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Antifibrinolytic (Gynaecological Use) Pregnancy: Contraindicated in pregnancy. §4.6 verbatim: 'Tranexamic acid is contraindicated in pregnancy. Although there is no evidence from animal studies of a teratogenic effect, the usual caution with use of drugs in pregnancy should be observed. Tranexamic acid crosses the placenta.' Breastfeeding, verbatim: 'Tranexamic acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely. Breastfeeding women should consult their doctor prior to taking tranexamic acid.'

Tranexamic Acid (Heavy Menstrual Bleeding)

Brand names: Cyklokapron, Urimex

Tranexamic acid is an antifibrinolytic used as a first-line non-hormonal treatment for heavy menstrual bleeding, taken orally only during menstruation.

Adult dose

Dose: Heavy menstrual bleeding — 2 tablets three times daily, started only once heavy bleeding has begun, for a maximum of 4 days. The sourced product is a 500 mg tablet, so 2 tablets is 1 g per dose and the recommended regimen is 3 g in 24 hours. §4.2 verbatim: 'Treatment with tranexamic acid is initiated only once heavy bleeding has started. The recommended dosage is 2 tablets 3 times daily as long as needed but for a maximum of 4 days. If there is very heavy menstrual bleeding, the dosage may be increased. A total dose of 4g daily (8 tablets) should not be exceeded. Tranexamic acid can be used as long as periods remain regular and heavy.' The 500 mg tablet strength is fixed by the product name and confirmed inside §4.2 itself, which equates a total dose of 4 g daily with 8 tablets.
Route: Oral. §4.2 verbatim: 'Method of Administration Route of administration: Oral'.
Frequency: Three times daily during heavy bleeding only, for a maximum of 4 days per episode; treatment is started only after heavy bleeding has begun, not in anticipation of it. It may be continued cycle to cycle for as long as periods remain regular and heavy. §4.4 sets a review point: 'Patients should consult their doctor if menstrual bleeding is not reduced after three menstrual cycles' and 'If menstrual bleeding is not adequately reduced by tranexamic acid, an alternative treatment should be considered.'
Max: 4 g daily (8 tablets of 500 mg) must not be exceeded, and treatment must not run beyond 4 days. §4.2 verbatim: 'A total dose of 4g daily (8 tablets) should not be exceeded.' The recommended regimen of 2 tablets three times daily is 3 g daily, so the ceiling sits above the recommended dose and applies to the permitted increase for very heavy bleeding.
The recovered UK SPC is 'Evana Heavy Period Relief 500 mg tablets' (eMC product 15636) — an oral tranexamic acid tablet whose licensed indication is heavy menstrual bleeding, which is precisely this page's identity (oral antifibrinolytic for HMB, obstetrics and gynaecology). BRAND SCOPE — READ THIS. This page names Cyklokapron and Urimex as its brands; the SPC sourced here is neither of those. The active substance, tablet strength, route, indication and population all match, so the DOSE is transferable and is published, but brand-specific content is not: the sourced product is a pharmacy-supply presentation whose §4.3 is markedly more restrictive than a prescription-only tranexamic acid label — it contraindicates mild to moderate renal insufficiency, concurrent oral contraceptives, concurrent warfarin or other anticoagulants, and any history of convulsions outright, rather than treating them as cautions or dose adjustments. Anyone prescribing Cyklokapron or Urimex must read that product's own SPC before relying on the contraindication and interaction lists below. ELDERLY (§4.2 verbatim): 'Elderly : Not recommended for use in the elderly.' UNDER-18s (§4.2 verbatim): 'Children : Not for use in children and adolescents under 18 years of age.' RENAL DOSING IS NOT AVAILABLE FROM THIS LABEL — a documented internal inconsistency. §4.4 states 'The blood levels are increased in patients with renal insufficiency. Therefore, a dose reduction is recommended (see section 4.2)', but the §4.2 retrieved here contains NO renal dose reduction of any kind, and §4.3 contraindicates both mild-to-moderate renal insufficiency and severe renal impairment outright. No renal figure has therefore been recorded. Likewise NOT sourced here and not carried over: the NICE NG88 first-line positioning, the levonorgestrel-IUS comparison, the '~50% blood loss reduction' figure, the MHRA 2010 VTE statement and the factor IX interaction — all are guideline or literature claims, not figures from this label.

Paediatric dose

Route: N/A
Frequency: N/A
NO PAEDIATRIC DOSE — the sourced SPC excludes under-18s outright. §4.2 verbatim: 'Children : Not for use in children and adolescents under 18 years of age.' §4.4 adds: 'Clinical experience with tranexamic acid in menorrhagic children under 15 years of age is not available.' dosePerKg is deliberately null and no per-kilogram figure may be derived: this label expresses its dose as a fixed number of 500 mg tablets, never per kilogram. Heavy menstrual bleeding in an adolescent is a specialist decision — verify against a children's formulary and current specialist guidance, and against the SPC of the specific product to be used.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • SCOPE NOTE — the list below is §4.3 of the sourced pharmacy-supply product (Evana Heavy Period Relief 500 mg tablets) and is more restrictive than some prescription-only tranexamic acid labels. Check the SPC of the specific brand being used, including this page's named brands Cyklokapron and Urimex.
  • Hypersensitivity to the active substance or any of the excipients listed in section 6.1
  • Mild to moderate renal insufficiency
  • Severe renal impairment (risk of accumulation)
  • Active thromboembolic disease
  • A previous thromboembolic event, and a family history of thrombophilia
  • Haematuria
  • Irregular menstrual bleeding
  • Patients taking warfarin or other anticoagulants
  • Patients taking oral contraceptives, because of the increased risk of thrombosis
  • Fibrinolytic conditions following disseminated intravascular coagulation
  • History of convulsions
  • Contraindicated in pregnancy (§4.6)
  • Not recommended for use in the elderly, and not for use in children and adolescents under 18 years of age (§4.2)

Side effects

  • Gastrointestinal discomfort is the most common undesirable effect and disappears when the dosage is reduced (§4.8)
  • Common (at a dose of 4 g/day) — nausea, vomiting, diarrhoea
  • Uncommon — allergic skin reactions
  • Very rare — hypersensitivity reactions including anaphylaxis
  • Frequency not known — fixed drug eruption
  • Frequency not known — acute renal cortical necrosis
  • Reported with tranexamic acid but frequency not estimable — thromboembolic events; retinal/artery occlusion and impaired colour vision or other visual disturbances; seizures, particularly in cases of misuse
  • Patients who experience visual disturbance should stop taking the product (§4.4)
  • Convulsions have been reported in association with tranexamic acid treatment; in cardiac surgery most such cases followed intravenous injection of tranexamic acid in high doses (§4.4)

Monitoring

  • Reassess if menstrual bleeding is not reduced after three menstrual cycles, and consider an alternative treatment if bleeding is not adequately reduced (§4.4)
  • Establish the cause of irregular menstrual bleeding before starting — patients with irregular bleeding should not use tranexamic acid until the cause is known (§4.4)
  • Advise the patient to stop the product if visual disturbance occurs (§4.4)
  • These patients should consult their doctor before taking the product: women over the age of 45 years; patients who are obese or diabetic; those with polycystic ovary syndrome or a history of endometrial cancer in a first-degree relative; women receiving unopposed oestrogen or tamoxifen (§4.4)
  • Patients with a previous thromboembolic event and a family history of thromboembolic disease (thrombophilia) should use tranexamic acid only if there is a strong medical indication and under strict medical supervision (§4.4)
  • Use with care in patients receiving oral contraceptives because of the increased risk of thrombosis — note that §4.3 of this SPC lists concurrent oral contraceptives as a contraindication (§4.4)
  • Blood levels are increased in renal insufficiency; this SPC recommends a dose reduction but states no renal regimen, and contraindicates renal insufficiency outright — obtain renal dosing from the SPC of the product actually being used (§4.3, §4.4)
  • Monitor closely for urinary obstruction in patients with haematuria or at risk of haematuria from the upper urinary tract; untreated obstruction may lead to renal insufficiency, urinary tract infection, hydronephrosis and anuria (§4.4)
  • Not recommended where there is increased fibrinolysis due to disseminated intravascular coagulation (§4.4)
  • Interaction — tranexamic acid will counteract the thrombolytic effect of fibrinolytic preparations (§4.5)
  • Excipient — contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free (§4.4)

Clinical monograph

How it works

It competitively inhibits the activation of plasminogen to plasmin, reducing clot breakdown in the endometrium and thereby decreasing menstrual blood loss.

Prescribing in practice

  • It is contraindicated in active thromboembolic disease and used with caution where there is a personal or strong family history of venous thromboembolism.
  • It is taken only on the days of heavy bleeding and is a suitable choice for women who wish to avoid hormonal treatment or who are trying to conceive.
  • Gastrointestinal upset is the commonest adverse effect, and it does not provide contraception.

Monitoring

Monitoring is by clinical response; review if bleeding does not improve after a few menstrual cycles to reconsider the diagnosis and treatment.

Counselling the patient

  • Take it only during your period on the heavy-bleeding days, as directed.
  • It reduces bleeding but does not act as a contraceptive or treat pain.
  • Stop and seek advice if you develop calf pain or swelling, breathlessness, or visual disturbance.

Evidence & guidelines

NICE recommends tranexamic acid as a first-line non-hormonal option for heavy menstrual bleeding.

Reference: NICE NG88 (Heavy Menstrual Bleeding 2018); WOMAN trial (Shakur et al. Lancet 2017 — PPH context); MHRA guidance on VTE and tranexamic acid; SPC Cyklokapron; 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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