Label: Information for the User

Fluticasona Teva 50 micrograms Nasal Suspension for Inhalation

fluticasona propionate

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

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

Contents of the package and additional information

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

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

Do not use Fluticasona Teva

• If you are allergic to fluticasone or any of the other components of this medication (described in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Fluticasona Teva:

• If you have ever had nasal surgery.
• If you are suffering or have recently suffered from any respiratory tract infection of the nose.
• If you are suffering or have recently suffered from any untreated infection, tuberculosis, or eye herpes.
• If you have recently followed a treatment with injected steroids, or have been taking oral steroids for a long period of time.
• If you are applying more than 8 sprays (daily maximum recommended dose) of Fluticasona Teva per day, as you may need additional steroid treatment in stressful situations.

Fluticasona Teva may decrease your own hormone production, especially if you use higher doses than recommended for a longer period of time. In this case, your doctor may need to administer an additional hormone replacement medication for extreme stress, after severe injuries, or before surgery.

Fluticasona Teva will normally control seasonal allergic rhinitis (allergy), however, if you are exposed to excessive amounts of pollen, an additional treatment may be helpful to control other symptoms such as eye itching. 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 that may include growth retardation in children and adolescents, and, less frequently, a variety of psychological or behavioral effects that include hyperactivity, sleep disorders, anxiety, depression, or aggression (particularly in children).

Use of Fluticasona Teva with other medications

Inform your doctor if you are taking/using, have taken/used recently, or may take/use, any other medication, including over-the-counter medications.

Some medications may interact with Fluticasona Teva, particularly, consult your doctor or pharmacist if you are taking:

• Any medication used in the treatment of fungal infections (e.g.: ketoconazole)
• Some medications may increase the effects of Fluticasona Teva, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

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

Driving and operating machinery

This medication has no or insignificant influence on the ability to drive or operate machinery.

Fluticasona Teva contains benzalkonium chloride solution

This medication contains 40 micrograms of benzalkonium chloride in each released dose.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults (including elderly) and children 12 years of age and older:

When you start using Fluticasona Teva for the first time, it will normally be applied 2 puffs in one nostril once a day, preferably in the morning. Your doctor may increase this dose to a maximum of 2 puffs in each nostril twice a day.

Once your symptoms are under control, your doctor may reduce your dose to one application in each nostril once a day. If reducing the dose makes your symptoms worse, you can increase your dose back to the initial dose.

Children between 4 and 11 years of age:

For children aged 4-11 years, the dose is normally one application in each nostril once a day, preferably in the morning. Your doctor may increase this dose to a maximum of one application in each nostril twice a day.

This medication 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 medication takes a few days to start working. Do not stop taking this medication unless your doctor tells you to.

Do not use a higher dose or use Fluticasona Teva more frequently than your doctor has prescribed. It is essential not to use this medication more than your doctor has indicated.

If, despite using this medication, your eyes itch or water due to hay fever (allergy), inform your doctor. They may give you another medication 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 applicator and replaced after use.

When you are about to use a new container of Fluticasona Teva, you must check its correct functioning as follows:

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

2. Hold the container upside down with your thumb under the bottle and your index and middle fingers on either side of the nozzle. Make sure the nozzle is away from you when doing this.

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

Figure 1

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

If you have not used Fluticasona Teva for 7 days, prepare it until a fine liquid spray comes out.

If, after trying to prepare the bottle, it does not work and you think it may be clogged, you can clean it using the following procedure:

Cleaning of your nasal spray suspension

1. Remove the dust cap (Figure 2) and pull the nozzle upwards to remove it (Figure 3).

2. Wash the nozzle and cap in hot water and soak for a few minutes, then rinse under running water (Figures 4 and 5).

3. Remove excess moisture by shaking them and let the nozzle and cap dry in a cool place (not with heat).

4. Put the nozzle back in the bottle (Figure 6).

5. Check the correct preparation of the bottle if necessary by pressing the spray several times until a fine spray comes out.

• You should clean your nasal spray at least once a week to prevent it from becoming clogged. You will need an additional cleaning when it appears that the spray is clogged.
• NEVER attempt to unclog or enlarge the spray hole with a pin or any other sharp object, as this may damage the mechanism of the spray.

When using your nasal spray suspension

1. Shake the bottle and remove the cap.

2. Gently blow your nose.

3. Cover one nostril with your finger and place the nozzle of the spray in the other nostril (Figure 7). Tilt your head slightly forward to keep the bottle upright.

(Figure 7)

4. Breathe slowly through your open nostril, at the same time pressing down on the nozzle ring with your fingers to dispense a fine spray into your nostril (Figure 8).

