Gynova Tablet

Short term treatment of climacteric complaints after the cessation of monthly bleeding, or deficiency symptoms after oophorectomy or radiological castration for non-carcinomatous diseases, such as hot flushes, outbreaks of sweat, sleep disturbances, depressive moods, irritability, headaches, dizziness. Estradiol also has a favourable influence on bladder irritation (a not infrequent occurrence in the climacteric), signs of cutaneous and mucosal involution (particularly in the genital region) which normally occur with advancing age.

Hormone therapy should only be continued as long as the benefit in alleviation of severe symptoms outweighs the risk. A complete medical history should be taken and a physical examination should be conducted prior to the initiation or reinstitution of HRT, should be repeated periodically. The frequency and nature of these examinations should be based on established practice guidelines, 6 monthly reviews are generally considered appropriate, and be adapted to the individual woman, but should generally include pelvic organs, including routine cervical cytology, abdomen, breasts and blood pressure. The need for continued therapy should be reconsidered at each review. Unless otherwise prescribed by the doctor, 1 tablet Estradiol is taken daily and the tablets are to be swallowed whole with some liquid. Each pack covers 30 days and treatment is continuous, which means that the next pack follows immediately without a break. It does not matter at what time of the day the patient takes her tablet, but once she has selected a particular time, she should keep it to every day. If she forgets to take a tablet at the usual time, she may take it within the following 12 to 24 hours. If the treatment is discontinued for longer, irregular bleeding may occur. Treatment may be started at any time provided that pregnancy has been excluded. High-dosed and long-term use of unopposed oestrogens during the climacteric may increase the incidence of endometrial carcinoma. Endometrial hyperplasia should be avoided in unopposed oestrogen treatment. It is therefore mandatory to add a progestogen for the last 10-14 days of each month of therapy. As a general rule, Estradiol treatment should be discontinued every 6 months in order to verify the persistence of complaints requiring treatment. It is essential to adhere to the dosage scheme prescribed by the doctor and to keep the appointments made for gynaecological check-ups.

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Interaction with laboratory tests: The use of sex steroids may influence biochemical parameters of, for example, liver, thyroid, adrenal and renal function, plasma levels of (carrier) proteins such as corticosteroid-binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism, and parameters of coagulation and fibrinolysis.

Interactions with other medicines: Long-term treatment with hepatic enzyme-inducing drugs (e.g. several anticonvulsants and antimicrobials) can increase the clearance of sex hormones and may reduce clinical efficacy. Such hepatic enzyme-inducing properties have been established for hydantoins, barbiturates, primidone, carbamazepine, and rifampicin and are also suspected for oxcarbazepine, topiramate, felbamate, griseofulvin and the herbal remedy St John’s Wort (hypericum perforatum). Maximal enzyme induction is generally not seen before 2-3 weeks but may be sustained for at least 4 weeks after cessation of drug therapy. In rare cases, reduced oestradiol levels have been observed under the simultaneous use of certain antibiotics (e.g. penicillins and tetracycline). Substances which undergo substantial conjugation (e.g. paracetamol) may increase the bioavailability of oestradiol by competitive inhibition of the conjugation system during absorption. In individual cases, the requirement for oral antidiabetics or insulin can change as a result of the effect on glucose tolerance.

HRT should not be started in the presence of any of the conditions listed below. Should any of the following conditions appear during HRT use, the product should be stopped immediately. Pregnancy and Lactation, undiagnosed vaginal bleeding, known or suspected cancer of the breast, known or suspected premalignant conditions or malignancies, if sex steroid-influenced, presence or history of liver tumours (benign or malignant), severe hepatic disease, acute arterial thromboembolism (e.g. myocardial infarction, stroke), active deep vein thrombosis, thromboembolic disorders, or a documented history of these conditions, a high risk of venous or arterial thrombosis, severe hypertriglyceridemia, Idiopathic cholestatic jaundice of pregnancy or jaundice with prior combined oral contraceptive use or combined HRT use, Otosclerosis with deterioration during pregnancy, Severe diabetes with vascular changes known hypersensitivity to any of the components of Estradiol.

Pregnancy category B3. Estradiol is contraindicated during pregnancy. If pregnancy occurs during medication with Estradiol, treatment must be discontinued immediately. In animal studies, maternal administration of high doses of synthetic oestrogens produced urogenital malformations in the offspring. However, the relevance of the animal findings for the clinical use of 17b-oestradiol is uncertain. Estradiol is contraindicated during lactation

The benefits and risks of HRT must be carefully weighed, including consideration of the emergence of risks as therapy continues. estrogens with or without progestogens should be prescribed at the lowest effective doses and for the shortest duration consistent with the treatment goal and risks for the individual women. If any of the conditions/risk factors mentioned below is present or deteriorates, an individual risk-benefit analysis should be done before HRT is started or continued. The potential for an increased synergistic risk of thrombosis should be considered in women who possess a combination of risk factors or exhibit a greater severity of an individual risk factor. This increase risk may be greater than a simple cumulative risk of the factor. HRT should not be prescribed in case of a negative risk benefit assessment.

Acute toxicity studies indicate that even in the case of inadvertent intake of a multiple of the therapeutic dose, no acute toxicity risk is to be expected. Overdose may cause nausea and vomiting and withdrawal bleeding may occur in some women. Management of acute overdose should be supportive.

Female Sex hormones

Paediatric use: Estradiol is not indicated for use in children and adolescents.

Patients with hepatic impairment: Estradiol has not been studied in hepatic impaired patients. Estradiol is contraindicated in women with severe hepatic disease.

Store in a cool (below 30°C) and dry place, away from light & children.