MOTUFE 27.5 micrograms/spray NASAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Motufe 27.5micrograms/spray suspension for nasal spray

fluticasone furuate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist .
• This medicine has been prescribed for you only, do not pass it on to others, it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist , even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is Motufe and what is it used for
2. What you need to know before you use Motufe
3. How to use Motufe
4. Possible side effects
5. Storing Motufe
6. Contents of the pack and further information

1. What is Motufe and what is it used for

Motufe belongs to a group of medicines called glucocorticoids. Fluticasone furuate acts by reducing the inflammation caused by the allergy (rhinitis) and thus reduces the symptoms of the allergy.

Motufe nasal spray suspension is used for the treatment of symptoms of allergic rhinitis, including nasal congestion, increased nasal secretion, and itching of the nose, sneezing, and tearing and itching or redness of the eyes in adults and children 6 years and older.

Allergic symptoms may appear at certain times of the year as a result of allergy to plant or tree pollen (hay fever), or may be present throughout the year as a result of allergy to animals, dust mites, or molds, to name a few of the most common ones.

2. What you need to know before you use Motufe

Do not use Motufe

• If you are allergic to fluticasone furuate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Motufe.

Children and adolescents

Do not use in children under 6 years.

The use of Motufe:

• may cause a delay in the growth of children when used for long periods. The doctor will regularly check the child's height and ensure that the child receives the minimum effective dose;
• may cause eye disorders such as glaucoma (increased eye pressure) or cataracts (loss of lens transparency). Inform your doctor if you have had any of these disorders in the past or if you experience blurred vision or other visual disturbances while using fluticasone furuate.

Other medicines and Motufe

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

It is especially important that you inform your doctor if you are using or have recently used any of the following medicines:

• steroids in tablets or injectable steroids
• steroids in cream
• medicines for asthma
• ritonavir or cobicistat, used in the treatment of AIDS
• ketoconazole, used in the treatment of fungal infections

Your doctor will determine if you should use fluticasone furuate along with these medicines. Some medicines may increase the side effects of Motufe, so your doctor will monitor you closely if you are taking these medicines.

Fluticasone furuate should not be used at the same time as other nasal sprays that contain steroids.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Do not use Motufe if you are pregnant, or plan to become pregnant, unless your doctor or pharmacist tells you to.

Do not use Motufe if you are breastfeedingunless your doctor or pharmacist tells you to.

Driving and using machines

It is unlikely that Motufe will affect your ability to drive or use machines.

Motufecontains benzalkonium chloride

This medicine contains 8.25 micrograms of benzalkonium chloride and 13.75 micrograms of polysorbate in each spray.

Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for long-term treatment.

Polysorbates may cause allergic reactions.

Tell your doctor or pharmacist if you experience discomfort when using the spray.

3. How to use Motufe

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

When to use Motufe

• Use once a day.
• Use at the same time every day.

This medicine will treat your symptoms throughout the day and night.

How long it takes for Motufe to work

Some people may not feel the full effects until several days after starting to use Motufe.

However, it is usually effective within 8 to 24 hours after use.

How much to use

Adults and children 12 years and older

• The usual starting doseis 2 sprays in each nostril once a day.
• Once symptoms are under control, it may be possible to reduce the dose to 1 spray in each nostril once a day.

Children6 to 11 years

• The usual starting doseis 1 spray in each nostril once a day.
• If symptoms are very severe, your doctor may increase the dose to 2 sprays in each nostril once a day until symptoms are under control. After that, it may be possible to reduce the dose to 1 spray in each nostril once a day.

How to use the nasal spray

Motufe has almost no taste or smell. It is sprayed into the nose as a fine mist. Be careful not to spray the medicine into your eyes. If this happens, rinse your eyes with water.

There is a step-by-step guide for using the nasal spray after section 6 of this leaflet. Follow the guide carefully to get the full benefit of using Motufe.

See the sectionStep-by-step guide for using the nasal spray after section6.

If you use more Motufe than you should

Talk to your doctor or pharmacist.

If you forget to use Motufe

If you miss a dose, take it as soon as you remember.

If it is almost time for your next dose, wait until then. Do not take a double dose to make up for missed doses.

If you have any other questions about using this medicine, or if you experience any discomfort when using the nasal spray, ask your doctor or pharmacist .

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions: seek medical help immediately

Allergic reactions to Motufe are rare and affect less than 1 in 1,000 people. In a small number of people, allergic reactions can become more serious, even life-threatening if not treated. The symptoms include:

• appearance of many wheezes (wheezing), coughing, or breathing difficulties;
• feeling of sudden weakness or dizziness (which may lead to collapse or loss of consciousness);
• swelling in the face;
• rashes or redness of the skin.

In many cases, these symptoms will be signs of less serious side effects. However, you should be aware that they can be potentially serious;therefore, if you notice any of these symptoms:

Contact your doctor as soon as possible.

Very common side effects(may affect more than 1 in 10 people)

Nosebleeds (usually minor), especially if you use Motufe for more than 6 weeks in a row.

