Fluticasone Teva 50 micrograms nasal spray suspension

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fluticasona Teva 50 micrograms Nasal Spray Suspension

fluticasona propionato

Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are 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

Package contents and additional information

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

Your medicine is called Fluticasona Teva 50 micrograms nasal spray suspension (referred to as “Fluticasona Teva” in this leaflet) and contains 50 micrograms of the active substance, fluticasone propionate, in each spray. Fluticasone propionate belongs to a group of medicines known as corticosteroids.

Fluticasona Teva has anti-inflammatory properties. When applied in your nose, it reduces inflammation and irritation. It is used to prevent and treat seasonal allergic rhinitis (e.g. hay fever) and perennial rhinitis (e.g. nasal congestion or runny nose, sneezing, and itching caused by house dust mites or pets such as cats and dogs). It can be used by adults and children over 4 years of age.

2. What you need to know before using Fluticasona Teva

Do not use Fluticasona Teva

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

Warnings and precautions

Talk to your doctor or pharmacist before using Fluticasona Teva:

• If you have ever had nasal surgery.
• If you are currently suffering or have recently suffered from a nasal respiratory tract infection.
• If you are currently suffering or have recently suffered from any untreated infection, tuberculosis, or ocular herpes.
• If you have recently received treatment with injected steroids, or have been taking oral steroids for a long period of time.
• If you are using more than 8 sprays (maximum recommended daily dose) of Fluticasona Teva per day, as you may require additional steroid treatment during periods of stress.

Fluticasona Teva may reduce your body's own production of hormones, especially if doses higher than recommended are used for prolonged periods. In such cases, your doctor may need to give you an additional adrenal hormone medication during times of extreme stress, after serious injury, or before surgery.

Fluticasona Teva will usually control seasonal allergic rhinitis (allergy); however, if you are exposed to high levels of pollen, additional treatment may be helpful to control other symptoms such as itchy eyes. Consult your doctor in these cases.

Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

Fluticasona Teva may have potential systemic effects, including growth retardation in children and adolescents, and, more rarely, various psychological or behavioral effects such as psychomotor hyperactivity, sleep disorders, anxiety, depression, or aggression (particularly in children).

Use of Fluticasona Teva with other medicines

Inform your doctor if you are taking/using, have recently taken/used, or might take/use any other medicines, including medicines obtained without a prescription.

Some medicines may interact with Fluticasona Teva. In particular, consult your doctor or pharmacist if you are taking:

• Any medicine used to treat fungal infections (e.g.: ketoconazole).
• Some medicines may increase the effects of Fluticasona Teva, so your doctor will monitor you closely if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

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

Driving and using machines

This medicine has no or negligible influence on the ability to drive or operate machinery.

Fluticasona Teva contains benzalkonium chloride solution

This medicine contains 40 micrograms of benzalkonium chloride in each delivered dose.

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

3. How to use Fluticasona Teva

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults (including elderly) and children aged 12 years and older:

When you first start using Fluticasona Teva, the usual dose is 2 sprays in each nostril once daily, preferably in the morning. Your doctor may increase this dose up to a maximum of 2 sprays in each nostril twice daily.

Once your symptoms are under control, your doctor may reduce your dose to 1 spray in each nostril once daily. If reducing the dose causes your symptoms to worsen, your dose may be increased again to the initial dose.

Children between 4 and 11 years of age:

For children aged 4 to 11 years, the usual dose is 1 spray in each nostril once daily, preferably in the morning. Your doctor may increase this dose up to a maximum of 1 spray in each nostril twice daily.

This medicine is not suitable for children under 4 years of age.

Your doctor will prescribe the lowest dose of Fluticasona Teva that effectively controls your symptoms.

This medicine may take several days to start working. Do not stop taking this medicine unless instructed by your doctor.

Do not use a higher dose or use Fluticasona Teva more frequently than prescribed by your doctor. It is important not to use this medicine more than your doctor has instructed.

If, despite using this medicine, your eyes become itchy or watery due to hay fever (allergy), inform your doctor. He/She may give you another medicine to treat your eye symptoms.

Before using your nasal spray suspension

Fluticasona Teva has a cap that protects the nozzle from dust – this cap must be removed before using the spray and replaced after use.

When you are using a new container of Fluticasona Teva, check that it is working properly as follows:

1. Shake the container gently and remove the dust-protecting cap.

2. Hold the container upright with your thumb underneath the bottle and your index and middle fingers on either side of the nozzle. Make sure the nozzle is pointed away from you when performing this step.

3. Press down with your fingers to release a spray (Figure 1).

Figure 1

4. Repeat steps 2 and 3 about five times – the bottle is now ready for use.

If you have not used Fluticasona Teva for 7 days, prepare it again by spraying until a fine mist appears.

If, after attempting to prepare the bottle, it still does not work and you think it may be blocked, you may clean it using the following procedure:

Cleaning your nasal spray suspension

1. Remove the protective cap (Figure 2) and pull upwards on the ring to remove the nozzle (Figure 3).

1. Wash the mouthpiece and cap in hot water and let them soak for a few minutes, then rinse thoroughly under running tap water (Figures 4 and 5).

1. Remove excess moisture by shaking them and allow the mouthpiece and cap to dry in a warm place (not hot).

2. Put the mouthpiece back into the bottle (Figure 6).

1. Check that the bottle is properly prepared by pressing the spray several times, if necessary, until a fine mist is produced.

• You should clean your nasal spray at least once a week to prevent blockage. Additional cleaning will be needed if the spray appears to be blocked.
• NEVER unblock or enlarge the spray hole with a pin or any other sharp object, as this may damage the spray mechanism.

When using your nasal spray suspension

1. Shake the bottle and remove the cap.

2. Gently blow your nose.

3. Close one nostril by pressing with your finger and insert the spray nozzle into the other nostril (Figure 7). Tilt your head slightly forward to keep the bottle upright.

(Figure 7)

1. Breathe in slowly through your open nostril while simultaneously pressing down with your fingers on the nozzle ring to deliver a fine spray into your nose (Figure 8).

Figure 8

1. Exhale through your mouth. Repeat step 4 to administer a second dose into the same nostril.

2. Remove the nozzle from the nostril and exhale through your mouth.

3. Repeat steps 3 to 6 for the other nostril (Figure 9).

Figure 9

After using your nasal spray suspension

• Carefully dry the nozzle with a clean tissue and replace the cap.

If you use more Fluticasona Teva 50 micrograms nasal spray suspension than you should:

It is important that you take the dose as indicated in this leaflet or as directed by your doctor. You should only use the amount recommended by your doctor; using more or less may worsen your symptoms.

If you accidentally use more Fluticasona Teva than you should, contact your doctor or pharmacist immediately or contact the Toxicology Information Service. Telephone: 91 562 04 20.

Take this leaflet and your Fluticasona Teva with you to show your doctor.

If you forget to use Fluticasona Teva 50 micrograms nasal spray suspension:

Do not take a double dose to make up for a missed dose. If you forget to take a dose at the correct time, use the medicine as soon as you remember. If it is almost time for your next dose, wait until then and continue as before.

If you stop using Fluticasona Teva 50 micrograms nasal spray suspension:

Your nasal symptoms may only begin to improve after a few days of using the medicine, so it is very important to continue using the medicine regularly as prescribed and not to stop unless your doctor tells you to, even if you feel better.

If you have any doubts about how to use the medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

If you are using high doses of Fluticasona Teva, you may require additional steroid supplementation in cases of extreme stress, during hospitalization following a serious accident or injury, or before surgical procedures.

