Details for: GD-TRANEXAMIC ACID
Company: GENMED A DIVISION OF PFIZER CANADA ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02409097 | GD-TRANEXAMIC ACID | TRANEXAMIC ACID | 500 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
GD-Tranexamic Acid is a prescription medicine which is used to prevent or reduce bleeding in different conditions. You may have been prescribed it for one of the following:
- After minor surgery such as tooth removal in people with a hereditary blood clotting disorder (haemophiliacs)
- Cervical surgery (Conization of the cervix)
- Nose bleeds (Epistaxis)
- Heavy periods (menorrhagia)
- Bleeding inside the eye (hyphaema)
- A hereditary disease called angioneurotic oedema - a doctor will have told you if you have this.
What it does
GD-Tranexamic Acid belongs to one of a group of medicines called antifibrinolytic agents, which are used to stop excessive bleeding after an operation or to assist with blood clotting. When you bleed your body forms clots as part of healing. In some people these clots do not stay in place long enough. This can cause too much bleeding.
When it should not be used
Do not take GD-Tranexamic Acid:
- If you have a history or risk of blood clots (thromboembolism), especially in the leg, lung, brain, or tissues surrounding the brain.
- If you are allergic to tranexamic acid or any of its ingredients or similar medicines
- If you have acquired disturbances of colour vision
- If you have blood in the urine or any bleeding related to the kidney.
What the medicinal ingredient is
Tranexamic acid
What the non-medicinal ingredients are
Tablets: cellulose microcrystalline, colloidal silica anhydrous,
eudragit, hydroxypropylcel, magnesium stearate, PEG 8000,
Povidone ,talcum, titanium dioxide.
Solution for injection: water for injection
What dosage form it comes in
Tablets: 500 mg
Injection: 100 mg/ ml.
Warnings and precautions
BEFORE you use GD-Tranexamic Acid talk to your doctor or pharmacist if:
- you have kidney disease. The medicine can accumulate in your body. Therefore a lower dose might be given to you
- you have bleeding from the upper urinary tract. This shows as blood in your urine.
- you have ever had any uncontrollable bleeding (including irregular menstrual bleeding).
- you are pregnant or breastfeeding.
- you are taking “the pill” (hormonal contraceptives) or anticoagulants (drugs to inhibit blood from clotting as much)
- you are being treated for disseminated intravascular coagulation GD-Tranexamic Acid will only be given if your doctor has done blood tests to check you are suitable, otherwise other anti-clotting medicines may be a better option for you
- You are obese, diabetic, have been told you have polycystic ovary syndrome a history of cancer of the endometrium in a close relative, are on estrogen therapy or are taking tamoxifen.
Tell your doctor or pharmacists about any prescription and nonprescription
medicines you are taking, including natural or herbal
remedies.
GD-Tranexamic Acid is not recommended for children under 18
years of age with abnormally heavy menstrual flow
(hypermenorrhea).
GD-Tranexamic Acid may cause disturbance to your colour
vision. If you are to be treated for several weeks with
GD-Tranexamic Acid, it is advisable to have an eye check up (for
sharpness of vision, colour vision, field of vision etc.) before you
start on GD-Tranexamic Acid and at regular intervals. If you
notice any change in your vision, especially in your colour vision,
tell your doctor or pharmacist right away so that they can arrange
for you to safely stop taking GD-Tranexamic Acid.
If you are taking GD-Tranexamic Acid for heavy periods, you
should monitor your menstrual flow. If menstrual bleeding is not
reduced after three menstrual cycles, consult with your doctor, an
alternative treatment may be necessary.
If you experience (feel) dizziness, do not drive or use machinery.
Interactions with this medication
Tell your doctor or pharmacist about any medicines you use
including any prescription, over the counter or natural health
products.
Drugs that may interact with GD-Tranexamic Acid include:
- any medicines used to help your blood clot.
- medicines that decrease blood clots (anticoagulants) . Treatment with anticoagulants must take place under the strict supervision of a physician experienced in this field.
- birth control that contains hormones such as “The Pill”. The Pill along with GD-Tranexamic Acid may increase your chance of having a blood clot, stroke, or heart attack.
- hydrochlorothiazide, desmopressin, sulbactam-ampicillin, carbazochrome, ranitidine, or nitroglycerin. These medicines along with GD-Tranexamic Acid may lead to heart attacks.
Proper use of this medication
Usual dose
Take GD-Tranexamic Acid exactly as directed by your health care
professional. Always take the number of tablets your doctor tells
you.
The usual adult dose is 2-3 tablets two-three times daily.
Depending on why you have been given these tablets, your dose
may be different.
The dose for children is calculated according to body weight (25
mg/kg).
Patients with kidney disease should receive lower doses.
GD-Tranexamic Acid solution for injection will usually be given to
you by slow injection into a vein as a bolus intravenous (IV) dose
over 5 minutes or as an IV drip. Your doctor will decide the best
dose for you, based on your weight.
It should be inspected visually for clarity, particulate matter,
precipitation, discolouration, and leakage prior to administration
Overdose
Missed Dose
If you forget to take your tablets you should take your next dose as usual. Do not take extra tablets to make up for the missed dose.
Side effects and what to do about them
Along with its intended action, any medication may cause unwanted effects. However, check with your doctor or pharmacist promptly if any of the following persist or become troublesome:
- Nausea (feeling sick),
- Vomiting (being sick) and
- Diarrhoea
If the injection is given too quickly, you can feel dizzy due to reduced blood pressure.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and seek immediate emergency treatment |
|---|---|---|---|
| Uncommon | |||
| Allergic reactions (skin rash), hives, swelling of the face, lips, tongue or throat, and difficulty swallowing or breathing) | ✔ | ||
| Central retinal artery and vein obstruction. Changes in your eyesight (such as changes to the sharpness of vision or field of vision and especially impaired color vision) | ✔ | ✔ | |
| Dizziness | ✔ | ✔ | |
| Seizures or fits | ✔ | ✔ | |
| Pain in your chest or legs | ✔ | ||
| Heart attack (chest pain) | ✔ | ✔ | |
| Blood clots/deep vein thrombosis/arte rial thrombosis limb (redness, warmth, swelling in your hands, legs, ankles or feet) | ✔ | ✔ | |
| Cerebral infarction/cereb rovascular accident/cerebr al thrombosis (problems with speech, walking, sudden confusion, numbness or weakness) | ✔ | ✔ | |
| Acute renal cortical necrosis (trouble urinating) | ✔ | ✔ | |
| Low blood pressure (may occur after fast injection. Symptoms include dizziness, headache, and light headedness especially if you change positions quickly) | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking GD-Tranexamic Acid, contact your doctor or pharmacist.
How to store
Store at room temperature (15 - 30°C).
Keep your medicine out of the reach and sight of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 1908C
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for
health professionals can be found at:
http://www.pfizer.ca or by contacting the sponsor, GenMed, a
division of Pfizer Canada Inc., at: 1-800-463-6001
This leaflet was prepared by GenMed, a division of Pfizer Canada Inc.
Last revised: October 22, 2018