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Combined oral contraceptive (monophasic) Pregnancy: Not indicated during pregnancy. If pregnancy occurs while taking Zoely, further intake should be stopped. Most epidemiological studies have revealed neither an increased risk of birth defects in infants born to women who used ethinylestradiol-containing COCs prior to pregnancy, nor a teratogenic effect when such COCs were taken inadvertently in early pregnancy; clinical data on a limited number of exposed pregnancies indicate no adverse effect of Zoely on the foetus or neonate. Reproductive toxicity has been observed in animal studies with the nomegestrol acetate / estradiol combination. The increased risk of VTE during the postpartum period should be considered when re-starting Zoely. Breast-feeding: small amounts of contraceptive steroids and/or their metabolites may be excreted in breast milk with no evidence of adverse effect on infant health, but COCs may reduce the quantity and change the composition of breast milk — use is not recommended until the mother has completely weaned her child, and an alternative contraceptive method should be proposed.

Estradiol with nomegestrol

Brand names: Zoely

A fixed-dose combination of estradiol (a body-identical oestrogen) with nomegestrol acetate (a progestogen) used as a monophasic combined oral contraceptive.

Adult dose

Dose: Combined oral contraception (Zoely 2.5 mg/1.5 mg): one tablet daily for 28 consecutive days. Each pack starts with 24 white active tablets, followed by 4 yellow placebo tablets. A subsequent pack is started immediately after finishing the previous pack, without a break in daily tablet intake and irrespective of the presence or absence of withdrawal bleeding.
Route: Oral — take every day at about the same time, without regard to meals, with some liquid as needed and in the order directed on the blister
Frequency: Once daily, continuous 24 active + 4 placebo (24/4) regimen with no tablet-free interval
Withdrawal bleeding usually starts on day 2-3 after intake of the last white tablet and may not have finished before the next pack is started. STARTING: with no preceding hormonal contraceptive use in the past month, start on day 1 of the menstrual cycle — no additional contraceptive measures needed. Switching from a combined hormonal contraceptive — preferably start the day after the last active tablet of the previous COC, at the latest the day after its usual tablet-free or placebo interval; for a vaginal ring or transdermal patch, preferably on the day of removal, at the latest when the next application would have been due. Switching from a progestogen-only method (minipill, implant, injectable) or a hormone-medicated IUS — switch from the minipill any day and start the next day; start on the day an implant or IUS is removed, or on the day the next injection would have been due; in all these cases use a barrier method until 7 days of uninterrupted white active tablet-taking are completed. After a first-trimester abortion, tablet-taking may start immediately with no additional measures. After delivery or a second-trimester abortion, start between day 21 and 28; if starting later use a barrier method until 7 days of uninterrupted white active tablet-taking are completed, and exclude pregnancy first if intercourse has already occurred. MISSED WHITE ACTIVE TABLETS: less than 24 hours late — contraceptive protection is not reduced; take it as soon as remembered and continue as usual. 24 or more hours late — protection may be reduced; 7 days of uninterrupted white active tablet-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian axis, and risk rises the more tablets are missed and the closer they are to the 4 yellow placebo tablets. Day 1-7: take the last missed white tablet at once (even if that means two in one day), continue as usual, and use a barrier method until 7 days of uninterrupted white tablet-taking are completed; consider pregnancy if intercourse took place in the preceding 7 days. Day 8-17: take the last missed white tablet at once and continue as usual — no extra precautions if the preceding 7 days were taken correctly, but if more than one tablet was missed use extra precautions until 7 uninterrupted days are completed. Day 18-24: either take the last missed tablet at once, continue to the end of the active tablets, discard the 4 placebo tablets and start the next pack right away; or discontinue the current pack, take placebo tablets for a maximum of 3 days so that placebo plus missed white tablets total no more than 4, then continue with the next pack. Missed YELLOW placebo tablets do not reduce protection — discard them to avoid prolonging the placebo phase. GASTROINTESTINAL UPSET: if vomiting occurs within 3-4 hours of taking a white tablet, treat it as missed and take a new tablet as soon as possible, within 24 hours of the usual time if possible. DELAYING A PERIOD: continue with another pack without taking the current pack's yellow placebo tablets, up to the end of the white active tablets in the second pack. To shift the period to another day, shorten the forthcoming yellow placebo phase by a maximum of 4 days.

Paediatric dose

Route: N/A
Frequency: N/A
Max: Not established
UK SPC: safety and efficacy have not been established in adolescents under 18 years of age, and there is no relevant use of Zoely in children and pre-menarchal adolescents. No paediatric dose is published here.

Dose adjustments

Renal

No data are available in patients with renal impairment, although renal impairment is unlikely to affect the elimination of nomegestrol acetate and estradiol.

