SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Femstrual 500mg tablets.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 500mg Tranexamic Acid.

For excipients see 6.1.

3 PHARMACEUTICAL FORM

Tablet.

Femstrual tablets are white caplet shaped tablets marked TXA 26 on one face and blank on the reverse.

4    CLINICAL PARTICULARS

4.1    Therapeutic indication

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

Route of Administration Oral.

Posology

Femstrual therapy is initiated only once heavy bleeding has started. The recommended dosage is 2 tablets 3 times daily for 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 4 g daily (8 tablets) should not be exceeded.

Femstrual 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

Severe renal failure because of risk of accumulation

4.4    Special Warnings and Precautions for Use

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

menstrual cycles.

The following patients should consult their doctor prior to initiating treatment with

Femstrual:

•    Women over the age of 45 years

•    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Patients who experience visual disturbance should be withdrawn from treatment.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    Interactions with other medicinal products and other forms of Interaction

Femstrual will counteract the thrombolytic effect of fibrinolytic preparations.

Drugs which also have effects on haemostasis should be given with caution to patients receiving tranexamic acid. There is a theoretical risk of increased potential for thrombus formation e.g. with oestrogens. Alternatively the action of the antifibrinolytic could be antagonised by thrombolytics.

Pregnancy and Lactation

Pregnancy: Femstrual 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.

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.

Breastfeeding women should consult their doctor prior to taking Femstrual.

4.7 Effects on ability to drive and use machines

Tranexamic Acid is not expected to affect a patients ability to drive and/or operate machines.

4.8 Undesirable Effects

Gastrointestinal discomfort is the most common undesirable effect that may occur but

disappear when the dosage is reduced.

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

Adverse Events:

Other adverse events reported with the prescription use of tranexamic acid (by injection or by mouth) are listed below by System Organ Class and frequency.

Frequencies are defined as: very common (>1/l0), common (>1/100 and <1/10), uncommon ( >1/1000 and <1/100), rare ( > 1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports, not known (cannot be estimated from the available data).

Immune system disorders	Very rare: Hypersensitivity reactions including anaphylaxis
Nervous system disorders	Very rare: Convulsions
Eye disorders	Rare: Colour vision disturbances, retinal vein/artery occlusion Patients who experience disturbance of colour vision should be withdrawn from treatment.
Vascular disorders	Rare: Thromboembolic events (arterial or venous thrombosis). Hypotension, with or without loss of consciousness. This generally occurs as a consequence of rapid intravenous injection, but may occur exceptionally after oral administration.
Renal and urinary disorders	Not known: Renal infarct, acute renal failure

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.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

ATC Code: B02A A02.

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 pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Calcium hydrogen phosphate (anhydrous), croscarmellose sodium, povidone, talc and magnesium stearate.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25 °C.

6.5 Nature and contents of container

Blister packs of white PVC coated with PVdC and hard-tempered aluminium foil on the reverse, in cardboard boxes of 18 tablets.

6.6 Special precautions for disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

Manx Healthcare Limited Taylor Group House Wednock Lane Warwick CV34 5YA United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 14251/0026

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

17 June 2008/7 April 2009

10 DATE OF REVISION OF THE TEXT

01/07/2014