Patient Medication Information: uses, side effects, how to take - Reactine Chewable Tablets 5 mg
ABOUT THIS MEDICATION
What the medication is used for:
Adults and children 12 years of age and over: REACTINE® (cetirizine hydrochloride) 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 2-12 years of age: REACTINE® is indicated for fast, long-lasting relief of seasonal allergy symptoms. REACTINE® 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 2 -12 years of age. The effectiveness of REACTINE® in relieving the symptoms associated with year-round and recurring localized swelling has not been established in this age group.
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. REACTINE® (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. REACTINE®s anti-inflammatory properties also help by reducing swelling and related symptoms, including redness and hives (red, itchy bumps or welts on your skin).
REACTINE® can start to work in just 20 minutes, and provides effective relief of your worst allergy symptoms for a full 24 hours!
When it should not be used:
REACTINE® (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).
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What the medicinal ingredient is:
Cetirizine hydrochloride
What the nonmedicinal ingredients are:
5, 10 & 20 mg Tablets: Corn starch, hypromellose, lactose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide. May or may not contain carnauba wax.
5 & 10 mg Chewable Tablets: Acesulfame potassium, artificial grape flavour, betadex, microcrystalline cellulose, FD&C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, mannitol, natural flavour, red dye (carmine), silicon dioxide.
10 mg FAST MELT™ (Orally Disintegrating) Tablets: Amino methacrylate copolymer, anhydrous citric acid, colloidal silicon dioxide, crospovidone, flavours, hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, sodium bicarbonate, sodium starch glycolate, sucralose.
10 mg Liquid Gels Capsules: Gelatin, glycerin, lecithin, mannitol, medium chain triglycerides, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol.
5 mg/5 mL Grape Flavour Syrup: Acetic acid, artificial flavours, glycerin, parabens, propylene glycol, sodium acetate, sucrose, water.
5 mg/5 mL Sugar-free Grape Flavour Syrup: Anhydrous citric acid, flavours, propylene glycol, purified water, sodium benzoate, sorbitol solution and sucralose.
What dosage forms it comes in:
REACTINE® (cetirizine hydrochloride) Tablets are available as 5 or 10 mg scored tablets packaged in individually sealed blisters in 24 and 36 tablets for the 5 mg and in 10, 20, 30, 48 and 84 tablet packages for the 10 mg. REACTINE®10 mg tablets are also available in an 8 count vial. They are also available by prescription as 20 mg tablets.
REACTINE® (cetirizine hydrochloride) Chewable Tablets are available as 5 mg or 10 mg tablets packaged in individually sealed blisters, in counts of 10, 20 and 30 tablets.
REACTINE® (cetirizine hydrochloride) FAST MELT™ Junior Tablets are available as 10 mg tablets packed in individually sealed blisters in 12 and 24 tablet packages.
REACTINE® (cetirizine hydrochloride) Allergy Liquid Gels Capsules are available as 10 mg capsules packaged in bottles of 25 or 40 capsules.
REACTINE® (cetirizine hydrochloride) Syrup is available in a colourless, sugar and sugar-free grape flavoured preparations. Each teaspoonful (5 mL) contains 5 mg of cetirizine hydrochloride. The original syrup is supplied in amber glass bottles containing 100 mL. The sugar-free syrup is supplied in 15 mL, 60 mL , and 120 mL polypropylene bottles.
WARNINGS AND PRECAUTIONS
BEFORE you use REACTINE® capsules, tablets or syrup 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 REACTINE® use, do not drive a car or operate machinery. KEEP OUT OF REACH OF CHILDREN.
INTERACTIONS WITH THIS MEDICATION
Do not use REACTINE® 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
Tablets (taken with or without food):
Children 6-12 years of age: One 10 mg (extra strength) tablet (film-coated or orally disintegrating tablet), 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 or orally disintegrating tablet), 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. REACTINE® comes in different doses (5 mg, 10 mg). REACTINE® 20mg Tablet is only available under prescription; please consult your physician. You and your doctor can determine the dose that works best for you.
Chewable Tablets (taken any time of day, with or without food or water):
Children 2-6 years of age: One 5 mg chewable tablet once daily
Children 6-12 years of age: Two 5 mg chewable tablets or one 10 mg chewable tablet, once daily
Adults and children 12 years of age and over: Two 5 mg chewable tablets or one 10 mg chewable tablet, once daily. For twice daily dosing, one 5 mg chewable tablet in the morning and one 5 mg chewable tablet in the evening
Adults 65 years of age and over: One 5 mg chewable tablet once daily; or consult a doctor
Capsules (liquid gels):
Adults and children 12 years of age and over: One 10 mg capsule once daily.
Syrup (taken with or without food for fast, long-lasting relief of seasonal allergy symptoms and itching due to allergic skin reactions (hives))
Children 2-6 years of age: 5 mL (1 teaspoon) of syrup given once daily. For twice daily dosing, 2.5 mL (one-half teaspoon) of syrup in the morning and 2.5 mL (one-half teaspoon) of syrup in the evening
Children 6-12 years of age: 10 mL (2 teaspoons) of syrup once daily. For twice daily dosing, 5 mL (one teaspoon) in the morning and 5 mL (one teaspoon) in the evening
Do not give REACTINE® 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 REACTINE®. 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. 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 REACTINE® (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 REACTINE®, contact your doctor or pharmacist.
HOW TO STORE IT
Store at temperatures between 15°C and 30°C.
REACTINE® Allergy Liquid Gels (cetirizine hydrochloride capsules, 10 mg): Store at temperatures between 15°C- 30°C. Avoid high humidity and excessive heat (above 40°C). Protect from light.
REPORTING SUSPECTED 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:
Postage paid labels, Canada Vigilance reporting Form and 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
Questions about REACTINE? 1-87-REACTINE www.reactine.ca
Product Monograph available to doctors and pharmacists upon request.
McNeil Consumer Healthcare, division of Johnson & Johnson Inc., Markham, Canada L3R 5L2
© J&J Inc. 2014