Patient Medication Information: uses, side effects, how to take - Cetirizine (Apotex)
ABOUT THIS MEDICATION
What the medication is used for:
Adults and children 12 years of age and over: CETIRIZINE (cetirizine hydrochloride) is indicated for the fast relief of nasal and non-nasal seasonal (e.g. tress, 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. 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. 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).
CETIRIZINE can start to work in just 20 minutes, and provides effective relief of your allergy symptoms for a full 24 hours!
When it should not be used:
CETIRIZINE (cetirizine hydrochloride) is contraindicated in those patients with a known hypersensitivity to it or to its parent compound, hydroxyzine, 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 important nonmedicinal ingredients are:
Non–medicinal ingredients include: corn starch, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol and titanium dioxide.
What dosage forms it comes in:
CETIRIZINE (cetirizine hydrochloride) Tablets are available as 5 or 10 mg scored tablets packaged in individually sealed blisters in 6, 12, 15, 18 and 30 tablets and bottles of 100 and 500 tablets.
WARNINGS AND PRECAUTIONS
BEFORE you use CETIRIZINE talk to your doctor or pharmacist if you are pregnant or nursing a baby, or have liver or kidney disease. Some people can experience drowsiness due to allergies or antihistamine use. If drowsiness does occur with CETIRIZINE use, do not drive a car or operate machinery. KEEP OUT OF REACH OF CHILDREN.
INTERACTIONS WITH THIS MEDICATION
Do not use 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
Usual dose:
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
Adults and children 12 years of age and over: 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. CETIRIZINE comes in different doses (5 mg, 10 mg).
Do not give 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:
In the event of overdosage, contact your doctor, hospital emergency department or regional Poison Control Centre Immediately.
Overdose has been reported with 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, tremor and inability to urinate. In case of suspected overdose or if any of these symptoms occur, IMPORTANT: PLEASE READ
Page 36 of 36 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. 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.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The most common side effects associated with CETIRIZINE (cetirizine hydrochloride) are headache, sleepiness and dry mouth. If these side effects do not go away, call your doctor or pharmacist.
This is not a complete list of side effects. For any unexpected effects while taking CETIRIZINE, contact your doctor or pharmacist.
HOW TO STORE IT
Store at temperatures between 15° and 30°C. Protect from moisture.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
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- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
For more information, please contact your doctor, pharmacist or other healthcare professional.
Ontario, M9L 1T9.