Valena

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.

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.

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.

Female Sex hormones

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.

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