Consumer medicine information

Azonaire Hayfever & Allergy Prevention & Relief

Mometasone furoate

BRAND INFORMATION

Brand name

Azonaire Hayfever & Allergy Prevention & Relief Nasal Spray

Active ingredient

Mometasone furoate

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Azonaire Hayfever & Allergy Prevention & Relief.

What is in this leaflet

This leaflet answers some common questions about AZONAIRE HAYFEVER & ALLERGY PREVENTION & RELIEF. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may want to read it again.

What AZONAIRE HAYFEVER & ALLERGY PREVENTION & RELIEF is used for

AZONAIRE HAYFEVER & ALLERGY PREVENTION & RELIEF contains the active ingredient mometasone furoate. This belongs to a family of medicines called corticosteroids, which are used to help reduce inflammation.

AZONAIRE HAYFEVER & ALLERGY PREVENTION & RELIEF is sprayed into the nose to help relieve symptoms that may occur with hayfever or other year-round allergies, including stuffiness (congestion) in the nose, discharge, itching and sneezing.

Hayfever is an inflammation or swelling of the nose lining (which may cause blockage, runny nose, itching and/or sneezing).

You may have symptoms only during spring or summer. This type of allergy is generally due to various pollens. Some people may experience symptoms all year round. This is usually caused by house dust mites, pets or moulds.

It may take a few days of use before you feel the full effects of AZONAIRE HAYFEVER & ALLERGY PREVENTION & RELIEF. If you suffer from moderate to severe symptoms, you may need to start AZONAIRE HAYFEVER & ALLERGY PREVENTION & RELIEF treatment 2-4 weeks before the beginning of the pollen season.

There is no evidence that this medicine is addictive.

This medicine is available from pharmacists without a prescription.

Before you use AZONAIRE HAYFEVER & ALLERGY PREVENTION & RELIEF

When you must not use it

Do not use the medicine if:

  1. You have an allergy to:
  • any medicine containing mometasone furoate
  • any of the ingredients listed at the end of this leaflet.
  1. You have a tendency to bleed or recurrent nose bleeding
  2. You have severe nose infection, especially fungal infection.
  3. You have had recent nose injury or nose surgery; check with your doctor, because you may be told to wait until healing has occurred before using this medicine.

Do not give this medicine to a child under the age of 12 years. If necessary, your doctor will prescribe a suitable medicine for children under 12 years of age who have hayfever.

Do not use it after the expiry date (EXP) printed on the pack or if the packaging is torn or shows sign of tampering.

If you are not sure whether you should start taking this medicine, contact your pharmacist or doctor.

Before you start to use it

Tell your pharmacist or doctor if you have or have had any medical conditions, especially the following:

  • a history of tuberculosis, or active tuberculosis
  • infection of the nose, sinus, mouth, throat, lungs or eye
  • sores in the nose
  • recent injury or surgery to your nose
  • open sores in your nose

Tell your pharmacist or doctor if you are taking other corticosteroid medicines, either by mouth, as eye drops, as an asthma inhaler or by injection.

Tell your pharmacist or doctor if you have allergies to:

  • any other medicines
  • any other substances, such as foods, preservatives or dyes

Tell your pharmacist or doctor if you are pregnant or intend to become pregnant. Your pharmacist or doctor will discuss the possible risks and benefits of using this medicine during pregnancy.

Tell your pharmacist or doctor if you are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with this medicine.

If you have not told your pharmacist or doctor about any of the above, tell them before you use this medicine.

Taking other medicines

Tell your pharmacist or doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Your pharmacist and doctor have more information on medicines to be careful with or avoid while using this medicine.

How to use AZONAIRE HAYFEVER & ALLERGY PREVENTION & RELIEF

AZONAIRE HAYFEVER & ALLERGY PREVENTION & RELIEF is to be sprayed into the nose only.

To prevent symptoms, start using the medicine

  • before the hayfever season,
    or
  • before coming into contact with something you know will cause your hayfever.