Common side effects(may affect up to 1 in 10 people)

• Nasal ulcers, which can cause irritation or discomfort in the nose. You may notice blood when you blow your nose.
• Headache.
• Shortness of breath.

Uncommon side effects(may affect up to 1 in 100 people)

• Pain, burning, irritation, painful sensation, or dryness inside the nose.

Rare side effects(may affect up to 1 in 10,000 people)

• Small holes (perforations) in the nasal septum that separates the nostrils.

Frequency not known(cannot be estimated from the available data)

• Slowing of growth in children.
• Blurred vision or temporary changes in vision with prolonged use.
• Chest tightness that causes difficulty breathing.
• Voice disorder, loss of voice.
• Taste disorder, loss of taste, loss of smell.

The use of nasal corticosteroids may affect the normal production of hormones in your body, especially if high doses are used for long periods. In children, these side effects may cause slower growth.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist , even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Motufe

Keep this medicine out of the sight and reach of children.

It is preferable to store Motufe 27.5 micrograms/spray, nasal spray suspension in an upright position.

Always keep the cap on.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month stated. Once opened, the validity period of Motufe is 2 months.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

• The active substance is fluticasone furuate. Each spray delivers 27.5 micrograms of fluticasone furuate.
• The other ingredients are glucose, microcrystalline cellulose (E460), sodium carmellose (E466), polysorbate 80 (E433), benzalkonium chloride, disodium edetate, and purified water (see section 2).

Appearance of the product and pack contents

The medicine is a white nasal spray suspension presented in a 15ml amber glass bottle with a metered-dose pump, a nasal applicator (actuator), and a cap.

Motufe is available in one pack size: 1 bottle of 120 sprays.

Marketing authorisation holder and manufacturer

Marketing Authorisation Holder

SUBSTIPHARM

24 Rue Erlanger

75016 Paris

France

Manufacturer

CURIDA AS

Solbærvegen 5 Elverum 2409

Norway

This medicine is authorised in the Member States of the European Economic Area under the following names:

Austria: Motufe 27,5 Mikrogramm/Sprühstoß Nasenspray, Suspension

Spain: Motufe 27,5 micrograms/spray, suspension for nasal spray

Date of last revision of this leaflet:06/2024

Other sources of information

Step-by-step guide for using the nasal spray.

STEP-BY-STEP GUIDE FOR USING THE NASAL SPRAY

Appearance of the nasal spray

The nasal spray is presented in an amber glass bottle. It will contain 120 sprays.

Five important things you need to know about using the nasal spray

• Motufe is presented in an amber glass bottle. If you need to check how much is left, hold the nasal spray upright to the light. This way, you will be able to see the level through the window.
• When you use the nasal spray for the first time, you will need to shake it vigorouslywith the cap on for 10 seconds. This is important because Motufe is a dense suspension that becomes liquid when shaken well. It will only spray when it becomes liquid.
• You must press the dosing button firmly and completelyto release the mist through the nasal applicator – see drawing a.
• Always keep the cap on the nasal spraywhen you are not using it. The cap prevents dust from entering, seals tightly under pressure, and prevents the nasal applicator from becoming blocked.
• Never use a pinor any other sharp object to unblock the nasal applicator. This will damage the nasal spray.

Preparing the nasal spray for use You must prepare the nasal spray:

• before using it for the first time
• if you have left it uncapped for 5 days or have not used the nasal device for 30 days or more.

Preparing the nasal spray helps ensure that you always receive the full dose of the medicine. Follow these steps:

1. Shake the nasal spray vigorouslywith the cap on for 10 seconds.
2. Remove the cap.
3. Hold the nasal spray upright, then tilt it and point the nasal applicator away from you.
4. Press the dosing button firmlyand completely – see drawing a. Do this at least 6 timesuntil a fine spray mist is released into the air.

a

The nasal spray is now ready for use.Using the nasal spray

1. Shake the nasal sprayvigorously.

2.

1. Blow your noseto clear your nostrils, then tilt your head slightly forward.
2. Place the nasal applicator in one of your nostrils. Point the tip of the applicator slightly outward, away from the nasal septum. This helps the medicine reach the right part of the nose – see drawing b.

b

1. Press the dosing button firmlyand completely while breathing in through your nose.
2. Remove the applicator and breathe out through your mouth.
3. If your dose is 2 sprays in each nostril, repeat steps 4 to 6.
4. Repeat steps 4 to 7 in the other nostril.
5. Replace the capon the nasal spray.

Cleaning the nasal spray

After each use:

1. Clean the nasal applicator with a dry and clean tissue.
2. Do not use water to clean it.
3. Never use a pinor any other sharp object in the nasal applicator.
4. Always replace the caponce you have finished.

If the nasal spray appears not to be working:

• Check that there is still medicine left. Look at the level through the window. If the level is very low, it may not be enough for the nasal spray to work.
• Check if the nasal spray has been damaged.
• If you think the nasal applicator may be blocked, do not use a pinor any other sharp object to unblock it.
• Try to restart it by following the instructions mentioned in “Preparing the nasal spray for use”.
• If it still does not work, or if a liquid jet is produced, take the nasal spray to the pharmacy and consult your pharmacist.