FLIXOTIDE 50 micrograms/inhalation, pressurized inhaler suspension

Introduction

Leaflet: information for the user

F

fluticasone propionate

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

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

Contents of the leaflet

1. What Flixotide 50 micrograms/inhalation is and what it is used for
2. What you need to know before starting to use Flixotide 50 micrograms/inhalation
3. How to use Flixotide 50 micrograms/inhalation
4. Possible side effects

5 Conservation of Flixotide 50 micrograms/inhalation

1. Contents of the pack and additional information

1. What Flixotide 50 micrograms/inhalation is and what it is used for

Fluticasone propionate belongs to a group of medicines called corticosteroids. Corticosteroids are used in the treatment of asthma due to their anti-inflammatory activity. They reduce inflammation and irritation in the walls of the small airways in the lungs and thus decrease respiratory problems. Corticosteroids also help prevent asthma attacks.

Flixotide 50 micrograms/inhalation is recommended for the treatment of mild to severe asthma.

2. What you need to know before starting to use Flixotide 50 micrograms/inhalation

Do not useFlixotide 50 micrograms/inhalation

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Flixotide 50 micrograms/inhalation:

• if you have ever had to stop using this or any other medication for the treatment of your disease due to allergy or any other problem
• if you notice that you increasingly require more use of this medication for adequate control of symptoms, your treatment should be reviewed
• if you have ever had ulcers/lesions in the mouth
• if you suffer from any liver disease
• if you have recently received or are receiving treatment for tuberculosis or if you are taking other corticosteroids orally 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 (Flixotide may increase blood sugar levels)
• if your breathing worsens immediately after using this medication, stop using it immediately and inform your doctor as soon as possible

Flixotide should not be used in acute attacks, but as habitual long-term treatment, and withdrawal of the medication 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 medications and Flixotide 50 micrograms/inhalation

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription.

Some medications may increase the effects of Flixotide 50 micrograms/inhalation, so your doctor will perform thorough checks if you are using these medications (including some for HIV: ritonavir, cobicistat).

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

No interactions with other medications have been described. However, you should inform your doctor or pharmacist if you are taking or have taken medications 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 medication.

Driving and using machines

Flixotide is unlikely to affect your ability to drive or use machines.

Warning to athletes

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

3. How to use Flixotide 50 micrograms/inhalation

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

Remember to use your medication.

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

It is essential to inhale each dose exactly 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: 1-2 applications twice a day (50 to 100 micrograms twice a day).

Children from 1 to 4 years: 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 Flixotide 50 micrograms/inhalation more times than indicated by the doctor.

This medication 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 Flixotide 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 medications.

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

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

Instructions for the correct use of Flixotide 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 protector by squeezing it gently on the sides, shake the inhaler thoroughlyand release two doses into the air to ensure the inhaler is working.

Using the inhaler:

1. Remove the mouthpiece protector 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 possible and then insert the mouthpiece into your mouth, between your teeth, closing your lips around the device but not biting it.

1. Immediately after starting to breathe in through your mouth, press the inhaler to release the fluticasone propionate and continue breathing in deeply and steadily.

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

1. If you need 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. Replace the mouthpiece protector by pushing it firmly and adjusting it until you hear a click.

Important

Do not quickly perform steps 5, 6, and 7. 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 "kind of mist" coming out of the top of the inhaler or the sides of your mouth, start again from step 2.

Patient who find it difficult to coordinate the handling of the inhaler with inhalation may use a suitable 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, with an adult handling the inhaler for them. Encourage the child to exhale and activate the inhaler just after the child starts breathing in. Practice the technique together.

Older children or people with fragile hands should hold the inhaler with both hands; they should place 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 protector.

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

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

• Replace the mouthpiece protector.

Do not put the metal cartridge in water.

If you use moreFlixotide 50 micrograms/inhalationthan you should

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

If you forget to useFlixotide 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 interrupt treatment with Flixotide 50 micrograms/inhalation

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences 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 medication. To avoid this, it is recommended to brush your teeth or rinse your mouth or gargle with water immediately after inhaling each dose. Inform your doctor, but do not interrupt treatment unless they tell you to.

If you experience any of the following symptoms after using Flixotide 50 micrograms/inhalation, stop using this medication 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)

• pneumonia (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 experience any of the following symptoms while inhaling fluticasone propionate. They could be symptoms of a lung infection:

• fever or chills
• increased mucus production, change in mucus color
• 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 lack of air or difficulty breathing) and/or bronchospasm (narrowing of the bronchial walls with decreased air intake)
• anaphylactic reactions (severe allergic reactions that can cause a sudden drop in blood pressure with loss of consciousness)
• 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 diabetes treatment
• 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them 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 medication.

5. Conservation of Flixotide 50 micrograms/inhalation

Immediately after use, replace the mouthpiece protector 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 medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

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

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications 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 medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition ofFlixotide 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 Container Content

Flixotide 50 micrograms/inhalation is an inhalation suspension in a pressure 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, 309400 Aranda de Duero (Burgos)

Spain

or

GlaxoSmithKline Pharmaceuticals, S.A.ul. Grunwaldzka, 189 (Poznan) - 60-322 - Poland

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/