Patient Medication Information: uses, side effects, how to take - Tranexamic Acid Tablets
What is Tranexamic Acid Tablets used for?
Tranexamic Acid Tablets are used in adults and children:
- to treat a genetic disorder known as hereditary angioneurotic oedema. This disorder is characterized by severe swelling of tissue under the skin; and
- to prevent or reduce bleeding from cervical cone surgery, tooth extraction, nosebleeds, and bleeding inside the eye.
Tranexamic Acid Tablets can also be used to prevent or reduce bleeding in adults with heavy menstrual periods.
How does Tranexamic Acid Tablets work?
Tranexamic Acid Tablets belong to a group of medicines called antifibrinolytic agents. It works by blocking the breakdown of blood clots, which helps to prevent or reduce bleeding.
What are the ingredients in Tranexamic Acid Tablets?
Medicinal ingredient: Tranexamic acid
Non-medicinal ingredients:
Core tablet: Cellulose microcrystalline, Colloidal silica anhydrous, Croscarmellose sodium, Magnesium stearate, Povidone, and Talc.
Coating: Basic Butylated Methacrylate copolymer, Macrogol, Vanillin, Magnesium Stearate, Talc and Titanium Dioxide.
Tranexamic Acid Tablets come in:
Tablets: 500 mg of tranexamic acid.
Do not use Tranexamic Acid Tablets if:
- you have a history or are at a higher risk for thrombosis (blood clots in the veins or arteries). This includes diseases where a blood clot breaks loose and blocks another blood vessel (e.g., deep vein thrombosis, pulmonary embolism, and cerebral thrombosis).
- you are allergic to tranexamic acid or any other ingredients in Tranexamic Acid Tablets.
- you have a colour vision problem that is not genetic.
- you have blood in the urine.
- you have bleeding in the space between your brain and the surrounding membrane (subarachnoid haemorrhage).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Tranexamic Acid Tablets. Talk about any health conditions or problems you may have, including if you:
- have kidney problems.
- have irregular menstrual bleeding where the cause is not known.
- are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. Tranexamic Acid Tablets can pass into breast milk and affect your unborn baby.
are taking any of the following:
- anticoagulants (used to prevent blood clots and thin the blood).
- hormonal birth control methods (e.g., “the pill”); or
- tamoxifen (used to treat breast cancer).
- have a condition known as disseminated intravascular coagulation (DIC; excessive blood clotting). Tranexamic Acid Tablets will only be given if your healthcare professional has done blood tests to check that you are suitable, otherwise other anti-clotting medicines may be a better option for you.
- are obese.
- have diabetes.
- have polycystic ovary syndrome (a condition that produces high levels of a male hormone called androgen causing irregular or no periods).
- have a history of cancer of the uterine (endometrial cancer) in a close relative.
- are on estrogen therapy.
- are over the age of 65 years old.
- are at a higher risk for blood clots in the veins or arteries (e.g., a history of blood clots or a family history of blood clotting conditions).
Other warnings you should know about:
Taking Tranexamic Acid Tablets can cause the following:
- Allergic reaction: This can occur when tranexamic acid solution is given intravenously (directly into your bloodstream). Your healthcare professional will closely monitor you after Tranexamic Acid administration.
- Seizures (fits)
- Thromboembolism (blood clot in a vein or artery)
- Vision problems: This can include blurred vision, loss of vision, and impaired colour vision. If you are prescribed to take Tranexamic Acid Tablets for several weeks, you should get an eye check-up before you start taking Tranexamic Acid Tablets and at regular intervals. These check-ups will assess the sharpness of your vision, colour vision, and field of vision. If you notice any change in your vision, especially in your colour vision, tell your healthcare professional right away.
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Pregnancy:
- Tranexamic Acid Tablets can pass through the placenta and harm your unborn baby. If you are able to get pregnant, plan to become pregnant, are pregnant, or are taking hormonal birth control methods, there are specific risks that you must first discuss with your healthcare professional.
- Tranexamic Acid Tablets can affect hormonal birth control methods such as “the pill” and can cause unwanted serious effects. Therefore, you should use a non-hormonal birth control method while you are taking Tranexamic Acid Tablets. If you have any questions about this, talk to your healthcare professional.
- If you become pregnant or think you are pregnant while taking Tranexamic Acid Tablets, tell your healthcare professional right away.
Driving and using machines:
Tranexamic Acid Tablets can cause dizziness. Before you drive or do tasks that require special attention, wait until you know how you respond to Tranexamic Acid Tablets.
