Monasal

Monasal

mometasone

Manufacturer:

Eurodrug

Distributor:

Eurodrug

Marketer:

Euro Asia Medico
Full Prescribing Info
Contents
Mometasone furoate.
Description
The active substance is mometasone furoate.
Each spray contains 50 micrograms of mometasone furoate, as the monohydrate.
Excipients/Inactive Ingredients: The other ingredients are benzalkonium chloride, glycerol, polysorbate 80, microcrystalline cellulose and carmellose sodium, citric acid monohydrate, sodium citrate, purified water.
Action
MONASAL Nasal Spray contains mometasone furoate, one of a group of medicines called corticosteroids. When mometasone furoate is sprayed into the nose, it can help to relieve inflammation (swelling and irritation of the nose), sneezing, itching and a blocked up or runny nose. Mometasone furoate should not be confused with "anabolic" steroids misused by some athletes and taken as tablets or injections.
Indications/Uses
MONASAL is used in adults and children aged 2 and older to treat the symptoms of seasonal or perennial rhinitis.
To help prevent moderate to severe symptoms of seasonal allergic rhinitis, MONASAL may be used 2 to 4 weeks before the beginning of the pollen season.
In adults aged 18 and over, MONASAL is also used to treat nasal polyps.
MONASAL may also be used in adults and children 12 years of age and older for the treatment of symptoms of acute rhinosinusitis (inflammation and blockage of the sinuses behind the nose) without signs or symptoms of bacterial infection.
Seasonal and perennial rhinitis: Seasonal allergic rhinitis, which occurs at certain times of the year, is an allergic reaction caused by breathing in pollen from trees, grasses, weeds and also moulds and fungal spores. Perennial rhinitis occurs throughout the year and symptoms can be caused by a sensitivity to a variety of things including house dust mite, animal hair (or dander), feathers and certain foods. MONASAL reduces the swelling and irritation in the nose and so relieves sneezing, itching and a blocked-up or runny nose.
Nasal polyps: Nasal polyps are small growths on the lining of the nose and usually affect both nostrils. The main symptom is a blocked feeling in the nose which may affect breathing through the nose. Watering from the nose, a feeling of something running down the back of the throat and loss of taste and smell may also occur. MONASAL reduces the inflammation in the nose, causing the polyps to gradually shrink.
Acute rhinosinusitis: Mild to moderate uncomplicated acute rhinosinusitis without signs and symptoms of bacterial infection is the inflammation and blockage of the sinuses behind the nose.
Symptoms can include a stuffy or runny nose, feeling of something running down the back of the throat, and facial pressure or pain. MONASAL relieves these symptoms by reducing the inflammation in the nose.
Dosage/Direction for Use
Always use MONASAL exactly as the doctor has told. The patient should check with the doctor or pharmacist if not sure. Do not use a larger dose or use the spray more often or for longer than the doctor has told.
Treatment of seasonal and perennial rhinitis: In some patients MONASAL begins to relieve symptoms within 12 hours after the first dose, however full benefit of treatment may not be seen in first two days. Therefore the patient should continue regular use to achieve full benefit of treatment.
If the patient or child suffer badly from seasonal allergic rhinitis, the doctor may tell to start using MONASAL two to four weeks before the start of the pollen season, as this will help to prevent the seasonal allergic rhinitis symptoms from occurring. At the end of the pollen season the seasonal allergic rhinitis symptoms should get better and treatment may then not be needed.
Use in adults and children over 12 years old: The usual dose is two sprays into each nostril once a day.
Once the symptoms are under control, the doctor may advise to decrease the dose.
If the patient does not start to feel any better, the patient should see the doctor and he may tell the patient to increase the dose to the maximum daily dose of four sprays into each nostril once a day.
Use in children aged 2 to 11 years: The usual dose is one spray into each nostril once daily.
Young children should be aided by an adult when using MONASAL.
Long term use of nasal steroids at high doses may cause slowing of growth in children. The doctor may check the child's height at intervals during treatment and reduce the dose if any effects are seen.
Nasal polyps: Use in adults over 18 years old: The usual starting dose is two sprays into each nostril once daily.
