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Evorel (Estradiol) Patches 75 mcg (8 patches)

Evorel (Estradiol) Patches 75 mcg (8 patches)

Evorel

Prescription medicine
  • Licensed in the UK as a prescription Only medicine under marketing authorisation number PL 49105/0007 (Evorel 75 Patch), held by Theramex HQ UK Limited.
  • Product information (SmPC and PIL) is published and regularly updated on the electronic medicines compendium (emc) in accordance with MHRA requirements.
  • Manufactured and controlled according to EU/UK Good Manufacturing Practice (GMP) for medicinal products.
  • Subject to ongoing pharmacovigilance, including reporting of suspected adverse reactions via the MHRA Yellow Card Scheme.
Oestrogen-only HRT transdermal patch

Description

Evorel 75 is an oestrogen-only hormone replacement therapy (HRT) transdermal patch containing estradiol hemihydrate, designed to relieve oestrogen deficiency symptoms associated with the peri- and post-menopause and to help prevent post-menopausal osteoporosis in appropriate women. Each Evorel 75 patch is a transparent, square, self-adhesive matrix transdermal delivery system with a surface area of 24 cm² and a thickness of approximately 0.2 mm. The matrix contains 4.8 mg estradiol hemihydrate (equivalent to 4.65 mg estradiol) and is formulated to deliver a nominal 75 micrograms of estradiol per 24 hours through the skin directly into the systemic circulation. The patch consists of a monolayered adhesive matrix in which 17β-estradiol is uniformly distributed, backed by a flexible polyethylene terephthalate film and protected by a polyester release liner with an S-shaped incision that is removed prior to application.\n\nEvorel 75 is indicated as HRT for oestrogen deficiency symptoms in peri- and post-menopausal women and, in the 50–100 micrograms strengths, for the prevention of osteoporosis in post-menopausal women at high risk of future fractures who are intolerant of, or have contraindications to, other medicines approved for osteoporosis prevention. It is an oestrogen-only patch and should therefore usually be combined with a separate progestogen for at least 12–14 days of each 28-day cycle in women with an intact uterus to reduce the risk of endometrial hyperplasia and carcinoma. Patches are applied to the trunk below the waist and changed twice weekly, providing a continuous transdermal supply of estradiol that bypasses first-pass hepatic metabolism and maintains physiologically relevant estradiol/estrone ratios. Treatment must be initiated and regularly reviewed by a healthcare professional, using the lowest effective dose for the shortest duration consistent with treatment goals.

Bnefits

  • Provides effective relief of menopausal oestrogen-deficiency symptoms such as hot flushes, night sweats, sleep disturbance, mood changes and vaginal dryness.
  • Delivers estradiol via a transdermal matrix system, bypassing first-pass hepatic metabolism and helping to maintain more stable serum estradiol levels compared with many oral formulations.
  • Evorel 50, 75 and 100 strengths are licensed for the prevention of post-menopausal osteoporosis in women at high fracture risk who cannot use other osteoporosis-prevention medicines.
  • Twice-weekly patch changes (one patch worn continuously) offer a convenient alternative to daily tablets and may improve adherence for some women.
  • Transdermal HRT is associated with a lower impact on certain hepatic proteins and may be preferable for some women with risk factors where oral oestrogens are less suitable, according to clinical judgement and guidelines.
  • Steady 24-hour release of 75 micrograms estradiol per day from a 24 cm² matrix patch minimises large peak–trough fluctuations in hormone levels, which may reduce certain side effects seen with oral dosing.
  • Memory-pack carton presentation (multiple individually pouched patches) supports consistent, scheduled patch changes and facilitates correct use.
  • Flexible dosing within the Evorel range (25, 50, 75, 100 micrograms per 24 hours) allows titration to the lowest effective estradiol dose for each woman.

