For a full list of adverse events, warnings, precautions and contraindications, please refer to SmPC.1
Oestrogel is contraindicated in previous or current thromboembolism disorders1
Patients with risk factors for thromboembolic disorders should be closely supervised.
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
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) 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
Please consult the SmPC for a full list of Warnings & Precautions before prescribing Oestrogel.
Monitoring Requirements1
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, including appropriate imaging tools in accordance with currently accepted screening practices. HRT should only be continued as long as the benefit outweighs the risk.
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
The overall evidence show an increased risk of breast cancer in women taking combined oestrogen-progestogen or oestrogen-only HRT, that is dependent on the duration of taking HRT.
Summary of the safety profile
The reporting rate of adverse drug reactions with Oestrogel was calculated as 5/10,000 patient year’s corresponding to approximately five spontaneously reported cases in every 10,000 patients exposed to Oestrogel (Periodic Benefit Risk Evaluation Report 01 September 2016 to 30 November 2017).
Tabulated list of adverse reactions
The table lists adverse experiences which were reported in > 10% of patients (regardless of relationship to treatment) who received percutaneous estradiol gel 1.25g (containing 0.75mg of estradiol) or 2.5g (containing 1.5mg of estradiol) or placebo gel applied once daily for 12 weeks1*
| Adverse experience | Placebo (n=73) | 0.75mg estradiol (n=75) | 1.5mg estradiol (n=73) |
|---|---|---|---|
| Headache | 13 | 13 | 14 |
| Nausea | 3 | 4 | 9 |
| Breast pain | 7 | 8 | 8 |
| Infection | 5 | 12 | 5 |
| Pain | 8 | 5 | 4 |
| Vaginitis | 3 | 8 | 1 |
* In a multi-centre, randomised, double-blind, placebo-controlled clinical trial in 221 postmenopausal women
The information given below is based on extensive post marketing experience from administration of Oestrogel.
Adverse effects have been ranked under headings of frequency using the following convention: very common (≥ 1/10); common (≥ 1/100; ≤ 1/10); uncommon (≥ 1/1,000; ≤ 1/100); rare (≥ 1/10,000; ≤ 1/1,000); very rare (<1/10,000); frequency not known (cannot be estimated from the available data).
| System organ class | Frequency Not known (cannot be estimated from the available data) |
| Gastrointestinal disorders | Nausea |
| Nervous system disorders | Dizziness Headache |
| Skin and subcutaneous tissue disorders | Alopecia Pruritus |
Description of selected adverse reactions1
Please see SmPC for description of selected adverse reactions.
Medical examination and follow-up1
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 the contraindications and warnings for use. During treatment, periodic check-ups are recommended of a frequency and nature adjusted for the individual patient. Women should be advised what changes in their breasts should be reported to their doctor or nurse.
Investigations, including appropriate imaging tools, e.g. mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.
References:
1. Oestrogel Summary of Product Characteristics. Available from https://www.medicines.org.uk/emc/product/353/smpc Last accessed: March 2023.
5. Archer DF, et al. Menopause 2012;19(6):622-629.
