Leaflet: information for the user

Flusonal 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 give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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 air passages in the lungs and thus decrease respiratory problems. Corticosteroids also help prevent asthma attacks.

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

Do not use Flusonal 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 useFlusonal Accuhaler 500micrograms/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 use more of this medicine to control your symptoms adequately, 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 surgery and are being treated with high doses of inhaled steroids, you may need additional steroids
• if you have diabetes mellitus (Flusonal 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.

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

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

Children and adolescents

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

Use of Flusonal Accuhaler 500 micrograms/inhalationwithother medicines

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

Some medicines may increase the effects of Flusonal Accuhaler 500 micrograms/inhalation, so your doctor will make close checks 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, consultyour doctor or pharmacist before using this medicine.

Driving and operating machines

It is unlikely thatFlusonalwill affect your ability to drive or operate machines.

Flusonal Accuhaler 500 micrograms/inhalation contains lactose.It may cause allergic reactions in patients with milk protein allergy.If your doctor has told you that you are intolerant to certain sugars, consult with him before using this medicine.

Warning to athletes

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

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

It is essential to inhale each dose as instructed by your doctor. The normal dose is:

• ASTHMA

Adults and adolescents over 16 years old:1-2 applications twice a day (500 to1,000 micrograms twice a day).

• CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD):

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

The content of Flusonal Accuhaler 500 micrograms/inhalation applications should not be ingested, but inhaled to reach the lungs. You may not be able to taste or feel the powder in 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 Flusonal 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 your breathing or wheezing worsens after using Flusonal Accuhaler 500 micrograms/inhalation. Inform your doctor if your 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, as 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 effect of Flusonal Accuhaler 500 micrograms/inhalation is too strong or too weak, inform your doctor or pharmacist.

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

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

CLOSED

When you first remove the device from the aluminum envelope, 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 at the top of the device, shows how many doses are left. The numbers from 5 to 0 will appear in RED to warn you that there are few doses left.

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

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

Device Functioning

When you slide the device's lever, a small opening is created in the mouthpiece or mouthpiece, and a prepared dose is available for inhalation. When you close the device, the lever automatically returns to its original position, ready for the next dose you need. The outer casing protects the device when not in use.

E.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.

REMEMBER

Keep the device dry.

Keep the device closed when not in use.

Do not exhale into the device.

Only slide the lever when ready to inhale a dose.

Consult your doctor or pharmacist if you have any doubts.

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

If you have used more Flusonal Accuhaler 500 micrograms/inhalation than you should, contact the Toxicological Information Service at 91 562 04 20 or inform your doctor immediately or visit the nearest emergency hospital. Bring this leaflet with you.

If you forget to use Flusonal 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 Flusonal Accuhaler 500 micrograms/inhalation

It is very important to use Flusonal Accuhaler 500 micrograms/inhalation every day as indicated by your doctor. Do not stop using Flusonal Accuhaler 500 micrograms/inhalation unless your doctor tells you to, as this may worsen your breathing. Do not abruptly stop treatment with Flusonal Accuhaler 500 micrograms/inhalation.

Like all medicines, this medicine can 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, spitting 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 Flusonal 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.

Uncommon (may affect less than 1 in 100 people)

• cutaneous 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 seizures
• 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).

Frequency not known

• 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 use Flusonal Accuhaler 500 micrograms/inhalation after 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 disposed of through drains or in the trash. Deposit the containers and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. By doing so, you will help protect the environment.

Composition of Flusonal Accuhaler 500 micrograms/inhalation

• The active ingredient is 500 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.

Marketing authorization holder and manufacturer

Marketing authorization 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

or

Glaxo Wellcome, S.A.

Avda. de Extremadura, 3

09400 - Aranda de Duero (Burgos) Spain

Last review date of this leaflet:January 2022.

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