FLUSONAL ACCUHALER 100 micrograms/inhalation, powder for inhalation

2. What you need to know before you use Flusonal Accuhaler 100 micrograms/inhalation

Do not use Flusonal Accuhaler 100 micrograms/inhalation

• if you are allergic (hypersensitive) to fluticasone propionate or 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 Flusonal Accuhaler 100 micrograms/inhalation:

• if you have ever had to stop using this or any other medicine for the treatment of your disease due to allergy or any other problem
• if you notice that you need to increase the use of this medicine to control your symptoms, your treatment should be reviewed
• if you have ever had ulcers/lesions in the mouth
• 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 a lot of stress or if you are admitted to the hospital after a serious injury or accident or before surgery and are being treated with high doses of steroids by inhalation, you may need additional steroid administration
• 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 in acute attacks but as habitual long-term treatment, and 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 100 micrograms/inhalation is not indicated for use in children under 4 years of age. There are other presentations of Flusonal more suitable for the treatment of children under 4 years of age.

For the treatment of children over 4 years of age, it is advisable to periodically check their height.

Using Flusonal Accuhaler 100 micrograms/inhalation with other medicines

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

Some medicines may increase the effects of Flusonal Accuhaler 100 micrograms/inhalation, so your doctor will monitor you closely 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, 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

It is unlikely that Flusonal will affect your ability to drive or use machines.

Flusonal Accuhaler 100 micrograms/inhalation contains lactose.It may cause allergic reactions in patients with cow's milk protein allergy. If your doctor has told you that you have an intolerance to certain sugars, consult with him before using this medicine.

Warning to athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test result.

3. How to use Flusonal Accuhaler 100 micrograms/inhalation

Follow the instructions for administration of Flusonal Accuhaler 100 micrograms/inhalation indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to use your medicine.

Your doctor will indicate the duration of treatment with Flusonal Accuhaler 100 micrograms/inhalation. Do not stop treatment before, even if you feel better.

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

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

Children over 4 years of age: 1 application twice a day (100 micrograms twice a day).

The content of the applications of Flusonal Accuhaler 100 micrograms/inhalation should not be ingested, but inhaled to reach the lungs. You may not be able 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 the use of this medicine.

Do not inhale more doses or use Flusonal Accuhaler 100 micrograms/inhalation more times than indicated by the doctor.

This medicine may take a few days to take effect. Therefore, it is very important to use it regularly. Inform your doctor and interrupt treatment if your breathing or "wheezing" worsens after using Flusonal Accuhaler 100 micrograms/inhalation. Inform your doctor if your breathing difficulties or "wheezing" worsen or do not improve after 7 days or if you notice that you are increasing the use of other inhaled medicines.

Do not use this medicine to treat a sudden attack of shortness of breath; it will not work. For this, you will need a different medicine. If you use more than one medicine, be careful not to confuse them.

If you think the action of Flusonal Accuhaler 100 micrograms/inhalation is too strong or too weak, inform your doctor or pharmacist.

Instructions for the correct use of Flusonal Accuhaler 100 micrograms/inhalation

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

CLOSED

When you open the case and take the device out of 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 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 from 5 to 0 will appear in RED to warn that there are few doses left.

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

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

Device operation

When you slide the lever on the device, a small hole opens in the mouthpiece or mouthpiece, and a dose is prepared to be inhaled. When you close the device, the lever automatically returns to its original position, and it is ready for the next dose you need. The external casing protects the device when not in use.

1. Rinse:

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

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

REMEMBER

Keep the device dry.

Keep the device closed when not in use.

Do not expel the air inside 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 Flusonal Accuhaler 100 micrograms/inhalation than you should

If you have used more Flusonal Accuhaler 100 micrograms/inhalation than you should, consult the Toxicological Information Service, telephone 91 562 04 20, or inform your doctor without delay or go to the emergency department of the nearest hospital. Bring this leaflet with you.

If you forget to use Flusonal Accuhaler 100 micrograms/inhalation

Do not inhale a double dose to make up for forgotten doses. If you forget a dose, wait for the next dose.

If you stop using Flusonal Accuhaler 100 micrograms/inhalation

It is very important that you use Flusonal Accuhaler 100 micrograms/inhalation every day as indicated. Do not stop using Flusonal Accuhaler 100 micrograms/inhalation unless your doctor tells you to, as this could make your breathing worse. Do not stop treatment with Flusonal Accuhaler 100 micrograms/inhalation abruptly.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some people may develop fungal infections in the mouth (candidiasis) and experience throat or tongue pain, or their voice may become hoarse after inhaling this medicine. To avoid 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 says so.

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

• sudden onset of wheezing or chest pressure
• swelling of the eyelids, face, lips, tongue, or throat
• skin rash (hives) or urticaria anywhere on 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 up to 1 in 10 people)

• neumonia (lung infection) and bronchitis (inflammation of the airways) in patients with chronic obstructive pulmonary disease (COPD) (a disease that causes difficulty breathing)

Tell your doctorif you have any of the following symptoms while inhaling fluticasone propionate. They could be symptoms of a lung infection:

• fever or chills
• increased production of mucus, change in the color of mucus
• increased cough or increased breathing difficulties
• hoarseness
• bruises.

Uncommon (may affect up to 1 in 100 people)

• skin hypersensitivity reactions.

Rare (may affect up to 1 in 1,000 people)

• esophageal candidiasis.

Very rare (may affect up to 1 in 10,000 people)

• angioedema (skin reactions with redness, swelling, and itching), mainly facial and oropharyngeal edema
• respiratory symptoms such as dyspnea (feeling of shortness of breath or difficulty breathing) and/or bronchospasm (narrowing of the bronchial walls with decreased air intake)
• 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 (increased blood sugar levels). If you have diabetes, you may need to check 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 decreased air intake after using the inhaler).

Frequency not known

• nasal bleeding
• blurred vision.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Flusonal Accuhaler 100 micrograms/inhalation

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

Keep the device in the aluminum wrapper until you are going to use it for the first time. Discard the wrapper once opened.

Keep out of the sight and reach of children.

Do not use Flusonal Accuhaler 100 micrograms/inhalation after the expiration date that appears on the packaging after EXP. The expiration date is the last day of the month indicated.

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

6. Package Contents and Additional Information

Composition ofFlusonal Accuhaler 100 micrograms/inhalation

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

Appearance of the Product and Package Contents

Package with a device containing 60 alveoli with powder for oral inhalation. The device is packaged inside 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)

Spain

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

Date of the Last Revision of this Leaflet:January 2022.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/