FLUSONAL 50 micrograms/inhalation, pressurized inhalation suspension

2. What you need to know before you start using Flusonal 50 micrograms/inhalation

Do not use Flusonal 50 micrograms/inhalation

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start using Flusonal 50 micrograms/inhalation:

• if you have ever had to stop using this or any other medicine for the treatment of your disease due to allergy or any other problem
• if you notice that you need to increase the use of this medicine to control your symptoms, your treatment should be reviewed
• if you have ever had ulcers/lesions in the mouth
• if you have liver disease
• if you have recently received or are receiving treatment for tuberculosis or if you are taking other corticosteroids by mouth or by inhalation
• if you are under a lot of stress or if you are hospitalized after a serious injury or accident or before surgery and are being treated with high doses of steroids by inhalation, you may need additional steroid administration
• if you have diabetes mellitus (Flusonal may increase blood sugar levels)
• if your breathing worsens immediately after using this medicine, stop using it immediately and inform your doctor as soon as possible

Flusonal should not be used for acute attacks, but as regular long-term treatment, and withdrawal of the medicine should be gradual.

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

Children and adolescents

It is advisable to monitor height periodically.

Other medicines and Flusonal 50 micrograms/inhalation

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Some medicines may increase the effects of Flusonal 50 micrograms/inhalation, so your doctor will monitor you closely if you are using these medicines (including some for HIV: ritonavir, cobicistat).

Oral medicines for the treatment of fungal infections (ketoconazole).

No interactions with other medicines have been described. However, you should inform your doctor or pharmacist if you are taking or have taken medicines for the treatment of tuberculosis.

Pregnancy and breastfeeding

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

Driving and using machines

It is unlikely that Flusonal will affect your ability to drive or use machines.

Warning to athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

3. How to use Flusonal 50 micrograms/inhalation

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

Remember to use your medicine.

Your doctor will indicate the duration of treatment with Flusonal 50 micrograms/inhalation. Do not stop treatment before, even if you feel better.

It is essential to inhale each dose as your doctor indicates. The normal dose is:

Adults and adolescents over 16 years of age: 2 to 10 applications twice a day (100 to 500 micrograms twice a day).

Children over 4 years of age: 1-2 applications twice a day (50 to 100 micrograms twice a day).

Children from 1 to 4 years of age: 2 applications twice a day (100 micrograms twice a day), administered through a pediatric inhalation chamber with a mask (such as Babyhaler).

The doctor should decide the dose and frequency of administration, as well as the type of inhaler.

Do not inhale more doses or use Flusonal 50 micrograms/inhalation more times than indicated by the doctor.

This medicine may take a few days to take effect. Therefore, it is very important to use it regularly. Inform your doctor and interrupt treatment if breathing or "wheezing" worsens after using Flusonal 50 micrograms/inhalation. Inform your doctor if respiratory difficulties or "wheezing" worsen or do not improve after 7 days or if you notice that you are increasing the use of other inhalation medicines.

Do not use this medicine to treat a sudden attack of shortness of breath; it will not work. For this, you will need a different medicine. If you use more than one medicine, be careful not to confuse them.

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

Instructions for the correct use of Flusonal 50 micrograms/inhalation

Checking the inhaler:

Before using the inhaler for the first time or if it has not been used for a week or more, remove the mouthpiece cover by squeezing it gently on the sides, shake the inhaler thoroughly, and release two doses into the air to ensure the inhaler is working.

Using the inhaler:

1. Remove the mouthpiece cover by squeezing it gently on the sides.

1. Check that there are no foreign particles inside and outside the inhaler, including the mouthpiece.

1. Shake the inhaler cartridge well to ensure that any foreign particles are eliminated and that the inhaler contents are mixed properly.

1. Hold the inhaler vertically between your index and thumb fingers, placing your thumb on the base, below the mouthpiece.

1. Exhale as much air as you can and then put the mouthpiece in your mouth, between your teeth, closing your lips around the device but not biting it.

1. Immediately after starting to take air through your mouth, press the inhaler to release the fluticasone propionate and continue taking air deeply and steadily.

1. Hold your breath and remove the inhaler from your mouth. Continue holding your breath for as long as you can.

1. If you are going to administer another inhalation, keep the inhaler vertical and wait for about half a minute before repeating steps 3 to 7.
2. Then, rinse your mouth with water and spit it out.
3. Put the mouthpiece cover back on by pushing it firmly and adjusting it until you hear a click.

Important

Do not perform steps 5, 6, and 7 quickly. It is essential to start breathing in as slowly as possible, just before pressing the inhaler. Practice in front of a mirror during the first few times. If you see a "mist" coming out of the top of the inhaler or the sides of your mouth, start again from step 2.

Patients who have difficulty coordinating the handling of the inhaler with inhalation may use an appropriate inhalation chamber.

If your doctor gave you different instructions, follow them carefully. Consult your doctor or pharmacist if you have difficulties.

Use in children:

Young children may need help; an adult should handle the inhaler for them. Encourage the child to exhale and activate the inhaler just after the child starts taking air. Practice the technique together.

