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Details for: TEVA-MOMETASONE

Company: TEVA CANADA LIMITED

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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

TEVA-MOMETASONE is a corticosteroid, which reduces inflammation. It was prescribed to you by your doctor to treat the symptoms of one of the following conditions:

In adults, adolescents and children between the ages of 3 and 11 years:

Seasonal allergic rhinitis: also called “hay fever” is caused by allergies to grass, pollen, ragweed, etc. Symptoms include stuffiness/congestion in the nose, runny nose, itching and sneezing.
Perennial allergic rhinitis: year round allergies caused by dust mites, animal dander and molds.
Symptoms include stuffiness/congestion in the nose, runny nose, itching and sneezing.

In adults and children 12 years of age or older: Adjunctive treatment to antibiotics in acute episodes of rhinosinusitis, where signs or symptoms of bacterial infection are present: acute rhinosinusitis is the inflammation of the nasal sinuses that may be complicated with a bacterial infection. TEVA-MOMETASONE is used for the treatment of the inflammatory component and the antibiotic is used for the infection of the nasal sinuses. Symptoms include (but are not limited to) stuffiness/congestion in the nose, runny nose, feeling of something running down the back of the throat, fever, severe facial/tooth pain (especially on one side of the face), facial swelling or thick nasal discharge with a yellow or green colour.

Mild to moderate uncomplicated acute rhinosinusitis, where signs or symptoms of bacterial infection are not present: TEVA-MOMETASONE is used for the treatment of symptoms related to the inflammation and blockage of the sinuses behind the nose. Symptoms include stuffiness/congestion in the nose, runny nose, feeling of something running down the back of the throat, and facial pressure or pain. If symptoms get worse or you start to have fever, persistent severe facial/tooth pain (especially on one side of the face), facial swelling or thick nasal discharge with a yellow or green colour, consult your physician immediately.

In adults 18 years of age or older:

Nasal polyps: small growths on the lining of the nose that usually affect both nostrils. The main symptom is a blocked feeling in the nose which may affect breathing through the nose. Other symptoms may include watery nose, a feeling of something running down the back of the throat, loss of taste and smell.

What it does

When sprayed into the nose it helps reduce symptoms of the conditions listed above

When it should not be used

TEVA-MOMETASONE should not be used

  • if you are allergic to TEVA-MOMETASONE 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. In this case you may be told to wait until healing has occurred before using TEVA-MOMETASONE.
  • 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

Benzalkonium chloride, carboxymethycellulose sodium, citric acid monohydrate, glycerin, microcrystalline cellulose, polysorbate 80, sodium citrate dihydrate, and water for injections.

What the non-medicinal ingredients are

TEVA-MOMETASONE comes in a nasal spray device which delivers 140 sprays. Each spray delivers an unscented mist, containing the equivalent of 50 mcg* of mometasone furoate.
* Calculated on the anhydrous basis.

What dosage form it comes in

TEVA-MOMETASONE comes in a nasal spray device which delivers 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 TEVA-MOMETASONE into your eyes or mouth. It is for use in the nose only.

Before you use TEVA-MOMETASONE talk to your doctor or pharmacist if you are pregnant or nursing a baby. Breast-feeding is not recommended during treatment with TEVA-MOMETASONE

Tell your doctor, if you have any of the following conditions before you start using TEVA-MOMETASONE or develop them during treatment. Your doctor may need to lower your dose of this medication, or you may need extra treatment to control the condition. Once advised, your doctor will decide whether any changes in your treatment are needed. In some cases it may be necessary to stop treatment.

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

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

If you think you have developed an infection in the nose after starting TEVA-MOMETASONE (i.e. normally clear discharge from the nose has turned yellow or green) contact your doctor.

If you have been prescribed TEVA-MOMETASONE (but not with antibiotics) for mild-moderate uncomplicated acute rhinosinusitis, consult your doctor if you develop signs or symptoms of bacterial infection (such as fever, persistent severe facial/tooth pain (especially on one side of the face), facial swelling, worsening of symptoms after an initial improvement) or thick nasal discharge with a yellow or green colour.

Be sure to use this medicine exactly as your doctor or pharmacist has instructed. Do not use more TEVA-MOMETASONE than prescribed in an attempt to increase its effectiveness, and do not use this medicine more often than prescribed. Only a physician can prescribe TEVA-MOMETASONE for you. Do not share this medicine with anyone else; it may harm them even if their symptoms are the same as yours. Do not use this product for other disorders.

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. The dose of some medications may need adjustment while you are treated with TEVA-MOMETASONE.

Drugs that may interact with TEVA-MOMETASONE are listed below. Your doctor may wish to monitor you carefully if you are taking these medicines:

  • Ketoconazole
  • Itraconazole
  • Clarithromycin
  • Ritonavir
  • Cobicistat-containing products
Proper use of this medication

DO NOT SPRAY INTO EYES; FOR INTRANASAL USE ONLY.

