Leaflet: information for the user

Flixotide Accuhaler 500 micrograms/inhalation, powder for inhalation

fluticasone propionate

Read this leaflet carefully before you start using this medicine, because 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What is Flixotide Accuhaler 500 micrograms/inhalation and what it is used for

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

3.How to use Flixotide Accuhaler 500 micrograms/inhalation

4.Possible side effects

5.Storage of Flixotide Accuhaler 500 micrograms/inhalation

6.Contents of the pack and additional information

Fluticasone propionate belongs to a group of medications 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 Accuhaler 500 micrograms/inhalation is recommended for the treatment in adults of moderate to severe asthma and chronic obstructive pulmonary disease (COPD).

No useFlixotide 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

Consult your doctor, pharmacist, or nurse before starting to use Flixotide Accuhaler 500 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 increase your use of this medicine for adequate control of symptoms, 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 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 admitted to hospital after an injury or accident or before a surgical operation and are being treated with high doses of inhaled steroids, you may need additional steroid treatment
• 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 inform your doctor as soon as possible

Flixotide should not be used for acute attacks but as long-term habitual treatment, and the withdrawal of the medicine should be done gradually.

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

Children and adolescents

Flixotide Accuhaler 500 micrograms/inhalation is not indicated for use in children. There are other Flixotide presentations more suitable for the treatment of children and adolescents under 16 years.

Use ofFlixotide Accuhaler 500 micrograms/inhalationwith other medicines

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

Some medicines may increase the effects of Flixotide Accuhaler 500 micrograms/inhalation, so your doctor will perform close monitoring 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 described. However, 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, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

Flixotide is unlikely to affect your ability to drive or operate machinery.

Flixotide Accuhaler 500 micrograms/inhalation contains lactose.Lactose may cause allergic reactions in patients with a milk protein allergy. If your doctor has told you that you have an intolerance to certain sugars, consult with them before using this medicine.

Warning to athletes

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

Follow exactly the administration instructions forFlixotide Accuhaler 500 micrograms/inhalationas 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 Accuhaler 500 micrograms/inhalation. Do not stop treatment before, even if you feel better.

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

• ASTHMA

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

• CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD):

Adults:One application twice a day (500 micrograms twice a day).

The content of Flixotide Accuhaler 500 micrograms/inhalation applications should not be ingested, but inhaled to reach the lungs. It may not be possible to 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 using this medication.

Do not inhale more doses or use Flixotide Accuhaler 500 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 Accuhaler 500 micrograms/inhalation. Inform your doctor if respiratory 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, 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 action of Flixotide Accuhaler 500 micrograms/inhalation is too strong or too weak, inform your doctor or pharmacist.

Instructions for the correct use of Flixotide Accuhaler 500 micrograms/inhalation

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

CLOSED

When opening the case and removing the device from the aluminum foil wrapper for the first time, it will be closed.

OPEN

The device contains 60 individual doses of the medication in powder form. The dose indicator shows how many doses are left.

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 5 to 0 will appear in RED to warn that there are few doses left.

The device is easy to handle. When a dose is needed, follow the five simple instructions below:

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

Device operation

When the device is slid, a small hole opens in the mouthpiece or mouthpiece and a prepared dose becomes available for inhalation. When the device is closed, the slide automatically returns to its original position, ready for the next dose that is needed. The outer casing protects the device when it is not in use.

1. Open:

To open the device, hold the outer casing with one hand and place the thumb of the other hand in the reserved hole. Push with the thumb, moving it away from you, until it reaches.

1. Slide:

Hold the device with the mouthpiece towards you. Slide the slide, moving it away, until it clicks. The device is ready for use. Each time the slide is moved back, a dose becomes available for inhalation. This is shown by the dose counter. Do not manipulate the slide, as doses will be wasted.

1. Inhale:

-Before starting to inhale a dose, read this section carefully.

-Hold the device away from your mouth. Exhale as much as possible - DO NOT do it INSIDE the device.

-Place the mouthpiece in your mouth. Take a deep and intense breath - THROUGH THE DEVICE, NOT THROUGH YOUR NOSE.

-Remove the device from your mouth.

-Hold your breath for 10 seconds or as long as possible.

-Exhale slowly.

1. Close:

To close the device, place the thumb in the reserved hole and slide it towards you, until it reaches.

When closing the device, a dry sound will be heard. The slide automatically returns to its original position and is ready to be used again.

1. Swallow:

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

If your doctor has prescribed two inhalations, close the device and repeat the instructions A to E.

RECORDER

Keep the device dry.

Keep the device closed when not in use.

Do not exhale inside the device.

Only slide the slide when ready to inhale a dose.

Consult your doctor or pharmacist if you have doubts.

If you use moreFlixotide Accuhaler 500 micrograms/inhalationthan you should

If you have used more Flixotide Accuhaler 500 micrograms/inhalation than you should, consult the Toxicological Information Service, phone 91 562 04 20 or inform your doctor immediately or go to the nearest hospital emergency room. Bring this leaflet with you.

If you forget to useFlixotide Accuhaler 500 micrograms/inhalation

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

If you interrupt treatment with Flixotide Accuhaler 500 micrograms/inhalation

It is very important to use Flixotide Accuhaler 500 micrograms/inhalation every day as indicated. Do not stop using Flixotide Accuhaler 500 micrograms/inhalation unless your doctor tells you to, as this could make your breathing worse. Do not abruptly stop treatment with Flixotide Accuhaler 500 micrograms/inhalation.

Like all medicines,this medicinecan 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 Accuhaler 500 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.

Rare (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 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 convulsions
• 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).

Unknown frequency

• 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.

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

Store the device in the aluminum wrapper until it is used for the first time. Dispose of the wrapper once opened.

Keep out of the sight and reach of children.

Do not useFlixotide Accuhaler 500 micrograms/inhalationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition ofFlixotide Accuhaler 500 micrograms/inhalation

• The active ingredient is500 micrograms of fluticasone propionate per inhalation (alveolus).
• The other component is lactose monohydrate (contains milk proteins).

Appearance of the product and contents of the packaging

Packaging with a device containing 60 alveoli with oral inhalation powder. The device is packaged within an aluminum wrapper.

Holder of the marketing authorization and 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]

Manufacturer:

Glaxo Wellcome Production

Zone Industrielle Nº2

23 Rue Lavoisier,

27000 Evreux

France

Last review date of this leaflet:January 2022.

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