Flixotide 50 micrograms/inhalation, suspension for inhalation in pressurized container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Flixotide 50 micrograms/inhalation, suspension for inhalation in pressurized container

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 you should not give it to others, even if they have the same symptoms as you, because it could 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 package leaflet

1. What Flixotide 50 micrograms/inhalation is and what it is used for
2. What you need to know before using Flixotide 50 micrograms/inhalation
3. How to use Flixotide 50 micrograms/inhalation
4. Possible side effects
5. Storage of Flixotide 50 micrograms/inhalation
6. Contents of the pack and other information

1. What Flixotide 50 micrograms/inhalation is and what it is used for

Fluticasone propionate belongs to the group of medicines 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, thereby decreasing breathing difficulties. Corticosteroids also help prevent asthma attacks.

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

2. What you need to know before using Flixotide 50 micrograms/inhalation

Do not use Flixotide 50 micrograms/inhalation

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

Warnings and precautions

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

• if you have ever had to stop using this or any other medicine for treating 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 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 prior to 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 for 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

Regular monitoring of height is advisable.

Other medicines and Flixotide 50 micrograms/inhalation

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

Some medicines may increase the effects of Flixotide 50 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 operate machinery.

Warning for athletes

Athletes are advised that this medicine contains a component that may lead to a positive analytical finding in doping controls.

3. How to use Flixotide 50 micrograms/inhalation

Follow exactly the instructions for administering this medicine 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 take Flixotide 50 micrograms/inhalation. Do not stop treatment early, even if you feel better.

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

Adults and adolescents over 16 years of age: 2 to 10 actuations twice daily (100 to 500 micrograms twice daily).

Children over 4 years of age: 1 to 2 actuations twice daily (50 to 100 micrograms twice daily).

Children from 1 to 4 years of age: 2 actuations twice daily (100 micrograms twice daily), administered using a paediatric spacer device with a face mask (such as Babyhaler).

Your doctor will decide the dose, frequency of administration, and type of inhaler.

Do not inhale more doses or use Flixotide 50 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 Flixotide 50 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 think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

Instructions for correct use of Flixotide 50 micrograms/inhalation

Checking the inhaler:

Before using the inhaler for the first time, or if it has not been used for one week or longer, remove the mouthpiece protector by gently squeezing the sides, shake the inhaler well, and release two doses into the air to ensure the inhaler is working properly.

Using the inhaler:

1. Remove the mouthpiece protector by gently squeezing the sides.

2. Check that there are no foreign particles inside or outside the inhaler, including the mouthpiece.

3. Shake the inhaler well to ensure any foreign particles are removed and the contents are properly mixed.

4. Hold the inhaler vertically between your index finger and thumb, placing your thumb on the base, below the mouthpiece.

5. Breathe out as fully as possible, then place the mouthpiece in your mouth between your teeth, closing your lips around it without biting.

6. Immediately after starting to inhale through your mouth, press down on the inhaler to release fluticasone propionate, and continue inhaling deeply and steadily.

7. Hold your breath and remove the inhaler from your mouth. Continue holding your breath for as long as comfortably possible.

8. If another inhalation is needed, keep the inhaler upright and wait about half a minute before repeating steps 3 to 7.
9. Afterwards, rinse your mouth with water and spit it out.
10. Replace the mouthpiece protector by firmly pushing and fitting it until you hear a click.

Important

Do not carry out steps 5, 6, and 7 too quickly. It is important to start inhaling as slowly as possible, just before pressing the inhaler. Practise in front of a mirror the first few times. If you see a "mist" escaping from the top of the inhaler or from the sides of your mouth, start again from step 2.

Patients who have difficulty coordinating the use of the inhaler with inhalation may use an appropriate spacer device.

If your doctor gives different instructions, follow them carefully. Consult your doctor or pharmacist if you have any difficulties.

Use in children:

Young children may need help, with an adult operating the inhaler for them. Encourage the child to breathe out, and activate the inhaler just after the child begins to inhale. Practise the technique together.

Older children or people with weak hands should hold the inhaler with both hands; place both index fingers on the top of the inhaler and both thumbs on the base, below the mouthpiece.

Cleaning

Clean the inhaler at least once a week.

• Remove the mouthpiece cap.

• Do not remove the metal cartridge from the plastic holder.

• Clean the inside and outside of the mouthpiece with a dry tissue or cloth.

• Replace the mouthpiece cap.

Do not immerse the metal cartridge in water.

If you use more Flixotide 50 micrograms/inhalation than you should

If you have used more Flixotide 50 micrograms/inhalation than you should, contact the Toxicology Information Service, telephone 91 562 04 20, or inform your doctor immediately, or go to the nearest hospital emergency department. Take this leaflet with you.

If you forget to use Flixotide 50 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 50 micrograms/inhalation

It is very important that you use this medicine every day as directed. Do not stop using Flixotide 50 micrograms/inhalation unless your doctor tells you to, as this could cause your breathing to worsen. Do not stop treatment with this medicine 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 50 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 cough 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 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 behavioral changes 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 50 micrograms/inhalation

Immediately after use, replace the mouthpiece cap by pushing it firmly until you hear a click. Do not use excessive force.

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 warm it.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Keep this medicine out of the sight and reach of children.

The cartridge contains a pressurised liquid. Do not expose to temperatures above 50°C. Do not pierce, break or burn the cartridge, even if it appears to be empty.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Flixotide 50 micrograms/inhalation

• The active substance is 50 micrograms of fluticasone propionate per dose.
• The other component is norflurane q.s.

This medicinal product contains fluorinated greenhouse gases.

Each inhaler contains 10.6 g of HFC-134a (also known as norflurane or HFA 134a), equivalent to 0.0152 tonnes of CO2 (global warming potential GWP = 1,430).

Appearance of the product and contents of the pack

Flixotide 50 micrograms/inhalation is a pressurised suspension for inhalation, free from chlorofluorocarbon propellants. Each cartridge provides 120 doses.

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 S.A.S.
Zone Industrielle Nº 2
23 rue Lavoisier
27000 - Evreux
France

or

Glaxo Wellcome S.A.
Avenida Extremadura, 30
09400 Aranda de Duero (Burgos)
Spain

or

GlaxoSmithKline Pharmaceuticals, S.A.
ul. Grunwaldzka, 189 (Poznan) - 60-322 - Poland

Date of the most recent revision of this leaflet: 01/2025

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/