Tranexamic acid P medicine https://www.rpharms.com/resources/quick-reference-guides/tranexamic-...

Tranexamic acid P
medicine

Quick reference guide 

In 2010, Tranexamic acid 500mg tablets became available over the
counter as a Pharmacy (P) medicine for the relief of heavy menstrual
bleeding. It has been shown to reduce menstrual loss by up to 58 per
cent and it is likely to be an advantage for certain women who want to
try a drug treatment for heavy menstrual bleeding without having to
consult a doctor.

This guidance for pharmacists provides a summary of the product information relating to
the over-the-counter use of tranexamic acid. It does not cover the full list of contra-
indications or full details of the risk information (further details can be found on the
summary of product characteristics). 

Sections on this page

What is tranexamic acid indicated for?
Who to refer to a doctor?
What is “heavy” menstrual bleeding?
How does tranexamic acid work?
What is the dose of tranexamic acid?
When should tranexamic acid not be supplied?

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What are the side effects of tranexamic acid?

Are there any drug interactions with tranexamic aicd?
Where to go for further information

What is tranexamic acid indicated for?

OTC tranexamic acid is indicated for the reduction of heavy menstrual
bleeding over several cycles in women aged 18 years and over, with
regular 21-35 day cycles, with no more than three days individual
variability in cycle duration.

Who to refer to a doctor?

Women under 18 and those over 45 years
Patients who have been taking tranexamic acid for three menstrual
cycles without a reduction in bleeding
Breastfeeding women
Patients who are obese or diabetic
Patients with polycystic ovary syndrome or a history of endometrial
cancer in a first degree relative
Women taking unopposed oestrogen or tamoxifen
Patients who have a condition which means tranexamic acid is
contraindicated for use (see below)
Patients taking medicines that interact with tranexamic acid (see
below).

What is “heavy” menstrual bleeding?

“Heavy” menstrual bleeding (menorrhagia) is excessive menstrual blood
loss which interferes with a woman's physical, social, emotional and/or

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material quality of life. It can occur alone or in combination with other

symptoms. Research has shown that the average menstrual blood loss
is 30 to 40ml each cycle, however women who experience heavy
bleeding may lose 60 to 80ml or more. As this is impractical to measure
and often does not correlate with the impact on quality of life, heavy
bleeding will often be determined by the patient.

Heavy bleeding can often be a cause of iron-deficiency anaemia,

patients that present with signs or symptoms of this, should be referred
to their prescriber. 

Pharmacists should be aware that irregular bleeding, abnormal

bleeding, bleeding between periods or prolonged periods could be a
sign of endometrial cancer. Bleeding between periods, pain during
sex, bleeding after sex and bleeding after menopause and could
be signs or symptoms of cervical cancer. 

How does tranexamic acid work?

Tranexamic acid is an antifibrinolytic which inhibits fibrinolysis, which
subsequently increases clot formation and reduces blood loss. It is often
used to prevent bleeding or to treat bleeding associated with excessive
fibrinolysis.

What is the dose of tranexamic acid?

It should be taken only once heavy bleeding has started at a dose of two
500mg tablets three times a day until the symptoms are alleviated. It will
not work properly if taken before menstruation has started. It should not
be taken for more than four consecutive days. If menstrual bleeding is
very heavy the dose may be increased to a maximum of eight tablets a
day (4g daily). It can be used as long as periods remain regular and
heavy.

When should tranexamic acid not be

supplied?
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Tranexamic acid is contraindicated in the following conditions:

Mild to moderate renal insufficiency

Hypersensitivity to tranexamic acid or any of the excipients
Active thromboembolic disease
Previous thrombolic event and a family history of thrombophilia
Haematuria
Irregular menstrual bleeding
Patients taking warfarin or other anticoagulants
Patients taking oral contraceptives
Pregnancy
Severe renal impairment
History of convulsions 

These patients should be referred to their GP for further advice.

What are the side effects of tranexamic

acid?
Gastrointestinal discomfort, including nausea, vomiting and diarrhoea
are common, however reducing the dose will resolve these adverse
effects. If patients experience visual disturbances they should be
advised to stop taking the tablets and to see their doctor. Other adverse
effects include allergic skin reactions (uncommon) and thromboembolic
events (frequency unknown).

Are there any drug interactions with

tranexamic acid?
Tranexamic acid will counteract the thrombolytic effects of fibrinolytic
agents.

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Where to go for further information

external resources
Press release – First over the Counter (OTC) medicine for heavy menstrual
bleeding approved (http://www.mhra.gov.uk/NewsCentre/Pressreleases
/CON076475 )  - MHRA
Summary of Product Characteristics (https://www.medicines.org.uk/ )
Clinical Guidelines – Heavy menstrual bleeding (CG44 (http://www.nice.org.uk
/CG44 ) ) - NICE
OTC tranexamic acid for heavy menstrual bleeding? (http://dtb.bmj.com/content
/49/1/6.abstract )  ( DTB 2011;49:6-8 doi:10.1136/dtb.2011.01.0002)(Free
abstract)
Menorrhagia (https://cks.nice.org.uk/menorrhagia ) - Clinical Knowledge
Summaries

Where to signpost patients wanting further

information?
NHS Choices (http://www.nhs.uk/Conditions/Pages/hub.aspx )
Patient.co.uk (http://www.patient.co.uk/ )

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