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Oestrogel Gel 0.06% (Oestrogel Pump Pack 750 micrograms/actuation Gel)

Oestrogel Gel 0.06% (Oestrogel Pump Pack 750 micrograms/actuation Gel)

Oestrogel

Prescription-only hormone replacement therapy (POM)
  • UK Medicines and Healthcare products Regulatory Agency (MHRA) marketing authorisation: Oestrogel Pump Pack 750 micrograms/actuation Gel, PL 28397/0002.
  • Classified as a Prescription Only Medicine (POM) in the United Kingdom.
  • ATC classification: G03CA03 (natural and semisynthetic oestrogens, plain).
  • SmPC and Patient Information Leaflet (PIL) for Oestrogel published on the electronic medicines compendium (emc) and approved by the MHRA, with the SmPC last revised on 03 July 2025.
  • Listed as an Actual Medicinal Product (AMP) and Virtual Medicinal Product (VMP) in the NHS dm+d and related UK prescribing resources as estradiol 0.06% transdermal gel (Oestrogel Pump Pack).
  • Manufacturing and quality standards: Besins Healthcare states that its products, including Oestrogel, are manufactured in facilities adhering to harmonised high production standards with rigorous quality control testing across product series.
  • No CE marking as a medical device; Oestrogel is regulated as a medicinal product under human medicinal product legislation.
Transdermal estradiol gel; systemic oestrogen-only HRT for menopausal symptoms and prevention of postmenopausal osteoporosis

Description

Oestrogel Gel 0.06% (Oestrogel Pump-Pack 750 micrograms/actuation Gel) is a prescription-only transdermal estradiol gel for hormone replacement therapy (HRT) in postmenopausal women. Each gram of gel contains 0.6 mg estradiol (0.06% w/w), delivered from a metered pump pack that dispenses 1.25 g of clear, colourless gel (0.75 mg estradiol) per actuation for application to intact skin. It is indicated for the treatment of oestrogen deficiency symptoms associated with menopause and for the prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or have contraindications to, other medicinal products approved for osteoporosis prevention. The gel is applied once daily to clean, dry skin on large areas such as the outer arms/shoulders or mid-inner thighs, providing systemic estradiol exposure while avoiding first-pass hepatic metabolism. In women with an intact uterus, it must be combined with a progestogen for at least 12–14 days per 28-day cycle to reduce the risk of endometrial hyperplasia and carcinoma. Oestrogel is authorised in the UK under PL 28397/0002 and classified as a prescription-only medicine (POM) with ATC code G03CA03 (natural and semisynthetic oestrogens, plain).

Bnefits

  • Provides systemic oestrogen replacement for relief of menopausal oestrogen deficiency symptoms in postmenopausal women (e.g. vasomotor symptoms such as hot flushes and night sweats).
  • Indicated for the prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for osteoporosis prevention.
  • Transdermal gel formulation avoids first-pass hepatic metabolism associated with oral oestrogens, providing a controlled systemic estradiol exposure.
  • Metered-dose pump pack delivers a consistent amount of gel (1.25 g per actuation, containing 0.75 mg estradiol) to support accurate dose titration and flexible adjustment between 2 and 4 actuations per day according to clinical response.
  • Clear, colourless gel applied to large skin areas (arms/shoulders or inner thighs), allowing convenient once-daily administration at home.
  • Bioidentical estradiol (chemically identical to endogenous 17β-estradiol) with pharmacokinetic profile achieving serum estradiol and estrone levels similar to those of the early–mid follicular phase when used at recommended doses.
  • Extensively characterised in regulatory documents (SmPC, PIL) with detailed information on indications, dosing, contraindications, warnings, pharmacokinetics, and safety profile.
  • Authorised as a prescription-only medicine with established MHRA marketing authorisation and up-to-date product information (SmPC and PIL) for healthcare professionals and patients.

Indications

  • Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women.
  • Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or have contraindications to, other medicinal products approved for the prevention of osteoporosis.

Composition

  • Active substance: Estradiol (as estradiol hemihydrate) 0.6 mg per gram of gel (0.06% w/w estradiol). Each metered pump actuation delivers 1.25 g of gel containing 0.75 mg estradiol.
  • Excipients (SmPC section 6.1): Ethanol (excipient with known effect), Carbomer, Trolamine, Purified water.
  • The medicinal product is a clear, colourless transdermal gel with an odour of alcohol.

