FLUTICASONE TEVA 27.5 micrograms/spray, nasal spray suspension

2. What you need to know before you use Fluticasone Teva

Do not useFluticasone 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 Fluticasone Teva:

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

Other medicines and Fluticasone Teva

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 injected steroids
• steroids in cream
• 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 with these medicines. Some medicines may increase the effects of fluticasone furoate, so your doctor will monitor you closely if you are taking these medicines.

This medicine 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 or pharmacist for advice before using this medicine.

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

Do not use this medicine if you are breastfeedingunless your doctor or pharmacist advises you to.

Driving and using machines

Fluticasone Teva is unlikely to affect your ability to drive or use machines.

Fluticasone 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 periods. Inform your doctor or pharmacist if you experience discomfort when using the spray.

3. How to use Fluticasone Teva

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

When to use Fluticasone Teva

• 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 Teva 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 and 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 controlled, 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 Teva 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 to using the nasal spray after section 6 of this leaflet. Follow the guide carefully to get the full benefit of using this medicine.

See thestep-by-step guide to using the nasal sprayafter section 6.

If you use more Fluticasone Teva than you should

Consult your doctor or pharmacist.

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

If you forget to use Fluticasone Teva

If you forget to administer a dose, do so 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 forgotten doses.

If you have any other 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 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 this medicine 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), cough, or breathing difficulties
• feeling of sudden 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. But you should be aware that they can be potentially serious– so 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 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 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 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.

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 can 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. Storing 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 which is stated on the carton. The expiry date refers to the last day of the month shown. Once opened, the validity period of Fluticasone Teva nasal spray suspension is 2 months.

Do not refrigerate or freeze.

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. Contents of the pack and other information

Composition of Fluticasone Teva

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

Appearance of the product and pack contents

The medicine is a white nasal spray suspension contained in a brown glass bottle, equipped with a spray pump, an applicator, and a protective cap. Fluticasone Teva is available in a pack of 120 sprays.

Marketing authorisation holder

Teva B.V.

Swensweg, 5

2031 GA Haarlem

Netherlands

Manufacturer

Teva Czech Industries s.r.o.

Ostravska 305/29

747 70 Opava – Komárov

Czech Republic

You can ask for more information about this medicine from the local representative of the marketing authorisation holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108, Madrid (Spain)

Date of last revision of this leaflet:April 2024

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

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. 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 TO USING THE NASAL SPRAY

Appearance of the nasal spray

The nasal spray comes in a brown glass bottle equipped with a spray pump, an applicator, and a protective cap. It contains 120 sprays.

Five important things you should know about using the nasal spray

• Fluticasone Teva comes in a brown glass bottle. If you need to check how much is left, hold the nasal spray upright against a light. This way, you can see the level through the bottle.

• When you use the nasal spray for the first time, you should shake 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 the nasal applicator.

• Always keep the cap on the nasal spraywhen not in use. The cap prevents dust from entering, seals tightly 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
• 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 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.

1. Activate the 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 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. Shakethe nasal spray vigorously.
2. Remove the cap.
3. Blow your noseto clear your nostrils and then tilt your head slightly forward.
4. Place the nasal applicator in one of your nostrils and block the other nostril with your finger; see image 3. Point the end of the applicator slightly outward, away from the septum of your nose. This helps the medicine reach the correct part of the nose.
5. Press the pumpfirmly and completely, while inhaling through your nose.

Image 3

1. Remove the applicator and exhale 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 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, dry cloth.
2. Do not use water to clean it.
3. Never use a pin or anything sharp in the nasal applicator.
4. Always replace the cap once you have finished.

If the nasal spray does not seem to be working:

• Check that you still have medicine left. Look at the level through the bottle. If the level is very low, it may not be enough 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 your pharmacist.