Patient Medication Information: uses, side effects, how to take - Apo-Cetirizine (Apotex, 10 mg, 5 mg)
What is APO-CETIRIZINE used for?
Adults and children 12 years of age and over: APO-CETIRIZINE is indicated for the fast relief of nasal and non-nasal seasonal (e.g. trees, grass, pollen, ragweed/hay fever) and year-round (e.g. dust, animal dander, mold) allergy symptoms, including: sneezing, runny nose, post-nasal discharge, nasal congestion/stuffiness, itchy, watery eyes, itchy nose/throat, and itching and hives due to allergic skin reactions.
How does APO-CETIRIZINE work?
Your allergy symptoms are simply your body’s over reaction in trying to protect you from allergens such as dust, ragweed, grass and tree pollen, animal dander or mold. When allergens are detected, the cells in your body release a chemical called histamine which binds to specific histamine receptors in your skin and tissues. The resulting reaction causes itchy, watery eyes, sneezing and runny nose. This product helps relieve your allergy symptoms by blocking these receptor sites before histamine binds there, preventing or reducing many of the symptoms of an allergic reaction. This product’s anti-inflammatory properties also help by reducing swelling and related symptoms, including redness and hives (red, itchy bumps or welts on your skin).
This product provides fast and effective relief of your worst allergy symptoms for a full 24 hours.
What are the ingredients in APO-CETIRIZINE?
Medicinal ingredient: Cetirizine hydrochloride
Non–medicinal ingredients: Carnauba wax, corn starch, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol and titanium dioxide.
APO-CETIRIZINE comes in the following dosage forms:
Tablets: 5 mg and 10 mg. Also available by prescription as 20 mg tablets.
Do not use APO-CETIRIZINE if:
- you have severe kidney impairment (less than 10 mL/min creatinine clearance)
- you have a known hypersensitivity to the product, or to its parent compound hydroxyzine, or to piperazine derivatives
- you are hypersensitive to any other ingredient in the product (see list of ingredients above)
- you are also taking any of the following medications: anti-anxiety medications, sleep aids, antihistamines, antidepressants, muscle relaxants, or prescription analgesics
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-CETIRIZINE. Talk about any health conditions or problems you may have, including if you:
are pregnant or nursing
- have liver or kidney disease
Other warnings you should know about:
- If signs and symptoms such as formation of small pimples occur, with or without fever or redness, then treatment with cetirizine should be discontinued and a doctor should be consulted
If drowsiness does occur with APO-CETIRIZINE use, do not drive a car or operate machinery
- If symptoms persist or worsen, or if new symptoms occur, stop use and consult a doctor
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 APO-CETIRIZINE:
Do not use this product with sedating substances such as alcohol and some other medications, including: anti-anxiety medications, sleep aids, antihistamines, antidepressants, muscle relaxants, or prescription analgesics.
How to take APO-CETIRIZINE:
The tablets can be taken with, or without food. DO NOT EXCEED RECOMMENDED DOSAGE. Prolonged use only as directed by a doctor. Do not use longer than 14 days in children unless directed by a doctor.
Usual dose:
Children 12 years of age and over and Adults (under 65 years of age): One half tablet (5 mg) once daily or one 10 mg (extra strength) tablet once daily.
Do not give APO-CETIRIZINE to children under 12 years of age, unless advised by a physician.
Adults 65 years of age and over: Use 5 mg (half tablet) once daily or consult a doctor.
If you do not get the results you expect, talk with your doctor. APO-CETIRIZINE come in different doses (5 mg, 10 mg). APO-CETIRIZINE 20 mg Tablet is only available under prescription; please consult your physician. You and your doctor can determine the dose that works best for you.
Overdose:
Overdose has been reported with this product. Symptoms reported after an overdose of at least five times the recommended daily dose are: confusion, diarrhea, dizziness, sleepiness, headache, fatigue, feeling of bodily discomfort, excessive dilation of the pupil, itching, restlessness, sedation, lowered level of consciousness, rapid heartbeat, high blood pressure, tremor, and inability to urinate. Extreme activity and extreme lack of energy have been seen in children.
If you think you, or a person you are caring for, have taken too much APO-CETIRIZINE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Treatment in a hospital setting is preferred. Notify of any other medications you may have been taking. VOMITING SHOULD NEVER BE INDUCED IN UNCONSCIOUS INDIVIDUALS OR IN CHILDREN UNDER 1 YEAR WITHOUT MEDICAL HELP.
Missed Dose:
If you missed a dose of this medication, you do not need to make up the missed dose. Skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time. Do not exceed the maximum daily dose.
What are possible side effects from using APO-CETIRIZINE?
These are not all the possible side effects you may have when taking APO-CETIRIZINE. If you experience any side effects not listed here, tell your healthcare professional.
The most common side effects associated with APO-CETIRIZINE are headache, sleepiness and dry mouth. If these side effects do not go away, call your doctor or pharmacist.
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 | |||
| Restlessness with increased body movement | √ | ||
| Difficulty urinating | √ | ||
| New rash or itching after stopping drug | √ | ||
| Liver dysfunction (inflammation of the liver, appearance of jaundice, i.e., yellowing of the skin) | √ | ||
The following side effects have been reported very rarely: aggression, agitation, hallucination, memory impairment/amnesia, insomnia, dizziness, loss of taste, erectile dysfunction, eye pain or swelling and blurred vision.
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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/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.
Storage:
Store at temperatures between 15°C-30°C. Protect from moisture.
Keep out of reach and sight of children.
If you want more information about APO-CETIRIZINE:
- 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.apotex.ca/products), or by calling 1-800-667-4708
Date of Authorization: 2025-07-24