Patient Medication Information: uses, side effects, how to take - Erfa-Tranexamic
ABOUT THIS MEDICATION
What the medication is used for:
ERFA-TRANEXAMIC 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).
What it does:
ERFA-TRANEXAMIC 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 ERFA-TRANEXAMIC:
- 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 color 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: sodium hydroxide and/or hydrochloric acid to adjust pH and water for injection.
What dosage forms it comes in:
ERFA-TRANEXAMIC solution for injection Ph. Eur, 100 mg/mL is available in 5 mL and 10 mL single use vials, boxes of 10 and in 50 mL format, boxes of one unit.
WARNINGS AND PRECAUTIONS
BEFORE you use ERFA-TRANEXAMIC 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 ERFA-TRANEXAMIC 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.
ERFA-TRANEXAMIC is not recommended for children under 18 years of age with abnormally heavy menstrual flow(hypermenorrhea).
ERFA-TRANEXAMIC may cause disturbance to your color vision. If you are to be treated for several weeks with ERFA-TRANEXAMIC, it is advisable to have an eye check up (for sharpness of vision, color vision, field of vision etc.) before you start on ERFA-TRANEXAMIC and at regular intervals. If you notice any change in your vision, especially in your color vision, tell your doctor or pharmacist right away so that they can arrange for you to safely stop taking ERFA- TRANEXAMIC.
If you are taking ERFA-TRANEXAMIC 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.
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 ERFA-TRANEXAMIC 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 ERFA-TRANEXAMIC 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 ERFA- TRANEXAMIC may lead to heart attacks.
PROPER USE OF THIS MEDICATION
Usual dose:
ERFA-TRANEXAMIC 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, discoloration, and leakage prior to administration
Overdose:
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).
- Diarrhoea.
If the injection is given too quickly, you can feel dizzy due to reduced blood pressure.
INTERACTIONS WITH THIS MEDICATION
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom/effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency treatment | ||
| Only if severe | In all cases | |||
| Uncommon | Allergic reactions (skin rash) | |||
| 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/ arterial thrombosis limb (redness, warmth, swelling in your hands, legs, ankles or feet) | ||||
| Cerebral infarction/ cerebrovas- cular accident/ cerebral thrombosis (problems with speech, walking, sudden confusion, numbness or weakness) | ||||
| Acute renal cortical | ||||
This is not a complete list of side effects. For any unexpected effects while taking ERFA-TRANEXAMIC, contact your doctor or pharmacist.
HOW TO STORE IT
Store between 15 and 30°C. Discard unused portion. Protect from light.
Mixture must be kept refrigerated between 2 and 8oC for not more than 24 hours. Mixture not used within 24 hours of preparation, should be discarded.
MORE INFORMATION
This document plus the full Product Monograph, prepared for health professionals, can be obtained by contacting the sponsor, Searchlight Pharma Inc. at:
1-647-945-9762
or by written request at:
1600 Notre-Dame West, suite 312
Montreal, Quebec
Canada H3J 1M1
or on our website at: http://www.searchlightpharma.com
Preparation: OCT 18, 2022
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND | ||||
| WHAT TO DO ABOUT THEM | ||||
Symptom/effect necrosis (trouble urinating) Low blood pressure (may occur after fast injection). Symptoms include dizziness, headache, and light headedness (especially if you change positions quickly) | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency treatment | ||
| Only if severe | In all cases | |||
REPORTING SUSPECTED SIDE EFFECTS
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
Online at MedEffectTM
(www.healthcanada.gc.ca/medeffect);
- By calling 1-866-234-2345 (toll free);
By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E Ottawa, ON, K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffectTM
(www.healthcanada.gc.ca/medeffect).
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.