Trade Name of the Medicinal Product

Menstralite 500 mg tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Tranexamic acid 500 mg

For excipients, see section 6.1.

3.    Pharmaceutical Form

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.

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

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.

Children:

Not for use in children under 18 years of age.

Elderly patients:

Not recommended for use in the elderly.

4.3 Contraindications

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. Haematuria.

Irregular menstrual bleeding.

Patients being administered warfarin or other anticoagulants.

Patients taking oral contraceptives.

4.4 Special warnings and precautions for use

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Patients who experience visual disturbance should be withdrawn from treatment.

4.5 Interaction with other medicinal products and other forms of interaction

Tranexamic acid counteracts the thrombolytic effect of fibrinolytic preparations.

4.6 Pregnancy and lactation

Pregnancy

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.

Lactation

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.

4.7 Effects on ability to drive and use machines

Tranexamic acid has no or negligible influence on the ability to drive or use machines.

4.8    Undesirable effects

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.

4.9    Overdose

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.

Pharmacological Properties

5.1. Pharmacodynamic properties

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.

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

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.

Pharmaceutical Particulars

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Tablet core:

Microcrystalline cellulose Povidone K90 Croscarmellose sodium Colloidal anhydrous silica Talc

Magnesium Stearate

Film coating: Magnesium stearate

Methacrylate polymers Titanium dioxide (E171) Macrogol 8000 Vanillin

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

36 months.

6.4    Special precautions for storage

Do not store above 25°C.

Store in the original package.

6.5    Nature and contents of container

Blister pack of 25 pm, aluminium foil and 250pm, white opaque or transparent PVC. Pack sizes: 12 and 18.

6.6    Special precautions for disposal

Not applicable.

Administrative Data

7 MARKETING AUTHORISATION HOLDER

Waymade Plc trading as Sovereign Medical Sovereign House Miles Gray Road Basildon

Essex SS14 3FR United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 06464/2913

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19/04/2013

10    DATE OF REVISION OF THE TEXT

11/12/2014