4.1. Therapeutic indications

Reduction of heavy menstrual bleeding over several cycles in women with regular, 21-35 day cycles with no more than 3 days individual variability in cycle duration.

4.2. Posology and method of administration

Posology

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.

Elderly:

Not recommended for use in the elderly.

Children:

Not for use in children and adolescents under 18 years of age.

Method of Administration

Route of administration: Oral

4.3. Contraindications

• 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.

4.4. Special warnings and precautions for use

Patients should consult their doctor if menstrual bleeding is not reduced after three menstrual cycles.

Patients with irregular menstrual bleeding should not use tranexamic acid until the cause of irregular bleeding has been established. If menstrual bleeding is not adequately reduced by tranexamic acid, an alternative treatment should be considered.

Tranexamic acid should be administered with care in patients receiving oral contraceptives because of the increased risk of thrombosis.

The following patients should consult their doctor prior to 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.

Patients with a previous thromboembolic event and a family history of thromboembolic disease (patients with thrombophilia) should use tranexamic acid only if there is a strong medical indication and under strict medical supervision.

The blood levels are increased in patients with renal insufficiency. Therefore, a dose reduction is recommended (see section 4.2).

The use of tranexamic acid in cases of increased fibrinolysis due to disseminated intravascular coagulations is not recommended.

Patients who experience visual disturbance should stop taking the product.

Clinical experience with tranexamic acid in menorrhagic children under 15 years of age is not available.

In case of haematuria of renal origin (especially in haemophilia), there is a risk for urinary obstruction at the lower levels of the tract. If left untreated, urinary obstruction may lead to serious consequences such as renal insufficiency, urinary tract infection, hydronephrosis, and anuria. Therefore, close monitoring is recommended for those patients with haematuria or risk of haematuria from the upper urinary tract.

Cases of convulsions have been reported in association with tranexamic acid treatment. In cardiac surgery, most of these cases were reported following intravenous (i.v.) injection of tranexamic acid in high doses.

This medicine contains less than 1mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

4.5. Interaction with other medicinal products and other forms of interaction

Tranexamic acid will counteract the thrombolytic effect of fibrinolytic preparations.

4.6. Fertility, pregnancy and lactation

Pregnancy

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

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.

4.7. Effects on ability to drive and use machines

Tranexamic acid has no or negligible influence on the ability to drive and use machines. Visual disturbances may occur following administration of tranexamic acid.

4.8. Undesirable effects

Gastrointestinal discomfort is the most common undesirable effect that may occur but disappears when the dosage is reduced.

Immune system disorders

Very rare (<1/10 000): Hypersensitivity reactions including anaphylaxis.

Frequency of undesirable effects at a dose of 4g/day (MedDRA LLT):

Gastrointestinal disorders

Common (≥1/100 to <1/10): Nausea, vomiting, diarrhoea.

Skin and subcutaneous tissue disorders

Uncommon (≥1/1,000 to <1/100) Allergic skin reactions.

Frequency not known: Fixed drug eruption.

Renal and urinary disorders

Frequency not known: Acute renal cortical necrosis.

Adverse Events:

Other adverse events have been reported with the use of tranexamic acid, but the frequency of the reports cannot be estimated from the available data: thromboembolic events, retinal/artery occlusion and impaired colour vision or other visual disturbances, seizures particularly in cases of misuse (refer to sections 4.3 and 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Signs

Signs and symptoms may include nausea, vomiting, orthostatic symptoms and / or hypotension, dizziness, headache and convulsions.

Treatment

Initiate vomiting, then stomach lavage and charcoal therapy. Maintain a high fluid intake to promote renal excretion. There is a risk of thrombosis in predisposed individuals. Anticoagulant treatment should be considered.