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Oestrogen Replacement Therapy Pregnancy: §4.6 VERBATIM: 'Pregnancy: Elleste Solo 1 mg is not indicated during pregnancy. If pregnancy occurs during medication with Elleste Solo 1 mg treatment should be withdrawn immediately. The results of most epidemiological studies to date relevant to inadvertent foetal exposure to oestrogens indicate no teratogenic or foetotoxic effects. Lactation: Elleste Solo 1 mg is not indicated during lactation.' §4.4 additionally lists pregnancy among the reasons for immediate withdrawal of therapy.

Estradiol (HRT — Hormone Replacement Therapy)

Brand names: Elleste Solo (oral), Evorel (patch), Oestrogel (gel), Lenzetto (spray), Vagifem (vaginal tablet), Estring (vaginal ring)

Estradiol is an oestrogen used in hormone replacement therapy (HRT) to relieve menopausal symptoms such as hot flushes, night sweats and vaginal dryness. It is available orally and transdermally as patches or gel.

Adult dose

Dose: 1 mg estradiol — one Elleste Solo 1 mg tablet — once daily. §4.2 verbatim: 'One tablet daily to be taken orally.' The strength behind that tablet count is pinned by §4.2 itself: 'Elleste Solo tablets are available in two strengths: Elleste Solo 1 mg (containing 1 mg estradiol) and Elleste Solo 2 mg (containing 2 mg estradiol).' §4.2 also verbatim: 'Elleste Solo 1 mg may be taken continuously in hysterectomised women. In women with a uterus, a progestogen should be added for 12 - 14 days each cycle to oppose the production of an oestrogen-stimulated hyperplasia of the endometrium. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women.'
Route: Oral. §4.2 verbatim: 'Method of administration: For oral use.'
Frequency: Once daily, continuously. In women with a uterus a progestogen is added for 12–14 days of each cycle (see dose).
SCOPE — THIS IS THE ORAL ROUTE ONLY, WHICH IS THIS PAGE'S LEAD ROUTE. The page's own brand list opens with 'Elleste Solo (oral)', its route field opens with 'Oral', and its existing dose opens with 'Systemic HRT (oral): estradiol 1–2mg OD' — and the fetched SPC is precisely that product, dosing precisely this page's indication (menopausal oestrogen replacement). ⚠️ NONE OF THE PAGE'S OTHER ROUTES ARE SOURCED BY THIS BUNDLE: the transdermal patch figure (25–100 micrograms/24h twice weekly), the Oestrogel figure (0.75–1.5 mg, 1–2 pumps daily), the Lenzetto spray, the Vagifem 10 microgram vaginal tablet regimen and the Estring 90-day ring all belong to separate products with their own SPCs, none of which was fetched. Do not read the 1 mg figure across routes — oral strengths are in MILLIGRAMS and patch strengths in MICROGRAMS/24 HOURS, a thousand-fold difference in unit. || THE 2 mg STRENGTH IS NAMED BUT NOT DOSED HERE. §4.2 verbatim: 'For initiation and continuation of treatment of post-and peri-menopausal symptoms, the lowest effective dose for the shortest duration (see also Section 4.4) should be used. Elleste Solo 2 mg is additionally indicated for prevention of osteoporosis in postmenopausal women at high risk of future fractures and who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.' The fetched SPC is the 1 mg product; the 2 mg product's own SPC was not fetched. || MAX DOSE DELIBERATELY LEFT EMPTY — §4.2 states no maximum dose. The nearest thing is a principle, not a ceiling: 'the lowest effective dose for the shortest duration ... should be used', reinforced by §4.4: 'HRT should only be initiated for symptoms that adversely affect quality of life. 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 outweighs the risk.' || STARTING AND SWITCHING, §4.2 verbatim: 'Therapy may start at any time in women with established amenorrhoea or who are experiencing long intervals between spontaneous menses. In patients who are menstruating, it is advised that therapy starts on the first day of bleeding. Patients changing from a cyclical or continuous sequential preparation should complete the cycle and may then change to Elleste Solo 1 mg without a break in therapy. Patients changing from a continuous combined preparation may start therapy at any time if amenorrhoea is established, or otherwise start on the first day of bleeding.' || MISSED OR EXTRA TABLET, §4.2 verbatim: 'If a tablet is missed it should be taken within 12 hours of when normally taken; otherwise the tablet should be discarded, and the usual tablet should be taken the following day. A missed dose may lead to break-through bleeding or spotting in non-hysterectomised women. If one extra tablet is taken inadvertently, the usual tablet should be taken the following day.' || ELDERLY, §4.2 verbatim: 'There are no special dosage requirements for elderly patients.' || PAEDIATRIC, §4.2 verbatim: 'Not to be used in children.' || ⚠️ §4.4 and §4.8 are truncated at the source-fetch limit, and §4.5 (interactions) was not retrieved at all, so the page's enzyme-inducer and thyroxine interaction items are not sourced from this bundle.

