Patient Medication Information: uses, side effects, how to take - Nat-Cetirizine (Natco Pharma (Canada), 10 mg)
What is NAT-CETIRIZINE used for?
Adults and children 12 years of age and over: NAT-CETIRIZINE 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.
Children 6-12 years of age: NAT-CETIRIZINE is indicated for fast, long-lasting relief of seasonal allergy symptoms. This product is also indicated for the fast and long-lasting relief of itching due to allergic skin reactions such as hives.
The nasal congestion/stuffiness and itchy nose/throat symptoms have not been adequately studied in children under 6-12 years of age. The effectiveness of NAT-CETIRIZINE in relieving symptoms associated with year round and recurring localized swelling has not been established in this age group.
How does NAT-CETIRIZINE work?
Your allergy symptoms are simply your body’s overreaction 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. This product 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. This product’s anti- inflammatory properties also help by reducing swelling and related symptoms, including redness and hives (red, itchy bumps or welts on your skin).
This product provides fast and effective relief of your worst allergy symptoms for a full 24 hours.
What are the ingredients in NAT-CETIRIZINE?
Medicinal ingredients: Cetirizine hydrochloride
Non-medicinal ingredients: Colloidal anhydrous silica, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.
NAT-CETIRIZINE comes in the following dosage forms:
10 mg scored tablets. Also available by prescription as 20 mg tablets.
Do not use NAT-CETIRIZINE if:
- you have severe kidney impairment (less than 10 mL/min creatinine clearance)
- you have a known hypersensitivity to the product, or to its parent compound hydroxyzine, or to piperazine derivatives
- you are hypersensitive to any other ingredient in the product (see list of ingredients above)
- you are also taking any of the following medications: anti-anxiety medications, sleep aids, antihistamines, antidepressants, muscle relaxants, or prescription analgesics
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NAT-CETIRIZINE. Talk about any health conditions or problems you may have, including if you:
are pregnant or nursing
- have liver or kidney disease
Other warnings you should know about:
- 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
If drowsiness does occur with NAT-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
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with NAT-CETIRIZINE:
Do not use this product with sedating substances such as alcohol and some other medications, including: anti-anxiety medications, sleep aids, antihistamines, antidepressants, muscle relaxants, or prescription analgesics.
How to take NAT-CETIRIZINE:
The tablets can be taken with, or without food. 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.
Usual dose:
Children 6-12 years of age: One 10 mg tablet once daily or half a 10 mg tablet (5 mg) twice daily. For twice daily dosing, break one 10 mg tablet in two halves across the score-line and take one half tablet in the morning and another half tablet in the evening.
Children 12 years of age and over and Adults (under 65 years of age): One 10 mg tablet or one half tablet (5 mg) once daily. Manually break the 10 mg in two halves across the score-line to take one half tablet.
Do not give NAT-CETIRIZINE to children under 6 years of age, unless advised by a physician.
Adults 65 years of age and over: One half of a 10 mg tablet (5 mg) once daily. Consult a doctor if unsure about dosage.
Patients with liver or kidney problems: One half of a 10 mg tablet (5 mg) once daily. Consult a doctor if you are unsure about dosage.
If you do not get the results you expect, talk with your doctor. You and your doctor can determine the dose that works best for you.
Overdose:
Overdose has been reported with cetirizine hydrochloride. 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.
| If you think you, or a person you are caring for, have taken too much NAT-CETIRIZINE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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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 WITHOUT MEDICAL HELP.
Missed Dose:
If you missed a dose of this medication, you do not need to make up the missed dose. Skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time. Do not exceed the maximum daily dose.
What are possible side effects from using NAT-CETIRIZINE?
These are not all the possible side effects you may have when taking NAT-CETIRIZINE. If you experience any side effects not listed here, tell your healthcare professional.
The most common side effects associated with NAT-CETIRIZINE are headache, sleepiness and dry mouth. If these side effects do not go away, call your doctor or pharmacist.
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| RARE | |||
| 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) | √ | ||
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.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
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Storage:
Store at temperatures between 15°C and 30°C. Protect from moisture.
Keep out of reach and sight of children.
If you want more information about NAT-CETIRIZINE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html).
- Call 1-800-296-9329 or visit www.natcopharma.ca .