Older children or people with fragile hands should hold the inhaler with both hands; they should put their two index fingers on the top of the inhaler and their two thumbs on the base, below the mouthpiece.

Cleaning

Clean the inhaler at least once a week.

• Remove the mouthpiece cover.

• Do not remove the metal cartridge from the plastic casing.

• Clean the inside and outside of the mouthpiece with a dry cloth or tissue.

• Put the mouthpiece cover back on.

Do not put the metal cartridge in water.

If you use more Flusonal 50 micrograms/inhalation than you should

If you have used more Flusonal 50 micrograms/inhalation than you should, talk to the Toxicology Information Service, telephone 91 562 04 20, or inform your doctor immediately or go to the emergency department of the nearest hospital. Bring this package leaflet with you.

If you forget to use Flusonal 50 micrograms/inhalation

Do not inhale a double dose to make up for forgotten doses. If you forget a dose, wait for the next dose.

If you stop treatment with Flusonal 50 micrograms/inhalation

It is very important that you use this medicine every day as indicated. Do not stop using Flusonal 50 micrograms/inhalation unless your doctor tells you to, as this may make your breathing worse. Do not stop treatment abruptly.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some people may develop fungal infections in the mouth (candidiasis) and experience throat or tongue pain, or their voice may become hoarse after inhaling this medicine. To avoid this, it is recommended to brush your teeth or rinse your mouth or gargle with water and spit it out immediately after inhaling each dose. Inform your doctor but do not interrupt treatment unless he says so.

If you experience any of the following symptoms after using Flusonal 50 micrograms/inhalation, stop using this medicine and inform your doctor immediately:

• sudden onset of wheezing or chest pressure
• swelling of the eyelids, face, lips, tongue, or throat
• skin rash (hives) or urticaria anywhere on the body.

Other side effects include:

Very common(may affect more than 1 in 10 people)

• candidiasis (fungal infection) in the mouth and throat.

Common(may affect less than 1 in 10 people)

• neumonia (lung infection) and bronchitis (inflammation of the airways) in patients with chronic obstructive pulmonary disease (COPD) (a disease that causes difficulty breathing).

Tell your doctorif you have any of the following symptoms while inhaling fluticasone propionate. They could be symptoms of a lung infection:

• fever or chills
• increased production of mucus, change in the color of mucus
• increased coughing or increased difficulty breathing
• hoarseness
• bruising.

Uncommon(may affect less than 1 in 100 people)

• skin hypersensitivity reactions.

Rare(may affect less than 1 in 1,000 people)

• esophageal candidiasis.

Very rare(may affect less than 1 in 10,000 people)

• angioedema (skin reactions with redness, swelling, and itching), mainly facial and oropharyngeal edema
• respiratory symptoms such as dyspnea (feeling of shortness of breath or difficulty breathing) and/or bronchospasm (narrowing of the bronchial walls with decreased air intake)
• anaphylactic reactions (severe allergic reactions in which a sudden drop in blood pressure with loss of consciousness may occur)
• moon face (Cushing's syndrome)
• suppression of adrenal gland activity, which may cause fatigue, weight loss, nausea, vomiting, headache, decreased blood pressure, numbness, and convulsions
• delayed growth in children and adolescents
• decreased bone mineral density
• cataracts and glaucoma
• hyperglycemia (increased blood sugar levels). If you have diabetes, you may need to check your blood sugar more frequently and possibly adjust your usual treatment for diabetes control
• anxiety, sleep disorders, and behavioral changes including hyperactivity and irritability (mainly in children)
• paradoxical bronchospasm (temporary narrowing of the bronchial walls with decreased air intake after using the inhaler).

Frequency not known

• nasal bleeding
• blurred vision.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Flusonal 50 micrograms/inhalation

Immediately after use, put the mouthpiece cover back on by pushing it firmly until you hear a click. No excessive force is necessary.

Do not store above 30°C. Do not freeze. Keep in the original packaging to protect from light.

If the inhaler is very cold, remove the cartridge and warm it in your hand for a few minutes before use. Do not use any other method to heat it.

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

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

The cartridge contains a pressurized liquid. Do not expose to temperatures above 50°C. Do not pierce, break, or burn the cartridge even if it appears to be empty.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Flusonal 50 micrograms/inhalation

• The active ingredient is 50 micrograms of fluticasone propionate per application.
• The other component is norflurane c.s.

This medication contains fluorinated greenhouse gases.

Each inhaler contains 10.6 g of HFC-134a (also known as norflurane or HFA 134a) which corresponds to 0.0152 tons of CO2 equivalent (global warming potential GWP = 1,430).

Product Appearance and Package Contents

Flusonal 50 micrograms/inhalation is an inhalation suspension in a pressurized container, without chlorofluorocarbon propellants. Each cartridge provides 120 applications.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer:

Glaxo Wellcome Production S.A.S.Zone Industrielle Nº 2

23 rue Lavoisier27000 - Evreux

France

or

Glaxo Wellcome S.A.Avenida Extremadura, 30

9400 Aranda de Duero (Burgos)

Spain

Date of the Last Revision of this Prospectus:01/2025

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