Details for: APO-MOMETASONE
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02403587 | APO-MOMETASONE | MOMETASONE FUROATE | 50 MCG / ACT | SPRAY, METERED DOSE | NASAL |
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
APO-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.
APO-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: APOMOMETASONE 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
APO-MOMETASONE should not be used:
- if you are allergic to APO-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 APO-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
APO-MOMETASONE contains mometasone furoate.
What the non-medicinal ingredients are
(alphabetical order): benzalkonium chloride, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, purified water and sodium citrate dihydrate.
What dosage form it comes in
APO-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.
Warnings and precautions
Do not spray APO-MOMETASONE into your eyes or
mouth. It is for use in the nose only.
Before you use APO-MOMETASONE talk to your
doctor or pharmacist if you are pregnant or nursing a
baby. Breast-feeding is not recommended during
treatment with APO-MOMETASONE.
Tell your doctor, if you have any of the following
conditions before you start using APOMOMETASONE 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 APO-MOMETASONE (i.e. normally
clear discharge from the nose has turned yellow or
green) contact your doctor.
If you have been prescribed APO-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 APOMOMETASONE than prescribed in an attempt to
increase its effectiveness, and do not use this
medicine more often than prescribed. Only a
physician can prescribe APO-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 APOMOMETASONE.
Drugs that may interact with APO-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 to 3 days before APOMOMETASONE 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 APOMOMETASONE.
- 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 APO-MOMETASONE.
In some patients, APO-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 APO-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. 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 APO-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 APOMOMETASONE, are headache, nose-bleed or bloodtinged 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 post-market side effects have been seen:
nasal septum perforation.
| 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 seek immediate emergency medical attention |
|---|---|---|---|
| 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 between 2°C and 25°C.
- Protect from light.
- Do not freeze.
- Do not use this product after the expiration date on the package.
When APO-MOMETASONE 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
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
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.
If you want more information about APOMOMETASONE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html); the manufacturer’s website http://www.apotex.ca/products, or by calling 1- 800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto,
Ontario, M9L 1T9.
Last revised: February 22, 2019