Usual Dose

In case of severe nasal congestion, your doctor may recommend the use of a nasal decongestant (vasoconstrictor) 2-3 days before TEVA-MOMETASONE to help clear nasal passages and to aid drug delivery.

Treatment of seasonal or perennial allergic rhinitis:

  • For children between the ages of 3 and 11 years the usual recommended dose is one (1) spray in each nostril once a day. Young children should be aided by an adult when using TEVA-MOMETASONE.
  • For adults (including the elderly) and children 12 years of age and older, the usual recommended dose is two (2) sprays into each nostril once a day. When your symptoms are under control, your physician may recommend one (1) spray into each nostril once daily to maintain control of your symptoms.

Your physician may change this dosage, depending on your response to TEVA-MOMETASONE

In some patients, TEVA-MOMETASONE may relieve symptoms within 12 hours; others may have to wait at least 48 hours. Full effect depends on regular and continued use (unlike other medications which are used only when necessary). For full benefit of therapy, continue regular use.

Adjunctive treatment to antibiotics in acute episodes of rhinosinusitis:

For adults (including the elderly) and children 12 years of age and older, the usual recommended dose is two (2) sprays into each nostril twice a day. If needed for better control of your symptoms, your doctor may recommend that the dose be increased to four (4) sprays into each nostril twice daily.

Your physician may change this dosage, depending on your response to TEVA-MOMETASONE.

Treatment of mild to moderate uncomplicated acute rhinosinusitis:
For adults (including the elderly) and children 12 years of age and older, the usual recommended dose is two (2) sprays into each nostril twice a day.

Contact your doctor if symptoms worsen during treatment (see WARNINGS AND PRECAUTIONS).

Treatment of Nasal Polyps:
For adults 18 years and older (including the elderly), the usual recommended dose is two (2) sprays into each nostril twice a day. Once symptoms are controlled, your physician may reduce your dose to two sprays in each nostril once daily.

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.

Directions for Use
Do not spray into the eyes. For intranasal use only.

Read complete instructions carefully and use only as directed.

Shake well before each use.

  1. Remove the plastic dust cap.

  2. The very first time the spray is used; prime the pump by pressing downward on the shoulders of the white applicator, using your forefinger and middle finger while supporting the base of the bottle with your thumb. Do not pierce the nasal applicator. Press down and release the pump 10 times or until a fine spray appears. The pump is now ready to use. The pump may be stored unused for up to 2 weeks without repriming. If unused for more than 2 weeks, prime the pump again two (2) times, until a fine spray appears.

  3. Gently blow your nose to clear your nostrils. Close one nostril using your finger. Tilt your head forward slightly and, keeping the bottle upright, carefully insert the nasal applicator into the other nostril.

  4. For each spray, press firmly downward once on the shoulder of the white applicator, using your forefinger and middle finger while supporting the base of the bottle with your thumb. Spray while breathing gently inward through the nostril, with the mouth closed.

  5. Then breathe out through your mouth.

  6. Repeat in the other nostril.
  7. Replace the plastic dust cap after each use.

The correct amount of medication in each spray can only be assured up to 140 sprays from the bottle even though the bottle may not be completely empty. You should keep track of the number of sprays used from each bottle of TEVA-MOMETASONE, and discard the bottle after using 140 sprays (approximately five weeks of supply, depending on the prescribed dose).

Cleaning: To clean the nasal applicator, remove the plastic dust cap and pull gently upward on the white nasal applicator so that it comes free. Wash the applicator and dust cap under a cold-water tap. Do not try to unblock the nasal applicator by inserting a pin or other sharp object as this will damage the applicator and cause you not to get the right dose of medicine. Dry and replace the nasal applicator followed by the plastic dust cap.

Re-prime the pump with two (2) sprays when first used after cleaning.

Side effects and what to do about them

Side effects that may occur with the use of corticosteroid nasal sprays, including TEVA-MOMETASONE, are headache, nosebleed or blood-tinged mucus, burning or irritation inside the nose, sneezing or sore throat.

Disturbances of taste and smell have been reported very rarely.

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 postmarket side effects have been seen: nasal septum perforation.

Serious side effects and what to do about them
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
Rare
Immediate hypersensitivity: an allergic reaction which may cause sudden onset of wheezing or difficulty in breathing shortly after taking this medication     ✔
Uncommon
Chest pain, irregular or fast heartbeat     ✔
Unknown
Blurred vision, increased pressure in your eyes, eye pain, distorted vision   ✔  

If you experience any undesirable or troublesome effects, including any that are not listed, advise your physician or pharmacist.

How to store

Keep out of the reach of children.

  • Store 2-25°C
  • Do not freeze.
  • Do not use this product after the expiration date on the package.
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 3 ways:

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

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 Teva Canada Limited by:
Phone: 1-800-268-4127 ext. 3;
Email: druginfo@tevacanada.com; or
Fax: 1-416-335-4472

This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada

www.tevacanada.com

Last revised: May 17, 2018

Date modified: