estradiol acetate 0.05 mg/24 hr vaginal ring

Generic name:
Estradiol acetate ring - vaginal

Pronunciation
(ES-tra-DYE-ol AS-e-tate)

Brand name(s)
Femring

Estrogens, either used alone or with another hormone (progestin), have rarely caused very serious side effects. Discuss the risks and benefits of hormone treatment with your doctor. Estrogens should not be used to prevent heart disease or dementia.

Estrogens can increase the risk of cancer of the uterus (endometrial cancer). Taking a progestin as directed by your doctor can help decrease this risk. Tell your doctor right away if you have any unusual vaginal bleeding.

In postmenopausal women, estrogens, taken with or without a progestin, increase the risk of cancer of the breast/ovaries, stroke, dementia, and serious blood clots. When used along with a progestin, estrogens also increase the risk of heart disease (such as heart attacks).

The risk for serious side effects may depend on the dose of estrogen and the length of time it is used. This medication should be used at the lowest effective dose and for the shortest amount of time. Discuss the use of this medication with your doctor and check with him/her regularly (for example, every 3 to 6 months) to see if you still need to take this medication. If you will be taking this medication long-term, you should have regular complete physical exams (for example, once a year) as directed by your doctor. See also Notes section.

This medication is a hormone (estrogen). It is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). These symptoms are caused by the body making less estrogen. If you are using this medication to treat symptoms only in and around the vagina, other products applied directly inside the vagina (such as cream, vaginal tablet) should be considered before this product.

Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. Learn how to use this medication properly. If you have any questions, ask your doctor or pharmacist.

Wash and dry your hands before handling the ring. Insert the ring high into the vagina as directed. The ring is usually left in place for 3 months and then removed and replaced with a new ring if treatment is to be continued. Do not leave a ring in place for longer than 3 months. Follow the dosing schedule carefully.

The dosage is based on your medical condition and response to treatment.

If the ring is put in properly, you should not be able to feel it and it will not interfere with sexual intercourse. If you are able to feel the ring or feel slight discomfort from the ring, it may mean that the ring is not high enough. Gently push the ring higher with your finger.

If the ring falls out of the vagina, rinse the ring with lukewarm water and put it back into the vagina. Contact your doctor if the ring falls out often.

The ring is removed by hooking your finger through the ring and gently pulling it out. Contact your doctor if you have trouble removing the ring. Discard the used ring in the trash. Do not flush it down the toilet.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

Nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• nausea/vomiting that doesn't stop
• mental/mood changes (such as depression, memory loss)
• breast lumps
• unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding)
• increased or new vaginal irritation/itching/odor/discharge
• severe stomach/abdominal pain
• yellowing eyes/skin
• dark urine
• swelling hands/ankles/feet
• increased thirst/urination

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). Get medical help right away if you have:

• chest/jaw/left arm pain
• unusual sweating
• sudden/severe headaches
• weakness on one side of the body
• confusion
• trouble speaking
• sudden vision changes
• pain/swelling/warmth in the groin/calf
• shortness of breath/rapid breathing
• sudden dizziness/fainting

Vaginal rings have rarely caused a very serious (possibly fatal) bacterial infection (toxic shock syndrome-TSS). Remove this product and get medical help right away if you have any symptoms of toxic shock syndrome, including:

• high fever
• sudden dizziness/fainting
• unusual muscle pain
• sunburn-like rash
• diarrhea

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using estradiol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• vaginal bleeding of unknown cause
• certain cancers (such as breast cancer, cancer of the uterus/ovaries)
• blood clots (such as in the legs, eyes, lungs)
• blood clotting disorders (such as protein C or protein S deficiency)
• stroke
• heart disease (such as heart attack)
• liver disease
• kidney disease
• family medical history (especially breast lumps, cancer, blood clots)
• family or personal history of a certain swelling disorder (angioedema)
• blood clotting disorders (such as protein C or protein S deficiency)
• high blood pressure
• diabetes
• high cholesterol/triglyceride levels
• obesity
• lupus
• underactive thyroid (hypothyroidism)
• mineral imbalance (low or high level of calcium in the blood)
• a certain hormone problem (hypoparathyroidism)
• uterus problems (such as fibroids, endometriosis)
• gallbladder disease
• asthma
• seizures
• migraine headaches
• mental/mood disorders (such as dementia, depression)
• a certain blood disorder (porphyria)
• frequent vaginal infections

Do not smoke or use tobacco. Estrogens combined with smoking further increases your risk of stroke, blood clots, high blood pressure, and heart attack, especially in women older than 35.

Tell your doctor if you just had or will be having surgery, or if you will be confined to a chair or bed for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using an estrogen product. You may need to stop this medication for a time or take special precautions.

This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

If you get a vaginal infection while using this ring, you may leave the ring in place while the infection is being treated. Consult your doctor or pharmacist for treatment options.

This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away.

This medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• aromatase inhibitors (such as anastrozole, exemestane, letrozole)
• fezolinetant
• fulvestrant
• ospemifene
• raloxifene
• tamoxifen
• toremifene
• tranexamic acid

This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe nausea/vomiting, unusual vaginal bleeding.

Do not share this medication with others.

Regular complete physical exams which include lab and/or medical tests (such as blood pressure, breast exam/mammogram, pelvic exam, Pap smear) should be done while you are using this medication. Follow your doctor's instructions for examining your breasts, and report any lumps right away. Keep all medical and lab appointments. Consult your doctor for more details.

Preventing or controlling high blood pressure, high cholesterol, and diabetes can help to reduce your chances of heart disease and stroke. Lifestyle changes that can help to control or prevent these diseases include reducing stress, eating a low fat/salt diet, losing weight if overweight, exercising regularly, and stopping smoking. Keep your mind active with mental exercises (such as reading, solving crossword puzzles) to help prevent dementia. Talk to your doctor about lifestyle changes that might benefit you.

Lifestyle changes that may help reduce hot flashes include stopping smoking, dressing lightly or in layers, avoiding/limiting certain foods (spicy foods, caffeine, alcohol), reducing stress, and exercising regularly.

Not applicable. However, if you have not inserted a new ring after 3 months, ask your doctor or pharmacist right away for a new dosing schedule.

Store at room temperature. Do not remove the ring from the pouch until ready for use. Keep all medications 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.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.