Details for: TEVA-MOMETASONE
Company: TEVA CANADA LIMITED
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
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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
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.
- Remove the plastic dust cap.
- 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.
- 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.
- 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.
- Then breathe out through your mouth.
- Repeat in the other nostril.
- 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.
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:
- Report online at www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada.html
- 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, Ontario
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
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