FLUTICASONE FUROATE CIPLA 27.5 micrograms/spray NASAL SUSPENSION

2. What you need to know before you use Fluticasone Furoate Cipla

Do not use Fluticasone Furoate Cipla

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use this medicine.

Children and adolescents

Do not use in children under 6 years of age.

The use of Fluticasone Furoate Cipla:

• may cause a delay in the growth of children when used for long periods of time. Your 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 furoate.

Other medicines and Fluticasone Furoate Cipla

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

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

• corticosteroids in tablets or injected corticosteroids
• corticosteroids in creams
• medicines for asthma
• ritonavir or cobicistat, used to treat AIDS
• ketoconazole, used to treat fungal infections

Your doctor will assess whether you should take fluticasone furoate with these medicines. It is possible that your doctor may want to monitor you closely if you are taking any of these medicines, as they may increase the effects of Fluticasone Furoate Cipla.

Fluticasone Furoate 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 are planning to have a baby, ask your doctor for advice before using this medicine.

Do not use Fluticasone Furoate Cipla if you are pregnant, or are planning to become pregnant, unless your doctor or pharmacist advises you to do so.

Do not use Fluticasone Furoate Cipla if you are breastfeedingunless your doctor or pharmacist advises you to do so.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use machines.

Fluticasone Furoate Cipla contains benzalkonium chloride

This medicine contains 8.25 micrograms of benzalkonium chloride per spray and 13.75 micrograms of polysorbate per 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 Fluticasone Furoate Cipla

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

When to use Fluticasone Furoate Cipla

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

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

How long it takes for Fluticasone Furoate Cipla to work

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

However, it is usually effective between 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.

Children 6 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

Fluticasone Furoate Cipla 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 on using the nasal spray after section 6 of this leaflet. Follow the guide carefully to get the full benefit of using Fluticasone Furoate Cipla.

See the Step-by-step guide for using the nasal sprayafter section 6.

If you use more Fluticasone Furoate Cipla than you should

Consult your doctor or pharmacist.

If you forget to use Fluticasone Furoate Cipla

If you miss a dose, use it when you remember.

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

If you have any further questions on the use of this medicine or if you experience discomfort when using the nasal spray, ask your doctor, pharmacist, or nurse.

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 fluticasone furoate are rare and affect less than 1 in 1,000 people. In a small number of people, allergic reactions can become severe and may be life-threatening if not treated. Symptoms include:

• wheezing, coughing, or difficulty breathing
• a sudden feeling of weakness or dizziness (leading to collapse or loss of consciousness)
• swelling of the face
• skin rash or redness.

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 mild), especially if you use this medicine for more than 6 weeks continuously.

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

• Nasal ulcers - which can cause irritation or discomfort in your 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(frequency cannot be estimated from the available data)

• Slowing of growth in children.
• Blurred vision or temporary changes in vision with prolonged use.
• Chest tightness causing 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 of time. In children, these side effects may cause slower growth.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluticasone Furoate Cipla

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

It is preferable to store Fluticasone Furoate Cipla 27.5 micrograms/spray suspension for nasal spray 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.

This medicine must be used within 2 months after first opening.

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

6. Container Contents and Additional Information

Composition of Fluticasone Furoate Cipla

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

Appearance of the Product and Container Contents

The medication is a white nasal spray suspension contained in a 15 ml amber glass bottle, equipped with a metered-dose pump, a nasal applicator (sprayer), and a cap.

Fluticasone Furoate Cipla is available in one pack size: 1 bottle of 120 sprays.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Cipla Europe NV

De Keyserlei 60C,

Bus 1301, 2018 Antwerp

Belgium

Manufacturer

Curida AS

Solbærvegen 5,

2409 Elverum,

Norway

You can request more information about this medication by contacting the local representative of the marketing authorization holder

Cipla Europe NV branch in Spain

C/Guzmán el Bueno 133, Edificio Britannia

28003, Madrid

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Austria: Fluticasonfuroat Cipla 27.5 Mikrogramm/Sprühstoß Nasenspray, Suspension

Spain: Fluticasone Furoate Cipla 27.5 micrograms/spray suspension for nasal spray

Date of the last revision of this leaflet:January 2025

Other sources of information

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

STEP-BY-STEP GUIDE FOR USING THE NASAL SPRAYER

Appearance of the Nasal Sprayer

The nasal sprayer is contained in an amber glass bottle. It will contain 120 sprays.

Five important aspects you need to know about using the nasal sprayer

• Fluticasone Furoate Cipla is contained in an amber glass bottle. If you need to check how much is left, hold the nasal sprayer upright against a light source.This way you will be able to see the level through the window.
• When using the nasal sprayer for the first timeyou will need to shake it vigorouslywith the cap on for 10 seconds. This is important because Fluticasone Furoate Cipla 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 completely to release the mist through the nasal applicator – see drawing a.
• Always keep the cap on the nasal sprayerwhen not in use. The cap prevents dust from entering, seals tightly under pressure, and prevents the nasal applicator from clogging.
• Never use a pinor any other sharp object to unclog the nasal applicator. This would damage the nasal sprayer.

Preparing the Nasal Sprayer for Use

You must prepare the nasal sprayer:

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

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

1. Shake the nasal sprayer vigorouslywith the cap on for 10 seconds.
2. Remove the cap.
3. Hold the nasal sprayer upright, then tilt 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 sprayer is now ready for use.

Using the Nasal Sprayer

1. Shake the nasal sprayervigorously.
2. Remove the cap.
3. Blow your noseto clear your nostrils, then tilt your head slightly forward.
4. 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 medication 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 exhale 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 sprayer.

Cleaning the Nasal Sprayer

After each use:

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

If the nasal sprayer appears not to be working:

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

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/