Company: BGP Products Ltd.
Legal category: Prescription. Sport permitted.
Active ingredients: Estradiol hemihydrate 1mg (white tablets); estradiol hemihydrate/ dydrogesterone 1/10mg (grey tablets).
Description: Round, biconvex, film-coated tablets marked 379, respectively.
Presentation: 28, €6.34.
Indications: Oestrogen deficiency symptoms in postmenopausal women at least 6 months since last menses. Prevention of osteoporosis in postmenopausal women at high risk of fractures where other drugs are inappropriate.
Pharmacology: Synthetic 17β-estradiol, is chemically and biologically identical to endogenous human estradiol. It substitutes for loss of estrogen production in menopausal women, and alleviates menopausal symptoms. Estrogens prevent bone loss following menopause or ovariectomy. Dydrogesterone is an orally-active progestogen having activity comparable to parenterally administered progesterone. The addition of a progestogen greatly reduces estrogen-induced risk of endometrial hyperplasia in non-hysterectomised women.
Dosage: Adult: 1 daily without break starting with white tablets. Start by 5th day of menstruation if present or at any time if not. Children: <18 years, not recommended.
Contraindications: Hypersensitivity to the active ingredient or to any of the excipients. Breast cancer or oestrogen-dependent malignant tumours (including past or suspected). Undiagnosed genital bleeding. Untreated endometrial hyperplasia. Venous thromboembolism (or previous). Thrombophilic disorders. Active or previous arterial thromboembolic disease. Acute liver disease or a history of liver disease as long as liver function tests not normal. Porphyria.
Special precautions: Monitor for breast changes. Supervise closely: Uterine fibroids or endometriosis, risk factors for thromboembolic disorders or for oestrogen dependent tumours, hypertension, liver disorders, diabetes, cholelithiasis, migraine or (severe) headache, systemic lupus erythematosus, history of endometrial hyperplasia, epilepsy, asthma, otosclerosis, cardiac or renal impairment, pre-existing hypertriglyceridaemia (risk of pancreatitis). Discontinue immediately: Jaundice or deterioration in liver function, significant increase in blood pressure, new onset of migraine-type headache, pregnancy. Unopposed oestrogens: Risk of endometrial hyperplasia and carcinoma increased when oestrogens administered alone for prolonged periods; consider adding a progestogen for at least 12 days per cycle in non-hysterectomised women. Investigate if breakthrough bleeding continues, appears after some time during therapy or persists after treatment is discontinued. Increased risk of venous thromboembolism, breast cancer, ovarian cancer, coronary artery disease, or ischaemic stroke. Suspend therapy 4 to 6 weeks before elective surgery if prolonged immobilisation is to follow. Discontinue if VTE develops; seek immediate medical advice if painful leg swelling, sudden chest pain, dyspnea occurs. May affect radiological breast cancer detection. May lead to increased circulating total thyroid hormone, corticosteroids and sex steroids. Some evidence of increased risk of probable dementia in women who start using continuous combined or oestrogen-only HRT after 65 years. Patients over 65 years, limited experience. Contains lactose.
Drug interactions: CYP450 inducers or inhibitors such as anticonvulsants, anti-infectives, St. John’s Wort, ritonavir, nelfinavir. Anticoagulants.
Adverse drug reactions: Cystitis-like syndrome, vaginal candidiasis, headache, migraine, gastrointestinal disorders, allergic skin reactions (e.g. rash, urticaria, pruritus), leg cramps, breast pain/tenderness, metrorrhagia, breakthrough bleeding and spotting, pelvic pain, asthenia, increased/decreased weight.
Full prescribing information and references available from BGP Products Ltd.
E-mail: medinfo.shl@mylan.com