FLIXOTIDE 250 micrograms/inhalation, pressurized inhaler suspension

Introduction

Package Leaflet: Information for the User

F

fluticasone propionate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Flixotide 250 micrograms/inhalation is and what it is used for
2. What you need to know before you use Flixotide 250 micrograms/inhalation
3. How to use Flixotide 250 micrograms/inhalation
4. Possible side effects

5 Storage of Flixotide 250 micrograms/inhalation

1. Contents of the pack and further information

1. What Flixotide 250 micrograms/inhalation is and what it is used for

Fluticasone propionate belongs to a group of medicines called corticosteroids. Corticosteroids are used to treat asthma because of their anti-inflammatory action. They reduce inflammation and irritation in the walls of the small airways in the lungs and so reduce problems with breathing. Corticosteroids also help to prevent asthma attacks.

Flixotide 250 micrograms/inhalation is recommended for the treatment of mild to severe asthma and chronic obstructive pulmonary disease (COPD).

2. What you need to know before you use Flixotide 250 micrograms/inhalation

Do not useFlixotide 250 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

Consult your doctor, pharmacist, or nurse before starting to use Flixotide 250 micrograms/inhalation:

• if you have ever had to stop using this or any other medicine for your condition because of an allergy or other problem
• if you notice that you need to use more of this medicine to control your symptoms, your treatment should be reviewed
• if you have ever had ulcers or lesions in your 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 stress or if you are admitted to hospital after an injury or serious accident or before surgery and are being treated with high doses of steroids by inhalation, you may need additional steroid medication
• if you have diabetes mellitus (Flixotide may increase blood sugar levels)
• if your breathing worsens immediately after using this medicine, stop using it immediately and tell your doctor as soon as possible

Flixotide 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

Flixotide 250 micrograms/inhalation is not indicated for use in children. There are other formulations of Flixotide more suitable for the treatment of children and adolescents under 16 years of age.

Other medicines and Flixotide 250 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 Flixotide 250 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 reported. 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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

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

Warning for athletes

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

3. How to use Flixotide 250 micrograms/inhalation

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

Remember to use your medicine.

Your doctor will tell you how long to use Flixotide 250 micrograms/inhalation. Do not stop treatment before then, even if you feel better.

It is important to inhale each dose as your doctor has told you. The normal dose is:

• Asthma

Adults and adolescents over 16 years of age: 2 to 4 applications twice a day (500 to 1,000 micrograms twice a day).

• Chronic obstructive pulmonary disease (COPD):

Adults: 2 applications twice a day (500 micrograms twice a day).

Your doctor will decide the dose and frequency of administration, as well as the type of inhaler.

Do not inhale more doses or use Flixotide 250 micrograms/inhalation more often than your doctor has told you.

This medicine may take some time to start working. Therefore, it is very important to use it regularly. Tell your doctor and stop treatment if your breathing or wheezing worsens after using Flixotide 250 micrograms/inhalation. Tell your doctor if your breathing difficulties or wheezing worsen or do not improve within 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 that the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

Instructions for the correct use of Flixotide 250 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 gently squeezing 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 cover by gently squeezing 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 removed and the contents of the inhaler 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 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 breathe in through your mouth, press the inhaler to release the fluticasone propionate and continue breathing in slowly and deeply.

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 to take 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 cover by pushing 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 slowly, 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 a suitable spacer device.

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

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.

• Replace the mouthpiece cover.

Do not put the metal cartridge in water.

If you use moreFlixotide 250 micrograms/inhalationthan you should

If you have used more Flixotide 250 micrograms/inhalation than you should, consult the Toxicology Information Service, telephone 91 562 04 20, or contact your doctor immediately or go to the emergency department of the nearest hospital. Bring this leaflet with you.

If you forget to useFlixotide 250 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 using Flixotide 250 micrograms/inhalation

It is very important that you use this medicine every day as directed. Do not stop using Flixotide 250 micrograms/inhalation unless your doctor tells you to, as this may make your breathing worse. Do not stop treatment with this medicine 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. Tell your doctor but do not stop treatment unless he tells you to.

If you have any of the following symptoms after using Flixotide 250 micrograms/inhalation, stop using this medicine and tell 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 up to 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 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 up to 1 in 100 people)

• skin hypersensitivity reactions

Rare (may affect up to 1 in 1,000 people)

• esophageal candidiasis

Very rare (may affect up to 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 in which blood pressure may drop 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 of side effects

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

5. Storage of Flixotide 250 micrograms/inhalation

After use, replace the mouthpiece cover by pushing firmly until you hear a click. No excessive force is needed.

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 expiry date stated on the packaging after EXP. The expiry 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 puncture, break, or burn the cartridge even if it appears to be empty.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition ofFlixotide 250 micrograms/inhalation

• The active substance is 250 micrograms of fluticasone propionate per application.
• The other ingredient is norflurane c.s.

This medicine contains fluorinated greenhouse gases.

Each inhaler contains 12 g of HFC-134a (also known as norflurane or HFA 134a), which corresponds to 0.0172 tons of CO2 equivalent (global warming potential GWP = 1,430).

Appearance of the product and contents of the pack

Flixotide 250 micrograms/inhalation is a suspension for inhalation 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, 309400 Aranda de Duero (Burgos)

Spain

or

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

Date of last revision of this leaflet:01/2025

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