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Product Information

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body. Dosing Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Adults—At first, 4 micrograms (mcg) or one insert into the vagina once a day for 2 weeks, followed by one insert 2 times a week (every 3 to 4 days). Your doctor may adjust your dose as needed. Once the ring is in place inside your vagina, you should not be able to feel it. If you feel uncomfortable, the ring may not be inserted far enough. Gently push the ring farther into your vagina. If you feel pain, talk to your doctor.Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

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), unusual vaginal irritation/ itching/odor/discharge, severe stomach/ abdominal pain, yellowing eyes/ skin, dark urine, swelling hands/ ankles/feet, increased thirst/urination. If any of the above conditions appear for the first time while taking Estring, stop taking it at once and consult your doctor immediately. As the oestrogen is administered within the vagina and due to the low levels released, it is unlikely that any clinically relevant drug interactions will occur with ESTRING vaginal delivery system. A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using systemic HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.31-1.56). For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users. In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period. No overall difference for primary CHD events (nonfatal MI, silent MI and CHD death) and invasive breast cancer incidence in women receiving CE-alone compared with placebo was reported in final centrally adjudicated results from the estrogen-alone substudy, after an average follow-up of 7.1 years.

Pharmacokinetics

The Estring vaginal ring does not need to be removed during sexual intercourse. It should not be felt by either partner. If it is bothersome, it can be removed, rinsed with warm water, and reinserted following intercourse. 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. If you are going to have surgery, you may need to stop taking this medication. Consult your care team for advice before you schedule the surgery. Nausea/ vomiting, bloating, increased vaginal discharge, breast tenderness, headache, or weight changes may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. If more than 5 days have passed since the miscarriage or abortion, you need to use additional contraception (such as condoms) for 7 days after you insert the ring. Advantages and disadvantages

A very small number of people using the vaginal ring may develop a blood clot in a vein or an artery. Don't use the ring if you've had a blood clot before. Cancer If any of the side effects gets serious, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. In postmenopausal women, mean dose of estradiol systemically absorbed unchanged from ESTRING is ~8 percent [95 percent CI: 2.8–12.8 percent] of the daily amount released locally. TABLE 1: PHARMACOKINETIC MEAN ESTIMATES FOLLOWING SINGLE ESTRING APPLICATION Estrogen

E. Carcinogenesis, Mutagenesis, and Impairment of Fertility

doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Estring should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions. All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

Getting Familiar

Taking oestrogen-only HRT tablets for a long time can increase the risk of developing cancer of the womb lining (the endometrium). You can have sex and use tampons while the ring is in your vagina. You and your partner may feel the ring during sex, but this isn't harmful. If you forget to take the ring out after 21 days In a Phase I study of 14 postmenopausal women, the insertion of ESTRING (estradiol vaginal ring) rapidly increased serum estradiol (E 2) levels. The time to attain peak serum estradiol levels (T max) was 0.5 to 1 hour. Peak serum estradiol concentrations post-initial burst declined rapidly over the next 24 hours and were virtually indistinguishable from the baseline mean (range: 5 to 22 pg/mL). Serum levels of estradiol and estrone (E 1) over the following 12 weeks during which the ring was maintained in the vaginal vault remained relatively unchanged (see Table 1). For the treatment of postmenopausal symptoms, Hormone Replacement Therapy (HRT) should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.