Formulation

  • Pharmaceutical form: Transdermal gel for cutaneous use.
  • Strength: 0.6 mg/g estradiol (0.06% w/w).
  • Each pump actuation delivers 1.25 g of gel containing 0.75 mg estradiol.
  • Physical characteristics: clear, colourless gel with an odour of alcohol.
  • ATC code: G03CA03 (natural and semisynthetic oestrogens, plain).
  • Legal category in the UK: Prescription Only Medicine (POM).

Packaging

  • Metered-dose pump pack containing 80 g of transdermal gel in a metering canister composed of a polypropylene bottle, LDPE pouch, polypropylene metering pump and polypropylene cap.
  • Each pump pack is designed to deliver metered doses of 1.25 g of gel per actuation until the labelled content is exhausted; the SmPC and PIL describe that a standard pump pack will last approximately 4 weeks when using the usual dose of 2 actuations per day.
  • Outer packaging: carton containing the pump pack, labelled with the product name Oestrogel Pump-Pack 750 micrograms/actuation Gel, strength, active substance, legal category, and regulatory information (PL 28397/0002).

Usage

  • Oestrogel should be used exactly as prescribed and as described in the official SmPC and Patient Information Leaflet for Oestrogel Pump-Pack 750 micrograms/actuation Gel.
  • Posology – general: Oestrogel is administered once daily on a continuous basis. The usual starting dose for menopausal symptoms is two pump actuations (2.5 g of gel, 1.5 mg estradiol) once daily. The dose may be adjusted based on clinical response up to a maximum of four actuations (5 g gel, 3.0 mg estradiol) per day.
  • Postmenopausal symptoms: Each metered dose (one pump actuation) is 1.25 g of gel (0.75 mg estradiol). Two actuations once daily is the usual starting dose; if effective relief is not obtained after approximately one month, the dose may be increased up to a maximum of four actuations daily. The lowest effective dose for the shortest duration should be used.
  • Prevention of postmenopausal osteoporosis: The usual dose is two actuations (2.5 g of gel, 1.5 mg estradiol) once daily; the lowest effective dose for prevention of osteoporosis is not established and individualised medical assessment is required.
  • Women without a uterus: Oestrogel (oestrogen-only HRT) is particularly indicated for women who have had a hysterectomy. It is administered daily on a continuous basis without the need for progestogen addition (unless there is a previous diagnosis of endometriosis, where a progestogen may be considered).
  • Women with an intact uterus: A progestogen (including progesterone) should be added for at least 12–14 days every month / 28-day cycle to reduce the risk of endometrial hyperplasia and carcinoma. Oestrogel is then administered daily on a continuous sequential basis with cyclical progestogen.
  • Initiation of treatment: In postmenopausal women who are not currently on HRT or who have very infrequent menstrual cycles, treatment may be started on any convenient day. When switching from continuous combined HRT, treatment can be started on any day; when switching from cyclic or sequential HRT, the current therapeutic sequence should be completed before starting Oestrogel.
  • Method of administration – application site: For local cutaneous use on intact skin. The gel should be applied by the patient herself, not by another person. Recommended application sites are large areas of clean, dry, unbroken skin on the outer arm and shoulder, or the mid-inner thighs. The area of application should be as large as possible.
  • Method of administration – how to apply: Dispense the prescribed number of pump actuations into the palm of the hand and spread the gel in a thin layer over the chosen skin area (e.g. entire outer arm and shoulder of both arms or mid-inner thighs of both legs). Do not apply on or near the breasts or on the vulval/genital area. Allow at least 5 minutes for the gel to dry before covering with clothing.
  • Secondary exposure precautions: After application, wash hands with soap and water. Avoid skin-to-skin contact of the application site with others, particularly children, for at least one hour after application. If accidental contact occurs, the affected skin of the other person should be washed with soap and water as soon as possible.
  • Site care: Do not apply Oestrogel to damaged or irritated skin. Avoid washing the application area or using other skin products on the area for at least one hour after application.
  • Missed dose: If a dose is forgotten and more than 12 hours remain before the next scheduled dose, the missed dose should be applied as soon as possible and normal dosing resumed the following day. If the next dose is due in less than 12 hours, the missed dose should be skipped and the regular dosing schedule resumed. Double doses should not be applied.
  • Clinical monitoring: Treatment should be reviewed regularly (at least annually) to reassess the benefit–risk ratio, adjust dose as needed, and evaluate the ongoing need for therapy. Women should attend regular breast screening and gynaecological examinations as advised by their healthcare provider.
  • Combination with progestogen: In women with a uterus, a progestogen should be added for at least 12–14 days per cycle; regimens and products (e.g. micronised progesterone) must follow prescriber guidance and product literature for the specific progestogen used.

