Consumer medicine information

What is in this leaflet

Read this leaflet carefully before taking your medicine.

This leaflet answers some common questions about mometasone. It does not contain all the available information.

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

The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.

Ask your doctor or pharmacist:

• if there is anything you do not understand in this leaflet,
• if you are worried about taking your medicine, or
• to obtain the most up-to-date information.

All medicines have risks and benefits.

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

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

What this medicine is used for

The name of your medicine is APOHEALTH Sensease Nasal Allergy Relief. It contains the active ingredient mometasone furoate.

It is used for the prevention or treatment of allergic rhinitis for up to six months in adults and children 12 years of age and over.

Symptoms of Allergic Rhinitis can include:

• stuffiness (congestion) in the nose
• discharge, itching and sneezing

This medicine is available only from a pharmacy.

How it works

Mometasone belongs to a family of medicines called corticosteroids.

These medicines work by helping to reduce inflammation.

There is no evidence that this medicine is addictive.

It may take a few days of use before you feel the full effects of the medicine.

If you suffer moderate to severe symptoms, you may need to start treatment 2 - 4 weeks before the beginning of the 'pollen' season.

Use in children

Do not use in children under 12 years of age.

Before you use this medicine

When you must not use it

Do not use this medicine if:

• You have or have had any of the following:
  - a tendency to bleed or recurrent nose bleeding
  - a severe nose infection, especially fungal infection.
• You are hypersensitive to, or have had an allergic reaction to, mometasone or any of the ingredients listed at the end of this leaflet.
  Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.
  If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.

Do not continue using this medicine if you have already used it, or a similar corticosteroid nasal spray, for 6 months or longer.

Do not use if the expiry date (EXP) printed on the pack has passed.

Do not use if the packaging is torn, shows signs of tampering or it does not look quite right.

Before you start to take it

Before you start taking this medicine, tell your pharmacist or doctor if:

1. You have allergies to:

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

2. You have or have had any medical conditions, especially the following:

• tuberculosis
• infection of the nose, sinus, mouth, throat, lungs or eye
• sores in the nose, including open sores
• recent injury or surgery to 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.

3. You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.
4. You are currently breastfeeding or you plan to breastfeed. Do not take this medicine whilst breastfeeding until you and your doctor have discussed the risks and benefits involved.
5. You are currently receiving or are planning to receive dental treatment.
6. You are planning to have surgery or an anaesthetic.
7. You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

How to use this medicine

Follow carefully all the directions provided to you on the product packaging, the package insert and in this information leaflet. If you do not understand the instructions, ask your pharmacist or doctor for help.

Administration to children 12 years and over should be aided by an adult to ensure correct use.

How much to use

Adults and Children 12 years and over:
The usual dose is two sprays into each nostril once a day. Once your symptoms have improved, you may be able to halve the dose to one spray into each nostril once a day. If symptoms get worse again, the dosage may be increased back to two sprays into each nostril once a day.

Always use the lowest dose which controls your symptoms.

Do not use in children under 12 years of age.

When to use it

It may take a few days to significantly improve symptoms, therefore to prevent the onset of symptoms, start to use APOHEALTH Sensease Nasal Allergy Relief a few days before expected exposure to one of your usual 'triggers'.

If you suffer moderate to severe symptoms, you may need to start treatment 2 - 4 weeks before the beginning of the 'pollen' season.

It is very important that you use APOHEALTH Sensease Nasal Allergy Relief regularly. If you stop the treatment when you feel better, your symptoms may returns as the medication wears off.

How long to use it

If you have used the spray for 7 days and the symptoms have not improved, or not improved enough, see your pharmacist or doctor for advice.

Do not use a larger dose or use your nasal spray more often than recommended. Do not use more than 2 sprays in each nostril daily.

If symptoms worsen during treatment, see your pharmacist or doctor immediately.

Do not use for more than 6 months continuously without the advice of a doctor. If you have already used a similar nasal spray for 6 months, or are currently using a similar nasal spray, seek the advice of your pharmacist or doctor before using this medicine.

This medicine must be discarded 60 days after you first open it.

If you have the 140 spray pack, depending on the dose you use, you may have some left over medicine.

The medicine must be discarded 60 days after opening, regardless of whether there are sprays remaining.

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. 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

1. Shake the bottle gently and remove the dust cap.
2. Gently blow your nose.
3. Close one nostril with the opposite hand (left hand for right nostril, right hand for left nostril), and using your other hand, put the nozzle of the spray just inside the open nostril, aiming towards the outside wall of your nose.
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. Avoid sniffing too hard as the contents are then likely to go straight down the throat.
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.

If you forget to take it

If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time.

Otherwise take it as soon as you remember and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for missed doses.

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

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency department at your nearest hospital.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using this medicine

Things you must do

Tell your doctor that you are taking this medicine if:

• you are about to be started on any new medicine
• you are pregnant or are planning to become pregnant
• you are breastfeeding or are planning to breast-feed
• you are about to have any blood tests
• you are going to have surgery or an anaesthetic or are going into hospital.

Go to your doctor immediately if you notice symptoms of a 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.

Go to your doctor regularly for a check-up.

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

Things you must not do

Do not:

• Give this medicine to anyone else, even if their symptoms seem similar to yours.
• Take your medicine to treat any other condition unless your doctor tells you to.
• Take your medicine for a longer than 6 months continuously without the advice of a doctor.
• Stop taking your medicine suddenly, or change the dosage, unless advised to do so by your doctor.
• Take this medicine if you are already taking a similar nasal spray, or have used a similar nasal spray continuously over the last 6 months without the advice of a pharmacist or doctor.

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.

Possible side effects

Tell your doctor as soon as possible if you do not feel well while you are taking mometasone or if you have any questions or concerns.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.

Tell your doctor if you notice any of the following:

• headache
• sneezing
• nosebleeds
• blood in mucus
• nasal burning
• nasal irritation
• nasal ulceration
• sore throat
• sneezing
• disturbances of taste or smell
• diarrhoea
• nausea
• abdominal pain.

There is evidence that corticosteroid nasal sprays may reduce the speed of growth in children. The growth of children receiving corticosteroid nasal sprays should be monitored routinely.

If you have eye pain or visual disturbances, stop treatment and see your doctor.

Other side effects not listed above may occur in some patients.

Allergic reactions

If you think you are having an allergic reaction to mometasone, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

Symptoms of an allergic reaction may include some or all of the following:

• cough, shortness of breath, wheezing or difficulty breathing
• swelling of the face, lips, tongue, throat or other parts of the body
• rash, itching or hives on the skin
• fainting
• hay fever-like symptoms.

Storage and Disposal

Storage

Keep your nasal spray in a cool dry place where the temperature will stay below 25°C.

After opening, please discard product after 60 days.

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

Keep this medicine where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor or pharmacist tells you to stop taking this medicine or they have passed their expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What APOHEALTH Sensease Nasal Allergy Relief looks like

APOHEALTH Sensease Allergy Relief is a white suspension contained in a plastic bottle with a metered-dose, manual spray pump for intranasal administration.

Ingredients

Each actuated spray contains 50 µg of the active ingredient mometasone furoate.

It also contains the following inactive ingredients:

• citric acid
• glycerol
• microcrystalline cellulose
• carmellose sodium
• polysorbate 80
• sodium citrate
• purified water

With benzalkonium chloride 0.02% as preservative

This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.

APOHEALTH Sensease Nasal Allergy Relief is available in bottles of 65 and 140 sprays.

Not all pack sizes may be available.

Australian Registration Numbers

APOHEALTH Sensease Nasal Allergy Relief: AUST R 230124

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park, NSW 2113
Australia

The APOTEX and Sensease trademarks are used under licence.

This leaflet was prepared in May 2021.

Published by MIMS March 2022

Name of the medicine

Mometasone furoate.

Excipients.

Description

Chemical name: 9,21-dichloro-11β-hydroxy-16α-methyl-3,20-dioxopregna-1,4-17-yl furan-2-carboxylate. Molecular formula: C₂₇H₃₀C_l2O₆. Molecular weight: 521.4. CAS: 83919-23-7. Mometasone furoate is a white or almost white powder that is practically insoluble in water, soluble in acetone and in methylene chloride, slightly soluble in ethanol (96 per cent). Sensease Nasal Allergy Relief is a white suspension. The pKa and log P for mometasone furoate is 13.02 and 3.59 respectively. The pH of the drug product is 4.3 to 4.9.

Pharmacology

Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties at doses that are not systemically active.
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 are no relevant pharmacokinetic data for this dosage form. The study demonstrates, however, that 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.
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 prior to excretion in urine and bile.
In studies utilising nasal antigen challenge, mometasone nasal spray 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.

Pharmacokinetics.

Clinical Trials

In a clinical study comparing Sensease Nasal Allergy Relief 50 microgram with the US reference product, the efficacy of the two products was assessed in patients with seasonal allergic rhinitis. The assessment was based on the change in mean reflective Total Nasal Symptom Scores (TNSS, range: 0-12) from baseline after 2 weeks of drug treatment.
The results of the study showed that both mometasone nasal spray and the reference product provided significantly (p < 0.05) greater reduction in mean reflective TNSS than placebo. No significant difference was found between the mean change from baseline TNSS scores for the two products (p = 0.8914), and the actual difference in LS mean change from baseline was within ± 50% of the drug effect size (reference TNSS minus placebo TNSS). Due to the narrow equivalence bounds in relation to the variability of the TNSS data, caused by the relatively large placebo effect, the 90% confidence interval (CI) of the difference between the two products was not completely within the equivalence bounds (-0.29, +0.29). Thus the prespecified equivalence criteria were not met.
However, a secondary analysis showed that the ratio (%) of means (mometasone/ reference) for the change in mean reflective TNSS was 101% and the 90% CI was 86-117%, within 80-125%. This additional analysis can be used to suggest support for clinical equivalence of the two products.
A qualitative and quantitative analysis was carried out on the US reference product and the Australian reference product and these two products were shown to be similar.

Allergic rhinitis.

Indications

Sensease Nasal Allergy Relief is indicated for the prophylaxis or treatment of allergic rhinitis for up to six months in adults and children 12 years of age and over.

Contraindications

Sensease Nasal Allergy Relief is contraindicated for use in the following.
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.
This product should not be used for the following.
Treatment longer than 6 months without the advice of a doctor or pharmacist.
In children under 12 years of age.

Precautions

Mometasone nasal spray 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.
Mometasone furoate tended to reverse the nasal mucosa closer to a normal histological phenotype. As with any long-term treatment, patients using mometasone nasal spray 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 nasal spray therapy or appropriate treatment may be required. Persistence of nasopharyngeal irritation may be an indication for discontinuing mometasone nasal spray.
Mometasone nasal spray 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 nasal spray. Patients who are transferred from long-term administration of systemically active corticosteroids to mometasone nasal spray 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 nasal spray, 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 nasal spray 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. chicken pox, 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 periorbital facial swelling, or worsening of symptoms after an initial improvement), the patient should be advised to consult their doctor immediately. If these signs and symptoms are present at the time of diagnosis, treatment with mometasone should not be initiated.
Improvement should be seen within 7 days of starting treatment. If improvement is not seen within 7 days of continuous use, treatment should be stopped and the advice of a doctor sought. If after 7 days of continuous use, symptoms have improved but are not adequately controlled then the advice of a pharmacist or doctor should be sought.
If signs or symptoms of eye pain and/or visual disturbance develop, treatment should be ceased and the advice of a doctor sought.

Effects on fertility.

Use in pregnancy.

Mutagenicity.

Use in lactation.

Use in children.

Interactions

There have been no formal interaction studies performed.

Adverse Effects

Treatment related local adverse events reported in clinical studies include 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%).
In patients treated for nasal polyposis, the overall incidence of adverse events was comparable to placebo and similar to that observed for patients with allergic rhinitis.

Dosage and Administration

Do not exceed the recommended dosage. For intranasal use only.
The effect of Sensease Nasal Allergy Relief is not immediate. Full therapeutic benefit takes a few days to develop. Dosage should be administered as directed and not be taken by the patients at will for symptomatic relief.
Administration to children 12 years and over should be aided by an adult to ensure correct use.

For prophylaxis or treatment of allergic rhinitis in adults and children 12 years of age and over.

Instructions to patients.

Cleaning your nasal spray.

Overdosage

Contact the Poisons Information Centre on 131 126 (Australia) for advice on the management of overdosage.
Because of the low systemic bioavailability of mometasone nasal spray, 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.

Presentation

Nasal spray (mometasone furoate 50 microgram/actuation): 65*, 140 metered doses (metered atomising pump unit, AUST R 230124).
*Not currently available in Australia.

Storage

Store below 25°C. Do not freeze.
After opening, please discard product after 60 days.

Poison Schedule

S2.