Hepatic

No clinical studies have been performed in patients with hepatic insufficiency. Since the metabolism of steroid hormones may be impaired in severe hepatic disease, use is not indicated in these women as long as liver function values have not returned to normal.

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

  • Presence or risk of venous thromboembolism (VTE) — current VTE (on anticoagulants) or a history of VTE such as deep vein thrombosis or pulmonary embolism
  • Known hereditary or acquired predisposition for venous thromboembolism — such as activated protein C (APC) resistance including Factor V Leiden, antithrombin-III deficiency, protein C deficiency, protein S deficiency
  • Major surgery with prolonged immobilisation
  • A high risk of venous thromboembolism due to multiple risk factors
  • Presence or risk of arterial thromboembolism (ATE) — current ATE, a history of ATE (e.g. myocardial infarction) or a prodromal condition (e.g. angina pectoris)
  • Cerebrovascular disease — current stroke, history of stroke, or a prodromal condition such as transient ischaemic attack
  • Known hereditary or acquired predisposition for arterial thromboembolism — such as hyperhomocysteinaemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant)
  • History of migraine with focal neurological symptoms
  • A high risk of arterial thromboembolism due to multiple risk factors, or one serious risk factor such as diabetes mellitus with vascular symptoms, severe hypertension, or severe dyslipoproteinaemia
  • Pancreatitis or a history of pancreatitis associated with severe hypertriglyceridaemia
  • Presence or history of severe hepatic disease as long as liver function values have not returned to normal
  • Presence or history of liver tumours (benign or malignant)
  • Known or suspected sex steroid-influenced malignancies (e.g. of the genital organs or the breasts)
  • Meningioma or history of meningioma
  • Undiagnosed vaginal bleeding
  • Hypersensitivity to the active substances or to any of the excipients

Side effects

  • Acne — very common (15.4% in clinical trials)
  • Irregular withdrawal bleeding — very common (9.8%)
  • Headache and migraine — common
  • Nausea — common
  • Decreased libido, depression / depressed mood, mood altered — common
  • Increased appetite, fluid retention — common
  • Hot flush — common
  • Metrorrhagia, menorrhagia, breast pain, pelvic pain — common
  • Weight increased — common
  • Irritability, oedema — common
  • Hyperhidrosis, alopecia, pruritus, dry skin, seborrhoea — uncommon
  • Venous thromboembolism — uncommon
  • Cerebrovascular accident, transient ischaemic attack, disturbance in attention — uncommon
  • Cholelithiasis, cholecystitis — uncommon
  • Contact lens intolerance / dry eye — uncommon
  • Hypomenorrhoea, breast swelling, galactorrhoea, uterine spasm, premenstrual syndrome, breast mass, dyspareunia, vulvovaginal dryness — uncommon
  • Chloasma, hypertrichosis — rare; increased libido — rare; decreased appetite — rare; dry mouth — rare; hepatic enzyme increased
  • Hypersensitivity reactions — frequency unknown
  • An increased risk of arterial and venous thrombotic and thromboembolic events — including myocardial infarction, stroke, transient ischaemic attack, venous thrombosis and pulmonary embolism — has been observed in women using combined hormonal contraceptives
  • NOTE: the SPC adverse-reaction section was truncated in this source capture — this list may not be complete; consult the SPC

Monitoring

  • Cycle control — withdrawal bleeding pattern, breakthrough bleeding and spotting, particularly when packs are run together or the placebo phase is shortened
  • Exclude pregnancy if withdrawal bleeding is absent after tablets have been missed
  • Liver function values where there is a history of hepatic disease — use is not indicated until they return to normal

Clinical monograph

How it works

The oestrogen and progestogen suppress the hypothalamic-pituitary axis to inhibit ovulation, while the progestogen additionally thickens cervical mucus and renders the endometrium unfavourable to implantation.

Prescribing in practice

  • Like all combined hormonal contraceptives it carries a risk of venous and arterial thromboembolism; assess personal and family VTE risk and avoid in those with significant risk factors or migraine with aura.
  • Use the UKMEC framework to screen for cardiovascular, hepatic and breast-related contraindications before prescribing.
  • Counsel on missed-pill rules and the reduced efficacy seen with enzyme-inducing drugs and significant vomiting or diarrhoea.

Monitoring

Review blood pressure and reassess VTE and cardiovascular risk at initiation and periodically thereafter.

Counselling the patient

  • Take at the same time each day and follow the missed-pill instructions if a dose is delayed.
  • Seek urgent care for calf swelling, chest pain, breathlessness, sudden severe headache or visual disturbance.
  • Tell any clinician you are taking a combined contraceptive before starting new medicines.

Evidence & guidelines

UK Medical Eligibility Criteria (UKMEC) and MHRA guidance underpin combined hormonal contraceptive prescribing and VTE risk stratification.

Reference: FSRH CHC guideline; UKMEC; 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.

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