ESTREVA Gel Ref.[50461] Active ingredients: Estradiol

A medical examination is necessary before and periodically during the course of treatment. Tests will essentially concern weight, blood pressure, breasts, uterus. Careful monitoring of all aptients presenting with epilepsy, asthma, family history of breast cancer, hepatic function disorders or severe hypertension is necessary.

The risk of cancer of the endometrium and mammary pathologies increases with prolonged administration of estrogens; it is thus highly recommended that a progestogen be associated with this treatment at least 12 days per month.

• Although rare, most of the following severe incidents have essentially been observed with artificial estrogens and in the course of administration by oral route. Nevertheless, as a precautionary measure, it would be preferable to stop treatment should any of the following phenomena occur:
  • Cardiovascular and thromboembolic
  • Cholestatic icterus
  • Benign or malignant mastopathy, uterine tumour (for example: increase in a fibroma);
  • Hepatic adenoma: this can give rise to intra-abdominal haemorrhage incidents;
  • Galactorrhoea: its appearance make it necessary to investigate hypophyseal adenoma.
• More frequent though minor incidents not usually requiring discontinuation of treatment but making it necessary to adapt the dosage depending on signs of over-or under-dosing:
  • Sign of hypooestrogenia
    • Persistent hot flushes
    • Banal headaches, migraines
    • Intermenstrual bleeding requiring investigation of a subjacent pathology,
    • Vaginal dryness
    • Ocular irritation by contact lenses
  • Signs of hyperestrogenia:
  • Nausea
  • Breast tension,
  • Irritability
  • Heaviness in the legs,
  • Exacerbation of cervical glair secretion
• Incidents linked to acute or chronic overdosage may be observed with all active forms of oestrogenisation, including percutaneous forms:
  • Exacerbation of epilepsy

Drugs which trigger hepatic enzymes such as barbiturates, hydantoins, carbomazepin, meprobamate, phenylbutazone or rifampicin may alter the effect of estrogens. The existence of such interference for the percutaneous route is not known.

Pregnancy is absolute contraindicated. In the case of accidental administration, treatment must be stopped without any other special measures being taken as this concerns adminitration of a natural hormone and the administration route itself precludes the occurence of high plasma levels.