Trialona Accuhaler 500 micrograms/inhalation, powder for inhalation

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Trialona Accuhaler 500 micrograms/inhalation, inhalation powder

Fluticasone propionate

Read the entire package leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Package leaflet contents

1. What Trialona Accuhaler 500 micrograms/inhalation is and what it is used for
2. What you need to know before using Trialona Accuhaler 500 micrograms/inhalation
3. How to use Trialona Accuhaler 500 micrograms/inhalation
4. Possible adverse effects
5. How to store Trialona Accuhaler 500 micrograms/inhalation
6. Contents of the pack and other information

1. What Trialona Accuhaler 500 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, thereby decreasing breathing difficulties. Corticosteroids also help prevent asthma attacks.

Trialona Accuhaler 500 micrograms/inhalation is recommended for the treatment of moderate to severe asthma and chronic obstructive pulmonary disease (COPD) in adults.

2. What you need to know before using Trialona Accuhaler 500 micrograms/inhalation

Do not use Trialona Accuhaler 500 micrograms/inhalation

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Trialona Accuhaler 500 micrograms/inhalation:

• if you have ever had to stop using this or any other medicine for your condition due to an allergy or other problem
• if you notice that you increasingly require higher use of this medicine for adequate symptom control, your treatment should be reviewed
• if you have ever had mouth ulcers/lesions
• if you have any liver disease
• if you have recently received or are currently receiving treatment for tuberculosis, or if you are taking other corticosteroids orally or by inhalation
• if you are under periods of high stress or are admitted to hospital following a serious injury or accident, or before undergoing surgery, and are being treated with high doses of inhaled steroids, you may require additional steroid administration
• if you have diabetes mellitus (Trialona may increase blood sugar levels)
• if your breathing worsens immediately after using this medicine, stop using it immediately and contact your doctor as soon as possible

Trialona should not be used during acute attacks but only as a long-term maintenance treatment, and discontinuation of the medicine should be done gradually.

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

Children and adolescents

Trialona Accuhaler 500 micrograms/inhalation is not indicated for use in children. Other formulations of Trialona are more appropriate for the treatment of children and adolescents under 16 years of age.

Use of Trialona Accuhaler 500 micrograms/inhalation with other medicines

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

Some medicines may increase the effects of Trialona Accuhaler 500 micrograms/inhalation, so your doctor will monitor you closely if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

Oral medicines used to treat 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

It is unlikely that Trialona will affect your ability to drive or operate machinery.

Trialona Accuhaler 500 micrograms/inhalation contains lactose. It may cause allergic reactions in patients with allergy to cow's milk protein. If your doctor has told you that you have an intolerance to certain sugars, consult with him before using this medicine.

Warning for athletes

Athletes are advised that this medicine contains a component that may result in a positive analytical finding in doping control tests.

3. How to use Trialona Accuhaler 500 micrograms/inhalation

Follow exactly the administration instructions for Trialona Accuhaler 500 micrograms/inhalation as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to use your medicine regularly.

Your doctor will tell you how long to continue treatment with Trialona Accuhaler 500 micrograms/inhalation. Do not stop treatment early, even if you feel better.

It is important to inhale each dose exactly as instructed by your doctor. The usual dose is:

• ASTHMA

Adults and adolescents over 16 years of age: 1–2 inhalations twice daily (500 to 1,000 micrograms twice daily).

• CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD):

Adults: One inhalation twice daily (500 micrograms twice daily).

The inhalations of Trialona Accuhaler 500 micrograms/inhalation must not be swallowed, but inhaled to reach the lungs. You may not taste or feel the powder on your tongue, even if you have used the Accuhaler correctly. Consult your doctor or pharmacist if you have any doubts about how to use this medicine.

Do not inhale more doses or use Trialona Accuhaler 500 micrograms/inhalation more often than prescribed by your doctor.

This medicine may take several days to become effective. Therefore, it is very important to use it regularly. Inform your doctor and stop treatment if your breathing or wheezing worsens after using Trialona Accuhaler 500 micrograms/inhalation. Inform your doctor if breathing difficulties or wheezing worsen or do not improve within 7 days, or if you notice an increased need for other inhaled medicines.

Do not use this medicine to treat a sudden attack of breathlessness, as it will not help. For such attacks, you will need a different medicine. If you use more than one medicine, be careful not to confuse them.

If you think the effect of Trialona Accuhaler 500 micrograms/inhalation is too strong or too weak, tell your doctor or pharmacist.

Instructions for correct use of Trialona Accuhaler 500 micrograms/inhalation

The device is packaged in an aluminum foil wrapper to protect it from moisture. This should only be opened when first used. Once the aluminum wrapper is opened, it should be discarded. The device has two positions: closed and open.

CLOSED

When you open the case and remove the device from the aluminum wrapper for the first time, it will be closed.

OPEN

The device contains 60 individual doses of the medicine in powder form. The dose indicator shows how many doses remain.

Each dose is precisely measured and hygienically protected. No maintenance or refilling is required.

The dose indicator, located on the top of the device, shows how many doses are left. The numbers from 5 to 0 will appear in RED to warn that only a few doses remain.

