Tranexamic acid Accord – Tranexamic acid uses, dose and side effects


100 mg/ml solution 

for injection
tranexamic acid

What Tranexamic acid Accord is and what it is used for

Tranexamic acid Accord contains tranexamic acid, which belongs to a group of medicines called hemostatics, and fibrinolysis inhibitors (medicines that stop bleeding).

Tranexamic acid Accord is used in adults and children over 1 year of age to prevent and treat bleeding due to fibrinolysis, which means that the blood has difficulty clotting.

Specific uses include:

  • Heavy menstruation in women
  • Bleeding in the stomach/intestines
  • Bleeding in the urinary tract after prostate surgery or surgical procedures affecting the urinary tract
  • Ear, nose, and throat surgery
  • Heart, abdominal or gynecological surgery
  • Bleeding after you have been treated with another anti-clotting medicine

Tranexamic acid contained in Tranexamic acid Accord may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Tranexamic acid Accord

Do not use Tranexamic acid Accord

  • if you are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6)
  • if you have (or have had) a disease that causes you to get blood clots
  • if you have a disease called ‘consumptive coagulopathy’, where the blood throughout the body begins to form blood clots (coagulate)
  • if you have problems with your kidneys
  • if you have previously had convulsions

Due to the risk of edema (fluid accumulation) in the brain and convulsions, use in the brain ( intrathecal and intraventricular injection or intracerebral application) is not recommended.

If you think any of the above applies to you, or if you are in any doubt, talk to your doctor before you are given Tranexamic acid Accord.

Warnings and precautions

Tell your doctor if any of the following apply to you to help him or she decides if the Tranexamic acid Accord is right for you:

  • If you have had blood in your urine; it can lead to obstruction in the urinary tract.
  • If you have an increased risk of blood clots.
  • If you have severe clotting or bleeding throughout your body (disseminated intravascular coagulation ), Tranexamic acid Accord may not be suitable for you.
  • If you have had convulsions in the past, you should not be treated with Tranexamic acid Accord. The doctor must use the lowest possible dose to avoid convulsions when treated with Tranexamic acid Accord.
  • If you are on long-term treatment with Tranexamic acid Accord, any changes in color vision should be monitored, and if necessary, the treatment should be discontinued. In case of continued long-term use of Tranexamic acid Accord, you should go for regular eye examinations (checking visual acuity, color vision, fundus, the field of vision, etc.).

Other medicines and Tranexamic acid Accord

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including over-the-counter medicines, vitamins, minerals, herbal remedies, or dietary supplements.

In particular, tell the doctor if you are taking:

  • other medicines to make the blood clot called antifibrinolytics
  • medicines that prevent the formation of blood clots, so-called thrombolytic medicines
  • birth control pills

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Tranexamic acid is excreted in breast milk. The use of Tranexamic acid Accord during breastfeeding is therefore not recommended.

Driving ability and use of machinery

No studies have been performed on the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.

How to use Tranexamic acid Accord

Use for adults

  • Treatment of local fibrinolysis:
    The usual dose is 500-1000 mg (5-10 ml) two to three times per day.
  • Treatment of generalized fibrinolysis:
    The usual dose is 1,000 mg (10 ml) every 6 to 8 hours or up to 15 mg per kg of body weight.

Use for children

If Tranexamic acid Accord is given to children from 1 year of age, dose one is based on the child’s weight.

The doctor decides which dose is suitable and how long the child should be treated.

Use for the elderly

No dose reduction is needed unless there are signs of renal failure.

Use in patients with impaired renal function

In case of impaired kidney function, the dose can be reduced. The doctor decides which dose you should receive based on a blood test.

Use in patients with impaired liver function

No dose reduction is needed.

Mode of administration

Tranexamic acid Accord should only be injected slowly into a blood vessel (vein). Tranexamic acid Accord must not be injected into a muscle.

If you use too much Tranexamic acid Accord  

If you receive more Tranexamic acid Accord than the recommended dose, you may experience a temporary drop in blood pressure (you may feel faint or dizzy when you stand up). Talk to your doctor or pharmacist immediately.

If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects that have been reported with Tranexamic acid Accord

The following side effects have been reported with other Tranexamic acid Accord:

If you experience any of the following side effects after receiving the medicine, contact your doctor immediately. If you are not in a hospital, you MUST SEE a hospital immediately. These side effects are rare but serious.

  • The severe allergic reaction which may include red and raised rash, difficulty breathing, swelling of the face, mouth, lips, or eyelids, unexplained high fever, and feeling faint. If the swelling affects the pharynx and makes it difficult to breathe and swallow, go to the hospital immediately.
  • Symptoms of a blood clot may include swelling or pain in the legs or chest, headache, and weakness in the face or the arms and legs on one side of the body.

Other side effects that may occur are:

Common (may affect up to 1 in 10 users)

Uncommon (may affect up to 1 in 100 people)

  • rash

Has been reported (occurring in an unknown number of users)

  • malaise with low blood pressure, especially if the injection has been given too quickly
  • cramps
  • vision changes, including impaired color vision

If any side effects get worse or if you notice any side effects not mentioned in this information, contact your doctor or pharmacist.

How to store Tranexamic acid Accord

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage instructions. Use before the expiry date which is stated on the carton and the ampoule label after Ex.dat/EXP. The expiration date is the last day of the specified month. The doctor or nurse will check this before you receive an injection.

Unopened ampoules have no special storage instructions.

Contents of the packaging and other information

Contents declaration

The active substance is tranexamic acid.

Each 5 ml solution contains 500 mg tranexamic acid.

Each 10 ml solution contains 1,000 mg tranexamic acid.

Other ingredients are water for injections.

Appearance and package sizes of the medicine

Tranexamic acid Accord is a clear, colorless solution, free of visible particles.

Type I-glass ampoules are packed in a tray pack or blister pack packed in a cardboard box.

Package sizes

1 x 5 ml

5 x 5 ml

10 x 5 ml

1 x 10 ml

5 x 10 ml

10 x 10 ml

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 VK Utrecht



Accord Healthcare Limited

Sage House

319 Pinner Road

North Harrow

Middlesex HA1 4HF


Accord Healthcare Polska Sp.z oo,

ul. Lutomirska 50,95-200 Pabianice, Poland

Leave a Reply