Menstralite 500 mg tablets
Tranexamic acid 500 mg
For excipients, see section 6.1.
Film-coated tablet (tablet) for oral administration.
The film-coated tablet is white to off-white, oblong biconvex with a break line and marked TA on one side of the break line.
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.
For oral administration.
Treatment with tranexamic acid should not be initiated until menstrual bleeding has started. Recommended dosage is 2 tablets 3 times daily as long as needed for up to 4 days. If very heavy menstrual bleeding, 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.
Not for use in children under 18 years of age.
Not recommended for use in the elderly.
Mild to moderate renal insufficiency.
Hypersensitivity to tranexamic acid or any of the excipients.
Active thromboembolic disease.
A previous thromboembolic event and a family history of thrombophilia.
Irregular menstrual bleeding.
Patients being administered warfarin or other anticoagulants.
Patients taking oral contraceptives.
Patients should consult their doctor if menstrual bleeding is not reduced after three menstrual cycles.
Women over the age of 45 years should consult their doctor prior to taking tranexamic acid.
The following patients should consult their doctor prior to initiating treatment with tranexamic acid:
• patients who are obese and diabetic;
• those with polycystic ovary syndrome or a history of endometrial cancer in a first-degree relative;
• women receiving unopposed oestrogen or tamoxifen.
Patients who experience visual disturbance should be withdrawn from treatment.
Tranexamic acid counteracts the thrombolytic effect of fibrinolytic preparations.
Menstralite is contraindicated in pregnancy. Although there is no evidence from animal studies of a teratogenic effect, the usual caution with the use of drugs in pregnancy should be observed.
Tranexamic acid crosses the placenta.
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.
Breast-feeding women should consult their doctor prior to taking tranexamic acid.
Tranexamic acid has no or negligible influence on the ability to drive or use machines.
Gastrointestinal disorders (nausea, vomiting, diarrhoea) may occur but disappear when the dosage is reduced.
Rare instances of colour vision disturbances have been reported. Patients who experience disturbance of colour vision should be withdrawn from treatment.
Rare cases of thromboembolic events have been reported.
Rare cases of allergic skin reactions have also been reported.
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
Symptoms may be nausea, vomiting, orthostatic symptoms and / or hypotension. 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.
Tranexamic acid is an antifibrinolytic compound which is a potent competitive inhibitor of the activation of plasminogen to plasmin. At much higher concentrations it is a non-competitive inhibitor of plasmin. The inhibitory effect of tranexamic acid in plasminogen activation by urokinase has been reported to be 6-100 times and by streptokinase 6-40 times greater than that of aminocaproic acid. The antifibrinolytic activity of tranexamic acid is approximately ten times greater than that of aminocaproic acid.
A 2001 study involving more than 800 women demonstrated a significant improvement in their quality of life when taking tranexamic acid.
Following oral administration, 1.13% and 39% of the administered dose were recovered after 3 and 24 hours respectively. Tranexamic acid administered parenterally is distributed in a two compartment model.
Tranexamic acid crosses the placenta, and may reach one hundredth of the serum peak concentration in the milk of lactating women. Tranexamic acid crosses the blood brain barrier.
Following intravenous administration, the biological half-life of tranexamic acid has been determined to be 1.9 hours and 2.7 hours.
There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections of the Summary of Product Characteristics.
Colloidal anhydrous silica
Titanium dioxide (E171)
Do not store above 25ºC.
Store in the original package.
Blister pack of 25 μm, aluminium foil and 250μm, white opaque or transparent PVC.
Pack sizes: 12 and 18.
Waymade Plc trading as Sovereign Medical
Miles Gray Road