Treatment with nasal corticosteroids may affect the body's natural production of steroids. The likelihood of this occurrence increases with the use of high doses over a long period of time. This may cause children to grow more slowly than others. Therefore, children receiving long-term treatment with nasal corticosteroids should have their height monitored regularly by their doctor. Your doctor will help prevent this by prescribing the lowest steroid dose capable of adequately controlling your symptoms.

Some adverse effects are more serious than others. If you experience any of the following, you should stop using Fluticasona Teva and consult your doctor as soon as possible:

• Severe allergic reactions, causing sudden onset of skin rash, swelling (usually of the tongue, face, or lips), or difficulty breathing.
• Bronchospasm (narrowing of the airways in the lungs, with symptoms of breathing difficulty and cough).
• Sudden drowsiness or dizziness (leading to fainting or loss of consciousness).

Other adverse effects

Very common: may affect up to 1 in 10 people

• Epistaxis (nosebleed).

Common: may affect up to 1 in 10 people

• Headache.
• Bad breath or unpleasant smell in the nose.
• Dryness and irritation of the throat and nasal passages, and nasal discharge.

Very rare: may affect up to 1 in 10,000 people

• Glaucoma (increased pressure in the eye) and cataracts (loss of transparency of the eye's lens) have occurred during prolonged treatment.
• Perforation of the nasal septum (the partition dividing the nose) and ulceration of the nasal mucosal membrane—although these have occurred in patients who previously underwent nasal surgery.

Not known: frequency cannot be estimated from available data

• Blurred vision
• Nasal ulceration

Adverse effects in children and adolescents

Children undergoing treatment may grow more slowly than others. Therefore, children receiving corticosteroid treatment should have their height monitored regularly by a doctor. Your doctor will help prevent this by prescribing the lowest steroid dose capable of adequately controlling symptoms.

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluticasona Teva

Keep out of the sight and reach of children.

Do not use Fluticasona Teva after the expiry date stated on the pack after the abbreviation EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Use within 3 months after first use.

Use the label on the multi-dose pack to record the date of first use.

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

6. Contents of the pack and other information

Composition of Fluticasona Teva

The active substance is fluticasone propionate.

Each spray contains 50 micrograms of fluticasone propionate.

The other components are glucose, dispersible cellulose, phenethyl alcohol, benzalkonium chloride (40 micrograms per delivered dose), polysorbate 80, and purified water.

Appearance of the product and contents of the container

Fluticasona Teva consists of a white, opaque suspension contained in an amber glass multidose bottle equipped with a metered-dose spray pump to generate the spray. Each package contains suspension capable of delivering 60, 120, 150, 240 (2 bottles, each containing 120 sprays), or 360 sprays (3 bottles, each containing 120 sprays).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio B Albatros, 1st floor

28108 Alcobendas, Madrid, Spain

Manufacturer:

Teva Czech Industries s.r.o.

Ostravska 29

Opava, Czech Republic

or

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31-546 Kraków, Poland

This medicinal product is authorized in the EEA Member States under the following names:

Czech Republic: Nasofan, nasal spray
Germany: Flutica-TEVA 50 Mikrogramm Nasenspray, Suspension
Denmark: Fluticasonpropionat "Teva" 50 mikrogram/dosis, næsespray, suspension
Spain: Fluticasona Teva 50 microgramos suspensión para pulverización nasal
Finland: Nasofan 50 mikrog/annos nenäsumute
Hungary: Flutirin orrspray
Ireland: Nasofan Aqueous 50 microgram Nasal Spray, Suspension
Norway: Flutikason Teva
Poland: Fanipos, 50 mikrogramów/dawka donosowa aerosol donosowa, zawiesina
Portugal: Fluticasona Nasofan 50 microgramas Suspensão para pulverização nasal
Slovak Republic: Nasofan 50 mikrogramová nosová aerodisperzia aer nas
United Kingdom: Nasofan Aqueous 50 microgram Nasal Spray

Date of the most recent revision of this leaflet: May 2023

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (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 on the outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67852/P_67852.html

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