Contraindications

  • Hypersensitivity (allergy) to estradiol or to any of the excipients (ethanol, carbomer, trolamine, purified water).
  • Known, past, or suspected breast cancer.
  • Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer).
  • Undiagnosed genital/vaginal bleeding.
  • Untreated endometrial hyperplasia.
  • Previous or current venous thromboembolism (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.
  • Porphyria.
  • Pregnancy and lactation: Oestrogel is not indicated during pregnancy or breastfeeding; treatment should be stopped if pregnancy occurs.
  • Any other contraindication listed in the current MHRA-approved SmPC or PIL for Oestrogel Pump-Pack 750 micrograms/actuation Gel.

Adverse Effects

  • Adverse effects are generally mild and usually occur during the first months of treatment; they are detailed in section 4.8 of the SmPC and in the PIL.
  • Metabolism and nutrition disorders: Glucose intolerance.
  • Psychiatric disorders: Depression, mood swings, changes in libido.
  • Nervous system disorders: Headache (including migraine), vertigo; aggravation of epilepsy.
  • Gastrointestinal disorders: Nausea, abdominal pain, flatulence, vomiting.
  • Eye disorders: Contact lens intolerance.
  • Vascular disorders: Venous thromboembolic disease (e.g. deep venous thrombosis, pulmonary embolism), arterial hypertension.
  • Hepatobiliary disorders: Abnormal liver function tests, cholestasis and jaundice.
  • Skin and subcutaneous tissue disorders: Pruritus, skin discolouration, acne; melasma/chloasma may occur or worsen.
  • Musculoskeletal and connective tissue disorders: Bone pain.
  • Reproductive system and breast disorders: Breast swelling and/or pain, breast enlargement, dysmenorrhoea, menorrhagia, metrorrhagia, leukorrhoea, endometrial hyperplasia, increased volume of uterine fibroids, leiomyoma, vaginitis/vaginal candidiasis.
  • General disorders and administration site conditions: Weight change (increase or decrease), water retention with peripheral oedema, asthenia (fatigue).
  • Immune system disorders: Anaphylactic reaction in women with a history of allergic reaction (very rare).
  • Serious risks associated with systemic oestrogen-containing HRT (described in SmPC sections 4.4 and 4.8): increased risk of endometrial hyperplasia and carcinoma with unopposed oestrogen; increased risk of breast cancer with prolonged HRT use; slightly increased risk of ovarian cancer; increased risk of venous thromboembolism; slight increase in risk of coronary artery disease in certain populations; increased risk of ischaemic stroke; possible increased risk of probable dementia when HRT is initiated after age 65.
  • Post-marketing reports: Cases of precocious puberty, breast budding, and breast masses in children, and gynaecomastia in prepubertal males, have been reported following secondary exposure to estradiol gel due to skin-to-skin transfer; these effects generally resolved after removal of exposure.
  • The PIL advises patients to seek immediate medical attention if they develop signs of liver dysfunction (jaundice), significant blood pressure elevation, migraine-like headache, angioedema, or symptoms suggestive of venous thrombosis (e.g. painful leg swelling, sudden chest pain, dyspnoea).

Storage Conditions

  • According to SmPC section 6.4, Oestrogel Pump-Pack 750 micrograms/actuation Gel does not require any special storage conditions.
  • Shelf life: 3 years as stated in the SmPC (section 6.3).
  • Keep the pump pack in its original packaging and out of the sight and reach of children, as advised in the PIL.
  • The product contains ethanol and is flammable until dry. The PIL instructs users to avoid sources of heat or naked flames when first administering the product, until the gel has dried on the skin.
  • Standard good practice for medicines applies: do not use after the expiry date shown on the pack; do not dispose of via wastewater or household waste; ask a pharmacist how to dispose of medicines no longer required.

Duration

No fixed maximum treatment duration is specified in the SmPC; Oestrogel should be used at the lowest effective dose for the shortest duration consistent with treatment goals and the patient\u2019s risk profile. For the treatment of menopausal symptoms, therapy should be initiated only for symptoms that adversely affect quality of life, with regular (at least annual) re-evaluation to decide whether continuation is appropriate. For prevention of postmenopausal osteoporosis, Oestrogel may be used long-term in women at high fracture risk who cannot use other approved medicines, again with periodic review. Guidance in the PIL emphasises that the doctor will prescribe the lowest effective dose for as short a time as necessary, and that ongoing use should be regularly reassessed.

Onset

Not publicly listed (no precise, quantified onset-of-action timeframe is stated in the MHRA SmPC or PIL for Oestrogel Pump-Pack 750 micrograms/actuation Gel).

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