Fluticasone Teva 27.5 micrograms/dose, nasal spray suspension

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Fluticasona Teva 27.5 micrograms/spray, nasal spray suspension

fluticasone furoate

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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Fluticasona Teva is and what it is used for

2. What you need to know before using Fluticasona Teva

3. How to use Fluticasona Teva

4. Possible side effects

5. How to store Fluticasona Teva

6. Contents of the pack and other information

Step-by-step guide for using the nasal spray

1. What Fluticasona Teva is and what it is used for

Fluticasona Teva (fluticasona furoato) belongs to a group of medicines called glucocorticoids.

Fluticasona Teva works by reducing inflammation caused by allergy (rhinitis), and therefore helps relieve allergy symptoms.

Fluticasona Teva nasal spray suspension is used to treat the symptoms of allergic rhinitis, including nasal congestion, increased nasal discharge, nasal itching, sneezing, and watery, itchy, or red eyes in adults and children aged 6 years and older.

Allergic symptoms may occur at certain times of the year due to allergies to pollen from plants or trees (hay fever), or they may occur throughout the year due to allergies to animals, house dust mites, moulds, among some of the more common triggers.

2. What you need to know before using Fluticasona Teva

Do not use Fluticasona Teva

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

Warnings and precautions

Children and adolescents

Do not use in children under 6 years of age.

The use of Fluticasona Teva:

• may cause delayed growth in children when used for prolonged periods. Your doctor will regularly monitor the child's height and ensure the child receives the lowest effective dose.

• may cause eye disorders such as glaucoma (increased eye pressure) or cataracts (loss of lens transparency). Inform your doctor if you have previously had any of these conditions, or if you experience blurred vision or other visual disturbances while using Fluticasona Teva.

Other medicines and Fluticasona Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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:

• steroid tablets or injected steroids
• steroid creams
• medicines for asthma
• ritonavir or cobicistat, used in the treatment of HIV
• ketoconazole, used in the treatment of fungal infections

Your doctor will assess whether you should use fluticasone furoate together with these medicines. Some medicines may increase the effects of fluticasone furoate, so your doctor will carry out careful monitoring if you are taking these medicines.

This medicine should not be used at the same time as other nasal sprays containing steroids.

Pregnancy and breastfeeding

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

Do not use this medicine if you are pregnant, or planning to become pregnant, unless advised by your doctor or pharmacist.

Do not use this medicine while breastfeeding unless advised by your doctor or pharmacist.

Driving and using machines

Fluticasona Teva is unlikely to affect your ability to drive or operate machinery.

Fluticasona Teva contains benzalkonium chloride

This medicine contains 8.25 micrograms of benzalkonium chloride per spray (27.5 micrograms). Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for long-term treatment. Inform your doctor or pharmacist if you experience discomfort when using the spray.

3. How to use Fluticasona Teva

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. Do not exceed the recommended dose. If in doubt, consult your doctor or pharmacist again.

When to use Fluticasona Teva

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

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

How long it takes for Fluticasona Teva to take effect

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

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

How much to use

Adults and children aged 12 years and older

• The usual starting dose is 2 sprays in each nostril once daily.
• Once symptoms are under control, the dose may be reduced to 1 spray in each nostril once daily.

Children aged 6 to 11 years

• The usual starting dose is 1 spray in each nostril once daily.
• If symptoms are severe, your doctor may increase the dose to 2 sprays in each nostril once daily until symptoms are under control. After that, the dose may be reduced to 1 spray in each nostril once daily.

How to use the nasal spray

Fluticasona Teva has little or 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.

A step-by-step guide on how to use the nasal spray is provided below section 6 of this leaflet. Follow the guide carefully to get the full benefit from using this medicine.

See the step-by-step guide for using the nasal spray, located below section 6.

If you use more Fluticasona Teva than you should

Consult your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested/used.

If you forget to use Fluticasona Teva

If you forget to take a dose, take it as soon as you remember.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Allergic reactions: seek immediate medical help

Allergic reactions to this medicine are rare and affect fewer than 1 in 1,000 people. In a small number of individuals, allergic reactions may become more severe and can even be life-threatening if not treated. Symptoms include:

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

In many cases, these symptoms may indicate less serious adverse effects. However, you should be alert, as they can potentially be severe – therefore, if you notice any of these symptoms:

Contact your doctor as soon as possible.

