Patient Medication Information: uses, side effects, how to take - Etibi
Serious warnings and precautions box
What ETIBI is used for:
- ETIBI is used to treat tuberculosis.
- ETIBI is used along with other antibacterial drugs to treat all forms of tuberculosis.
- Antibacterial drugs like ETIBI treats only bacterial infections. They do not treat viral infections such as the common cold.
How ETIBI works:
ETIBI helps your body fight bacteria by stopping them from reproducing. ETIBI takes a few weeks to work.
The ingredients in ETIBI are:
Medicinal ingredient(s): Ethambutol Hydrochloride
Non-medicinal ingredients: Corn Starch, D&C Yellow No. 10 Al Lake, FD&C Blue No. 1 Al Lake, Hydroxypropyl Cellulose, Lactose, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Alcohol, Talc, Titanium Dioxide
ETIBI comes in the following dosage form(s):
Severe Cutaneous Adverse Reactions (SCARs) are severe skin reactions that have been reported in patients taking ethambutol, the active ingredient in ETIBI. These reactions can be life-threatening or deadly. Stop taking this drug and get immediate medical help if you notice the following symptoms:
- Skin peeling, scaling, or blistering (with or without pus) which may also affect your eyes, mouth, nose or genitals, itching, severe rash, bumps under the skin, skin pain, skin color changes (redness, yellowing, purplish)
- Swelling and redness of eyes or face
- Flu-like feeling, fever, chills, body aches, swollen glands, cough
- Shortness of breath, chest pain or discomfort
100 mg and 400 mg tablets
Do not use ETIBI if:
- You have an eye problem called optic neuritis, unless your doctor tells you that you can take ETIBI.
- You are allergic to any of the ingredients in ETIBI.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ETIBI. Talk about any health conditions or problems you may have, including if you:
- Have eye problems where you experience a sudden loss of vision, sudden blurry vision, inflammation of the eye or, pain moving your eye;
- Have eye problems including the conditions cataracts, diabetic retinopathy, etc.;
- Have a condition called gout;
- Have reduced kidney function or other kidney problems;
Are pregnant or are planning to become pregnant;
- Are breastfeeding;
- Are under the age of 13 years old;
- Are elderly
Other warnings you should know about:
- ETIBI may cause a decrease in the clarity of your vision, blurry vision or other changes in vision. Your doctor will test your vision before you take ETIBI and while you are taking it.
- ETIBI may cause abnormal blood test results. Your doctor may perform blood tests before you take ETIBI and while you are taking it.
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 ETIBI:
Neurotoxic medicines. These are medicines that can have a toxic effect on your nerves. An example of a neurotoxic medicine is docetaxel. If you are not sure if you are taking a neurotoxic medicine, ask your doctor.
How to take ETIBI:
- Swallow ETIBI tablets with water.
You may take ETIBI with food if you have difficulty digesting ETIBI.
- You will take ETIBI along with other antituberculosis drugs.
- Although you may feel better early in treatment, ETIBI should be taken exactly as directed.
- Misuse or overuse of ETIBI could lead to the growth of bacteria that will not be killed by ETIBI (resistance). This means that ETIBI may not work for you in the future.
- Do not share your medicine.
Usual dose:
- The dose you are given will be based on your weight. It is usually around 15 to 25 milligrams per kilogram of bodyweight.
- Your doctor will decide how much ETIBI you should take, when you should take it and for how long you should take it.
- The dose can be different from one person to another.
- ETIBI is usually taken once a day.
Overdose:
Symptoms of overdose include a change in vision.
If you think you, or a person you are caring for, have taken too much ETIBI, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
- If you forget a dose, take it as soon as you remember, unless it is almost time for your next dose.
- In this case, skip the missed dose and take the next one.
- Do not take a double dose to make up for a missed dose.
Possible side effects from using ETIBI:
These are not all the possible side effects you may have when taking ETIBI. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- abdominal pain
- confusion
- disorientation
- dizziness
- fever
- headache
- itchy red skin
- joint pain
- loss of appetite
- nausea
- upset stomach
- vomiting
Serious side effects and what to do about them
Serious side effects and what to do about them
| Symptom/effect | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Anaphylactic Reactions (allergic reactions): difficulty breathing, fever, hives, itching, rash, swelling of your tongue or throat | √ | ||
| Hallucinations | √ | ||
| Impairment of Liver Function (swelling or inflammation of the liver): fatigue, weakness, loss of appetite, stomach pain, nausea, vomiting, yellowing of the skin or eyes | √ | ||
| Optic neuritis (eye problems): loss of vision in one, or both eyes, eye pain that is worse when you move your eye, not seeing colors correctly | √ | ||
| Peripheral Neuritis: numbness and/or tingling in the hands and feet | √ | ||
| Precipitation of Acute Gout (inflammation): pain, swelling, redness and/or warmth in the joints | √ | ||
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:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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:
Store in well-closed containers at room temperature (15 – 30º C).
Protect from light, moisture, and excessive heat.
Keep out of reach and sight of children
If you want more information about ETIBI:
- 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: https://bauschhealth.ca; or by calling 1-800-361-4261.
Date of Authorization: 2025-09-26