Dose adjustments

Renal

Not stated. No renal-impairment section was retrieved from this SPC and no renal dose adjustment appears anywhere in the fetched text — do not infer one. (§4.8 lists urinary incontinence as an undesirable effect at unknown frequency; that is not a dosing statement.)

Hepatic

No dose adjustment is given; the SPC handles the liver by contraindication and by stopping rules instead. §4.3 verbatim: 'Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal'; and 'Porphyria'. §4.4 lists 'Liver disorders (e.g. liver adenoma)' among the conditions requiring close supervision, and gives as a reason for immediate withdrawal of therapy: 'Jaundice or deterioration in liver function'. §4.8 lists abnormal hepatic function, sometimes with jaundice, at unknown frequency.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • §4.3 verbatim: 'Known, past or suspected breast cancer'
  • §4.3 verbatim: 'Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)'
  • §4.3 verbatim: 'Undiagnosed genital bleeding'
  • §4.3 verbatim: 'Untreated endometrial hyperplasia'
  • §4.3 verbatim: 'Previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)'
  • §4.3 verbatim: 'Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency, see Section 4.4)'
  • §4.3 verbatim: 'Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)'
  • §4.3 verbatim: 'Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal'
  • §4.3 verbatim: 'Known hypersensitivity to the active substances or to any of the excipients listed in Section 6.1'
  • §4.3 verbatim: 'Porphyria'
  • Not a §4.3 contraindication but a §4.2 restriction: 'Not to be used in children.'
  • Not a §4.3 contraindication but §4.6: 'Elleste Solo 1 mg is not indicated during pregnancy' or 'during lactation'; pregnancy is also a §4.4 reason for immediate withdrawal.
  • The SPC does NOT make hypertension a contraindication. It lists hypertension among the conditions requiring close supervision (§4.4) and makes 'Significant increase in blood pressure' a reason for immediate withdrawal.
  • ⚠️ §4.4 is truncated at the source-fetch limit within the endometrial-hyperplasia section — this is not the complete set of cautions.

Side effects

  • Common (>1/100, <1/10), §4.8 table: metrorrhagia, breast tenderness, breast enlargement, uterine/vaginal bleeding including spotting; nausea, abdominal pain; headache
  • Uncommon (>1/1,000, <1/100), §4.8 table: breast pain; dyspepsia, vomiting, flatulence; gallbladder disorder, cholelithiasis; dizziness, migraine; visual disturbances; palpitations; rash, pruritus; oedema; weight increased, weight decreased; mood alterations including anxiety and depressed mood, libido disorder; vaginal candidiasis; hypersensitivity; muscle cramps
  • Rare (>1/10,000, <1/1,000), §4.8 table: dysmenorrhoea, vaginal discharge, premenstrual syndrome; pancreatitis (in women with pre-existing hypertriglyceridaemia); abnormal hepatic function, sometimes with jaundice; erythema nodosum, urticaria, hirsutism, acne; contact lens intolerance
  • Frequency unknown (post-marketing), §4.8 table: fibrocystic breast disease; gastroesophageal reflux disease; probable dementia over the age of 65 (see section 4.4), chorea, exacerbation of epilepsy; angioedema, erythema multiforme, vascular purpura, chloasma; urinary incontinence
  • Neoplasms, §4.8 table: breast cancer; oestrogen-dependent neoplasms benign and malignant, e.g. endometrial cancer, ovarian cancer; increase in size of leiomyoma
  • Vascular, §4.8 table: stroke; arterial thromboembolism, i.e. angina and myocardial infarction; venous thromboembolism, i.e. deep leg or pelvic venous thrombosis and pulmonary embolism
  • Breast cancer risk, §4.8 verbatim: 'An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined oestrogen-progestogen therapy for more than 5 years. The increased risk in users of oestrogen-only therapy is lower than that seen in users of oestrogen-progestogen combinations. The level of risk is dependent on the duration of use (see Section 4.4).'
  • Endometrial risk, §4.4 verbatim: 'In women with an intact uterus, the risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administered alone for prolonged periods. The reported increase in endometrial cancer risk among oestrogen-only users varies from 2-to 12-fold greater compared with non-users, depending on the duration of treatment and oestrogen dose (see Section 4.8). After stopping treatment, risk may remain elevated for at least 10 years.'
  • ⚠️ §4.8 is truncated at the source-fetch limit inside the tabulated absolute-risk estimates — the numerical risk tables were NOT retrieved, so no absolute risk figure is sourced from this bundle.

