Label: information for the user

Fluticasona Teva 27.5 micrograms/pulverization, suspension for nasal pulverization

fluticasona furoate

Read this label carefully before starting to use this medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacistor nurse.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this label. See section 4.

1.What is Fluticasona Teva and how is it used

2.What you need to know before starting to use Fluticasona Teva

3.How to use Fluticasona Teva

4.Possible adverse effects

5.Storage of Fluticasona Teva

6.Contents of the package and additional information

Step-by-step guide for using the nasal pulverizer

Fluticasona Teva(fluticasona furoate) belongs to a group of medicines calledglucocorticoids.

Fluticasona Teva acts by reducing the inflammation caused by an allergy (rinitis), and therefore, reduces the symptoms of an allergy.

Fluticasona Teva nasal spray suspension is used for the treatment of symptoms of allergic rhinitis including nasal congestion, increased nasal discharge, and nasal itch, sneezing, and tearing and itch or redness of the eyes in adults and children 6 years of age or older.

Allergic symptoms can appear at certain times of the year as a result of allergy to plant or tree pollen (hay fever), or they can occur throughout the year as a result of allergy to animals, dust mites, or mold, among others.

Do not useFluticasona Teva

• If you are allergicto fluticasona furoate or to any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Children and adolescents

Do not use in children under 6 years.

The use of Fluticasona Teva:

• may cause a delay in the growth of children when used for prolonged periods of time. The doctor will regularly monitor 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 transparency of the crystalline lens). Inform your doctor if you have had any of these disorders in the past, or if you experience blurry vision or other visual disturbances while using Fluticasona Teva.

Other medications and Fluticasona Teva

Inform your doctor or pharmacist if you are using, have used recently, or may have to use any other medication, including those purchased without a prescription.

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

• oral steroids or injected steroids
• steroid creams
• asthma medications
• ritonavir or cobicistat, used in the treatment of HIV
• ketoconazole, used in the treatment of fungal infections

Your doctor will evaluate whether you should use fluticasona furoate with these medications. Some medications may increase the effects of fluticasona furoate, so your doctor will perform thorough checks if you are taking these medications.

This medication should not be used at the same time with other nasal sprays containing steroids.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Do not use this medication if you are pregnant, or are planning to become pregnant, unless your doctor or pharmacist tells you to.

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

Driving and operating machinery

It is unlikely that Fluticasona Teva will affect your ability to drive and operate machinery.

Fluticasona Teva contains benzalkonium chloride

This medication contains 8.25 micrograms of benzalkonium chloride in each spray (27.5 micrograms). Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for a long treatment period. Inform your doctor or pharmacist if you experience discomfort while using the sprayer.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.Do not exceed the recommended dose. In case of doubt,consult your doctor or pharmacist again.

When to use Fluticasona Teva

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

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

How long does Fluticasona Teva take to work

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

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

How to use

Adults and children 12 years and older

• Initial normal doseis 2 sprays in each nostril once a day.
• Once symptoms are controlled, it may be possible to reduce the dose to 1 spray in each nostril, once a day.

Children 6 to 11 years

• Initial normal 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

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

There is a step-by-step guide on how to use the nasal spray following section 6 of this leaflet. Follow the guide carefully to get the most benefit from using this medication.

See thestep-by-step guide for using the nasal spray, following section 6.

If you use more Fluticasona Teva than you should

Consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested/used

If you forgot to use Fluticasona Teva

If you forgot to administer a dose, do it when you remember.

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

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

Like all medicines, this medicine may cause side 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 people, allergic reactions can become more severe, even life-threatening if not treated. Symptoms include:

• Appearance of many wheezes (sibilance), cough, or breathing difficulties
• Sudden feeling of weakness or dizziness (leading to collapse or loss of consciousness)
• Swelling in the face
• Skin rash or redness.

In many cases, these symptoms will be signs of less severe 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 affectmore than 1 in 10 people)

• Nasal bleeding (usually of little importance), especially if you use this medicine for more than 6 weeks continuously.

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

• Nasal ulceration – which may cause irritation or discomfort in your nose. You may see 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 nasal sensationor 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 nasal passages.

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

• Slowed growth in children.
• Blurred vision or temporary changes in vision with prolonged use.
• Chest tightness causing breathing difficulties.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine..

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

Always keep the cap in place.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated. Once opened, the shelf life of Fluticasona Teva nasal suspension is 2 months.

Do not refrigerate or freeze.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fluticasona Teva

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

Appearance of the product and contents of the package

The medicine is a nasal spray suspension of white color contained in an amber glass bottle equipped with a spray pump, an applicator, and a protective cap. Fluticasona Teva is available in a package of 120 inhalations.

Marketing Authorization Holder

Teva B.V.

Swensweg, 5

2031 GA Haarlem

Netherlands

Responsible for manufacturing

Teva Czech Industries s.r.o.

Ostravská 305/29

747 70 Opava – Komárov

Czech Republic

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

Teva Pharma, S.L.U.

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

Alcobendas, 28108, Madrid (Spain)

Last review date of this leaflet:April 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

STEP-BY-STEP GUIDE FOR USING THE NASAL SPRAY

Appearance of the nasal spray

The nasal spray is presented in an amber glass bottle equipped with a spray pump, an applicator, and a protective cap. It will contain 120 inhalations.

Five things you should know about using the nasal spray

• Fluticasona Teva is presented in an amber glass bottle. If you need to check how much is left, hold the nasal spray in a vertical position against the light. This way, you will be able to see the level through the bottle.

• When you use the nasal spray for the first time, you mustshake it vigorouslywith 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 becomes liquid.

• The pump must be pressed all the way down to release the mist through thenasal applicator.

• Always keep the cap on the nasal spraywhen not in use. The capprevents dust from entering, seals hermetically under pressure, and prevents the nasal applicator from becoming clogged.

• Never use a pinor any sharp object to clean the nasal applicator. This would damage the nasal spray.

Preparing the nasal spray for use

You must prepare the nasal spray:

• before using it for the first time
• ifit has been left uncoveredfor 5 days or you have not used the nasal device for 30 days or more.

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

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

Image 1

1. Hold the nasal spray in a vertical position, then tilt andorient the nasal applicator away from you.

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

Image 2

1. The nasal spray is now ready for use.

Using the nasal spray

1. Shakevigorouslythe nasal spray.
2. Remove the cap.
3. Blow your noseto clear your nasal passages and then lean your head slightly forward.
4. Place the nasal applicator in one of your nasal passages and cover the other nasal passage with your finger; see image 3. Orient the tip of the applicator slightly outward, away from the septum of your nose. This helps the medicine reach the correct part of your nose.
5. Press the pumpfirmly and completely,while inhaling through your nose.

Image 3

1. Remove the applicator andexhale through your mouth.
2. If your dose is 2 inhalations in each nasal passage, repeat steps 4 to 6.
3. Repeat steps 4 to 7 in the other nasal passage.
4. Replace the cap on the nasal spray.

Cleaning the nasal spray

After each use:

1. Clean the nasal applicator and the inside of the cap with a clean and dry cloth.

2. Do not use water to clean it.

3. Never use a pin or anything sharp on the nasal applicator.

4. Always replace the cap once you have finished.

If the nasal spray does not seem to be working:

• Check if there is still medicine left. Look at the level through the bottle. If the level is very low, it is possible that there is not enough left for the nasal spray to work.
• Check if the nasal spray is damaged.
• If you think the nasal applicator may be clogged, do not use a pin or any sharp object to clean it.
• Try to restore 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, take the nasal spray to the pharmacy and consult with your pharmacist.