German Drug Data (Deutsch)
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| Drug class description : | Oestrogens / progestogens. |
| Generic Name : | Estradiol, dydrogesterone |
| Drug description : | Salmon-coloured, round, biconvex, film-coated tablets imprinted 'S' on one side and '379' on the other. |
| Presentation : | Tablets, estradiol (as hemihydrate) 1mg , dydrogesterone 5mg . |
| Indications : | Hormone replacement therapy (HRT) for the relief of menopausal symptoms in women with a uterus. Femoston-conti should normally be used only in women more than 12 months post-menopause. Prophylaxis of postmenopausal osteoporosis in women with a uterus at risk of developing fractures. |
| Adult Dosage : | One tablet daily. Tablets should be taken continuously without a break between packs. Refer to Summary of Product Characteristics. |
| Child Dosage : | Not recommended. |
| Contra Indications : | Active deep venous thrombosis within the last two years, thromboembolic disorders or a thromboembolic disorders or a history of confirmed thromboembolism (see Special Warnings and Precautions). Diagnosed, suspected, or past history of breast cancer, endometrial carcinoma or other hormone dependent neoplasia. Acute or chronic liver disease, and a history of liver disease where the liver function tests have failed to return to normal. Rotor syndrome or Dubin-Johnson syndrome. Cerebral vascular accident. Severe cardiac or renal disease. Undiagnosed vaginal bleeding. Known or suspected pregnancy. Lactation. Hypersensitivity to any of the components of the tablets. |
| Special Precautions : | A thorough examination is required before commencing therapy and at regular intervals thereafter. HRT is associated with an increased risk of venous thromboembolism (VTE). If risk factors present (personal or family history, severe obesity), weigh benefits against risks. An increased risk of being diagnosed with breast cancer has been reported with HRT. Monitor patients with otosclerosis, multiple sclerosis, systemic lupus erythematosus, porphyria, melanoma, epilepsy, migraine, asthma, haemoglobinopathies, diabetes mellitus, history of liver disease, uterine fibroids, history of endometriosis, hypertension, cardiac or renal dysfunction. Oestrogens can increase the risk of surgically confirmed gall bladder disease in women receiving postmenopausal oestrogens. Women of child bearing potential should use non- hormonal contraceptive methods. In the event of abnormal vaginal bleeding, a diagnostic endometrial biopsy should be performed. |
| Interactions : | Liver enzyme inducing drugs. |
| Adverse Reactions : | The following have been reported with oestrogen/progestogen therapy: breakthrough bleeding/ spotting, dysmenorrhoea, PMS, vaginal candidiasis, cervical changes, cystitis-like syndrome, breast tenderness/enlargement, nausea, vomiting, abdominal cramps/bloating, jaundice, skin reactions, eye changes, headache, migraine, dizziness, depression, chorea, changes in weight, carbohydrate metabolism or libido, oedema, porphyria and leg cramps. REASONS FOR IMMEDIATE DISCONTINUATION OF TREATMENT: Occurence of migraine-type headaches for the first time, frequent severe headaches, acute visual disturbances, signs of thrombophlebitis or thromboembolism, or any other possible prodromal symptoms of vascular occlusion. Rise in blood pressure. Jaundice. Pregnancy. Discontinue six weeks before major elective surgery and during immobilisation entailing risk of thrombosis. |
| Manufacturer : | Solvay |
| Drug Availability : | (POM) |
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