INALACOR ACCUHALER 500 micrograms/inhalation powder for inhalation

2. What you need to know before using Inalacor Accuhaler 500 micrograms/inhalation

Do not useInalacor 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 Inalacor Accuhaler 500 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 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 a 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 (Inalacor 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

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

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

Children and adolescents

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

Use ofInalacor Accuhaler 500 micrograms/inhalationwith other medicines

Tell 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 Inalacor Accuhaler 500 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 lactation

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

Inalacor is unlikely to affect your ability to drive or use machines.

Inalacor Accuhaler 500 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.

3. How to use Inalacor Accuhaler 500 micrograms/inhalation

Follow the instructions for administration of Inalacor Accuhaler 500 micrograms/inhalation indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to use your medicine.

Your doctor will indicate the duration of treatment with Inalacor Accuhaler 500 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:

• ASTHMA

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

• COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE):

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

The content of the applications of Inalacor Accuhaler 500 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 Inalacor Accuhaler 500 micrograms/inhalation more times than indicated by your 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 Inalacor Accuhaler 500 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 inhalation medicines.

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

If you think the effect of Inalacor Accuhaler 500 micrograms/inhalation is too strong or too weak, inform your doctor or pharmacist.

Instructions for the correct use of Inalacor Accuhaler 500 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 remove 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 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 a dose is needed, follow the five simple instructions below:

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

Device operation

When the device lever is slid, a small hole opens in the mouthpiece or mouthpiece, and a prepared dose is available for inhalation. When the device is closed, 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. Open:

To open the device, hold the external casing with one hand and place your thumb in the hole provided for it. Push with your thumb, moving it away from you, until it stops.

1. Slide:

Hold the device with the mouthpiece towards you. Slide the lever, moving it away, until it stops – you will hear a "click" sound. The device is ready for use. Each time the lever is pulled back, a dose is available for inhalation. This is shown by the dose counter. Do not manipulate the lever, as doses will be available that will be wasted.

1. Inhale:

• Before starting to inhale a dose, read this section carefully.
• Keep the device away from your mouth. Expel the air as much as reasonably possible – DO NOT DO IT INSIDE THE DEVICE.
• Place the mouthpiece in your lips. Take air progressively and intensely – THROUGH THE DEVICE, NOT THROUGH THE NOSE.
• Remove the device from your mouth.
• Hold your breath for 10 seconds or as long as possible.
• Expel the air slowly.

1. Close:

To close the device, put your thumb in the hole provided for it and slide it towards you, until it stops.

When closing the device, you will hear a sharp click. The lever automatically returns to its original position and is ready to be used again.

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 air into the device.

Slide the lever only when you are ready to inhale a dose.

Consult your doctor or pharmacist if you have doubts.

If you use moreInalacor Accuhaler 500 micrograms/inhalationthan you should

If you have used more Inalacor Accuhaler 500 micrograms/inhalation than you should, consult the Toxicology Information Service, telephone 91 562 04 20, or inform your doctor immediately or go to the emergency department of the nearest hospital. Bring this leaflet with you.

If you forget to useInalacor Accuhaler 500 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 interrupt treatment with Inalacor Accuhaler 500 micrograms/inhalation

It is very important that you use Inalacor Accuhaler 500 micrograms/inhalation every day as indicated by your doctor. Do not stop using Inalacor Accuhaler 500 micrograms/inhalation unless your doctor tells you to, as this could make your breathing worse. Do not abruptly interrupt treatment with Inalacor Accuhaler 500 micrograms/inhalation.

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 Inalacor Accuhaler 500 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 less than 1 in 10 people)

• pneumonia (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 less than 1 in 100 people)

• skin 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 redness, swelling, and itching), mainly facial and oropharyngeal edema
• respiratory symptoms such as dyspnea (feeling of lack of air or difficulty breathing) and/or bronchospasm (narrowing of the bronchial walls with decreased air intake)
• anaphylactic reactions (severe allergic reactions in which there may be a sudden drop in blood pressure with loss of consciousness)
• 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 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 intake after using the inhaler)

Frequency not known

• nasal bleeding
• blurred vision

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are 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 contribute to providing more information on the safety of this medicine.

5. Storage of Inalacor Accuhaler 500 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 it is going to be used for the first time. Discard the wrapper once opened.

Keep out of the sight and reach of children.

Do not use Inalacor Accuhaler 500 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 through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofInalacor 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 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)

Tel: +34 900 202 700

[email protected]

Manufacturer:

Glaxo Wellcome Production

Zone Industrielle Nº2

23 Rue Lavoisier,

27000 Evreux

France

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/