Generic Medicine Info
May be taken with or without food.
Hypersensitivity. History of or current breast cancer (except for certain metastatic breast cancer cases), CV disorders (e.g. MI, stroke, pulmonary embolism, DVT). Oestrogen-dependent tumours (e.g. endometrial cancer). Undiagnosed genital bleeding. Untreated endometrial hyperplasia. Thrombophilic disorders (e.g. protein C, protein S, antithrombin deficiency). Porphyria. Hepatic impairment. Pregnancy and lactation.
Special Precautions
Patient with history of endometrial hyperplasia, cholestatic jaundice; risk factors for CV disorders (e.g. personal or family history, obesity, diabetes mellitus, hypertension, hypercholesterolaemia, SLE, prolonged immobilisation); leiomyoma (uterine fibroids) or endometriosis, coronary artery disease, migraine, epilepsy, asthma, cholelithiasis, hepatic haemangiomas, hypertriglyceridemia, hypoparathyroidism, severe hypocalcaemia, otosclerosis, cardiac impairment, hereditary angioedema; short narrow vagina, uterovaginal prolapse, vaginal infection (vaginal). Patient who underwent surgery. Not intended for prevention of dementia. Renal impairment. Non-hysterectomised women. Smoking. Monitoring Parameters Assess personal and family medical history before and regularly during therapy. Include blood pressure, breast and endometrial examinations including mammography, endometrial sampling and Papanicolaou smear. Also monitor bone density (when used as prophylaxis of osteoporosis); for signs and symptoms of retinal vascular thrombosis, thromboembolic disorders. Periodically evaluate the need to continue treatment.
Adverse Reactions
Significant: Breast, endometrial or ovarian cancers; endometrial hyperplasia, breakthrough bleeding and spotting, CV disorders (e.g. MI, stroke, pulmonary embolism, DVT), retinal vascular thrombosis, dementia, gallbladder disease, hypertension, increased HDL-cholesterol and decreased LDL-cholesterol, increased thyroid binding globulin levels, chloasma; impotence and feminising effects in males (when used as palliative treatment for advanced prostate cancer); UTI, vaginal irritation or infection (vaginal); breast budding or masses in prepubertal females, gynecomastia and breast masses in prepubertal males (due to secondary exposure). Ear and labyrinth disorders: Otitis media. Eye disorders: Conjunctivitis. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, dyspepsia, flatulence, abdominal pain, gastroenteritis. General disorders and administration site conditions: Weakness, lethargy, oedema, pain, flu-like symptoms. Infections and infestations: Infections (e.g. fungal infections). Injury, poisoning and procedural complications: Application site reactions (transdermal). Metabolism and nutrition disorders: Weight fluctuation. Musculoskeletal and connective tissue disorders: Arthropathy, arthalgia, myalgia, back, neck or limb pain. Nervous system disorders: Headache, dizziness, hypoaesthesia. Psychiatric disorders: Nervousness, anxiety, depression, insomnia, libido disorder. Renal and urinary disorders: Bladder discomfort (vaginal) Reproductive system and breast disorders: Dysmenorrhoea, metrorrhagia, vaginal discharge, breast tenderness, pain or enlargement; vulvovaginal discomfort, vaginal haemorrhage (vaginal). Respiratory, thoracic and mediastinal disorders: Cough, sinus congestion, sinusitis, nasopharyngitis, pharyngitis, upper respiratory tract infection, bronchitis, rhinitis, asthma. Skin and subcutaneous tissue disorders: Rash, erythema, pruritus, hyperhidrosis. Vascular disorders: Hot flushes.
Potentially Fatal: Anaphylaxis.
Drug Interactions
May cause increased exposure with CYP3A4 inhibitors (e.g. fluconazole, clarithromycin, diltiazem. May cause decreased exposure with CYP3A4 inducers (e.g. phenobarbital, griseofulvin, rifampicin, efavirenz. Decreases absorption of folic acid.
ATC Classification
G03CA03 - estradiol ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.
Disclaimer: This information is independently developed by CIMS based on estradiol from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by
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