Patient Medication Information: uses, side effects, how to take - NRA-Cetirizine

ABOUT THIS MEDICATION

What the medication is used for:

NRA-CETIRIZINE 20 mg tablets are used in adults and children 12 years of age and older for the fast, 24-hour 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. NRA-CETIRIZINE 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. The anti-inflammatory properties of NRA-CETIRIZINE also help by reducing swelling and related symptoms, including redness and hives (red, itchy bumps or welts on your skin).

When it should not be used:

Do not take NRA-CETIRIZINE if you:

are allergic (hypersensitive) to cetirizine
hydrochloride, hydroxyzine, piperazine derivatives or any of the other ingredients in NRA-CETIRIZINE
have serious kidney problems

.What the medicinal ingredient is:

Cetirizine hydrochloride

What the nonmedicinal ingredients are:

Microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol.

What dosage forms it comes in:

Tablets: 20 mg

WARNINGS AND PRECAUTIONS

BEFORE you use NRA-CETIRIZINE 20 mg tablets, talk to your doctor or pharmacist if you:

have kidney or liver problems
are pregnant or planning to become pregnant
are breastfeeding or planning to breastfeed
are 65 years of age or older

Driving and using machines: NRA-CETIRIZINE can cause drowsiness. If drowsiness occurs, do not drive or operate machinery.

INTERACTIONS WITH THIS MEDICATION

The following may interact with NRA-CETIRIZINE:

alcohol
other substances that cause sedation such as anti-anxiety medications, sleep aids, antihistamines, antidepressants, muscle relaxants and pain medication .

PROPER USE OF THIS MEDICATION

NAT-CETIRZINE 20 mg tablets can be taken with or without food.

Usual dose:

Children 12 years of age and over and Adults: One tablet once per day.

NRA-CETIRIZINE 20 mg tablets should not be taken by:

Adults 65 years of age and over
Patients with liver or kidney problems
Children less than 12 years of age

Overdose:

If you think you have taken too much NRA-CETIRIZINE contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Symptoms of an overdose include: confusion, diarrhea, dizziness, sleepiness, headache, fatigue, feeling of bodily discomfort, large pupils, 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.

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.

IMPORTANT: PLEASE READ

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects may include:

headache
sleepiness, fatigue
dry mouth
loss of taste
nausea
dizziness
trouble sleeping (insomnia)
eye pain or swelling
blurred vision
erectile dysfunction

	SERIOUS SIDE EFFECTS, HOW OFTEN THEY
	HAPPEN AND WHAT TO DO ABOUT THEM
Symptom/effect		Talk with your doctor or pharmacist		Stop taking drug and seek immediate medical help
		Only if severe	In all cases
VERY RARE:
Agitation, aggressiveness			✓
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing				✓
Difficulty urinating			✓
Hallucinations: seeing or hearing things that are not really there				✓
Liver problems: yellowing of the skin or eyes			✓
Memory problems, partial or total memory loss			✓
New rash or itching after stopping drug			✓
Restlessness with increased body movement			✓

	SERIOUS SIDE EFFECTS, HOW OFTEN THEY
	HAPPEN AND WHAT TO DO ABOUT THEM
Symptom/effect		Talk with your doctor or pharmacist		Stop taking drug and seek immediate medical help
		Only if severe	In all cases
Severe Skin Reaction: rash with small pimples and redness on the skin folds, trunk and arms, with or without fever				✓

This is not a complete list of side effects. For any unexpected effects while taking NRA-CETIRIZINE, contact your doctor or pharmacist.

HOW TO STORE IT

Store at temperatures between 15°C and 30°C. Protect from moisture.

Keep out of reach and sight of children.

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.

MORE INFORMATION

If you want more information about NRA-CETIRIZINE:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); or by calling the Sponsor, Nora Pharma Inc. at 1-888-270-9874.