IMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION estrogen levels results in what is known as "surgically induced menopause". ESTRING* (Estradiol Vaginal Ring) The declining estrogen levels associated with menopause may result in urogenital atrophy This leaflet is part III of a three-part “Product (thinning and drying of the tissue of the urinary tract Monograph” published when ESTRING was and vagina). Symptoms of urogenital atrophy approved for sale in Canada and is designed include vaginal dryness, genital itching, burning and specifically for Consumers. This leaflet is a pain during intercourse, sensation of urinary urgency summary and will not tell you everything about and pain on urination. ESTRING. Contact your doctor or pharmacist if you have any questions about this drug. Drug Response It will take about 2 to 3 weeks to restore the tissue of ABOUT THIS MEDICATION the vagina and urinary tract to a healthier condition What this medication is used for: and to feel the full effect of ESTRING in relieving ESTRING is used to relieve postmenopausal vaginal vaginal and urinary symptoms. If your symptoms and urinary symptoms associated with estrogen persist for more than a few weeks after beginning deficiency. ESTRING therapy, contact your doctor or healthcare If you still have your uterus, you should discuss provider. progestin therapy with your doctor. The purpose of When it should not be used: adding progestin therapy is to reduce the risk of endometrial hyperplasia (overgrowth of the lining of Do not use ESTRING if you: the uterus). • have a personal history of breast cancer or a The maximum recommended duration of continuous personal or family history of endometrial cancer treatment with ESTRING is 2 years. (cancer of the lining of the uterus) • have been diagnosed with endometrial ESTRING should be used only under the supervision hyperplasia (overgrowth of the lining of the of a doctor, with regular follow-up at least once a uterus) year to identify adverse effects associated with its • have experienced undiagnosed or abnormal use. Your visit may include a blood pressure check, genital bleeding a breast exam, a Pap smear and pelvic exam. You • have liver disease should have a mammogram before starting treatment • have or have had blood clot disorders including and at regular intervals as recommended by your blood clots in the leg, lung or thrombophlebitis doctor. Your doctor may recommend some blood • have vision loss due to a blood vessel disease tests. • are pregnant or think you may be pregnant • are breast feeding You should carefully discuss the risks and benefits of • have or had an allergic or unusual reaction to hormone replacement therapy with your doctor. You any of the ingredients of ESTRING. See What and your doctor should talk regularly about whether the medicinal ingredient is and What the you still need treatment with hormone replacement nonmedicinal ingredients are, following this therapy. section for a list of ingredients. What it does: • have or have had a stroke, heart attack, or ESTRING (estradiol vaginal ring) contains a drug coronary artery disease reservoir of 2 mg of estradiol (an estrogen • have or had porphyria medication) in its core. ESTRING releases estradiol • have some types of congenital coagulation into the vagina in a consistent, stable manner. abnormalities (e.g. protein C, protein S, or antithrombin deficiency) Estrogens are hormones made by the ovaries of women during their reproductive years. Between What the medicinal ingredient is: ages 45 and 55, the ovaries normally stop making 17 β-Estradiol estrogens. This leads to a drop in body estrogen What the nonmedicinal ingredients are: levels which causes the "change of life" or meno- Silicone elastomer, silicone fluid and barium sulfate. pause (the end of monthly menstrual periods). If both ovaries are removed during an operation before natural menopause takes place, the sudden drop in ESTRING*(17 β-Estradiol) Product Monograph Page 32 of 38 IMPORTANT: PLEASE READ What dosage forms it comes in: In addition, women with a family history of breast Each ESTRING (estradiol vaginal ring) is cancer or women with a history of breast lumps, individually packaged in a heat-sealed rectangular breast biopsies or abnormal mammograms (breast x- pouch. The pouch is provided with a tear-off notch rays) should consult with their doctor before starting on one side. hormone replacement therapy (HRT). ESTRING (estradiol vaginal ring) is available in Women should have a mammogram before starting single units. Each unit contains 2 mg 17ß-estradiol HRT and at regular intervals during treatment as recommended by their doctor. WARNINGS AND PRECAUTIONS Regular breast examinations by a doctor and Serious Warnings and Precautions regular self-examination of the breast are The Women’s Health Initiative (WHI) trial is a large recommended for all women. You should review clinical study that assessed the benefits and the technique for breast self-examination with your risks of oral combined