Label: information for the user

Flonase 50 micrograms/pulverization suspension for nasal pulverization

Fluticasone Propionate

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

Follow exactly the administration instructions of the medicine contained in this label or those indicated by your pharmacist.

-Keep this label, as you may need to read it again.

-If you need advice or more information, consult your pharmacist.

-If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4

-You should consult a doctor if it worsens or does not improve after 7 days.

1.What is Flonase and what is it used for

2.What you need to know before starting to use Flonase

3.How to use Flonase

4.Possible adverse effects

5.Storage of Flonase

6.Contents of the package and additional information

The active ingredient is fluticasone propionate, a corticosteroid that, when used daily, has anti-inflammatory action. This nasal spray suspension helps to control the body's reaction to allergens ("triggers") present in the environment.

Flonase is used in adults 18 years and older to relieve symptoms associated with allergic rhinitis caused by pollen and other airborne allergens, such as allergies to domestic animals, dust mites, and fungal spores. It relieves symptoms like sneezing, nasal discharge, nasal itching, congestion, eye itching, and tearing for up to 24 hours.

It may take 3 or 4 days to reach the maximum level of protection. Therefore, it is essential to continue regular use to achieve maximum therapeutic benefit.

You should consult a doctor if symptoms worsen or do not improve after 7 days.

No use Flonase:

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Flonase:

-If you are using medications that contain corticosteroids (including creams for eczema, inhalers for asthma, tablets, injections, nasal sprays, or eye or nasal drops).

-If you have a nasal or sinus infection, have a cold, fever, or have recently undergone surgery, injuries, or ulcers in the nose.

If your symptoms do not improve after 7 days, speak with your doctor.

Do not use the medication continuously for more than 3 months, unless your doctor advises you to.

Contact your doctor if you experience blurred vision or other visual changes, which could be caused by conditions such as cataracts or glaucoma.

When corticosteroids are used in nasal sprays at high doses, for prolonged periods, adverse reactions may occur due to the absorption of the medication by the body.These effects are much less likely to occur with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations.The potential systemic effects may include Cushing's syndrome, cushingoid symptoms, adrenal suppression, growth retardation in children and adolescents, and, less frequently, reduced bone mineral density, effects on glucose metabolism, and a range of psychological and behavioral effects including hyperactivity, sleep disorders, anxiety, depression, or aggression (especially in children).

Treatment with higher doses of the recommended corticosteroid nasal sprays may result in clinically significant adrenal suppression. If there is evidence of use of doses greater than the recommended, additional coverage with systemic corticosteroids should be considered during periods of stress or elective surgery.

Use of Flonase with other medications

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medication, including those purchased without a prescription, especially:

-Medications that contain corticosteroids (including creams for eczema, inhalers for asthma, tablets, injections, nasal sprays, or eye or nasal drops);

-Ritonavir or cobicistat (an HIV medication)

-Ketoconazole (for fungal infections).

Some medications may increase the effect of Flonase, and your doctor may wish to closely monitor you if you are taking these medications (including some HIV medications: ritonavir, cobicistat).

Use of Flonase with food and beverages

You can use Flonase at any time of day, with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication. There are no data on the effects of this medication on fertility.

Driving and operating machinery

It is unlikely that Flonase will affect your ability to drive or use tools or machinery.

Flonase contains benzalkonium chloride.

This medication contains 0.02 mg of benzalkonium chloride in each dose of spray solution, equivalent to 0.2 mg of benzalkonium chloride in 1 ml of solution.

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

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Adults 18 years and older:

The recommended dose is two sprays in each nasal passage once a day (200 micrograms of fluticasone propionate), ideally in the mornings.

Once your symptoms have improved, you can reduce the dose to one spray in each nasal passage once a day.

If your symptoms are especially strong, you may need to apply two sprays in each nasal passage twice a day until your symptoms improve, but this is only for short-term use.

-Do not use more than 8 sprays (4 sprays per nasal passage) per day.

-Use the lowest dose possible to control your symptoms.

-If your symptoms do not improve, or are not well controlled after 7 days, consult your doctor or pharmacist.

-Do not use more than the recommended dose.

Use in children and adolescents:

This medication should not be used in children or adolescents under 18 years old.

Administration form:

Use only in the nose.

Do not ingest.

Do not spray in the eyes.

Before using a new Flonase bottle:

The Flonase sprayer has a cap that protects the nozzle and keeps it clean. Remember to remove it before using the sprayer (Figure 1).

Before starting a new Flonase bottle, or if you have not used the sprayer in a few days, prime the device (press the sprayer several times) to ensure you receive the correct dose.

Hold the bottle with your thumb under it and your index and middle fingers on the neck on both sides of the nozzle. Keeping your thumb steady, press down with your fingers several times until you get a fine spray.(Figure 2)

By doing this, make sure you do not point the nozzle at yourself or others.

If the sprayer still does not work, try cleaning it as described in the "Sprayer Cleaning" section. Do not try to unclog or enlarge the small spray nozzle with a needle or other pointed object, as this will damage the sprayer mechanism.

Figure 1

Figure 2

Using Flonase:

·Blow your nose gently.

·Shake the bottle well and remove the protective cap.

·If it is a new Flonase bottle, or if you have not used the sprayer in a few days, you will need to prime the device. Press the sprayer several times until you get a fine spray.

·Hold the bottle as shown in Figure 3. Place the nozzle in one nasal passage and cover the other,

·Incline your head slightly forward and keep the bottle straight as shown in Figure 4. Point slightly off-center from the center of your nose.