It may take a few days to get the full effect of this medicine. Therefore, to help reduce the severity of your symptoms, start to use AZONAIRE HAYFEVER & ALLERGY PREVENTION & RELIEF for a few days before expected exposure to your usual triggers. If you suffer moderate to severe symptoms, you may need to start treatment 2-4 weeks before the pollen season. It is very important that you use AZONAIRE HAYFEVER & ALLERGY PREVENTION & RELIEF regularly. If you stop the treatment when you feel better, your symptoms may return as the medication wears off.

Follow all directions given to you by your pharmacist or doctor carefully and do not use more than the recommended dose. These directions may differ from the information contained in this leaflet.

If you do not understand the instructions, ask your pharmacist or doctor for help.

How much to use

Hayfever and allergies in adults (including the elderly) and children 12 years of age and older:

Two sprays into each nostril once daily.

Do not exceed the maximum dose. Once your symptoms have improved, reduce the dose to one spray into each nostril once daily.

If symptoms worsen during treatment, see your doctor immediately.

About your nasal spray

Your 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.

Do not pierce the nasal applicator.

If you are using the spray for the first time prime the pump by pumping the spray 10 times until a fine mist is produced. If you have not used the pump for 14 days or more reprime by pumping 2 times.

It is important to clean the nozzle regularly; otherwise, it may not work properly. Remove the dust cap and gently pull off the nozzle. Wash the nozzle and dust cap in warm water and then rinse under a running 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.

Allow the nozzle to dry. Push the nozzle back onto the bottle and replace the dust cap. The pump will need to be reprimed when first used after cleaning.

How to use it

Each pack of this medicine contains an instruction leaflet that tells you the correct way to use it.

  1. Shake the bottle gently and remove the dust cap.
  2. Gently blow your nose.
  3. Close one nostril and put the nozzle into the other nostril.
  4. Tilt your head forward slightly, keeping the bottle upright.
  5. Start to breathe in gently or slowly through your nose and whilst you are breathing in squirt a spray of fine mist into your nose by pressing down ONCE with your fingers.
  6. Breathe out through your mouth. Repeat step 5 to inhale a second spray in the same nostril.
  7. Remove the nozzle from this nostril and breathe out through the mouth.
  8. Repeat steps 3 to 7 for the other nostril. After using the spray, wipe the nozzle carefully with a clean tissue and replace the dust cap.

How long to use it

See your pharmacist or doctor or if your symptoms are not relieved within 7 days. It generally takes a few days before you notice any improvement in your symptoms.

The medicine only works if it is used on a regular basis.

For the prevention of symptoms relating to seasonal hayfever, AZONAIRE HAYFEVER & ALLERGY PREVENTION & RELIEF can be used for up to 6 months.

If you forget to use it

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to.

Otherwise, use it as soon as you remember, and then go back to use your medicines as you would normally.

Do not use a double dose to make up for the dose you missed.

If you are not sure what to do, ask your pharmacist or doctor.

If you use too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Azonaire Hayfever & Allergy Prevention and Relief. Do this even if there are no signs of discomfort or poisoning.

Keep telephone numbers for these places handy.

While you are using AZONAIRE HAYFEVER & ALLERGY PREVENTION & RELIEF

Things you must do

See your doctor or pharmacist if your symptoms are not relieved within 7 days. It generally takes a few days before you notice any improvement in your symptoms.

Ask your doctor to examine your nose if you have been using the medicine for several months without a break.

Ask your doctor to examine your nose from time to time to make sure the medicine is working and to prevent unwanted side effects.

If you become pregnant while you are using this medicine tell your doctor.

Tell any other doctors, dentists and pharmacists who are treating you that you are using this medicine.

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are using this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are using this medicine.

See your doctor immediately if you notice the symptoms of severe bacterial infection. These symptoms may include fever, persistent face/tooth pain on one side of the face, swelling around the eye area, or worsening of symptoms after an initial improvement.

Things you must not do

Do not give this medicine to anyone else, even if they have the same condition as you.

Do not use it to treat any other complaints unless your doctor tells you to.

Things to be careful of

This medicine generally does not cause any problems with your ability to drive a car or operate machinery.

If you have a lower resistance to infection, avoid coming into contact with anyone who has measles or chickenpox especially while you are using cortisone-type medicines. Tell your doctor if you do.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using this medicine.

The doctor will decide whether any change in your treatment is needed.

This medicine helps most people, but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. If you are over 65 years of age, you may have an increased chance of getting side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Most people do not have any problems after using the nasal spray. However, a few people may find that they suffer from one or more of the following:

  • headache
  • sneezing
  • nosebleeds or blood-tinged mucus
  • glaucoma
  • increased intraocular pressure
  • cataracts
  • blurred vision
  • sore throat or burning or irritation inside the nose after using this medicine. These symptoms are consistent with the use of corticosteroid nasal sprays.

If you develop a rash, wheezing or breathlessness, stop using the nasal spray, as you may be allergic to it and contact your doctor immediately.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using AZONAIRE HAYFEVER & ALLERGY PREVENTION & RELIEF

Storage

Keep the nasal spray in a cool dry place where the temperature stays below 25°C. Do not freeze. Store it away from heat.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car or on windowsills. Heat and dampness can destroy some medicines.

Keep it where children cannot reach.

Disposal

If you stop using this medicine or it has passed the expiry date, ask your pharmacist what to do with any that is left over.

Discard 2 months after opening.

Further information

Drug testing for sport events:

This product is a corticosteroid for intranasal administration; it is not a restricted drug for sports. Corticosteroid may be detected in blood and in the urine during drug testing; thus prior written permission for its use may be required by some sport agencies.

Product description

What it looks like

The nasal spray is a white to off-white suspension contained in a plastic bottle with a metered-dose, manual spray pump for intranasal administration.

Ingredients

Active ingredient:

Mometasone furoate monohydrate.

Inactive ingredients:

Microcrystalline cellulose and carmellose sodium glycerol, citric acid monohydrate, sodium citrate, poylsorbate 80, purified water.

Preservatives:

Benzalkonium chloride

This medicine does not contain lactose, sucrose, gluten, tartrazine or any azo dyes.

Sponsor

Sandoz Pty Ltd
54 Waterloo Road,
Macquarie Park, NSW 2113
Australia
Tel: 1800 726 369

Australian Registration Number

60 metered doses per pack

140 metered doses per pack

Azonaire Hayfever & Allergy Prevention & Relief

AUST R: 228266

Date of Preparation

May 2019

Published by MIMS August 2019

BRAND INFORMATION

Brand name

Azonaire Hayfever & Allergy Prevention & Relief Nasal Spray

Active ingredient

Mometasone furoate

Schedule

S2

 

1 Name of Medicine

Mometasone furoate (as monohydrate).

2 Qualitative and Quantitative Composition

Azonaire Hayfever & Allergy Prevention & Relief Nasal Spray contains mometasone furoate 0.5 mg/g (as the monohydrate).
Each actuation delivers approximately 100 mg of mometasone furoate monohydrate suspension, containing mometasone furoate monohydrate equivalent to mometasone furoate 50 microgram.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Azonaire Hayfever & Allergy Prevention & Relief Nasal Spray 50 microgram/actuation is a metered-dose, manual pump spray unit containing a white homogenous suspension of mometasone furoate.

4 Clinical Particulars

4.1 Therapeutic Indications

Azonaire Hayfever & Allergy Prevention & Relief Nasal Spray is indicated for the treatment of symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis and the prophylaxis of seasonal allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

4.2 Dose and Method of Administration

Dosage.

Do not exceed the recommended dosage. For intranasal use only.
The effect of Azonaire Hayfever & Allergy Prevention & Relief Nasal Spray is not immediate. Full therapeutic benefit takes a few days to develop. Dosage should be administered as directed and not to be administered by the patients at will for symptomatic relief.

Allergic rhinitis.

In patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis, prophylactic treatment with Azonaire Hayfever & Allergy Prevention & Relief Nasal Spray is recommended two to four weeks prior to the anticipated start of the pollen season.

Adults (including geriatric patients) and children 12 years of age and over.

The usual recommended dose for prophylaxis and treatment is two sprays (50 microgram/spray) in each nostril once daily (total daily dose 200 microgram). Once symptoms are controlled, reducing the dose to one spray in each nostril (total daily dose 100 microgram) may be effective for maintenance.
After the first dose of mometasone furoate aqueous nasal spray 0.05%, clinically significant improvement of symptoms was achieved within 12 hours in 28% of a group of patients (n = 190) with seasonal allergic rhinitis (median = 36 hours). However, the full benefit of treatment may not be achieved in the first 48 hours; therefore, the patient should continue regular use to achieve full therapeutic benefit.

Method of administration.

Instructions to patients.

Shake container well before each use. Do not pierce the nasal applicator. After the initial priming of the Azonaire Hayfever & Allergy Prevention & Relief Nasal Spray (10 actuations, until a uniform spray is observed), each actuation delivers approximately 100 mg of mometasone furoate suspension, containing mometasone furoate monohydrate equivalent to 50 microgram of mometasone furoate. If the spray pump has not been used for 14 days or longer, it should be reprimed with 2 actuations, until a uniform spray is observed, before the next use.
Use this medicine within 2 months after bottle is first opened.

Cleaning your nasal spray.

It is important to clean your nasal spray regularly, otherwise it may not work properly. Remove the dust cap and gently pull off the nozzle. Wash the nozzle and dust cap in warm water and then rinse under a running 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. Allow to dry in a warm place. Push the nozzle back onto the bottle and replace the dust cap. The spray will need to be re-primed with 2 sprays when first used after cleaning.

4.3 Contraindications

Patients with known hypersensitivity to mometasone furoate or any of the excipients.
Severe nasal infection, especially candidiasis.
Persons with haemorrhagic diathesis or with a history of recurrent nasal bleeding.
Azonaire Hayfever & Allergy Prevention & Relief should not be used:
For treatment longer than six months without the advice of a doctor or pharmacist.
In children under 12 years of age.

4.4 Special Warnings and Precautions for Use

Mometasone furoate aqueous nasal spray 0.05% should not be used in the presence of untreated localised infection involving the nasal mucosa.
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred.
Following 12 months of treatment with mometasone furoate aqueous nasal spray 0.05%, there was no evidence of atrophy of the nasal mucosa. Mometasone furoate tended to reverse the nasal mucosa closer to a normal histological phenotype. As with any long-term treatment, patients using mometasone furoate aqueous nasal spray 0.05% over several months or longer should be examined periodically for possible changes in the nasal mucosa. If localised fungal infection of the nose or pharynx develops, discontinuance of mometasone furoate aqueous nasal spray 0.05% therapy or appropriate treatment may be required. Persistence of nasopharyngeal irritation may be an indication for discontinuing mometasone furoate aqueous nasal spray 0.05%.
Mometasone furoate aqueous nasal spray 0.05% should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, or in untreated fungal, bacterial, systemic viral infections or ocular herpes simplex.
Topical corticosteroids may be absorbed in amounts that can have systemic effects. Use of excessive doses may suppress HPA function. Physicians should be alert for evidence of systemic effects, especially in chronically treated patients.
However, there is no evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression following prolonged treatment with mometasone furoate aqueous nasal spray 0.05%. Patients who are transferred from long-term administration of systemically active corticosteroids to mometasone furoate aqueous nasal spray 0.05% require careful attention. Systemic corticosteroid withdrawal in such patients may result in adrenal insufficiency for a number of months until recovery of HPA axis function. If these patients exhibit signs and symptoms of adrenal insufficiency, systemic corticosteroid administration should be resumed and other modes of therapy and appropriate measures instituted.
During transfer from systemic corticosteroids to mometasone furoate aqueous nasal spray 0.05%, some patients may experience symptoms of withdrawal from systemically active corticosteroids (e.g. joint and/or muscular pain, lassitude and depression initially) despite relief from nasal symptoms and will require encouragement to continue mometasone furoate aqueous nasal spray 0.05% therapy. Such transfer may also unmask pre-existing allergic conditions such as allergic conjunctivitis and eczema, previously suppressed by systemic corticosteroid therapy.
Patients receiving corticosteroids who are potentially immunosuppressed should be warned of the risk of exposure to certain infections (e.g. chickenpox, measles) and of the importance of obtaining medical advice if such exposure occurs.
Following the use of intranasal aerosolised corticosteroids, instances of nasal septum perforation or increased intraocular pressure have been reported very rarely.
If signs or symptoms of severe bacterial infection are observed (such as fever, persistent severe unilateral facial/tooth pain, orbital or peri-orbital facial swelling, or worsening of symptoms after an initial improvement), the patient should be advised to consult their physician immediately. If these signs and symptoms are present at the time of diagnosis, treatment with mometasone furoate aqueous nasal spray 0.05% should not be initiated.
Improvement should be seen within seven days of starting treatment. Treatment should be reassessed if there is no improvement within seven days of continuous use, or if symptoms have improved but are not adequately controlled after seven days of continuous use.
If signs or symptoms of eye pain and/or visual disturbance develop, treatment should be ceased and advice of a doctor sought. Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, nasal septum perforation, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
The safety and efficacy of mometasone furoate has not been studied for use in the treatment of unilateral polyps, polyps associated with cystic fibrosis, or polyps that completely obstruct the nasal cavities. Unilateral polyps that are unusual or irregular in appearance, especially if ulcerating or bleeding, should be further evaluated.
It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid if possible, to the lowest dose at which effective control of symptoms is maintained. In addition, consideration should be given to referring the patient to a paediatric specialist.
Although mometasone furoate will control the nasal symptoms in most patients, the concomitant use of appropriate additional therapy may provide additional relief of other symptoms, particularly ocular symptoms.
Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence for higher than recommended doses being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

Use in the elderly.

No data available.

Paediatric use.

Azonaire Hayfever & Allergy Prevention & Relief is not recommended for use in children under 12 years of age.
Controlled clinical trials have shown that intranasal corticosteroids may cause a reduction in growth velocity in children. This effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in children than some commonly used tests of HPA-axis function. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for "catch up" growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied.
The growth of children receiving intranasal corticosteroids should be monitored routinely (e.g. via stadiometry). The potential growth effects of prolonged treatment should be weighed against the clinical benefits and the availability of safe and effective non-corticosteroid alternatives. To minimise the systemic effects of intranasal corticosteroids, each patient should be titrated to his/her lowest effective dose.
However, no reduction in growth velocity was observed in a placebo controlled clinical trial in which paediatric patients were administered mometasone furoate aqueous nasal spray 0.05% 100 microgram daily for one year. The effects of treatment for periods of greater than one year have not been studied.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

There have been no formal interaction studies performed.
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid side-effects.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

As with other corticosteroids, at exposure levels associated with marked signs of systemic corticosteroid toxicity, mometasone furoate had progestogenic effects on the female reproductive tract and mammary glands. There are no clinical data concerning the effect of mometasone furoate on fertility. However, fertility was unimpaired in a reproductive toxicity study carried out in rats.
(Category B3)
In animal studies, small quantities of mometasone furoate were found to cross the placenta barrier. Like other corticosteroids, at doses associated with signs of systemic toxicity, mometasone furoate reduced foetal growth and was teratogenic in mice, rats and rabbits after subcutaneous or topical application. Higher doses had progestogenic effects in pregnant rats, associated with prolonged gestation, dystocia and reduced pup survival.
There are no adequate or well controlled studies in pregnant women. Low levels of systemic mometasone have been measured following nasal administration of mometasone furoate aqueous nasal spray 0.05%.
As with other nasal corticosteroid preparations, mometasone furoate aqueous nasal spray 0.05% should be used in pregnant women only if the potential benefit justifies the potential risk to the mother or foetus. Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.
After oral administration, small quantities of mometasone furoate and/or its metabolites were transferred into the milk of lactating rats. There are no data on the extent of passage of mometasone furoate and/or its metabolites into the breast milk of women using mometasone furoate aqueous nasal spray 0.05%. As with other nasal corticosteroid preparation, mometasone furoate aqueous nasal spray 0.05% should be used by lactating mother only if the potential benefit justifies any potential risk to the infant.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Adult population.

Treatment-related local adverse events reported in clinical studies include upper respiratory tract infection, throat irritation, headache (8%), epistaxis (i.e. frank bleeding, blood-tinged mucus and blood flecks) (8% vs placebo 5%), nasal burning (2% vs placebo 3%), and nasal irritation (2% vs placebo 2%) and nasal ulceration, which are typically observed with the use of a corticosteroid nasal spray. Epistaxis was generally self-limiting and mild in severity, and occurred at a comparable or lower incidence compared to other active control nasal corticoids used in clinical studies (up to 15%). The incidence of all other effects was comparable with that of placebo.
In the elderly, the more common adverse events were epistaxis (12% vs placebo 5%), headache (9% vs placebo 6%) and pharyngitis (4% vs placebo 2%).

Paediatric population.

In the paediatric population, the most common adverse effects were epistaxis (6% vs placebo 6%), headache (3% vs placebo 4%), nasal irritation (2% vs placebo 1%) and sneezing (2% vs placebo 4%).
Rarely, immediate hypersensitivity effects (e.g. bronchospasm, dyspnea) may occur after intranasal administration of mometasone furoate monohydrate. Very rarely, anaphylaxis and angioedema have been reported.
Disturbances of taste and smell have been reported very rarely.
Glaucoma, increased intraocular pressure, cataracts, blurred vision and central serous chorioretinopathy have also been reported.
Growth suppression has been reported in association with administration of intranasal corticosteroids (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.

4.9 Overdose

Because the systemic bioavailability of mometasone furoate aqueous nasal spray 0.05% is low and has been estimated as < 1%, overdose is unlikely to require any therapy other than observation. Treatment can be reinitiated at the usual recommended dose.
Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of hypothalamic-pituitary-adrenal (HPA) axis function.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties at doses that are not systemically active.
In studies utilising nasal antigen challenge, mometasone furoate aqueous nasal spray 0.05% has shown anti-inflammatory activity in both the early- and late-phase allergic responses. This has been demonstrated by decreases (vs placebo) in histamine and eosinophil activity and reductions (vs baseline) in eosinophils, neutrophils and epithelial cell adhesion proteins.

Clinical trials.

Adult clinical program.

Allergic rhinitis.

The clinical program evaluated the efficacy and safety of mometasone furoate aqueous nasal spray 0.05% in the prophylaxis and treatment of seasonal allergic rhinitis and the treatment of perennial allergic rhinitis. Five Phase I clinical studies evaluated the systemic safety and local tolerability of mometasone furoate aqueous nasal spray 0.05%. Other clinical studies included:
One Phase II dose-ranging study conducted to determine the optimum dose for the Phase III program;
Seven Phase III studies designed to assess the safety and efficacy of mometasone furoate aqueous nasal spray 0.05% in treating seasonal allergic rhinitis for 28 days (including two studies which evaluated the prophylactic efficacy of mometasone furoate aqueous nasal spray 0.05% in preventing the symptoms of seasonal allergic rhinitis, and two which evaluated inflammatory response markers following nasal provocation with allergens); and
Five Phase III studies designed to assess the safety and efficacy of mometasone furoate aqueous nasal spray 0.05% in the treatment of perennial allergic rhinitis for 12 weeks. Four studies investigated the long-term safety and maintenance of therapeutic effect of mometasone furoate aqueous nasal spray 0.05% over 52 weeks; one perennial allergic rhinitis study was conducted in the elderly population; and three open-label perennial allergic rhinitis studies included a "variable-dose group" in which the dose of mometasone furoate aqueous nasal spray 0.05% varied from 100 to 400 microgram daily depending on symptoms.
During the course of the Phase II/III clinical program, 3120 patients (12 years of age and older) were treated with mometasone furoate aqueous nasal spray 0.05%. The majority (65%) of patients was treated with 200 microgram once daily. The remainder received mometasone furoate aqueous nasal spray 0.05% in a dose ranging from 50 microgram to 800 microgram once daily. A total of 712 patients were treated with mometasone furoate aqueous nasal spray 0.05% for at least 6 months and 350 patients were treated for 12 months or longer.
The results of the efficacy studies demonstrated that mometasone furoate aqueous nasal spray 0.05% 200 microgram/day was consistently superior to placebo in relieving the symptoms of both seasonal allergic rhinitis and perennial allergic rhinitis and was of comparable efficacy to other commonly used topical corticosteroid sprays. In the case of seasonal allergic rhinitis it is also superior to placebo in the prophylaxis of symptoms. In the long-term studies in perennial allergic rhinitis there was no evidence of any diminution of its efficacy over time.
After the first dose of mometasone furoate aqueous nasal spray 0.05%, clinically significant improvement of symptoms was achieved within 12 hours in 28% of a group of patients (n = 190) with seasonal allergic rhinitis (median = 36 hours). However, the full benefit of treatment may not be achieved in the first 48 hours; therefore, the patient should continue regular use to achieve full therapeutic benefit.

5.2 Pharmacokinetic Properties

Absorption.

Systemic absorption of mometasone furoate suspension administered as aqueous nasal spray, 200 microgram single dose, was measured using a sensitive assay with a lower quantitation limit of 0.25 picogram/mL. Mean Cmax was 5.77 picogram/mL (CV% 32) and mean AUC(0-12hr) 29.6 picogram.hr/mL (CV% 37). When compared with dose adjusted PK data for IV mometasone administration from earlier studies with a quantitation limit of 50 picogram/mL and longer sampling duration, the estimated relative systemic (or 'absolute') bioavailability is < 1%. The bioavailability of mometasone following intranasal administration is low.
Systemic effects were not detected in adults, adolescents or children following the administration of mometasone furoate aqueous nasal spray 0.05%.

Distribution.

Systemic bioavailability of mometasone furoate was investigated in 24 healthy volunteers following intranasal administration of 400 microgram of the suspension. Mometasone was detectable in plasma (at sporadic time points) in only 4 of the 24 subjects, despite the use of a sensitive assay with a limit of quantitation of 50 picogram/mL. Thus, there were no relevant pharmacokinetic data for this study.

Metabolism.

Mometasone furoate suspension is very poorly absorbed from the gastrointestinal tract, and the small amount that may be swallowed and absorbed undergoes extensive first pass metabolism.

Excretion.

Mometasone furoate is excreted in urine and bile.

5.3 Preclinical Safety Data

Genotoxicity.

Mometasone furoate is not considered to be genotoxic. There was no evidence of mutagenicity in in vitro tests which included tests for reverse mutation in Salmonella typhimurium and Escherichia coli and forward gene mutation in a mouse lymphoma cell line. Limited evidence of clastogenicity was obtained in Chinese Hamster ovary cells, although this finding was not confirmed in a second assay in Chinese Hamster lung cells in vitro, nor in vivo assays including a chromosomal aberration assay in mouse spermatogonia, a mouse micronucleus assay or in a rat bone marrow clastogenicity assay. Mometasone furoate did not cause DNA damage in rat liver cells.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Glycerol, microcrystalline cellulose, carmellose sodium, sodium citrate, citric acid monohydrate, purified water, polysorbate 80 and benzalkonium chloride as a preservative. Azonaire Hayfever & Allergy Prevention & Relief Nasal Spray does not contain fluorocarbon propellants.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
For information on interactions with other medicines and other forms of interactions, see Section 4.5.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.
Do not freeze.

6.5 Nature and Contents of Container

Metered atomising pump unit containing mometasone furoate (as the monohydrate) 50 microgram/actuation; 60 and 140 metered doses.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

The chemical name of Mometasone furoate (as monohydrate) is 9,21-dichloro-17-[(2-furanylcarbonyl)oxy]-11β-hydroxy-16α-methylpregna-1,4-diene-3,20-dione monohydrate. Its empirical formula is C27H30Cl2O6.H2O (MW: 539.45).

Chemical structure.


CAS number.

83919-23-7.

7 Medicine Schedule (Poisons Standard)

S2.

Summary Table of Changes