If symptoms are not controlled after 5 to 6 weeks, the dose may be increased to two sprays in each nostril twice daily. Once symptoms are under control, the doctor should ask the patient to reduce the dose to the lowest amount where symptoms are still controlled.
If no improvement in symptoms is seen after 5 to 6 weeks of twice daily administration, the patient should contact the doctor.
Treatment of acute rhinosinusitis: Use in adults and children 12 years of age and older: The usual recommended dose is two sprays into each nostril twice daily.
If no improvement in symptoms is seen after 15 days of twice daily administration, the patient should contact the doctor to discuss other treatments to replace MONASAL. If symptoms get worse during treatment the patient should contact the doctor.
Preparing the nasal spray for use: MONASAL nasal spray has a dust cap which protects the nozzle and keeps it clean.
Remember to take this off before using the spray and to replace it after use.
If the patient is using the spray for the first time the patient needs to 'prime' the bottle by pumping the spray 10 times until a fine mist is produced: 1. Gently shake the bottle and remove the dust cap.
2. Put the forefinger and middle finger either side of the nozzle and the thumb underneath the bottle. Do not pierce the nasal applicator. Do not spray into eyes.
3. Point the nozzle away from the patient and then press down with the fingers to pump the spray.
If the patient has not used the spray for 14 days or more, the patient needs to re-prime the bottle by pumping the spray 2 times until a fine mist is produced.
How to use the nasal spray: 1. Shake the bottle gently before each use and remove the dust cap.
2. Gently blow the nose.
3. Close one nostril and put the nozzle into the other nostril. Tilt the head forward slightly, keeping the bottle upright. Do not spray directly onto the nasal septum (the wall between the two nostrils).
4. Start to breathe in gently or slowly through the nose and whilst the patient is breathing in squirt a spray of fine mist into the nose by pressing down once with the fingers.
5. Breathe out through the mouth. Repeat step 4 to inhale a second spray in the same nostril if applicable.
6. Remove the nozzle from this nostril and breathe out through the mouth.
7. Repeat steps 3 to 6 for the other nostril.
After using the spray, wipe the nozzle carefully with a clean handkerchief or tissue and replace the dust cap.
Cleaning the nasal spray: It is important to clean the nasal spray regularly, otherwise it may not work properly.
1. Remove the dust cap and gently pull off the nozzle.
2. Wash the nozzle and dust cap in warm water and then rinse under a running tap.
3. Do not try to unblock the nasal applicator by inserting a pin or other sharp object as this will damage the applicator and cause the patient not to get the right dose of medicine.
4. Allow the dust cap and nozzle to dry in a warm place.
5. Push the nozzle back onto the bottle and replace the dust cap.
6. The spray will need to be primed again with 2 sprays when first used after cleaning.
If the patient uses more MONASAL than she/he should: Tell the doctor if the patient accidentally uses more than she/he were told
If the patient uses steroids for a long time or in large amounts they may, rarely, affect some of the hormones. In children this may affect growth and development.
If the patient forgets to use MONASAL: If the patient forgets to use the nasal spray at the right time, use it as soon as she/he remember, then carry on as before. Do not take a double dose to make up for a forgotten dose.
If the patient stops using MONASAL: In some patients MONASAL should begin to relieve symptoms 12 hours after the first dose. However, full benefit of treatment may not be seen for up to two days. It is very important that the patient uses the nasal spray regularly. Do not stop the treatment even if the patient feels better unless told to do so by the doctor.
If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.
Contraindications
Do not use MONASAL: If the patient is allergic (hypersensitive) to mometasone furoate or any of the other excipients of MONASAL.
If the patient has an infection in the nose, such as herpes, as it can worsen the infection. The patient should wait until the infection is resolved before using the nasal spray.
If the patient recently had an operation on the nose or had injured the nose. The patient should wait until it has healed before using the nasal spray.
Special Precautions
Take special care with MONASAL: If the patient has or ever had tuberculosis.
If the patient has herpes simplex (virus) infection of the eye.
If the patient has any other type of infection (fungal, bacterial or viral).
If the patient is taking other corticosteroid medicines, either by mouth or by injection.