Indications

  • Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in peri- and post-menopausal women.
  • Prevention of post-menopausal osteoporosis in post-menopausal women at high risk of future fractures who are intolerant of, or have contraindications to, other medicinal products approved for the prevention of osteoporosis (Evorel 50, 75 and 100 strengths only).
  • Use as part of an oestrogen-only HRT regimen in women who have undergone hysterectomy, where progestogen is not required (unless residual endometriosis is suspected, when a progestogen may still be considered).
  • Use as the oestrogen component of a combined HRT regimen in non-hysterectomised women, with a separate progestogen given cyclically or continuously sequentially for at least 12–14 days per 28-day cycle to protect the endometrium.

Composition

  • Active substance per Evorel 75 patch (24 cm² matrix patch):
  • - Estradiol hemihydrate 4.8 mg (equivalent to 4.65 mg estradiol), delivering approximately 75 micrograms of estradiol per 24 hours.
  • Excipients / patch components:
  • - Adhesive acrylic polymer (Duro-Tak 387-2287) forming the pressure-sensitive matrix.
  • - Guar gum (Meyprogat 90) as a matrix component.
  • - Polyethylene terephthalate (PET) backing film (e.g. Hostaphan MN 19) providing the outer backing layer.
  • - Polyester release liner (siliconised PET film) covering the adhesive surface and removed immediately before application.
  • Container:
  • - Each patch supplied in a sealed protective pouch composed of a Surlyn ionomer film / aluminium foil / polyethylene / reinforced paper laminate, packed within a cardboard carton (memory pack).

Formulation

  • Estradiol-only matrix-type transdermal patch (Transdermal Delivery System, TDS) for twice-weekly application.
  • Transparent, square patch with rounded corners, approximately 0.2 mm thick and 24 cm² in surface area for Evorel 75.
  • Monolayered adhesive matrix in which 17β-estradiol (as estradiol hemihydrate) is uniformly dispersed.
  • Outer backing layer of polyethylene terephthalate film protecting the patch from the external environment.
  • Inner polyester release liner with an S-shaped incision, removed prior to use to expose the adhesive matrix for skin application.
  • Prescription-only medicinal product classified under ATC code G03CA03 (estradiol).

Packaging

  • Each Evorel 75 patch is individually sealed in a foil laminate protective pouch.
  • Pouches are packed in a cardboard memory-pack carton containing multiple patches; common retail pack sizes include 2, 8 or 24 patches (the 8-patch pack corresponds to approximately 4 weeks of treatment at twice-weekly patch changes).
  • Outer carton is printed with product name (Evorel 75 Patch), strength (75 micrograms per 24 hours), marketing authorisation number (PL 49105/0007), batch number and expiry date.
  • The carton and Patient Information Leaflet provide guidance on patch-change schedule and application sites.

Usage

  • Evorel 75 should be prescribed and supervised by a healthcare professional experienced in menopause management and HRT.
  • Posology: one Evorel patch applied to the skin twice weekly (i.e. every 3–4 days), so that one patch is worn at all times. The starting dose for most women is Evorel 50; Evorel 75 is used when a higher oestrogen dose is clinically indicated. The maximum recommended daily dose is 100 micrograms estradiol (Evorel 100).
  • Women with an intact uterus must usually receive an additional progestogen (e.g. oral norethisterone 1 mg/day or medroxyprogesterone acetate 2.5 mg/day) for at least 12–14 days of each 28-day cycle to reduce the risk of endometrial hyperplasia and carcinoma.
  • Apply the patch as soon as it is removed from the sachet to clean, dry, healthy, intact skin on the trunk below the waistline (e.g. lower abdomen, hip, buttock). Do not apply on or near the breasts or on irritated or damaged skin.
  • Avoid applying the patch to areas subject to tight clothing or waistbands and do not use creams, oils, lotions or talc on the application site beforehand, as these may impair adhesion.
  • To apply: open the sachet, remove the patch, peel off part of the S-shaped release liner and place the exposed adhesive side onto the chosen skin area, then remove the remaining liner and press the entire patch firmly in place with the palm of the hand for at least 10 seconds to ensure good adhesion.
  • Rotate application sites, allowing at least one week before re-using the same skin area.
  • The patch is designed to remain in place during bathing, showering and normal exercise. If a patch falls off, wait until the skin has cooled (if just bathed) and apply a new patch to a different site; continue with the original change schedule and do not apply more than one patch at a time.
  • If a patch change is forgotten, it should be changed as soon as remembered; if it is almost time for the next scheduled change, the missed patch should be skipped and the original schedule resumed. Missing doses may lead to breakthrough bleeding or spotting.
  • Evorel is not a contraceptive. Non-hormonal contraception should be used if pregnancy is possible.
  • Women should be reviewed at least annually to reassess the balance of benefits and risks and to decide whether continuation of HRT is appropriate, always aiming to use the lowest effective dose for the shortest duration.

