Adverse events

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Besins Healthcare (UK) Ltd Drug Safety on 0203 862 0920 or
Email: pharmacovigilance@besins-healthcare.com

Contraindications

Before initiating or reinstituting HRT, a complete personal and family medical history should be taken. Physical (including pelvic and breast) examination should be guided by this and by contraindications and warnings for use.1

Oestrogel (estradiol-17β) is contraindicated in patients with:1

  • Known, past or suspected breast cancer
  • Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)
  • Undiagnosed genital bleeding
  • Untreated endometrial hyperplasia
  • Previous or current VTE (e.g. deep venous thrombosis, pulmonary embolism)
  • Known thrombophilic disorders (e.g. protein C, protein S or antithrombin deficiency)
  • Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)
  • Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal
  • Known hypersensitivity to the active substances or to any of the excipients
  • Porphyria

Monitoring

For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life.1

In all cases, a careful appraisal of the risks and benefits should be undertaken, at least annually, and HRT should only be continued as long as the benefit is considered to outweigh the risk.1

Evidence regarding the risks associated with HRT in the treatment of premature menopause (patients < 40 years old) is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits to risks for these women may be more favourable than in older women.1

Undesirable effects

Undesirable effects are generally mild and rarely require treatment withdrawal. Undesirable effects, if any, usually occur during the first months of treatment.1

References

1. Besins Healthcare (UK) Ltd; EMC. Oestrogel Pump-Pack. Summary of Product Characteristics (last updated July 2019). Available from medicines.org.uk/emc/product/353/smpc [accessed July 2019].

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