Consumer Information for: ALLER-RELIEF
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
Adults and children 12 years of age and over: ALLER-RELIEF (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. ALLER-RELIEF (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. ALLER-RELIEF’s antiinflammatory
properties also help by reducing swelling and related
symptoms, including redness and hives (red, itchy bumps or welts
on your skin).
ALLER-RELIEF 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
ALLER-RELIEF (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 non-medicinal ingredients are
Non–medicinal ingredients include: corn starch, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol and titanium dioxide.
What dosage form it comes in
ALLER-RELIEF (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 ALLER-RELIEF 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 ALLER-RELIEF use, do not drive a car or operate machinery. KEEP OUT OF REACH OF CHILDREN.
Interactions with this medication
Do not use ALLER-RELIEF 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.
ALLER-RELIEF comes in different doses (5 mg, 10 mg).
Do not give ALLER-RELIEF 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 ALLER-RELIEF. 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, 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 ALLER-RELIEF
(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 ALLER-RELIEF, contact your doctor or
pharmacist.
How to store
Store at temperatures between 15° and 30°C. Protect from moisture.
Reporting 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:
- 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.
This leaflet plus the full product monograph, prepared for health
professionals, can be obtained by contacting <number of 3rd party>,
at: <number of 3rd party>
This leaflet was prepared by Apotex Inc., Toronto,
Ontario, M9L 1T9.
Last revised: October 5, 2011
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