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Elleste Duet 1mg Tablets

Elleste Duet 1mg Tablets

Elleste Duet

Prescription medicine
  • UK MHRA Authorised prescription Only medicine (PL 44081/0027).
  • Manufactured and controlled in accordance with EU/UK Good Manufacturing Practice (GMP).
  • Product information (SmPC and PIL) published on the electronic Medicines Compendium (emc) as trusted MHRA Aligned source.
Hormone Replacement Therapy (HRT) \u2013 sequential combined oral tablets

Description

Elleste Duet 1mg Tablets are a prescription-only, sequential combined hormone replacement therapy (HRT) for peri- and post-menopausal women. Each 28-day pack contains 16 white tablets with estradiol (as estradiol hemihydrate) only, followed by 12 pale green tablets with estradiol plus norethisterone acetate. The regimen provides oestrogen replacement to relieve menopausal symptoms, while the added progestogen phase protects the endometrium in women with an intact uterus. Elleste Duet 1mg is taken orally once daily without a tablet-free interval.

Bnefits

  • Relief of menopausal symptoms due to oestrogen deficiency (e.g. hot flushes, night sweats, vaginal dryness)
  • Sequential combined HRT suitable for women with an intact uterus
  • Provides endometrial protection by adding a progestogen phase (norethisterone acetate)
  • Continuous 28-day cycle with no tablet-free break for convenient dosing
  • Film-coated tablets for once-daily oral administration
  • Available in 84-tablet (3 × 28) packs for ongoing therapy

Indications

  • Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in post-menopausal and peri-menopausal women.
  • Relief of vasomotor and other menopausal symptoms (e.g. hot flushes, night sweats, urogenital atrophy) in women whose symptoms significantly affect quality of life.
  • Sequential combined HRT for women with an intact uterus who are still having periods or irregular bleeding and require cyclical therapy.

Composition

  • Active ingredients per tablet cycle:
  • White film-coated tablet (days 1–16): 1 mg estradiol (as estradiol hemihydrate).
  • Pale green film-coated tablet (days 17–28): 1 mg estradiol (as estradiol hemihydrate) and 1 mg norethisterone acetate.
  • Excipients (core, both tablet types): lactose monohydrate (62.8 mg in estradiol-only tablet, 61.8 mg in combination tablet), maize starch, povidone 25, purified talc, magnesium stearate.
  • Film coating (white tablets): hypromellose (E464), titanium dioxide (E171), macrogol 400.
  • Film coating (pale green tablets): hypromellose (E464), titanium dioxide (E171), macrogol 400, quinoline yellow (E104), indigo carmine (E132).

Formulation

  • Film-coated tablets for oral use.
  • Continuous sequential combined HRT regimen: estradiol-only phase followed by estradiol plus norethisterone phase in each 28-day cycle.

Packaging

  • Aluminium/PVC blister strips in cardboard carton.
  • Standard pack size: 84 film-coated tablets (3 × 28-day calendar blisters).
  • Each 28-tablet blister pack contains: 16 white tablets (estradiol only) and 12 pale green tablets (estradiol + norethisterone acetate).

Usage

  • For oral use only.
  • Take one tablet daily, preferably at the same time each day, swallowed with water.
  • Elleste Duet 1mg is a continuous sequential HRT: take one white tablet daily for the first 16 days of the cycle, followed by one pale green tablet daily for the next 12 days.
  • Start a new 28-day pack immediately after finishing the previous one, with no tablet-free interval.
  • Therapy may start at any time in women with established amenorrhoea or very infrequent menses; in menstruating women, start on the first day of bleeding.
  • When switching from another cyclical or continuous sequential HRT, complete the current cycle then start Elleste Duet 1mg without a break.
  • When switching from a continuous combined HRT, start Elleste Duet 1mg at any time if amenorrhoea is established, or on the first day of bleeding.
  • Missed dose: if a tablet is missed and less than 12 hours have passed, take it as soon as remembered and continue as normal. If more than 12 hours have elapsed, skip the missed tablet and take the next one at the usual time. A missed tablet increases the likelihood of breakthrough bleeding or spotting.
  • Use only under medical supervision as prescription HRT; regular clinical review is required.

Contraindications

  • 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 venous thromboembolism (deep vein 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 history of liver disease with abnormal liver function tests that have not returned to normal.
  • Known hypersensitivity to estradiol, norethisterone acetate or any excipients.
  • Porphyria.
  • Pregnancy and breast-feeding (Elleste Duet 1mg is not indicated during pregnancy or lactation).
  • Children and adolescents (not to be used in paediatric population).

Adverse Effects

  • Very common / common adverse reactions include: breast pain or tenderness, dysmenorrhoea, irregular vaginal bleeding or spotting, headache, nausea, abdominal pain or distension, weight increase, oedema, mood changes including depression, nervousness and libido changes.
  • Other reported reactions: dizziness, insomnia, migraine, varicose veins, hypertension, gastrointestinal disturbances (vomiting, diarrhoea, dyspepsia), gallbladder disorders including cholelithiasis, cholestatic jaundice, acne, rash, pruritus, dry skin, skin discolouration, hirsutism, alopecia, back pain, pain in extremity, muscle spasms.
  • Reproductive system and breast: breast enlargement, menstrual disorders, menorrhagia, genital discharge, uterine spasms, vaginal infection, endometrial hyperplasia, uterine leiomyoma, endocervical polyps.
  • Systemic / metabolic: pain, asthenia, peripheral oedema, increased liver enzymes (transaminases).
  • Serious but less frequent risks associated with HRT: venous thromboembolism (deep vein thrombosis, pulmonary embolism), arterial thromboembolic events, breast cancer, endometrial cancer (particularly with unopposed oestrogen), ovarian cancer, ischaemic stroke, gallbladder disease.
  • Skin and immune: hypersensitivity reactions, chloasma, erythema multiforme, erythema nodosum, vascular purpura, angioedema (particularly in women with hereditary angioedema).

Storage Conditions

  • Do not store above 30°C.
  • Store in the original package to protect from moisture and light.
  • Keep out of the sight and reach of children.
  • No special requirements for disposal; follow local regulations for medicinal waste.

Duration

Use the lowest effective dose for the shortest duration consistent with treatment goals. For post- and peri-menopausal symptoms, therapy should be reviewed at least annually and continued only as long as the benefit outweighs the risk.

Onset

Symptom relief from HRT may begin within a few weeks, with up to approximately 3 months for full therapeutic effect; response and timing vary between individuals.

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