"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
IMPORTANT: 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.
ESTRADIOL ACETATE RING - VAGINAL
COMMON BRAND NAME(S): Femring
WARNING: 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 can increase the risk of cancer of the ovaries, stroke, dementia, and serious blood clots in the legs. Estrogens alone do not appear to increase the risk of breast cancer when used for up to 7 years. Estrogen, when used with a progestin, can increase the risk of heart disease (such as heart attacks), stroke, serious blood clots in the lungs/legs, dementia, and cancer of the breast/ovaries.
The risk for serious side effects may depend on the dose of estrogen and the length of time it is used. Therefore, 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.
USES: This medication is a female 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.
HOW TO USE: 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 improve or if it worsens.
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