Details for: NRA-CETIRIZINE
Company: NORA PHARMA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02521806 | NRA-CETIRIZINE | CETIRIZINE HYDROCHLORIDE | 20 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
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 non-medicinal ingredients are
Microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol.
What dosage form 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 antianxiety medications, sleep aids, antihistamines, antidepressants, muscle relaxants and pain medication .
Proper use of this 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:
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.
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
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| 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 thing | ✔ | ||
| 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 | ✔ | ||
| 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
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/healthcanada/services/drugs-health-products/medeffectcanada/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/indexeng.jsp); or by calling the Sponsor, Nora Pharma Inc. at 1-888-270-9874.
This leaflet is prepared by:
Nora Pharma Inc.
40 rue Prince-Arthur, Suite 310
Saint-Lambert, Quebec
J4P 1X2
Preparation date: October 26, 2021