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended.

Drug Interactions

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: other vaginal products, corticosteroids (e.g., prednisone). Also tell your doctor or pharmacist of drugs you may use which affect certain liver enzymes (CYP450-3A4 enzymes) such as: azole antifungals (e.g., ketoconazole, itraconazole), carbamazepine, hydantoins (e.g., phenytoin), macrolide antibiotics (e.g., erythromycin, clarithromycin), phenobarbital, rifamycins (e.g., rifampin), ritonavir, St. John's wort. This product can affect the results of certain lab tests. 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: severe nausea/vomiting or excessive vaginal bleeding.

Notes

Do not share this medication with others. Keep all appointments with your doctor and the laboratory. You should have a complete physical examination, including blood pressure measurements, breast and pelvic examinations, and a PAP test (for vaginal cancer), at least once a year. You should also have periodic mammograms as determined by your doctor. Follow your doctor's instructions for examining your own breasts, and report any lumps immediately.

Missed Dose

Not applicable. However, if you have not inserted a new ring after 3 months, contact your doctor to establish a new schedule for using this medication.

Storage

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage from 59 to 86 degrees F (15 to 30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.