Flixotide Accuhaler 100 micrograms/inhalation, inhalation powder

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Flixotide Accuhaler 100 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 may 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.

Contents of the package leaflet

1. What Flixotide Accuhaler 100 micrograms/inhalation is and what it is used for
2. What you need to know before using Flixotide Accuhaler 100 micrograms/inhalation
3. How to use Flixotide Accuhaler 100 micrograms/inhalation
4. Possible adverse effects
5. How to store Flixotide Accuhaler 100 micrograms/inhalation
6. Contents of the pack and other information

1. What Flixotide Accuhaler 100 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 action. 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 100 micrograms/inhalation is recommended for the treatment of mild to severe asthma.

2. What you need to know before using Flixotide Accuhaler 100 micrograms/inhalation

Do not use Flixotide Accuhaler 100 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 100 micrograms/inhalation:

• if you have ever had to stop using this or any other medicine for treatment of your condition 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 receiving treatment for tuberculosis, or if you are taking other corticosteroids by mouth 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 (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 during acute attacks, but rather as a regular long-term treatment. Discontinuation of the medicine should be carried out gradually.

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

Children and adolescents

Flixotide Accuhaler 100 micrograms/inhalation is not indicated for use in children under 4 years of age. Other Flixotide formulations are more suitable for treating children under 4 years of age.

For treatment of children over 4 years of age, periodic monitoring of height is advisable.

Use of Flixotide Accuhaler 100 micrograms/inhalation with other medicines

Inform your doctor or pharmacist if you are using or 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 100 micrograms/inhalation, so your doctor will carry out careful monitoring if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

Oral medicines for the treatment of 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 Flixotide will affect your ability to drive or use machines.

Flixotide Accuhaler 100 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 doping control test.

3. How to use Flixotide Accuhaler 100 micrograms/inhalation

Follow exactly the instructions for using Flixotide Accuhaler 100 micrograms/inhalation as given by your doctor. If in doubt, please consult your doctor or pharmacist again.

Remember to use your medicine.

Your doctor will tell you how long to use Flixotide Accuhaler 100 micrograms/inhalation. Do not stop treatment earlier, even if you feel better.

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

Adults and adolescents over 16 years of age: 1-2 inhalations twice daily (100 to 200 micrograms twice daily).

Children over 4 years of age: 1 inhalation twice daily (100 micrograms twice daily).

The contents of the inhalations from Flixotide Accuhaler 100 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 100 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 100 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 such attacks, you will need a different medicine. If you are using more than one medicine, be careful not to confuse them.

If you feel that the effect of Flixotide Accuhaler 100 micrograms/inhalation is too strong or too weak, tell your doctor or pharmacist.

Instructions for correct use of Flixotide Accuhaler 100 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 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 in the closed position.

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 you slide the lever of the device, a small opening in the mouthpiece or inhaler is released, making a pre-measured dose available for inhalation. When the device is closed, the lever automatically returns to its original position, ready for the next dose needed. 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 your other hand in the designated groove. Push with your thumb away from you as far as it will go.

2. Slide:

Hold 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, a dose becomes available for inhalation, as indicated by the dose counter. Do not touch or manipulate the lever unnecessarily, as this may release doses that will then be wasted.

3. Inhale:

• Before inhaling a dose, read carefully all the instructions in this section.
• Keep the device away from your mouth. Breathe out as much air as reasonably possible – DO NOT breathe out INTO the device.
• Place the mouthpiece between 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 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 resets. The device is now ready for its next use.

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 questions.

If you use more Flixotide Accuhaler 100 micrograms/inhalation than you should

If you have used more Flixotide Accuhaler 100 micrograms/inhalation than prescribed, contact the Toxicology Information Service at telephone number 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 100 micrograms/inhalation

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

If you stop using Flixotide Accuhaler 100 micrograms/inhalation

It is very important that you use Flixotide Accuhaler 100 micrograms/inhalation every day as directed. Do not stop using Flixotide Accuhaler 100 micrograms/inhalation unless your doctor tells you to, as this could cause your breathing to worsen. Do not stop treatment with Flixotide Accuhaler 100 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 or 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 to do so by your doctor.

If you experience any of the following symptoms after using Flixotide Accuhaler 100 micrograms/inhalation, stop using this medicine and contact your doctor immediately:

• sudden onset of wheezing or chest tightness
• swelling of eyelids, face, lips, tongue, or throat
• skin rash (wheals) or hives 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
• worsening cough or increased 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 dyspnea (feeling of breathlessness 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 with loss of consciousness)
• rounded face (moon face) (Cushing's syndrome)
• suppression of adrenal gland activity, 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 disturbances including hyperactivity and irritability (mainly in children)
• paradoxical bronchospasm (temporary narrowing of the bronchial walls with reduced airflow, occurring after using the inhaler).

Frequency not known

• nosebleeds
• blurred vision.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Flixotide Accuhaler 100 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 Flixotide Accuhaler 100 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 must 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 unsure, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Package contents and other information

Composition of Flixotide Accuhaler 100 micrograms/inhalation

• The active substance is 100 micrograms of fluticasone propionate per inhalation (blister).
• The other component is lactose monohydrate (contains milk proteins).

Appearance of the medicine and contents of the pack

Pack containing a device with 60 blisters of oral inhalation powder. The device is packaged within an aluminum 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/