Details for: APO-CETIRIZINE
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02231603 | APO-CETIRIZINE | CETIRIZINE HYDROCHLORIDE | 10 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
Adults and children 12 years of age and over: APO- CETIRIZINE (cetirizine hydrochloride) 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.
What it does
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. APO-CETIRIZINE (cetirizine hydrochloride) 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. APO-CETIRIZINE’s anti- inflammatory properties also help by reducing swelling and related symptoms, including redness and hives (red, itchy bumps or welts on your skin).
APO-CETIRIZINE provides fast and effective relief of your worst allergy symptoms for a full 24 hours.
When it should not be used
APO-CETIRIZINE (cetirizine hydrochloride) is contraindicated in those patients with a known hypersensitivity to it or to its parent compound, hydroxyzine, or to piperazine derivatives, in patients who are hypersensitive to any other ingredient in the formulation (see list of non-medicinal ingredients – below), or in patients with severe kidney impairment (less than 10 mL/min creatinine clearance).
What the medicinal ingredient is
Cetirizine hydrochloride
What the non-medicinal ingredients are
Non–medicinal ingredients include: carnauba wax, corn starch, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol and titanium dioxide.
What dosage form it comes in
APO-CETIRIZINE (cetirizine hydrochloride) Tablets are available as 5 or 10 mg scored tablets packaged in individually sealed blisters in 20 and 30 tablets and bottles of 100 and 500 tablets.
Warnings and precautions
Serious Warnings and Precautions
BEFORE you use APO-CETIRIZINE talk to your doctor or pharmacist if you are pregnant or nursing a baby, or have liver or kidney disease. Your doctor should determine if a different dose is needed. 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. Some people can experience drowsiness due to allergies or antihistamine use. 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. KEEP OUT OF REACH OF CHILDREN.
Interactions with this medication
Do not use APO-CETIRIZINE with sedating substances such as alcohol and some other medications, including: anti-anxiety medications, sleep aids, antihistamines, antidepressants, muscle relaxants, or prescription analgesics.
Proper use of this medication
Tablets (taken with or without food):
Children 6-12 years of age: One 10 mg (extra strength) tablet (film-coated), once daily. For twice daily dosing, one 5 mg (regular strength) film-coated tablet in the morning and one 5 mg film-coated tablet in the evening
Children 12 years of age and over and Adults (under 65 years of age): One or two 5 mg (regular strength) tablets (film-coated) or one 10 mg (extra strength) tablet (film-coated), once daily
Adults 65 years of age and over: One 5 mg (regular strength) tablet (film-coated) once daily. Consult a doctor if unsure about dosage
If you do not get the results you expect, talk with your doctor. APO-CETIRIZINE comes 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.
Do not give APO-CETIRIZINE to children under 2 years of age, unless advised by a physician. 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.
Overdose
Overdose has been reported with APO-CETIRIZINE. 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.
In case of suspected overdose or if any of these symptoms occur, stop taking the drug and immediately contact your doctor or the Poison Control centre at once.
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 miss taking your dose on time, do not worry; take your dose when you remember. Do not take more than one dose in 24 hours.
Side effects and what to do about them
The most common side effects associated with APO-CETIRIZINE (cetirizine hydrochloride) are headache, sleepiness and dry mouth. If these side effects do not go away, call your doctor or pharmacist.
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.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| 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) | ✔ |
This is not a complete list of side effects. For any unexpected effects while taking APO-CETIRIZINE, contact your doctor or pharmacist.
How to store
Store at temperatures between 15°C and 30°C. Protect from moisture.
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 for information on how to report online, by mail or by fax; or
- Call 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 APO-CETIRIZINE:
- Talk to your doctor or pharmacist.
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website; Find the Consumer Information on the manufacturer’s website, or by calling 1-800-667-4708
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last revised: December 02, 2019;