TRIALONA 50 micrograms/inhalation, pressurized inhaler suspension

Introduction

Package Leaflet: Information for the User

T

Fluticasone Propionate

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, 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 package leaflet. See section 4.

Contents of the Package Leaflet

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

5 Storage of Trialona 50 micrograms/inhalation

1. Contents of the pack and further information

1. What is Trialona 50 micrograms/inhalation and what is it 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.

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

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

Do not useTrialona 50 micrograms/inhalation

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

Warnings and Precautions

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

• if you have ever had to stop using this or any other medication for the treatment of your disease due to an allergy or any other problem
• if you notice that you need to increase the use of this medication 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 (Trialona 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

Trialona should not be used for acute attacks, but as regular 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 Trialona 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 Trialona 50 micrograms/inhalation, so your doctor will monitor you closely 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 reported. 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

It is unlikely that Trialona will 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 Trialona 50 micrograms/inhalation

Follow your doctor's instructions for using this medication exactly. If you are in doubt, consult your doctor or pharmacist again.

Remember to use your medication.

Your doctor will indicate the duration of treatment with Trialona 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: 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 will decide the dose and frequency of administration, as well as the type of inhaler.

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

This medication may take a few days to take effect. Therefore, it is crucial to use it regularly. Inform your doctor and interrupt treatment if your breathing or wheezing worsens after using Trialona 50 micrograms/inhalation. Inform 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 medications.

Do not use this medication to treat a sudden asthma attack; you will need a different medication for that. 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 Trialona 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 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 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 you can.

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 cover 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.

Patient who have difficulty coordinating 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; an adult should handle 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 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 moreTrialona 50 micrograms/inhalationthan you should

If you have used more Trialona 50 micrograms/inhalation than you should, consult the Toxicological 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 useTrialona 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 using Trialona 50 micrograms/inhalation

It is very important that you use this medication every day as indicated. Do not stop using Trialona 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 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 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 Trialona 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)

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

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 production of mucus, change in the color of mucus
• increased coughing or increased breathing difficulties
• 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 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 monitor 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 package 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. Storage of Trialona 50 micrograms/inhalation

Immediately after use, replace the mouthpiece cover 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 stated on the packaging after EXP. 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 pierce, 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 ofTrialona 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

Trialona 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 Lavoisier

27000 - Evreux

France

or

Glaxo Wellcome S.A.

Avenida Extremadura, 3

09400 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/