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Elleste Solo 1mg Tablets

Elleste Solo 1mg Tablets

Elleste Solo

Hormone Replacement Therapy (HRT) medicine
  • UK marketing authorisation number PL 44081/0024.
  • Licensed prescription Only medicine (POM) in the UK.
  • Authorised and monitored by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
  • Manufactured and released under EU/UK Good Manufacturing Practice (GMP) requirements for medicinal products.
Oral oestrogen-only HRT \u2013 estradiol film-coated tablets

Description

Elleste Solo 1mg Tablets are a prescription-only, oestrogen-only hormone replacement therapy (HRT) containing 1 mg estradiol (as hemihydrate) per film-coated tablet. They are used primarily to treat oestrogen deficiency symptoms associated with the peri- and post-menopause (such as hot flushes and night sweats) in women whose menopause is natural or surgical (e.g. after hysterectomy). The 1 mg strength is licensed for treatment of menopausal symptoms, with tablets taken orally once daily, usually continuously in women without a uterus and in combination with a progestogen in women with an intact uterus.

Bnefits

  • Provides systemic oestrogen replacement to alleviate common menopausal symptoms such as hot flushes, night sweats and vaginal dryness.
  • Helps improve quality of life in peri- and post-menopausal women with significant oestrogen deficiency symptoms.
  • Oestrogen-only regimen suitable for women who have had a hysterectomy (no uterus).
  • Well-characterised estradiol formulation with long-term clinical experience and updated SmPC (2025).
  • Oral, once-daily dosing for convenient administration.
  • Part of the wider Elleste HRT range, allowing flexible step-up or switching between strengths and combined preparations under medical supervision.

Indications

  • Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in post-menopausal women.
  • HRT for oestrogen deficiency symptoms in peri-menopausal women where clinically appropriate.
  • Use in women whose menopausal symptoms adversely affect quality of life and in whom the benefits of HRT outweigh the risks.
  • Generally used as oestrogen-only HRT in women who have undergone hysterectomy; in women with an intact uterus, a progestogen must be added for at least 12–14 days per 28-day cycle.

Composition

  • Active ingredient: 1 mg estradiol (as estradiol hemihydrate) per film-coated tablet.
  • Excipient with known effect: 62.8 mg lactose monohydrate per tablet.
  • Other core excipients: maize starch, povidone 25, purified talc, magnesium stearate.
  • Film-coating excipients: hypromellose (hydroxypropylmethyl cellulose, E464), titanium dioxide (E171), macrogol 400.

Formulation

  • Pharmaceutical form: film-coated tablet for oral use.
  • Appearance: white, round, biconvex tablets marked with "01" on one side.
  • Strength: 1 mg estradiol (as hemihydrate) per tablet.
  • ATC code: G03CA03 (natural and semisynthetic oestrogens, plain).

Packaging

  • Aluminium/PVC blister packs supplied in cardboard cartons.
  • Common marketed pack size: 3 × 28 film-coated tablets (84 tablets) per carton.
  • Other authorised pack sizes (not all may be marketed at a given time): 20, 28, 60, 84 or 100 film-coated tablets.
  • Prescription-only medicine (POM) – can only be supplied against a valid prescription.