Monitoring

  • Before starting, §4.4 verbatim: '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, §4.4 verbatim: 'During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised what changes in their breasts should be reported to their doctor or nurse (see 'Breast Cancer' below).'
  • Breast imaging, §4.4 verbatim: 'Investigations, including mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.'
  • At least annual benefit-risk review, §4.4 verbatim: '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 outweighs the risk.'
  • Reasons for immediate withdrawal of therapy, §4.4 verbatim: 'Jaundice or deterioration in liver function. Significant increase in blood pressure. New onset of migraine-type headache. Pregnancy.' — this is the SPC's blood-pressure monitoring cue.
  • Conditions requiring close supervision if present, previously present, or aggravated in pregnancy or previous hormone treatment, §4.4 verbatim: 'Leiomyoma (uterine fibroids) or endometriosis; Risk factors for thromboembolic disorders; Risk factors for oestrogen dependent tumours, e.g. 1st degree heredity for breast cancer; Hypertension; Liver disorders (e.g. liver adenoma); Diabetes mellitus with or without vascular involvement; Cholelithiasis; Migraine or (severe) headache; Systemic lupus erythematosus; A history of endometrial hyperplasia; Epilepsy; Asthma; Otosclerosis.'
  • Unscheduled bleeding — §4.2 warns that a missed dose 'may lead to break-through bleeding or spotting in non-hysterectomised women', and §4.4's endometrial-hyperplasia section (truncated at the source-fetch limit) is where the SPC's bleeding-investigation guidance sits.
  • ⚠️ §4.4 is truncated at the source-fetch limit — this is not the complete monitoring guidance.

Clinical monograph

How it works

It replaces declining endogenous oestrogen, relieving vasomotor and urogenital symptoms of the menopause by acting on oestrogen receptors throughout the body.

Prescribing in practice

  • Women with a uterus also need a progestogen, because unopposed oestrogen causes endometrial hyperplasia and endometrial cancer.
  • The transdermal route avoids the increased venous-thromboembolism risk seen with oral oestrogen and is preferred where thrombotic risk is a concern.
  • There is a small increase in breast cancer risk with combined HRT, and oral therapy carries small increases in stroke and venous thromboembolism, so individualise treatment and review regularly.

Monitoring

Review symptom control, bleeding pattern and risks regularly, including blood pressure; investigate unscheduled or persistent bleeding and reassess the benefit-risk balance at each review.

Counselling the patient

  • If you still have a womb, take the progestogen part exactly as prescribed to protect the lining of the womb.
  • Report any unexpected or persistent vaginal bleeding, or a new breast lump.
  • Continue to attend breast and cervical screening, and seek urgent help for symptoms of a clot such as leg swelling or breathlessness.

Evidence & guidelines

Recommended for menopausal symptoms by NICE (NG23).

Reference: NICE NG23 (Menopause); BMS HRT Guidelines 2020; WHI Trial; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.