Consumer medicine information

Chemmart Mometasone Nasal Spray

Contains the active ingredient mometasone furoate


Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

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

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 Chemmart Mometasone Nasal Spray. It contains the active ingredient mometasone furoate.

It is used to treat:

  • Allergic rhinitis:
    Mometasone is sprayed into the nose to help relieve symptoms that may occur with hay fever or other year round allergies, including stuffiness (congestion) in the nose, discharge, itching and sneezing. Your doctor may also prescribe this medicine to help prevent these symptoms two to four weeks before the beginning of the pollen season. Mometasone can be used for the treatment and prevention of allergic rhinitis in patients 3 years of age and older.
  • Nasal polyps:
    Swollen tissue in the nose can cause grape-like swellings called ‘polyps’. Polyps can cause nasal stuffiness, discomfort and loss of smell. Mometasone can be used for the treatment of nasal polyps in patients 18 years of age and older.
  • Acute rhinosinusitis:
    Rhinosinusitis is the swelling of the sinuses, resulting in stuffiness of the nose, large quantities of mucus from the nose, cough, face pain and/or fever. These symptoms usually last for less than 4 weeks. Mometasone is used to treat the symptoms of rhinosinusitis in patients 12 years of age and older, who do not have the signs or symptoms of a severe bacterial infection.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed this medicine for another reason.

This medicine is available only with a doctor’s prescription.

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.

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. The expiry date (EXP) printed on the pack has passed.
  • 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 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 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 directions given to you by your doctor. Their instructions may be different to the information in this leaflet.

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

Administration to young children should be aided by an adult.

How much to use

Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.

Do not stop taking your medicine or change your dosage without first checking with your doctor.

Do not use more than the dose recommended by your doctor.

Each actuation of the spray pump delivers the equivalent of 50 micrograms of mometasone furoate.

Allergic rhinitis in patients 12 years of age and over:
Two sprays into each nostril once daily.

When your symptoms have been controlled, your doctor may reduce your dose to one spray into each nostril once daily.

Allergic rhinitis in patients 3 to 11 years of age:
One spray into each nostril once daily.

Nasal Polyps in patients 18 years of age and older:
Two sprays into each nostril once daily. If your symptoms are not controlled, your doctor may increase your dose to two sprays into each nostril twice daily.

When your symptoms have been controlled, your doctor may reduce your dose.

Acute rhinosinusitis in patients 12 years of age and older:
Two sprays in each nostril two times a day.

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. 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 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.

When to use it

As instructed by your doctor. Do not use more frequently than instructed.

How long to use it

Continue taking your medicine for as long as your doctor tells you.

However, please note that this medicine must be discarded 60 days after opening.

The 140 spray pack may supply more than 60 days of treatment depending on the dose recommended by your doctor. The medicine must be discarded 60 days after opening, regardless of whether there are sprays remaining.

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 breastfeed
  • 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 period than recommended by your doctor.
  • Stop taking your medicine, or change the dosage, unless advised to do so by your 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.

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 Chemmart Mometasone Nasal Spray looks like

Chemmart Mometasone 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

Each actuated spray contains 50 mcg 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.

Chemmart Mometasone Nasal Spray is available in bottles of 140 and 65 sprays.

Not all strengths, pack types and/or pack sizes may be available.

Australian Registration Numbers

Chemmart Mometasone Nasal Spray 50 mcg:
AUST R 184661

Sponsor

Apotex Pty Ltd
Macquarie Park, NSW 2113
Australia

This leaflet was prepared in April 2014.

Published by MIMS November 2014