·Start breathing in slowly through your nose.While you are breathing in, press firmly on the neck of the sprayer with your fingers, to project a spray into your nose (Figure 4).

·Breathe out through your mouth. Repeat step 4 to apply a second spray in the same nasal passage.

·Remove the nozzle from the nasal passage you have already applied the medication to and breathe out through your mouth (Figure 5).

·Repeat steps 4 to 6 in the other nasal passage.

·After using the sprayer, clean the nozzle carefully with a clean tissue and replace the protective cap.

Figure 3

Figure 4

Figure 5

Sprayer Cleaning:

·Remove the protective cap and nozzle (Figure 6).

·Soak the nozzle and protective cap in warm water for a few minutes (Figure 7) and then rinse under the tap (Figure 8).

·Shake off any excess water and let it dry in a cool place - not too hot!

·Adjust the nozzle back onto the sprayer (Figure 9).

·If necessary, press the sprayer several times until you get a fine spray. Replace the protective cap.

·Do not try to unclog or enlarge the small spray nozzle with a needle or other pointed object, as this will damage the sprayer mechanism.

Figures 6, 7, 8, 9

It may take 3 or 4 days to reach the maximum level of protection provided by Flonase. To prevent symptoms, start using Flonase before exposure to your usual "triggers" (e.g. pollen).

Do not use Flonase for longer than you are exposed to your "triggers" (e.g. pollen).

If you use more Flonase than you should:

Speak with your doctor if you use more Flonase than recommended.

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

If you forget to use Flonase:

If you forget a dose, simply use the next dose when it is due. Do not use a double dose to compensate for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

When nasal corticosteroid sprays are used at high doses for prolonged periods of time, side effects may occur due to the absorption of the medication by the body.

Some side effects could be severe.

Seek immediate medical help if you experience any of the following very rare but severe side effects.

·Signs of allergic reaction, such as skin rash, swelling of the mouth or face, or difficulty breathing.

·Changes in vision that develop after starting to use this product.There have been rare cases of eye problems, such as cataracts or glaucoma in people who have used large quantities of corticosteroids over a period of several years.

·Small holes (perforations) in the nasal septum.

·Eye problems, such as pain.

Side effects of unknown frequency

The frequency of these side effects is unknown.

·Blurred vision.

- Nasal sores.

If you experience any of these symptoms, stop using the medication and seek immediate medical help.

Other side effects

Frequent side effects

Affect more than 1 in 10 people.

·Nasal bleeding occasionally.

Frequent side effects

Affect up to 1 in 10 people.

·Postnasal drip after using the spray. These usually subside quickly.

·Perception of an unpleasant odor or taste.

·Nasal or throat dryness or irritation.

·Headache.

Very rare side effects

Affect up to 1 in 10,000 people.

·Nasal problems such as persistent pain and/or bleeding.

If you experience any of these symptoms, stop using the medication and seek medical help.

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 to theSpanish 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 medication.

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

Do not use this medication after the expiration date that appears on the bottle after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above30°C.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and the medication that you no longer need at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose ofthe containers and the medicaments that you no longernecesita.By doing so, you will help protect the environment.

Composition of Flonase

-The active ingredient is fluticasone propionate. Each spray releases 100 mg of suspension containing 50 micrograms of fluticasone propionate as emitted dose.

-The other components (excipients) are glucose (anhydrous), microcrystalline cellulose, sodium carmellose, phenylethanol, benzalkonium chloride, polisorbate 80, and purified water.

Appearance of the product and contents of the package

Flonase is a white, opaque aqueous nasal spray suspension.

The amber-colored glass bottle is equipped with a spray device, nasal applicator, and protective cap. The bottle contains 60 sprays, with a total content not less than 7.0g, or 120 sprays, with a total content not less than 14.0g.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Haleon Spain, S.A.

C/Severo Ochoa, 2, P.T.M., Tres Cantos, 28760, Madrid.

Responsible for manufacturing:

Glaxo Wellcome S.A., 09400, Aranda de Duero, Burgos. Spain

or

Haleon Germany GmbH

Barthstrasse 4, 80339 Munich, Germany

This medicine is authorized in the member states of the European Economic Area with the following names::

BelgiumOtrivine Anti-Allergie 50 microgrammes/dose, nasal spray suspension

EstoniaFlixonase, 50 mikrogrammi/pihustuse ninasprei, suspension

HungaryFlixonase Allergia 50 mikrogramm/adag szuszpenziós orrspray

Irelanda Fluticasone propionate 50 micrograms/actuation, nasal spray, suspension

LithuaniaFlixonase 50 mikrogrami/izsmidzinajuma deguna aerosols, suspension

LuxembourgOtrivine Anti-Allergie 50 microgrammes/dose, nasal spray suspension

NetherlandsFlixonase GSK ConsHealth 50 microgram/dosis, neusspray, suspension

NorwayOtrason 50 mikrogram/dose nesespray, suspension

PolandOtriAllergy Control 50 mikrogramów/dawke aerosol do nosa, zawiesina

PortugalVibrocil Anti-Alergias 50 μg/dose Suspension for nasal spray

RomaniaFlonase 50 micrograme/doza spray nazal, suspension

SpainFlonase 50 microgramos/pulverización suspension for nasal spray

United Kingdom(Northern Ireland)Fluticasone propionate 50 micrograms/actuation, nasal spray, suspension

Date of the last review of thisleaflet:July 2023

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