Very common adverse 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 adverse effects (may affect up to 1 in 10 people)

• Nasal ulceration – which may cause irritation or discomfort in your nose. Blood traces may appear when you blow your nose.
• Headache
• Shortness of breath.

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

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

Very rare adverse 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 available data)

• Slowed growth in children.
• Blurred vision or temporary changes in vision with prolonged use.
• Chest tightness causing difficulty breathing.
• Voice disorders, loss of voice.
• Taste disturbances, 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 prolonged periods. In children, these adverse effects may result in slower growth.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluticasone Teva

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

Always keep the cap on.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated. After first opening, the shelf life of Fluticasone Teva nasal spray suspension is 2 months.

Do not refrigerate or freeze.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fluticasona Teva

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

Nature of the medicinal product and contents of the container

The medicine is a white nasal spray suspension contained in an amber-coloured glass bottle equipped with a spray pump, a nasal applicator, and a protective cap. Fluticasona Teva is available in a pack containing 120 sprays.

Marketing Authorisation Holder

Teva B.V.

Swensweg, 5

2031 GA Haarlem

The Netherlands

Manufacturer

Teva Czech Industries s.r.o.

Ostravska 305/29

747 70 Opava – Komárov

Czech Republic

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108, Madrid (Spain)

Date of the most recent review of this leaflet: April 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89694/P_89694.html

QR Code + URL

STEP-BY-STEP GUIDE FOR USING THE NASAL SPRAY

Appearance of the nasal spray

The nasal spray is supplied in an amber-coloured glass bottle equipped with a spray pump, a nasal applicator, and a protective cap. It contains 120 sprays.

Five important things you should know about using the nasal spray

• Fluticasona Teva comes in an amber-coloured glass bottle. If you need to check how much remains, hold the nasal spray upright against the light. This way you will be able to see the level through the bottle.

• When using the nasal spray for the first time, you must shake it vigorously with the cap on for about 10 seconds. This is important because this medicine is a dense suspension that becomes liquid when shaken well. It will only spray when it has become liquid.

• The pump must be pressed fully down to release the mist through the nasal applicator.

• Always keep the cap on the nasal spray when not in use. The cap prevents dust from entering, seals tightly under pressure, and prevents the nasal applicator from becoming blocked.

• Never use a pin or any sharp object to clean the nasal applicator. This could damage the nasal spray device.

Preparing the nasal spray for use

You must prepare the nasal spray:

• before first use, or
• if it has been left uncovered for 5 days, or
• if the intranasal device has not been used for 30 days or more.

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

1. Shake the nasal spray vigorously with the cap on for about 10 seconds.
2. Remove the cap; see image 1.

Image 1

1. Hold the nasal spray upright, then tilt and point the nasal applicator away from you.

2. Prime the pump by placing two fingers on either side of the spray pump and your thumb on the base of the bottle. Press down and release the pump. Do this at least 6 times until a fine spray is released into the air; see image 2.

Image 2

1. The nasal spray is now ready for use.

Using the nasal spray

1. Shake the nasal spray vigorously.
2. Remove the cap.
3. Blow your nose to clear your nasal passages, then tilt your head slightly forward.
4. Insert the nasal applicator into one nostril and close the other nostril with your finger; see image 3. Point the tip of the applicator slightly outward, away from the septum of your nose. This helps the medicine reach the correct area of the nose.
5. Press the pump firmly and completely, while inhaling through your nose.

Image 3

1. Remove the applicator and breathe out through your mouth.
2. If your dose is 2 sprays in each nostril, repeat steps 4 to 6.
3. Repeat steps 4 to 7 in the other nostril.
4. Replace the nasal spray cap.

Cleaning the nasal spray

After each use:

1. Wipe the nasal applicator and the inside of the cap with a clean, dry cloth.
2. Do not use water to clean it.
3. Never use a pin or any sharp object on the nasal applicator.
4. Always replace the cap after use.

If the nasal spray does not seem to work:

• Check whether you still have medicine left. Look at the level through the bottle. If the level is very low, there may not be enough left for the nasal spray to function.
• Check whether the nasal spray is damaged.
• If you think the nasal applicator may be blocked, do not use a pin or any sharp object to clean it.
• Try re-priming it by following the instructions in "Preparing the nasal spray for use".
• If it still does not work, or if it produces a stream of liquid instead of a spray, take the nasal spray to your pharmacist for advice.