Consumer Information for: ETIBI
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication 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.
What it does
ETIBI helps your body fight bacteria by stopping them from reproducing. ETIBI takes a few weeks to work.
When it should not be used
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.
What the medicinal ingredient is
Ethambutol Hydrochloride
What the non-medicinal ingredients are
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
What dosage form it comes in
100 mg and 400 mg tablets
Warnings and precautions
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
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.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
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.
Proper use of this medication
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.
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.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking ETIBI. If you experience
any side effects not listed here, contact 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
Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
---|---|---|---|
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 | ✔ |
ETIBI may cause abnormal blood test results. Your doctor may perform blood tests before you take ETIBI and while you are taking it.
How to store
Keep away from light, moisture, and excessive heat. Store in well-closed container at controlled
room temperature (15-30°C).
Keep out of reach and sight of children.
Reporting side effects
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 (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.
More information
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); by contacting the sponsor Bausch Health, Canada Inc., 2150 St-Elzéar Blvd. West, Laval, (Quebec) H7L 4A8; or by calling 1-800-361- 4261.
Last Revised: July 9, 2019
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