estrogen plus progestin doctor. therapy and oral estrogen-alone therapy compared with placebo (a pill with no active ingredients) in Overgrowth of the Lining of the Uterus and postmenopausal women. Cancer of the Uterus The WHI trial indicated an increased risk of The use of estrogen-alone therapy by myocardial infarction (heart attack), stroke, breast postmenopausal women who still have a uterus cancer, pulmonary emboli (blood clots in the lungs) increases the risk of developing endometrial and deep vein thrombosis (blood clots in the hyperplasia (overgrowth of the lining of the uterus), large veins) in postmenopausal women taking oral which increases the risk of endometrial cancer combined estrogen plus progestin. (cancer of the lining of the uterus). If you still have The WHI trial indicated an increased risk of stroke your uterus, you should take a progestin medication and deep vein thrombosis in postmenopausal (another hormone drug) regularly for a certain women with prior hysterectomy (surgical removal of number of days of each month to reduce the risk of the uterus) taking oral estrogen-alone. endometrial hyperplasia. You should discuss progestin therapy and risk factors Therefore, you should highly consider the following: for endometrial hyperplasia and endometrial • There is an increased risk of developing invasive carcinoma with your doctor. It is important to report breast cancer, heart attack, stroke and any unusual vaginal bleeding to your doctor right blood clots in both lungs and large veins with the use away while you are using ESTRING. Vaginal of estrogen plus progestin therapy. bleeding after menopause may be a warning sign of • There is an increased risk of stroke and blood clots cancer of the uterus (womb). Your doctor should in the large veins with the use of check any unusual vaginal bleeding to find out the estrogen-alone therapy. cause. • Estrogens with or without progestins should not be If you have had your uterus removed, you are not at used for the prevention of heart disease risk of developing endometrial hyperplasia or or stroke. endometrial carcinoma. Progestin therapy is • Estrogens with or without progestins should be therefore not generally required in women who have used at the lowest effective dose and for had a hysterectomy. the shortest period of time possible. Regular Ovarian Cancer medical follow-up is advised. Use of oral estrogen alone and estrogen plus progestin therapies for 5 or more years has been Breast Cancer associated with a small increased risk of ovarian The results of the Women’s Health Initiative WHI) ( cancer. trial indicated no difference in the risk of breast cancer in post-menopausal women with prior Heart Disease and Stroke hysterectomy taking oral estrogen-alone compared to The results of the WHI trial indicated an increased women taking placebo. risk of stroke and coronary heart disease in postmenopausal women taking combined oral Estrogens should not be taken by women who have a estrogen plus progestin compared to women taking personal history of breast cancer. placebo. ESTRING*(17 β-Estradiol) Product Monograph Page 33 of 38 IMPORTANT: PLEASE READ The results of the WHI trial indicated an increased BEFORE you use ESTRING talk to your doctor risk of stroke, but no difference in the risk of or pharmacist if you: coronary heart disease in postmenopausal women • have a history of allergy or intolerance to any with prior hysterectomy taking oral estrogen-alone medications or other substances compared to women taking placebo. • have a personal history of breast disease (including breast lumps) and/or breast biopsies, Abnormal Blood Clotting or a family history of breast cancer The results of the WHI trial indicated an increased • have experienced any unusual or undiagnosed risk of blood clots in the lungs and large veins in vaginal bleeding postmenopausal women taking combined estrogen • have a history of uterine fibroids or plus progestin compared to women taking placebo. endometriosis • have a history of liver disease, jaundice The results of the WHI trial indicated an increased (yellowing of the eyes and/or skin) or itching risk of blood clots in the large veins, but no related to estrogen use or during pregnancy difference in the risk of blood clots in the lungs in • have a history of migraine headache postmenopausal women with prior hysterectomy • have a history of high blood pressure taking estrogen-alone compared to women taking • have a personal or family history of blood clots, placebo. or a personal history of heart disease or stroke • have a history of kidney disease, asthma or The risk of blood clots also increases with age, if you epilepsy (seizures) or a family member has had blood clots, if you • have been diagnosed with diabetes smoke or if you are severely overweight. The risk of • are pregnant or may be pregnant blood clots is also temporarily increased if you are • are breast feeding immobilized for long periods of time and with major • If you think you may have a vaginal infection surgery.