Nasonex Allergy and Congestion: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

NASONEX ALLERGY AND CONGESTION is used in adults and children 12 years of age and older, for temporary relief of symptoms of the following conditions:

Seasonal allergic rhinitis: also called “outdoor allergies” is caused by allergies to grass, trees and ragweed pollen.

Perennial allergic rhinitis: year round/ indoor allergies caused by dust mites, animals and molds.

The allergy symptoms include

• stuffiness/nasal congestion,
• runny nose,
• nose itching
• sneezing.

Full effect depends on daily and continued use as long as allergy triggers remain.

What it does:

When sprayed into the nose, it helps reduce inflammation in nasal passages and relieves the allergy symptoms.

In some patients, NASONEX ALLERGY AND CONGESTION may relieve symptoms within 12 hours; others may have to wait at least 48 hours, even if used daily.

When it should not be used:

NASONEX ALLERGY AND CONGESTION should not be used:

• if you are allergic to Mometasone furoate monohydrate nasal spray or to any of its ingredients.

  • if you have an infection in the nose (i.e. yellow or green discharge from the nose) that is not being treated.
  • if your nose was recently operated on or injured.
  • If you have frequent and severe nosebleeds
  • if you have been diagnosed with tuberculosis and it is not being treated.*
  • if you have untreated fungal, bacterial, or systemic viral infections.*
  • if you have a herpes simplex (virus) infection of the eye and it is not being treated.*

* See WARNINGS AND PRECAUTIONS for additional information.

What the medicinal ingredient is:

NASONEX ALLERGY AND CONGESTION contains mometasone furoate monohydrate.

What the nonmedicinal ingredients are:

(alphabetical order): benzalkonium chloride, carboxymethylcellulose sodium, citric acid, glycerol, microcrystalline cellulose, polysorbate 80, purified water, and sodium citrate dihydrate.

What dosage forms it comes in:

NASONEX ALLERGY AND CONGESTION comes in a nasal spray device which delivers 60 sprays (sample and trade sizes) or 140 sprays. Each spray delivers an unscented mist, containing the equivalent of 50 mcg* of mometasone furoate. * Calculated on the anhydrous basis.

WARNINGS AND PRECAUTIONS

Do not spray NASONEX ALLERGY AND CONGESTION into your eyes or mouth. It is for use in the nose only.

Before you use NASONEX ALLERGY AND CONGESTION talk to your doctor or pharmacist if you are pregnant or nursing a baby. Breast-feeding is not recommended during treatment with this drug. If you have any of the following conditions consult your doctor or pharmacist before using NASONEX ALLERGY AND CONGESTION. If you develop one of these conditions while using this drug, stop treatment and see your doctor:

• sores in the nose
• tuberculosis (active or previous)
• infection (fungal, bacterial or viral)
• herpes simplex (virus) infection of the eye
• Change in vision
• Severe or frequent nose bleed

(See ABOUT THIS MEDICATION- When it should not be used, for additional information.)

Although not observed with NASONEX ALLERGY AND CONGESTION, development of glaucoma (elevated pressure inside the eye ball) or cataracts (clouding of the lens of the eye) have been reported with other intranasal and inhaled corticosteroids.

Although not observed with NASONEX ALLERGY AND CONGESTION, slower rate of growth has been reported in some children receiving other intranasal corticosteroid. You and your doctor should monitor your child’s growth.

Contact your doctor if you think you have developed an infection in the nose after starting NASONEX ALLERGY AND CONGESTION (i.e. normally clear discharge from the nose has turned yellow or green) or if you have, or come into contact with someone who has chickenpox, measles or tuberculosis;

Be sure to use this medicine exactly as instructed. Do not use more NASONEX ALLERGY AND CONGESTION than recommended in an attempt to increase its effectiveness, (See PROPER USE OF THIS MEDICATION for additional information.) Do not use this product for treating other disease such as cold.

INTERACTIONS WITH THIS MEDICATION

To avoid the possibility of drug interactions, be sure to advise your physician or pharmacist of any other medications that you are taking, particularly corticosteroid medicine, either by mouth or by injection.

PROPER USE OF THIS MEDICATION

FOR INTRANASAL USE ONLY. DO NOT SPRAY INTO EYES or MOUTH

Follow the INSTRUCTIONS FOR USE described below to properly use this spray bottle

If you have any questions, call 1-866-241-3891

Usual dose and Directions for use

Adults and children 12 years of age and older

Once daily, spray two times into each nostril while sniffing gently.

When your symptoms are under control, you may reduce to one (1) spray into each nostril once daily to maintain control of your symptoms.

You may stop and re-start use as needed based on your symptoms.

When using this product:

• Do not use more than 4 sprays in 24 hours;
• Do not share this bottle with anyone else as this may spread germs.
• Do not use continuously for more than six months without consulting your doctor.

