Combined oral contraceptive (quadriphasic, estradiol-based) Pregnancy: Not indicated during pregnancy — if pregnancy occurs during use, further intake must be stopped. Extensive epidemiological studies with ethinylestradiol-containing combined oral contraceptives have revealed neither an increased risk of birth defects in children born to women who used them prior to pregnancy, nor a teratogenic effect when they were taken inadvertently during pregnancy; animal studies do not indicate a risk for reproductive toxicity. The increased risk of venous thromboembolism during the postpartum period should be considered when restarting. Breastfeeding: lactation may be influenced as combined oral contraceptives may reduce the quantity and change the composition of breast milk, so their use should generally not be recommended until the nursing mother has completely weaned her child; small amounts of the contraceptive steroids and/or their metabolites may be excreted in milk and may affect the child.

Dienogest with estradiol valerate

Brand names: Qlaira

A combined oral contraceptive pairing the progestogen dienogest with the natural oestrogen estradiol valerate, used for contraception and, in some countries, for managing heavy menstrual bleeding.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: One tablet daily for 28 consecutive days, taken in the order directed on the pack. The wallet is four-phasic: days 1-2 dark yellow tablets (3.0 mg estradiol valerate); days 3-7 medium red tablets (2.0 mg estradiol valerate + 2.0 mg dienogest); days 8-17 and days 18-24 light yellow tablets (2.0 mg estradiol valerate + 3.0 mg dienogest); days 25-26 dark red tablets (1.0 mg estradiol valerate); days 27-28 white placebo tablets

Route: Oral

Frequency: Once daily at about the same time with some liquid as needed; tablet taking is continuous — each subsequent pack is started the day after the last tablet of the previous wallet

Max: Not more than two tablets are to be taken on a given day (stated in the missed-tablet instructions)

Fetched label is 'Qlaira film-coated tablets' (UK SPC) — a combined oral contraceptive; §4.8 also refers to its use in heavy menstrual bleeding in women without organic pathology who desire oral contraception. Withdrawal bleeding usually starts during intake of the last tablets of a wallet and may not have finished before the next wallet is started; in some women bleeding starts after the first tablets of the new wallet. STARTING: with no preceding hormonal contraceptive use in the past month, start on day 1 of the natural cycle (first day of menstrual bleeding). Changing from a combined hormonal contraceptive — start on the day after the last active tablet of the previous COC, or on the day of removal of a vaginal ring or transdermal patch. Changing from a progestogen-only method or progestogen-releasing IUS — may switch any day (from an implant or IUS on the day of removal, from an injectable when the next injection would be due) but a barrier method should additionally be used for the first 9 days. Following first-trimester abortion — may start immediately with no additional contraceptive measures. Following delivery or second-trimester abortion — start at day 21 to 28; if starting later, additionally use a barrier method for the first 9 days, and if intercourse has already occurred exclude pregnancy first. MISSED TABLETS (more than 12 hours late; missed white placebo tablets can be disregarded but should be discarded): days 1-2, 3-7, 8-17 and 25-26 — take the missed tablet immediately, take the next tablet at the usual time (even if this means two tablets in one day) and continue as usual; back-up contraception is needed for the next 9 days for days 1-17 but is not necessary for days 25-26. Days 18-24 — do NOT take the missed tablet, discard the current wallet, start the first tablet of a new wallet, continue as usual and use back-up contraception for the next 9 days. Days 27-28 (placebo) — discard the missed tablet and take the next tablet at the usual time; no back-up contraception necessary. If a woman has forgotten to start a new wallet, or has missed one or more tablets during days 3-9, she may already be pregnant if she has had intercourse in the preceding 7 days. GASTROINTESTINAL DISTURBANCE: if vomiting occurs within 3-4 hours after active tablet-taking, take the next tablet as soon as possible, ideally within 12 hours of the usual time; if more than 12 hours elapse, apply the missed-tablet advice. Not indicated after the menopause. Contraindicated in women with severe hepatic disease. Paediatric (non per-kg, so not expressed as a mg/kg dose): no data available for use in adolescents below 18 years. Verify any under-18 use against a children's formulary.

Dose adjustments

Renal

Has not been specifically studied in renally impaired patients.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Presence or risk of venous thromboembolism — current VTE (on anticoagulants) or a history of VTE (e.g. deep vein thrombosis or pulmonary embolism)
Known hereditary or acquired predisposition to venous thromboembolism, such as APC resistance (including Factor V Leiden), antithrombin-III deficiency, protein C deficiency or protein S deficiency
Major surgery with prolonged immobilisation, or a high risk of venous thromboembolism due to multiple risk factors
Presence or risk of arterial thromboembolism — current or previous arterial thromboembolism (e.g. myocardial infarction) or a prodromal condition such as angina pectoris
Cerebrovascular disease — current stroke, history of stroke or a prodromal condition such as transient ischaemic attack
Known hereditary or acquired predisposition to arterial thromboembolism, such as hyperhomocysteinaemia or antiphospholipid antibodies
History of migraine with focal neurological symptoms
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
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)
Undiagnosed vaginal bleeding
Hypersensitivity to the active substances or to any of the excipients

Side effects

Acne
Breast discomfort
Headache
Intracyclic (breakthrough) bleeding; amenorrhoea, dysmenorrhoea
Nausea and abdominal pain; weight increased
Serious adverse reactions: venous and arterial thromboembolism (uncommon/rare), hypertension, myocardial infarction (rare)

Clinical monograph

How it works

Suppresses ovulation through inhibition of gonadotrophin release, while dienogest also exerts an antiandrogenic effect and thins the endometrium; estradiol valerate provides cycle control.

Prescribing in practice

Avoid in women with a personal history of venous or arterial thromboembolism, known thrombogenic mutations, or other UKMEC category 4 conditions for combined hormonal contraception.
Assess cardiovascular risk factors (smoking, age, BMI, blood pressure, migraine with aura) before starting and at review.
Enzyme-inducing drugs and some antiretrovirals reduce contraceptive efficacy; check interactions before co-prescribing.

Monitoring

Review blood pressure and reassess thrombotic and cardiovascular risk factors at follow-up and periodically thereafter.

Counselling the patient

Seek urgent advice for calf swelling, chest pain, breathlessness, severe headache or sudden visual or speech disturbance.
Take tablets in the correct order following the supplied schedule, and use the missed-pill instructions if a dose is delayed.
This method does not protect against sexually transmitted infections.

Evidence & guidelines

Combined hormonal contraceptives are addressed by FSRH and MHRA guidance, which sets out the recognised venous thromboembolism and cardiovascular risk considerations.

Reference: FSRH CHC guideline; UKMEC; NICE NG88 HMB; 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).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways