Fluticasone Furoate Viatris

fluticasone furoate

FLUTICASONE FUROATE VIATRIS

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using FLUTICASONE FUROATE VIATRIS?

FLUTICASONE FUROATE VIATRIS contains the active ingredient fluticasone furoate. FLUTICASONE FUROATE VIATRIS is used to treat symptoms of allergic rhinitis including stuffy, runny or itchy nose, sneezing, and watery, itchy or red eyes. For more information, see Section 1. Why am I using FLUTICASONE FUROATE VIATRIS? in the full CMI.

2. What should I know before I use FLUTICASONE FUROATE VIATRIS?

Do not use if you have ever had an allergic reaction to fluticasone furoate or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use FLUTICASONE FUROATE VIATRIS? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with FLUTICASONE FUROATE VIATRIS and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use FLUTICASONE FUROATE VIATRIS?

  • Adults and adolescents 12 years and older: The usual starting dose is 2 sprays in each nostril once a day (55 micrograms fluticasone furoate). Once symptoms are controlled you may be able to decrease your dose to 1 spray in each nostril once a day.
  • Children (2 to 11 years): The usual starting dose is 1 spray in each nostril once a day (27.5 micrograms fluticasone furoate).

More instructions can be found in Section 4. How do I use FLUTICASONE FUROATE VIATRIS? in the full CMI.

5. What should I know while using FLUTICASONE FUROATE VIATRIS?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using FLUTICASONE FUROATE VIATRIS.
  • Tell your doctor, if you are taking any other medicines.
  • Tell your doctor if you become pregnant or are trying to become pregnant.
  • Tell your doctor if you are allergic to foods, dyes, preservatives or any other medicines.

Things you should not do
  • Do not stop using this medicine suddenly or change the dose without first checking with your doctor.
  • Do not use FLUTICASONE FUROATE VIATRIS in or near the eyes.
  • Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
  • Do not use FLUTICASONE FUROATE VIATRIS to treat any other complaints unless your doctor says to.]

Driving or using machines
  • FLUTICASONE FUROATE VIATRIS is unlikely to affect your ability to drive or use machinery.

Looking after your medicine
  • Store your FLUTICASONE FUROATE VIATRIS below 30°C, protected from direct sunlight. Always keep the cap on. Do not freeze.

For more information, see Section 5. What should I know while using FLUTICASONE FUROATE VIATRIS? in the full CMI.

6. Are there any side effects?

FLUTICASONE FUROATE VIATRIS can cause allergic reactions which may be severe. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FLUTICASONE FUROATE VIATRIS®

Active ingredient: Fluticasone furoate

Consumer Medicine Information (CMI)

This leaflet provides important information about using FLUTICASONE FUROATE VIATRIS. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using FLUTICASONE FUROATE VIATRIS.

Where to find information in this leaflet:

1. Why am I using FLUTICASONE FUROATE VIATRIS?

FLUTICASONE FUROATE VIATRIS contains the active ingredient fluticasone furoate. FLUTICASONE FUROATE VIATRIS belongs to a group of medicines known as corticosteroids, frequently called 'steroids'. FLUTICASONE FUROATE VIATRIS works to decrease inflammation caused by allergy (rhinitis).

FLUTICASONE FUROATE VIATRIS is used to treat symptoms of allergic rhinitis including stuffy, runny or itchy nose, sneezing, and watery, itchy or red eyes. The effects are usually felt within the first day, although some people will not feel the effects until several days after first taking it.

Your doctor may have prescribed FLUTICASONE FUROATE VIATRIS for another reason.

FLUTICASONE FUROATE VIATRIS is not addictive.

2. What should I know before I use FLUTICASONE FUROATE VIATRIS?

Warnings

Do not use FLUTICASONE FUROATE VIATRIS if:

  • you are allergic to fluticasone furoate, or any of the ingredients listed at the end of this leaflet.
  • the expiry date (EXP) printed on the pack has passed.
  • the packaging is torn or shows signs of tampering.

Check with your doctor if you:

  • you have any other medical conditions
  • you are allergic to foods, dyes, or any other medicine.
  • you take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

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

Some medicines may interfere with FLUTICASONE FUROATE VIATRIS and affect how it works.

For example, medicines like ketoconazole, used to treat fungal infection, and ritonavir used to treat HIV infection, may affect how FLUTICASONE FUROATE VIATRIS works. If you are taking these medicines, consult your doctor or pharmacist who will advise on what you should do.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect FLUTICASONE FUROATE VIATRIS.

4. How do I use FLUTICASONE FUROATE VIATRIS?

How much to use

Adults and adolescents 12 years and older:

  • The usual starting dose is 2 sprays in each nostril once a day (55 micrograms fluticasone furoate).
  • Once symptoms are controlled you may be able to decrease your dose to 1 spray in each nostril once a day.

Children (2 to 11 years):

  • The usual starting dose is 1 spray in each nostril once a day (27.5 micrograms fluticasone furoate).
  • If symptoms are severe, your doctor may increase the dose to 2 sprays in each nostril once a day until
  • symptoms are under control. It may then be possible for the dose to be reduced to 1 spray in each nostril once a day.

Follow the instructions provided and use FLUTICASONE FUROATE VIATRIS until your doctor tells you to stop.

When to use FLUTICASONE FUROATE VIATRIS

  • See the instruction leaflet inside the pack for information on how to use FLUTICASONE FUROATE VIATRIS .
  • Shake well before use.
  • FLUTICASONE FUROATE VIATRIS is sprayed into the nose as a fine mist. It has virtually no taste.
  • FLUTICASONE FUROATE VIATRIS is not for use in the eyes.
  • Use FLUTICASONE FUROATE VIATRIS once a day and at the same time each day. This will treat your symptoms throughout the day and night.

If you forget to use FLUTICASONE FUROATE VIATRIS

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, use the product as soon as you remember, then go back to using the product as you would normally.

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

Otherwise, your doctor may think that it was not working as it should and change your treatment unnecessarily.

If you use too much FLUTICASONE FUROATE VIATRIS

If you think that you have used too much FLUTICASONE FUROATE VIATRIS, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (Australia telephone 13 11 26) for advice, or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using FLUTICASONE FUROATE VIATRIS?

Things you should do

  • Tell your doctor or pharmacist that you are using FLUTICASONE FUROATE VIATRIS if you are about to be started on any new medicines.
  • Tell your doctor if you become pregnant or are trying to become pregnant.
  • Tell your doctor if, for any reason, you have not used your medicine exactly as prescribed.
  • Tell your doctor if you experience a change in your vision.
  • Use FLUTICASONE FUROATE VIATRIS only in your nose.

Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Call your doctor straight away if you:

  • Wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash (hives) or fainting. These could be a symptom of an allergic reaction.

Remind any doctor, dentist or pharmacist you visit that you are using FLUTICASONE FUROATE VIATRIS.

Things you should not do

  • Do not use FLUTICASONE FUROATE VIATRIS in or near the eyes.
  • Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
  • Do not use FLUTICASONE FUROATE VIATRIS to treat any other complaints unless your doctor says to.

Use in children

FLUTICASONE FUROATE VIATRIS is not recommended for use in children below 2 years of age.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how FLUTICASONE FUROATE VIATRIS affects you.

FLUTICASONE FUROATE VIATRIS is unlikely to affect your ability to drive or use machinery.

Looking after your medicine

  • Store your FLUTICASONE FUROATE VIATRIS below 30°C. Protect from direct sunlight.
  • Do not freeze.
  • Always keep the cap on.
  • Keep FLUTICASONE FUROATE VIATRIS in its pack until it is time to use it.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects

What to do
  • nose bleeds.
  • nasal ulceration - which may cause irritation or discomfort in your nose. You may also get streaks of blood when you blow your nose.
  • headache.
  • pain, burning, irritation, soreness or dryness in the inside of the nose.
  • slowing of growth in children has also been observed, however the frequency of this occurring cannot be estimated from the available data.

Speak to your doctor if you have any of these less serious side effects.

Serious side effects

Serious side effects

What to do

Allergic reaction:

  • wheezing
  • swelling of the lips/mouth
  • difficulty in breathing
  • hay fever
  • lumpy rash ("hives")
  • fainting

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What FLUTICASONE FUROATE VIATRIS contains

Active ingredient

(main ingredient)

fluticasone furoate

Other ingredients

(inactive ingredients)

glucose, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, and purified water.

Potential allergens

na

Do not take this medicine if you are allergic to any of these ingredients.

What FLUTICASONE FUROATE VIATRIS looks like

FLUTICASONE FUROATE VIATRIS nasal spray is a white suspension contained in an amber glass bottle, fitted with a pump (AUST R 448531).

The bottle contains 120 sprays.

Each spray delivers approximately 27.5 micrograms fluticasone furoate.

Who distributes FLUTICASONE FUROATE VIATRIS

Sponsor

Helix Pharmaceuticals Pty.Ltd

C/E-EGA Corporate Advisers Pty Ltd

Level 12, 468 St Kilda Rd

Melbourne VIC 3004

Australia

Distributor

FLUTICASONE FUROATE VIATRIS is distributed in Australia by:

Alphapharm Pty Ltd trading as Viatris

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

www.viatris.com.au

Phone: 1800 274 276

This leaflet was prepared in May 2024.

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