Contraindications

  • Known, current, past or suspected breast cancer.
  • Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial carcinoma) or untreated atypical endometrial hyperplasia.
  • Undiagnosed genital (vaginal) bleeding.
  • Untreated endometrial hyperplasia.
  • Previous or current venous thromboembolism (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. myocardial infarction, angina, stroke or transient ischaemic attack).
  • Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal.
  • Known hypersensitivity to estradiol or any of the excipients (e.g. acrylic adhesive, guar gum, polyester film).
  • Porphyria.
  • Pregnancy or breastfeeding (Evorel is not indicated during pregnancy or lactation).

Adverse Effects

  • Very common and common adverse reactions reported with Evorel include application-site reactions (pruritus, rash, erythema, oedema), breast pain or tenderness, metrorrhagia or breakthrough bleeding, headache, abdominal pain, nausea and weight increase.
  • Other commonly reported effects with oestrogen-only HRT may include breast enlargement, dysmenorrhoea, mood changes, fluid retention, peripheral oedema, and gastrointestinal symptoms such as bloating or diarrhoea.
  • Uncommon or rare reactions associated with HRT in general include chloasma and other pigmentary skin changes, erythema multiforme or nodosum, vascular purpura, gallbladder disease and muscle cramps.
  • Use of oestrogen-only or combined HRT is associated with increased risks of certain serious conditions, including endometrial hyperplasia and carcinoma (if unopposed by progestogen in women with a uterus), venous thromboembolism, ischaemic stroke, and in some regimens breast and ovarian cancer. The magnitude of risk depends on treatment type, dose, duration and individual baseline risk.
  • Oestrogens may cause fluid retention and can exacerbate conditions such as cardiac or renal dysfunction; they can also worsen hypertriglyceridaemia and precipitate pancreatitis in susceptible individuals.
  • If the woman develops jaundice, significant rise in blood pressure, new migraine-type headache, pregnancy, signs of thrombosis (e.g. painful leg swelling, sudden chest pain, dyspnoea) or other serious symptoms, treatment should be stopped and urgent medical evaluation sought.

Storage Conditions

  • Do not store above 25 °C.
  • Store in the original protective sachet and outer carton until use to protect from light and moisture.
  • Keep patches out of the sight and reach of children and pets, both before and after use.
  • Do not refrigerate or freeze.
  • Used patches still contain active hormone; fold used patches with the adhesive sides together and dispose of them safely in household waste or as advised by a pharmacist. Do not flush patches down the toilet.
  • Shelf life is 24 months for the product as packed for sale; do not use after the expiry date printed on the carton and sachet.

Duration

Duration of therapy is individualised. For relief of menopausal symptoms and prevention of post-menopausal osteoporosis, Evorel 75 should be used at the lowest effective dose for the shortest duration consistent with treatment goals. The need for continuing HRT should be reviewed at least once a year; long-term use beyond several years requires careful risk\u2013benefit assessment, particularly in older women.

Onset

Improvement in vasomotor symptoms is generally observed within the first few weeks of therapy, with many women experiencing meaningful relief of hot flushes and night sweats during the initial 4\u201312 weeks. Bone-density benefits accrue over months to years of continuous treatment.

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