The device is easy to use. When a dose is needed, follow these five simple steps:

1. Open.
2. Slide.
3. Inhale.
4. Close.
5. Rinse.

How the device works

When the lever of the device is slid, a small opening in the mouthpiece becomes available, and one pre-measured dose is ready to inhale. When the device is closed, the lever automatically returns to its original position, ready for the next dose. The outer casing protects the device when not in use.

1. Open:

To open the device, hold the outer casing in one hand and place the thumb of your other hand in the designated groove. Push with your thumb away from you as far as it will go.

2. Slide:

Keep the device with the mouthpiece facing you. Slide the lever away from you as far as it will go – you will hear a "click" sound. The device is now ready for use. Each time the lever is pulled back, one dose becomes available for inhalation. This is indicated by the dose counter. Do not manipulate the lever unnecessarily, as this may waste doses.

3. Inhale:

• Before inhaling a dose, read this entire section carefully.
• Keep the device away from your mouth. Breathe out as much as reasonably possible – DO NOT breathe out INTO the device.
• Place the mouthpiece in your mouth. Breathe in steadily and deeply – THROUGH THE DEVICE, NOT through your nose.
• Remove the device from your mouth.
• Hold your breath for about 10 seconds, or as long as possible.
• Breathe out slowly.

4. Close:

To close the device, place your thumb in the designated groove and slide it toward you as far as it will go.

When closing the device, you will hear a distinct click. The lever automatically returns to its original position and is reset. The device is now ready for reuse.

5. Rinse:

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

If your doctor has prescribed two inhalations, close the device and repeat steps 1 to 5.

REMEMBER

Keep the device dry.

Keep the device closed when not in use.

Do not breathe out into the device.

Slide the lever only when you are ready to inhale a dose.

Consult your doctor or pharmacist if you have any doubts.

If you use more Trialona Accuhaler 500 micrograms/inhalation than you should

If you have used more Trialona Accuhaler 500 micrograms/inhalation than prescribed, contact the Toxicology Information Service at telephone 91 562 04 20, inform your doctor immediately, or go to the nearest hospital emergency department. Take this leaflet with you.

If you forget to use Trialona Accuhaler 500 micrograms/inhalation

Do not inhale a double dose to make up for a missed dose. If you forget a dose, wait and take the next dose at the usual time.

If you stop using Trialona Accuhaler 500 micrograms/inhalation

It is very important that you use Trialona Accuhaler 500 micrograms/inhalation every day as prescribed. Do not stop using it unless your doctor tells you to, as this could cause your breathing to worsen. Do not stop treatment with Trialona Accuhaler 500 micrograms/inhalation abruptly.

4. Possible adverse effects

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

Some people may develop fungal infections in the mouth (candidiasis) and experience throat or tongue pain, or hoarseness of voice after inhaling this medicine. To prevent this, it is recommended to brush your teeth, rinse your mouth, or gargle with water and spit it out immediately after inhaling each dose. Inform your doctor, but do not stop treatment unless instructed by your doctor.

If you experience any of the following symptoms after using Trialona Accuhaler 500 micrograms/inhalation, stop using this medicine and contact your doctor immediately:

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

Other adverse 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 causing breathing difficulties).

Tell your doctor if you experience any of the following symptoms while inhaling fluticasone propionate. These could be symptoms of a lung infection:

• fever or chills
• increased mucus production, change in mucus color
• increased coughing or worsening breathing difficulties
• 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 erythema, swelling, and itching), mainly facial and oropharyngeal edema
• respiratory symptoms such as dyspnea (shortness of breath or difficulty breathing) and/or bronchospasm (narrowing of the bronchial walls leading to reduced airflow)
• anaphylactic reactions (severe allergic reactions which may cause a sudden drop in blood pressure and loss of consciousness)
• rounded face (moon face) (Cushing's syndrome)
• adrenal gland suppression, which may cause fatigue, weight loss, nausea, vomiting, headache, low blood pressure, numbness, and seizures
• growth retardation in children and adolescents
• decreased bone mineral density
• cataracts and glaucoma
• hyperglycemia (increased blood glucose 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 disturbances including hyperactivity and irritability (mainly in children)
• paradoxical bronchospasm (temporary narrowing of the bronchial walls with reduced airflow following inhaler use).

Frequency not known

• nosebleeds
• blurred vision.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Trialona Accuhaler 500 micrograms/inhalation

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

Keep the device in the aluminium wrapper until first use. Discard the wrapper once opened.

Keep out of the sight and reach of children.

Do not use Trialona Accuhaler 500 micrograms/inhalation after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Trialona Accuhaler 500 micrograms/inhalation

• The active substance is 500 micrograms of fluticasone propionate per inhalation (blister).
• The other component is lactose monohydrate (contains milk proteins).

Appearance of the product and contents of the pack

Pack containing a device with 60 blisters of powder for oral inhalation. The device is packaged within an aluminium foil wrapper.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

Zone Industrielle Nº2

23 Rue Lavoisier,

27000 Evreux

France

Date of the most recent revision of this leaflet: January 2022.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/