Menstrual Periods:
- If you are taking Tranexamic Acid Tablets for heavy periods, you should monitor your menstrual flow. If menstrual bleeding is not reduced after three menstrual cycles, consult with your healthcare professional. They may recommend an alternative treatment.
Tranexamic Acid Tablets should not be used in children (under 18 years of age) to prevent or reduce bleeding during heavy menstrual periods.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Tranexamic Acid Tablets:
- medicines used to help your blood clot.
- hormonal birth control (e.g., “the Pill”);
- anticoagulants used to prevent blood clots and thin the blood;
- hydrochlorothiazide, a diuretic that is typically used to treat high blood pressure;
- desmopressin, a medicine used to treat diabetes;
- sulbactam-ampicillin, an antibiotic used to treat bacterial infections;
- carbazochrome, a medicine used to help your blood clot;
- ranitidine, a medicine used to lower the amount of stomach acid;
- nitroglycerin, a medicine used to treat or prevent chest pain.
How to take Tranexamic Acid Tablets:
- Take Tranexamic Acid Tablets by mouth exactly as directed by your healthcare professional. Always take the number of tablets your healthcare professional tells you.
Usual dose:
The usual adult dose is 2-3 tablets (1000 mg to 1500 mg) two to three times a day.
The dose for children will be calculated by the healthcare professional based on their body weight.
Overdose:
Symptoms of an overdose with Tranexamic Acid Tablets include:
- diarrhea;
- dizziness;
- headache;
- nausea;
- seizures;
- symptoms of low blood pressure (e.g., blurry vision, confusion, fainting, light-headedness, weakness); and
- vomiting.
| If you think you, or a person you are caring for, have taken too much Tranexamic Acid Tablets, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If you forget or miss a dose of Tranexamic Acid Tablets, do not take the missed dose. Instead, take the next scheduled dose at the usual time. Do not try to make up for the missed dose by taking extra tablets.
What are possible side effects from using Tranexamic Acid Tablets?
These are not all the possible side effects you may have when taking Tranexamic Acid Tablets. If you experience any side effects not listed here, tell your healthcare professional.
Side effects of Tranexamic Acid Tablets may include:
- diarrhea;
- dizziness,
- nausea (feeling sick);
- vomiting.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|---|---|
| Only if severe | In all cases | |
| RARE | ||
| Allergic reaction: difficulty swallowing or breathing, wheezing, drop in blood pressure, feeling sick to your | ||
| √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| stomach, vomiting, hives, rash, or swelling of the face, lips, tongue or throat. | |||
| Eye problems: blurred vision, changes to the sharpness of vision, loss of vision, or colour vision change, changes to the field of vision, or sudden loss of eyesight in one eye. | √ | ||
| Seizures (fits): loss of consciousness with uncontrollable shaking. | √ | ||
Myocardial infarction (heart attack): pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, dizziness, fatigue, light- headedness, clammy skin, sweating, indigestion, anxiety, feeling faint, or possible irregular heartbeat. | √ | ||
Thromboembolism (blood clot in a vein or artery, including in the brain, limbs, and heart): arm or leg pain, tenderness or swelling, skin that is red or warm, coldness, tingling, numbness, pale skin, muscle pain, muscle spasms, weakness, dizziness, numbness, weakness on one side of the body, and problems with talking, writing, or understanding language. | √ | ||
| Stroke (bleeding or blood clot in the brain): sudden numbness, weakness or tingling of the face, arm, or | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
leg, particularly on one side of the body, sudden headache, blurry vision, difficulty swallowing, difficulty speaking, lethargy, dizziness, fainting, vomiting, trouble understanding, trouble with walking, or loss of balance. | |||
Acute renal cortical necrosis (death of the tissue in the outer part of the kidney): red or dark brown urine, blood in urine, lower back pain, fever, changes in blood pressure, or urine flow is reduced or stopped. | √ | ||
Hypotension (low blood pressure): dizziness, fainting, light- headedness, blurred vision, nausea, vomiting, or fatigue (may occur when you go from lying or sitting to standing up and after fast injection). | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Blisters: Store at room temperature (15°C to 30°C). HDPE bottle: Store at room temperature (15 - 30°C). Protect from light and moisture.
Keep out of reach and sight of children.
If you want more information about Tranexamic Acid Tablets:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.sterimaxinc.com), or by calling 1-800-881-3550