Flixotide Accuhaler 500 micrograms/inhalation, powder for inhalation

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Flixotide Accuhaler 500 micrograms/inhalation, powder for inhalation

fluticasone propionate

Read the entire patient information 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, consult 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, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Flixotide Accuhaler 500 micrograms/inhalation is 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. How to store Flixotide Accuhaler 500 micrograms/inhalation
6. Contents of the pack and other information

1. What Flixotide 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.

Flixotide 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 Flixotide Accuhaler 500 micrograms/inhalation

Do not use Flixotide 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 due to allergy or any 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 severe 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 (Flixotide 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

Flixotide 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

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

Use of Flixotide 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 Flixotide 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

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

Flixotide Accuhaler 500 micrograms/inhalation contains lactose. It may cause allergic reactions in patients with allergy to cow's milk protein. If your doctor has informed 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 controls.

3. How to use Flixotide Accuhaler 500 micrograms/inhalation

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

Remember to use your medicine.

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

It is important to inhale each dose exactly as directed 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 contents of Flixotide 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 Flixotide Accuhaler 500 micrograms/inhalation more often than prescribed by your doctor.

This medicine may take several days to take effect. Therefore, it is very important to use it regularly. Inform your doctor and stop treatment if your breathing or wheezing worsens after using Flixotide Accuhaler 500 micrograms/inhalation. Inform your doctor if breathing difficulties or wheezing worsen or do not improve within 7 days, or if you notice you are increasing your use of other inhaled medicines.

Do not use this medicine to treat a sudden attack of breathlessness, as it will not help. 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 effect of Flixotide Accuhaler 500 micrograms/inhalation is too strong or too weak, tell your doctor or pharmacist.

Instructions for correct use of Flixotide Accuhaler 500 micrograms/inhalation

The device is packaged in an aluminum 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 opening the pack and removing 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 counter indicates how many doses remain.

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

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

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

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

How the device works

When the lever on 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, preparing it for the next dose. The outer casing protects the device when 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 designated slot. 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". The device is now ready for use. Each time the lever is pulled back, one dose becomes available for inhalation. This is shown by the dose counter. Do not manipulate the lever, as this may waste available doses.

3. Inhale:

• Before starting to inhale a dose, read this entire section carefully.
• Keep the device away from your mouth. Breathe out as much air as reasonably possible – DO NOT do this INTO the device.
• Place the mouthpiece in your lips. 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 slot 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 resets. 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 A to E.

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 Flixotide Accuhaler 500 micrograms/inhalation than you should

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

If you forget to use Flixotide Accuhaler 500 micrograms/inhalation

Do not inhale a double dose to make up for a missed dose. If you miss a dose, wait until your next scheduled dose.

If you stop using Flixotide Accuhaler 500 micrograms/inhalation

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

4. Possible adverse effects

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

Some people may develop fungal infections in the mouth (candidiasis) and experience sore throat or tongue, or hoarseness 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 Flixotide Accuhaler 500 micrograms/inhalation, stop using this medicine and contact your doctor immediately:

• sudden onset of wheezing or chest tightness
• 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 signs 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)

• oesophageal 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 dyspnoea (shortness of breath or difficulty breathing) and/or bronchospasm (narrowing of the bronchial walls reducing 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, possibly causing 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
• hyperglycaemia (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 behavioural changes including hyperactivity and irritability (mainly in children)
• paradoxical bronchospasm (temporary narrowing of the bronchial walls with reduced airflow after using the inhaler).

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 may also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Flixotide Accuhaler 500 micrograms/inhalation

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

Keep the device in the aluminum foil wrapper until first use. Discard the wrapper after opening.

Keep out of the sight and reach of children.

Do not use Flixotide 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 collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Flixotide 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 medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/