Usage

  • Dose: one Elleste Solo 1 mg tablet taken orally once daily, at approximately the same time each day.
  • Tablets should be swallowed whole with liquid; do not chew or crush.
  • In hysterectomised women (no uterus), Elleste Solo 1 mg may usually be taken continuously without a tablet-free interval, as advised by the prescriber.
  • In women with an intact uterus, a suitable progestogen must be added for 12–14 days of each 28-day cycle to reduce the risk of endometrial hyperplasia and endometrial cancer.
  • Treatment should start at the lowest effective dose for the shortest duration necessary to relieve symptoms; therapy should be reviewed at least annually.
  • Initiation: in women with established amenorrhoea or long intervals between spontaneous menses, therapy may start at any time; in menstruating women, starting on the first day of bleeding is usually recommended.
  • Switching: women changing from cyclical or continuous sequential HRT should normally finish the current cycle before switching; from continuous combined HRT, switching may be done when amenorrhoea is established or on the first day of a withdrawal bleed.
  • Missed dose: if a tablet is forgotten, it should be taken within 12 hours of the usual time; if more than 12 hours have passed, the missed tablet should be skipped and the next tablet taken at the normal time. Do not take a double dose to make up for a missed tablet.
  • If signs of pregnancy, jaundice, significant rise in blood pressure, new-onset migraine-type headache, or symptoms of thromboembolism occur, treatment must be stopped and urgent medical advice sought.
  • Use only under the supervision of an appropriately qualified prescriber, following individual assessment of risks and benefits.

Contraindications

  • Known, past or suspected breast cancer.
  • Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer).
  • Undiagnosed genital (vaginal or uterine) bleeding.
  • Untreated endometrial hyperplasia.
  • Previous idiopathic or current venous thromboembolism (VTE), such as deep vein thrombosis or 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 where liver function tests have not returned to normal.
  • Known hypersensitivity (allergy) to estradiol or any of the excipients, including lactose.
  • Porphyria.
  • Known hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption (due to lactose content).
  • Pregnancy or breastfeeding (Elleste Solo is indicated only for postmenopausal women).
  • Use in children and adolescents (not indicated).

Adverse Effects

  • Very common/common adverse reactions include: headache, breast tenderness or enlargement, uterine/vaginal bleeding including spotting, nausea and abdominal pain, weight gain or weight loss, mood changes (including anxiety or depressed mood), libido changes, and fluid retention/oedema.
  • Other gastrointestinal effects: dyspepsia, vomiting, flatulence, and, in women with pre-existing hypertriglyceridaemia, rare cases of pancreatitis.
  • Reproductive system and breast: dysmenorrhoea, vaginal discharge, premenstrual-like symptoms, fibrocystic breast disease, metrorrhagia.
  • Skin and subcutaneous tissue: rash, pruritus, urticaria, erythema nodosum or multiforme, chloasma, hirsutism, acne, angioedema.
  • Nervous system: dizziness, migraine, possible exacerbation of epilepsy, probable dementia when HRT is initiated after age 65 (based on epidemiological data).
  • Hepatobiliary: gallbladder disease including cholelithiasis, abnormal liver function tests, jaundice.
  • Cardiovascular and vascular: venous thromboembolism (deep vein thrombosis, pulmonary embolism), arterial thromboembolic events (angina, myocardial infarction), and increased risk of ischaemic stroke with systemic HRT.
  • Neoplasms: increased risk of breast cancer with prolonged HRT use, increased risk of endometrial cancer with unopposed oestrogen in women with a uterus, and slightly increased risk of ovarian cancer with systemic HRT.
  • Other: visual disturbances, contact lens intolerance, palpitations, muscle cramps, urinary incontinence and generalised oedema.
  • Overdose may cause nausea, vomiting, sleepiness, dizziness and withdrawal bleeding; management is symptomatic.

Storage Conditions

  • Do not store above 25°C.
  • Store in the original package in order to protect from light and moisture.
  • Keep out of the sight and reach of children.
  • Shelf life: 3 years (refer to pack expiry date).

Duration

Individualised. HRT should be used at the lowest effective dose for the shortest duration necessary to control symptoms. The prescriber should review the need for ongoing Elleste Solo therapy at least once a year, weighing benefits and risks (including breast cancer, endometrial cancer, thromboembolism and cardiovascular events). Long-term use is generally reserved for women with persistent, distressing symptoms after careful risk\u2013benefit assessment.

Onset

Many women experience relief of vasomotor and other menopausal symptoms within a few weeks of starting therapy; optimal benefit is often reached within approximately 3 months of regular daily use, although this can vary between individuals.

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