Patient Medication Information: uses, side effects, how to take - Novo-Cetirizine
ABOUT THIS MEDICATION
What the medication is used for:
NOVO-CETIRIZINE is indicated for fast, long-lasting relief of allergy symptoms, including: nasal congestion/stuffiness, itchy nose/throat,
itchy, watery, eyes, sneezing, runny nose, and post-nasal discharge caused by seasonal allergies (e.g. trees, grass, pollen, ragweed/hay fever) and itching due to allergic skin reactions, such as hives, in adults and children 12 years of age and over. In adults and children over 12 years of age, NOVO-CETIRIZINE has also been proven effective in relieving the symptoms of year-round allergies (e.g. dust, animal dander, mold). Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.
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. NOVO-CETIRIZINE (cetirizine dihydrochloride) 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. NOVO-CETIRIZINEs anti-inflammatory properties also help by reducing swelling and related symptoms, including redness and hives (red, itchy bumps or welts on your skin).
What other things can I do for my allergies? Keep pollens out. Keep windows closed. Use an air conditioner.
Stay informed about pollen seasons and levels in your region.
Plan outdoor activities. Stay inside on warm and windy days. Most plants pollinate in the morning. Stay indoors until later.
Stay away from big pollen producers like birch, ash, maple, oak and walnut trees.
Hire someone to cut your grass.
Remove pets if possible. Keep them out of bedrooms.
Keep a dust-free home. Remove carpets, keep furnace ducts clean and vacuum often.
Control dust mites. Encase your mattress in a proper dust mite barrier and wash bedding often in very hot water.
Stay away from those foods, medications, insects, or even dyes and plants, that may cause itchy, irritating rashes called hives (urticaria).
When it should not be used:
NOVO-CETIRIZINE (cetirizine dihydrochloride) 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).
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What the medicinal ingredient is:
Cetirizine dihydrochloride
What the non-medicinal ingredients are:
Colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide and triacetin.
What dosage forms it comes in:
Available as 20 mg tablets.
WARN
UTIONS
WARNINGS AND PRECAUTIONS
BEFORE you use NOVO-CETIRIZINE Tablets talk to your doctor or pharmacist if you are pregnant or nursing a baby, or have liver or kidney disease. NOVO-CETIRIZINE is non-drowsy and let’s you perform normally, however, some people can experience drowsiness due to allergies or antihistamine use. If drowsiness does occur, do not drive or operate machinery. KEEP OUT OF REACH OF CHILDREN. IN
INTERACTIONS WITH THIS MEDICATION
MEDICATIONTHIS MEDICATION
Do not use NOVO-CETIRIZINE with sedating substances such as alcohol and some other medications, including: anti-anxiety medications, sleep aids, antihistamines, antidepressants, muscle relaxants, or prescription analgesics. PR
PROPER USE OF THIS MEDICATION
OPER USE OF THIS MEDICATION
Usual dose:
Tablets (taken with or without food):
Follow your doctor’s instructions about when and how to take your medicine. A daily dose of 20 mg should not be exceeded.
Overdose:
Overdose has been reported with NOVO-CETIRIZINE. Symptoms reported after an overdose of at least five times the
| IMPORTANT: PLEASE READ |
recommended daily dose are: confusion, diarrhea, dizziness, sleepiness, headache, fatigue, itching, restlessness, sedation, drowsiness, 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. If emergency help is not available, vomiting should be induced at once by Syrup of Ipecac. VOMITING SHOULD NEVER BE INDUCED IN UNCONSCIOUS INDIVIDUALS OR IN CHILDREN UNDER 1 YEAR WITHOUT MEDICAL HELP.E EFF
ECTS
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
WHAT TO DO OUT THEM
The most common side effects associated with NOVO-CETIRIZINE (cetirizine dihydrochloride) 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 NOVO-CETIRIZINE, contact your doctor or pharmacist.
HOW
HOW TO STORE IT
TO STORE IT
Store at between 15-30°C.
M
| MORE INFORMATIONMATION |
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Novopharm Limited at:
1-800-268-4127 ext. 5005 (English); 1-877-777-9117 (French) or druginfo@novopharm.com
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Last revised: September 4, 2008
REPORTING SUSPECTED SIDE EFFECTS To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
By toll-free telephone: 866-234-2345
By toll-free fax 866-678-6789
Online: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness Information Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Should you require information related to the management of the side effects, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance program does not provide medical advice.