Figure 8

5. Exhale through your mouth. Repeat step 4 to apply a second dose in the same nostril.

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

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

Figure 9

After using your nasal spray suspension

• Wipe the nozzle carefully with a clean tissue and replace the cap.

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

It is essential that you take the dose as indicated in the leaflet or as your doctor has prescribed. You should only use what your doctor recommends; if you use more or less, your symptoms may worsen.

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

Carry 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 administer a double dose to compensate for the missed dose. If you forget to apply a dose at the correct time, use the medication as soon as you remember. And if it is almost time for the next dose, wait until then and continue as before.

If you interrupt treatment with Fluticasona Teva 50 micrograms nasal spray suspension:

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you are using high doses of Fluticasona Teva, you may need an extra supply of steroids in case of extreme stress, or during a hospital stay after an accident or serious injury, or before surgery.

Nasal corticosteroid treatment may affect the body's 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, and therefore, children receiving nasal corticosteroid treatment over a long period of time will need to have their height checked regularly by their doctor. Your doctor will help prevent this from happening by prescribing the lowest dose of steroids necessary to control your symptoms effectively.

Some side effects are more serious than others. If you experience any of the following, 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.
• Asthma attack (constriction of the airways in the lungs with signs of difficulty breathing and coughing).
• Sudden dizziness or drowsiness (causing fainting or loss of consciousness).

Other side effects

Very common: may affect up to 1 in 10 people

• Nosebleeds.

Common: may affect up to 1 in 10 people

• Headache.
• Bad breath or unpleasant odor in the nose.

• Dryness and irritation of the throat and nasal passages and discharge.

Rare: may affect up to 1 in 10,000 people

• During prolonged treatment, glaucoma (increase in eye pressure) and cataracts (loss of transparency of the lens in the eye) have occurred..
• Nasal septum perforation (septum that divides the nose) and nasal mucous membrane ulceration - although this has occurred in patients who had previously undergone nasal surgery.

Unknown: cannot be estimated from available data

• Blurred vision
• Nasal ulceration

Side effects in children and adolescents

Children on treatment may grow more slowly than others and therefore children receiving nasal corticosteroid treatment need to have their height checked regularly by their doctor. Your doctor will help prevent this from happening by prescribing the lowest dose of steroids necessary to control your symptoms effectively.

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 Pharmacovigilance of Medicines for Human Use website: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use Fluticasona Teva after the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Use within 3 months after the first use.

Use the multi-dose packaging label to note the date of the first use.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medicines at the SIGRE point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Composition of Fluticasona Teva

The active ingredient is fluticasone propionate.

Each inhalation contains 50 micrograms of fluticasone propionate.

The other components are glucose, dispersible cellulose, phenylethyl alcohol, benzalkonium chloride (40 micrograms per released dose), polisorbate 80, and purified water.

Appearance of the product and contents of the package

Fluticasona Teva consists of a white and opaque suspension contained in an amber-colored glass multidose vial provided with a dosing atomizer pump to create the inhalation. Each package contains a suspension capable of releasing 60, 120, 150, 240 (2 vials containing each 120 inhalations) or 360 (3 vials containing each 120 inhalations) inhalations.120, 150, 240 (2 vials containing each 120 inhalations) or 360 (3 vials containing each 120 inhalations) inhalations.

Not all package sizes may be marketed.

Holder of the Marketing Authorization and responsible for manufacturing

Holder of the Marketing Authorization:

Teva Pharma, S.L.U.

Anabel Segura 11 Edificio B Albatros 1st floor

28108 Alcobendas, Madrid

Responsible for Manufacturing:

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 medication is registered in the Member States of the EEA with the following names

Republic of CzechNasofan, nasní sprej

GermanyFlutica-TEVA 50 Mikrogramm Nasenspray, Suspension

DenmarkFluticasonpropionat "Teva" 50 mikrogram/dosis, næsespray, suspension

SpainFluticasona Teva 50 microgramos suspension for nasal inhalation

FinlandNasofan 50 mikrog/annos nenäsumute

HungaryFlutirin orrspray

IrelandNasofan Aqueous 50 microgram Nasal Spray, Suspension

NorwayFlutikason Teva

PolandFanipos, 50 mikrogramów/dawke donosowa aerosol donosa, zawiesina

PortugalFluticasona Nasofan 50 microgramas Suspension for nasal inhalation

Republic of SlovakiaNasofan 50 mikrogramová nosová aerodisperzia aer nas

United KingdomNasofan Aqueous 50 microgram Nasal Spray

Last revision date of this leaflet:May 2023

Other sources of information

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

You can access detailed and updated information on this medication by scanning with your smartphone (smartphone) the QR code included in the packaging. You can also access this information on the following internet address:https://cima.aemps.es/cima/dochtml/p/67852/P_67852.html

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