User Information: Package Insert

Flixotide 50 micrograms/inhalation, Pressurized Suspension for Inhalation

Fluticasone Propionate

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

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

1.What is Flixotide 50 micrograms/inhalation and what is it 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 adverse effects

5.Storage of Flixotide 50 micrograms/inhalation

6. Contents of the package and additional information

Fluticasone propionate belongs to the group of substances known as 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.

Do not useFlixotide 50 micrograms/inhalation

• if you are allergic (hypersensitive) to fluticasone propionate or to any of the other ingredients ofthis medicine (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 medicine for your allergy or any other condition
• if you notice that you need to use more of this medicine to control your symptoms, you should have your treatment reviewed
• if you have ever had mouth ulcers/sores
• if you have any liver disease
• if you have recently received or are receiving treatment for tuberculosis or if you are taking other oral or inhaled corticosteroids
• if you are under a lot of stress or if you are being treated with high doses of inhaled steroids and are going into hospital after an injury or accident or before surgery, you may need additional steroids
• if you have diabetes mellitus (Flixotide may increase blood sugar levels)
• if your breathing gets worse 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 long-term maintenance treatment, and the medicine should be withdrawn gradually.

Get in touch with your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

It is advisable to have your height checked periodically.

Other medicines and Flixotide 50 micrograms/inhalation

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, including those bought without a prescription.

Some medicines may increase the effects of Flixotide 50 micrograms/inhalation, so your doctor will do a thorough check if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Oral medicines for 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 tuberculosis treatment.

Pregnancy and breastfeeding

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

Driving and operating machines

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

Warning to athletes

It is notified to athletes that this medicine contains a component that may result in a positive analytical control test for doping.

Follow exactly the administration instructions of this medication 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 discontinue treatment before, even if you feel better.

It is essential to inhale each dose as instructed by your doctor.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 1 to 4 years of age:2 applications twice a day (100 micrograms twice a day), administered through a pediatric inhalation chamber provided with a mask (such as Babyhaler).

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

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

This medication may take some days to take effect. Therefore, it is very important to use it regularly. Inform your doctor and discontinue treatment if breathing or wheezing worsens after using Flixotide 50 micrograms/inhalation. Inform your doctor if breathing difficulties or wheezing worsen or do not improve within 7 days, or if you notice an increase in the use of other inhalation medications.

Do not use this medication to treat a sudden asthma attack; it will not help. You will need a different medication for this. If you are using multiple medications, be careful not to confuse them.

If you estimate that the effect 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 pressing it gently on the sides,shake the inhaler thoroughlyand release two doses into the air to ensure the inhaler is functioning properly.

Using the inhaler:

1.Remove the mouthpiece protector by pressing it gently on the sides.

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

3.Shake the inhaler cartridge well to ensure the removal of any foreign particles and that the inhaler contents are mixed properly.

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

5.Breathe in as much air as reasonably possible and then insert the mouthpiece into your mouth, between your teeth, closing your lips over the device but not biting it.

6.Immediately after starting to breathe in, press the inhaler to release fluticasone propionate and continue breathing in deeply and constantly.

7.Hold your breath and remove the inhaler from your mouth. Continue holding your breath as long as reasonably possible.

8.If you are to administer another inhalation, hold the inhaler vertically and wait for approximately half a minute before repeating steps 3 to 7.

9.Afterwards, rinse your mouth with water and spit it out.

10.Replace the mouthpiece protector 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 times. If you notice a "fog" coming out of the top of the inhaler or from the sides of your mouth, start again from step 2.

Patients who find it difficult to coordinate the inhaler management with inhalation may use an appropriate inhalation chamber.

If your doctor gives 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 breathe in and press the inhaler just after the child starts breathing in. Practice together the technique.

Older children or people with fragile hands should hold the inhaler with both hands; for this, they will 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.

a.Remove the mouthpiece protector.

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

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

d.Replace the mouthpiece protector.

Do not immerse 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 Poison Information Service, phone 91 562 04 20 or inform your doctor immediately or go to the nearest emergency hospital. Bring this leaflet with you.

If you forget to useFlixotide 50 micrograms/inhalation

Do not inhale a double dose to compensate for the missed ones. If you forget a dose, wait for the next dose.

If you discontinue treatment with Flixotide 50 micrograms/inhalation

It is very important to use this medication every day as indicated. Do not stop using Flixotide 50 micrograms/inhalation unless your doctor tells you to, as this could make your breathing worse. Do not abruptly discontinue treatment with this medication.

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

Some people may develop fungal infections in the mouth (candidiasis) and experience throat or tongue pain, or have a hoarse voice after inhaling this medicine. To prevent 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 he tells you to.

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

• sudden onset of wheezing or chest tightness
• swelling of eyelids, face, lips, tongue, or throat
• skin rash (hives) or urticaria in any part of 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)

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

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

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

Uncommon (may affect less than 1 in 100 people)

• cutaneous 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 erythema, edema, and pruritus), mainly facial and oropharyngeal edema
• respiratory symptoms such as dyspnea (sensation of lack of air or difficulty breathing) and/or bronchospasm (narrowing of the bronchial walls with decreased air entry)
• 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 seizures
• delayed growth in children and adolescents
• decreased bone mineral density
• cataracts and glaucoma
• hyperglycemia (elevated blood glucose levels). If you have diabetes, you may need to monitor 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 entry, after using the inhaler).

Frequency not known

• nasal bleeding
• blurred vision.

Reporting of 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:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Immediately after use, replace the mouthpiece cover by pushing it firmly until you hear a click. Excessive force is not required.

Do not store at a temperature above 30°C. Do not freeze. Store in the original packaging to protect it from light.

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

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

Keep this medication out of 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 empty.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. In case of doubt ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofFlixotide 50 micrograms/inhalation

• The active ingredient is50 micrograms of fluticasone propionate per application.
• The other component is norflurano c.s.

This medicine contains fluorinated greenhouse gases.

Each inhaler contains 10.6 g of HFC-134a (also known as norflurano or HFA 134a) corresponding to 0.0152 tonnes of CO2equivalent (global warming potential PCG = 1,430).

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible manufacturer

Holderof the marketing authorization:

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Responsible manufacturer:

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

23 rue Lavoisier
27000 - Evreux

France

or

Glaxo Wellcome S.A.
Avenida Extremadura, 3
09400 Aranda de Duero (Burgos)

Spain

or

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

Last review date of this leaflet:01/2025

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