Details for: CLARITIN ALLERGY + SINUS
Company: BAYER INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 01945157 | CLARITIN ALLERGY + SINUS | LORATADINE; PSEUDOEPHEDRINE SULFATE | 5 MG; 120 MG | TABLET (IMMEDIATE AND EXTENDED RELEASE) | ORAL |
Summary Reports
Summary Safety Review - Over-the-Counter Products Containing Pseudoephedrine - Assessing the Potential Risk of Inflammation and Injury of the Large Intestine due to Insufficient Blood Supply (ischemic colitis)
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
CLARITIN® ALLERGY + SINUS provides:
- Fast and long-lasting relief of symptoms from indoor (dust mites, pet dander and moulds) and outdoor (tree, grass, and ragweed pollens) allergies (allergic rhinitis) including itchy, watery, red burning eyes; sneezing, runny nose, itchy nose, post-nasal drip/discharge; nasal congestion, sinus pressure and sinus congestion.
What it does
CLARITIN® ALLERGY + SINUS is a fast acting and long-lasting antihistamine + decongestant that contains:
- an antihistamine (loratadine), which blocks the action of histamine and relieves allergy symptoms. When you are exposed to indoor and or outdoor allergens your body responds by releasing histamine. Histamine causes allergy symptoms such as itchy, watery, red burning eyes; sneezing, runny nose, and itchy nose.
- a decongestant (pseudoephedrine sulfate) that relieves nasal congestion, sinus pressure and sinus congestion due to allergies by constricting the blood vessels in the lining of the nose and sinuses.
One dose of CLARITIN® ALLERGY + SINUS provides 12 hour relief of allergy symptoms.
When it should not be used
CLARITIN® ALLERGY + SINUS should not be used if you are/have:
- allergic to loratadine, desloratadine, pseudoephedrine or to any of the product ingredients (see What the important non-medicinal ingredients are).
- taking a monoamine oxidase inhibitor (MAOI) (drugs for depression or Parkinson's disease) or for 2 weeks after stopping the MAOI drug
- narrow-angle glaucoma (increased pressure in the eye)
- difficulty urinating due to enlargement of the prostate gland
- high blood pressure
- hyperthyroidism (overactive thyroid)
- heart disease
What the medicinal ingredient is
- Loratadine
- Pseudoephedrine sulfate
What the non-medicinal ingredients are
CLARITIN® ALLERGY + SINUS (in alphabetical order): black ink, croscarmellose sodium, calcium phosphate dibasic, hypromellose, lactose, magnesium stearate, povidone, titanium dioxide.
What dosage form it comes in
Modified-release tablets: containing 5 mg loratadine for immediate release & 120 mg pseudoephedrine sulfate for immediate and extended release.
Warnings and precautions
BEFORE you use CLARITIN® ALLERGY + SINUS talk to your doctor or pharmacist if you are/have:
- pregnant or breastfeeding
- elderly
- taking other medications
- liver or kidney disease as you may require a dose adjustment
- diabetes
- stomach problems
Stop use and ask a doctor if:
- symptoms do not improve within 7 days or are accompanied by skin blister, redness, rash or fever.
- nervousness, dizziness or sleeplessness occurs.
Stop taking CLARITIN® ALLERGY + SINUS 48 hours prior to any skin testing procedures.
Interactions with this medication
The drugs that may interact with CLARITIN® ALLERGY + SINUS: monoamine oxidase inhibitors, methyldopa, mecamylamine, reserpine and veratrum alkaloids, beta-adrenergic blocking agents, digitalis, antacids, kaolin, furazolidone, ketoconazole, erythromycin, cimetidine or other sympathomimetic amines, it is important to ask your doctor or pharmacist before taking CLARITIN® ALLERGY + SINUS.
Proper use of this medication
Usual Dose
- Adults and children (12 years of age and older): one tablet every 12 hours Do not exceed more than two tablets in 24 hours. Do not crush, break , chew or dissolve the tablet. Swallow whole with water
- Limited to 3 months of use unless recommended by a doctor.
Overdose
Missed Dose
If you miss taking your dose on time, do not worry; take your dose when you remember.
Side effects and what to do about them
Along with its desired effects, CLARITIN® ALLERGY +
SINUS may cause undesirable effects.
Side effects that may occur include dizziness, dry mouth,
fatigue, headache, sleeplessness, nervousness, nausea,
stomach discomfort and sleepiness. Taking more than
directed may cause drowsiness. If these side effects do not
go away or worsen, stop use and call your doctor or
pharmacist.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Rarely | |||
| ✔ | |||
| ✔ | |||
| ✔ | |||
| Very Rare | |||
| ✔ | |||
This is not a complete list of side effects. For any unexpected effects while taking CLARITIN® ALLERGY + SINUS, contact your doctor or pharmacist.
How to store
Store between 15° and 30°C.
Keep this and all medication stored in a safe place and
of reach of children.
Reporting 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 three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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
This document plus the full product monograph, prepared
for health professionals can be found at:
www.bayer.ca
This leaflet was prepared by Bayer Inc.,
Mississauga, ON, L4W 5R6
Last revised: May 3rd, 2019
® TM see www.bayer.ca/tm-mc