Mosaspray: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Mosaspray 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, Mosaspray 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:

Mosaspray should not be used:

• if you are allergic to mometasone furoate monohydrate aqueous 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:

Mosaspray contains mometasone furoate monohydrate.

What the important nonmedicinal ingredients are:

Benzalkonium chloride (0.02 mg/metered spray), citric acid monohydrate, carboxymethylcellulose sodium, glycerin, microcrystalline cellulose, polysorbate 80, purified water, and sodium citrate dihydrate.

What dosage forms it comes in:

Mosaspray comes in a nasal spray device which delivers 140 sprays. Each spray delivers a mist, containing the equivalent of 50 mcg* of mometasone furoate.

* Calculated on the anhydrous basis.

WARNINGS AND PRECAUTIONS

Do not spray Mosaspray into your eyes or mouth. It is for use in the nose only.

Before you use Mosaspray 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 Mosaspray. 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 Mosaspray, 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 Mosaspray, 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 Mosaspray (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 Mosaspray 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 nasal spray bottle.

Usual dose and direction 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 restart 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.
• You have changes to the eyesight.
• You have severe or frequent nosebleeds.
• You have or developed symptom of an infection.

Overdose:

In case of accidental oral ingestion or overdose, contact your doctor, regional Poison Control Center or hospital emergency department 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).

   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.

  Figure 2

• 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).

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

WHAT TO DO IF THE APPLICATOR IS 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).

1. 3.

   Rinse both ends of the nasal applicator under cold water. Let air dry (Figure 5).

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

(See HOW TO PRIME THE PUMP instructions).

Please keep this package insert for future use,

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects that may occur with the use of corticosteroid nasal sprays, including Mosaspray, 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, earache, 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 effect has 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 2ºC and 25ºC
• Protect from light
• Do not freeze
• Do not use this product after the expiration date on the package

When Mosaspray 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 Side Effects

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.

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

1-800-361-3062

or by written request at:

145 Jules-Léger

Boucherville, Québec, Canada

J4B 7K8

Or by e-mail at:

medinfo@sandoz.com

Last prepared: June 15, 2016