Patient Medication Information: uses, side effects, how to take - Mometasone (Sivem Pharmaceuticals)
ABOUT THIS MEDICATION
What the medication is used for:
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 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. 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:
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:
MOMETASONE should not be used:
- if you are allergic to 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 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:
MOMETASONE contains mometasone furoate monohydrate.
What the nonmedicinal ingredients are:
benzalkonium chloride (0.02 mg/ metered spray), citric acid monohydrate, carboxymethylcellulose sodium, glycerin, microcrystalline cellulose, polysorbate 80, water for injection, and sodium citrate dihydrate.
What dosage forms it comes in:
MOMETASONE 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 MOMETASONE into your eyes or mouth. It is for use in the nose only.
Before you use MOMETASONE talk to your doctor or pharmacist if you are pregnant or nursing a baby. Breast-feeding is not recommended during treatment with MOMETASONE.
Tell your doctor, if you have any of the following conditions before you start using 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 MOMETASONE (i.e. normally clear discharge from the nose has turned yellow or green) contact your doctor.
If you have been prescribed 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 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 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 MOMETASONE.
Drugs that may interact with 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 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 MOMETASONE.
Your physician may change this dosage, depending on your response to MOMETASONE.
In some patients, 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 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 accidental oral ingestion or overdose, contact 
healthcare professional, 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 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 MOMETASONE, 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.
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.
SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM | ||||
| Symptoms / effects | Talk with your healthcare professional | Stop taking drug and get immediate medical help | ||
| Only if severe | In all cases | |||
| 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 have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
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 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 side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting
(www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. 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 MOMETASONE:
- 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/services/drugs-health-products/drug-products/drug-product-database.html ; the manufacture’s website (www.sivem.ca), or by calling 1 855-788-3153.