If the patient has sores in the nose.
If the patient has cystic fibrosis.
While the patient is using MONASAL, talk to the doctor: If the immune system is not functioning well (if the patient has difficulty in fighting infection) and the patient comes into contact with anyone with measles or chickenpox. The patient should avoid coming into contact with anyone who has these infections.
If the patient has been prescribed MONASAL for mild to moderate uncomplicated acute rhinosinusitis, consult a doctor.
If the patient has an 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.
If the patient is using the medicine for several months or longer.
If the patient has a persistent irritation to the nose or throat.
Contact a doctor immediately if the patient experiences blurred vision or other visual disturbances.
When corticosteroid nasal sprays are used at high doses for long periods of time, side effects may occur due to the drug being absorbed in the body. If the eyes are itching or irritated, the doctor may recommend that the patient should use other treatments.
MONASAL contain benzalkonium chloride: MONASAL contains benzalkonium chloride which may cause irritation or swelling inside the nose, especially if used for a long time.
Driving and using machines: There is no known information on the effect of MONASAL on the ability to drive or use machinery.
Use In Pregnancy & Lactation
The patient should not use NASONEX if pregnant unless the doctor has told the patient to. Tell the doctor if the patient is pregnant before using this medicine. The patient should not breast feed when using this medicine unless the doctor has told the patient to.
Side Effects
Like all medicines, MONASAL can cause side effects, although not everybody gets them.
Rarely, immediate hypersensitivity (allergic) reactions may occur after use of this product. Very rarely, these reactions may be severe. The patient should stop taking MONASAL and get immediate medical help if the patient experiences symptoms such as: swollen face, tongue or pharynx, trouble swallowing, hives, wheezing or trouble breathing.
In rare cases, treatment with corticosteroid nasal sprays like MONASAL has led to an increase in pressure in the eye (glaucoma), causing visual disturbances and damage to the partition in the nose which separates the nostrils. Contact the doctor if the patient notices any of these side effects.
Other side effects: Most people do not have any problems after using the nasal spray. However, a few people after using MONASAL or other corticosteroid nasal sprays may find that they suffer from: headache, sneezing, nose bleeds, sore nose or throat, alterations in taste or smell which may occur very rarely, diarrhoea, nausea, stomach pain, chest pain, irregular or fast heartbeat which may occur very rarely, blurred vision.
Children: When used at high doses for long periods of time, corticosteroid nasal sprays may cause certain side-effects, such as growth reduction in children.
It is recommended that the height of children receiving long-term treatment with nasal corticosteroids is regularly monitored and if any changes are noted, their doctor should be notified.
If any of these side-effects get serious, or if the patient notices any side effects not listed in this monograph, tell the doctor or pharmacist.
Drug Interactions
Using other medicines: Tell the doctor or pharmacist if the patient is taking, have recently taken or might take any other medicines.
Some medicines may increase the effects of MONASAL and the doctor may wish to monitor the patient carefully if taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
If the patient is taking other corticosteroid medicines for allergy, either by mouth or injection, the doctor may advise the patient to stop taking them once she/he begin using MONASAL.
A few people may find that once they discontinue oral or injected corticosteroids they suffer from some undesirable effects, such as joint or muscular pain, weakness and depression.
The patient may also seem to develop other allergies, such as itchy, watering eyes or patches of red and itchy skin. If the patient develops any of these effects, contact the doctor.
Storage
Store the nasal spray below 30°C. Store away from heat. Do not freeze it.
Each bottle should be used within 2 months of first opening. Only open one bottle at a time.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer use. These measures will help protect the environment.
ATC Classification
R01AD09 - mometasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
Presentation/Packing
Nasal spray 50 mcg/spray (white to off white viscous suspension) x 140 sprays x 1's.
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