Stop use and ask a doctor or pharmacist if

• Your allergy symptoms do not improve after one week.
• Changes to the eyesight
• Severe or frequent nosebleeds
• You have or developed symptom of an infection

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you miss taking your dose on time, do not worry; take a dose if you remember within an hour or so. However, if you do not remember until later, skip the missed dose and go back to your regular dosing schedule. Do not double the dose.

INSTRUCTIONS FOR USE

HOW TO PRIME THE PUMP

1. 1. Shake the bottle well.
2. 2. Remove the plastic cap (Figure 1).
3. 3. Prime the pump into the air the first time it is used, or when not used for a week or more.

Do not pierce the nasal applicator.

• To prime the pump, press downward on the shoulders of the nasal applicator using your index finger and middle finger while holding the base of the bottle with your thumb (Figure 2). Point the spray away from you while doing this.

• Press down and release the pump ten times or until a fine spray appears, taking care not to spray into eyes or face.
• The pump is now ready to use.

HOW TO USE AND CLEAN

1. 1. Shake the bottle well before each use.
2. 2.

   . Gently blow your nose to clear the nostrils.

   . With your finger, hold one nostril shut.

   . Tilt your head forward slightly, keep the bottle upright,

   and carefully insert the nasal applicator into the other nostril (Figure 3).

Do not spray directly onto the nasal septum (the wall between the two nostrils).

1. 3.

   . Hold the spray bottle upright and press firmly downward

   on the shoulders of the nasal applicator.

   . Breathe gently inward through the nostril.

   . Then breathe out through the mouth.

2. – Adults and children 12 years and over: two sprays in each nostril.
3. 4.

   Repeat in the other nostril.

   1. 5. Wipe the outside of the nasal applicator with a clean tissue and replace the plastic cap after each use.

WHAT TO DO IF BLOCKED

Clean the inside of the applicator if it gets blocked. Do not try to unblock the nasal applicator by inserting a pin or other sharp object, as this will damage the applicator.

1. 1. Remove the plastic cap.
2. 2. Pull gently upward on the nasal applicator to remove (Figure 4).
3. 3.

   Rinse both ends of the nasal applicator under cold water.

   Let air dry (Figure 5).

4. 4. Once dry, put nasal applicator back on pump stem.
5. 5. Reprime the pump.

(See HOW TO PRIME THE PUMP instructions).

Please keep this package insert for future use. If you have any questions, call 1-866-241-3891

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects that may occur with the use of corticosteroid nasal sprays, including NASONEX ALLERGY AND CONGESTION, are headache, nose-bleed or blood-tinged mucus, burning or irritation inside the nose, sneezing or sore throat.

Disturbances of taste and smell have been reported very rarely. If these side effects do not go away or worsen, stop use and contact your doctor or pharmacist.

The following less common side effects have been seen in Clinical Trials: swollen lymph nodes, vision changes, eye tearing, dry eyes, eye inflammation or infection, ear ache, ringing in the ears, stomach pain, constipation, diarrhea, nausea, tongue and tooth disorders, dry mouth, aggravated allergy symptoms, swelling of the body including the face, fever, flu-like symptoms, thirst, cold sore, infections, muscle and/or joint pain, tremor, dizziness, migraine, depression, nightmares causing sleep disturbances, fatigue, loss of voice, bronchitis, shortness of breath, wheezing, acne, skin rashes and high blood pressure.

In addition to some of the above side effects, the following post-market side effects have been seen: nasal septum perforation.

IF YOU EXPERIENCE ANY UNDESIRABLE OR TROUBLESOME EFFECTS, INCLUDING ANY THAT ARE NOT LISTED, ADVISE YOUR PHYSICIAN OR PHARMACIST.

HOW TO STORE IT

KEEP OUT OF THE REACH OF CHILDREN.

• Store between 2° and 25°C (36° and 77°F).
• Protect from light.
• Do not freeze.
• Do not use this product after the expiration date on the package.

When NASONEX ALLERGY AND CONGESTION is removed from its cardboard container, prolonged exposure of the product to direct light should be avoided. Brief exposure to light, as with normal use, is acceptable.

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:

• 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 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

Drug testing for sports events: This product is a corticosteroid for nasal administration. Although it is not measurable in the blood, corticosteroids may be detected in the urine during drug testing. Thus, prior written permission for its use may be required by sports agencies.

You may want to read this leaflet again. Do not throw it away until you have finished your medication.

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor at:

Schering-Plough Canada Inc.

Kirkland, Québec

H9H 4M7

1-866-241-3891

Last revised: June 19, 2014

^®Registered trademark of Schering-Plough Canada Inc. Used under license.

^©2013, 2014 Schering-Plough Canada Inc., a subsidiary of Merck & Co., Inc. All rights reserved.