Flusonal Accuhaler 500 micrograms/inhalation, powder for inhalation
Spain
Table of Contents
- Patient Information Leaflet
- Introduction
- 1. What Flusonal Accuhaler 500 micrograms/inhalation is and what it is used for
- 2. What you need to know before using Flusonal Accuhaler 500 micrograms/inhalation
- 3. How to use Flusonal Accuhaler 500 micrograms/inhalation
- 4. Possible adverse effects
- 5. Storage of Flusonal Accuhaler 500 micrograms/inhalation
- 6. Contents of the pack and other information
Patient Information Leaflet
Introduction
Patient Information Leaflet
Flusonal Accuhaler 500 micrograms/inhalation, inhalation powder
fluticasone propionate
Read the entire 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 reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet Contents
- What Flusonal Accuhaler 500 micrograms/inhalation is and what it is used for
- What you need to know before using Flusonal Accuhaler 500 micrograms/inhalation
- How to use Flusonal Accuhaler 500 micrograms/inhalation
- Possible adverse effects
- How to store Flusonal Accuhaler 500 micrograms/inhalation
- Contents of the pack and other information
1. What Flusonal Accuhaler 500 micrograms/inhalation is and what it is used for
Fluticasone propionate belongs to the 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 airways in the lungs, thereby decreasing breathing difficulties. Corticosteroids also help prevent asthma attacks.
Flusonal Accuhaler 500 micrograms/inhalation is recommended for the treatment of moderate to severe asthma and chronic obstructive pulmonary disease (COPD) in adults.
2. What you need to know before using Flusonal Accuhaler 500 micrograms/inhalation
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
Talk to your doctor, pharmacist, or nurse before starting to use Flusonal Accuhaler 500 micrograms/inhalation:
- if you have ever had to stop using this or any other medicine for 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 conditions of high stress or are admitted to hospital following a severe injury or accident, or prior to surgical operation and are being treated with high doses of inhaled steroids, you may require 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 contact your doctor as soon as possible.
Flusonal 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
Flusonal Accuhaler 500 micrograms/inhalation is not indicated for use in children. Other formulations of Flusonal are more suitable for the treatment of children and adolescents under 16 years of age.
Using Flusonal Accuhaler 500 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 Flusonal Accuhaler 500 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 Flusonal will affect your ability to drive or operate machinery.
Flusonal Accuhaler 500 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 him before using this medicine.
Warning for athletes
Athletes are advised that this medicine contains a component that may lead to a positive analytical finding in doping control tests.
3. How to use Flusonal Accuhaler 500 micrograms/inhalation
Follow exactly the instructions for the administration of Flusonal Accuhaler 500 micrograms/inhalation provided by your doctor. If in doubt, consult your doctor or pharmacist again.
Remember to use your medicine regularly.
Your doctor will indicate how long you should continue treatment with Flusonal Accuhaler 500 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:
- ASTHMA
Adults and adolescents over 16 years of age: 1–2 inhalations twice daily (500 to 1,000 micrograms twice daily).
- CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD):
Adults: One inhalation twice daily (500 micrograms twice daily).
The contents of Flusonal Accuhaler 500 micrograms/inhalation inhalations 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 Flusonal Accuhaler 500 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 Flusonal Accuhaler 500 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 this, you will need a different medicine. If you use more than one medicine, take care not to confuse them.
If you think the effect of Flusonal Accuhaler 500 micrograms/inhalation is too strong or too weak, tell your doctor or pharmacist.
Instructions for the correct use of Flusonal Accuhaler 500 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 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 individually measured 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:
- Open.
- Slide.
- Inhale.
- Close.
- Rinse.
How the device works
When the lever on the device is slid, a small opening in the mouthpiece becomes accessible, and one pre-measured dose is made available for inhalation. When the device is closed, the lever automatically returns to its original position, preparing it for the next dose. The outer casing protects the device when not in use.
A. | Open: |
To open the device, hold the outer casing with one hand and place the thumb of the other hand into the designated recess. Push with the thumb away from you as far as it will go.
|
B. | 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" sound. The device is now ready for use. Each time the lever is slid back, one dose is made available for inhalation, as indicated by the dose counter. Do not handle the lever unnecessarily, as this may waste available doses.
|
C. | Inhale: | |
- | Before starting to inhale a dose, read carefully all of this section. | |
- | Keep the device away from the mouth. Breathe out as much air as reasonably possible – DO NOT do it INTO the device. | |
- | Place the mouthpiece between the lips. Breathe in steadily and deeply – THROUGH THE DEVICE, NOT THROUGH THE NOSE. | |
- | Remove the device from the mouth. | |
- | Hold breath for about 10 seconds or as long as possible. | |
- | Breathe out slowly.
|
D. | Close: |
To close the device, place your thumb in the recess provided for this purpose 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 is re-engaged. The device is now ready for reuse.
|
- Rinsing:
Then, 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 exhale into 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 500 micrograms/inhalation than you should
If you have used more Flusonal Accuhaler 500 micrograms/inhalation than prescribed, contact the Toxicology Information Service at telephone number 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 Flusonal Accuhaler 500 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 Flusonal Accuhaler 500 micrograms/inhalation
It is very important that you use Flusonal Accuhaler 500 micrograms/inhalation every day as directed. Do not stop using Flusonal Accuhaler 500 micrograms/inhalation unless your doctor tells you to, as this could cause your breathing to worsen. Do not stop treatment with Flusonal Accuhaler 500 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, 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 Flusonal Accuhaler 500 micrograms/inhalation, stop using this medicine and contact your doctor immediately:
- sudden onset of wheezing or chest tightness
- 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 condition causing breathing difficulties)
Tell your doctor if you experience any of the following symptoms while inhaling fluticasone propionate. These may be symptoms of a lung infection:
-
fever or chills
-
increased mucus production, change in mucus color
-
increased coughing 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 (shortness of breath or difficulty breathing) and/or bronchospasm (narrowing of the bronchial walls leading to reduced airflow)
- anaphylactic reactions (severe allergic reactions that may cause a sudden drop in blood pressure and loss of consciousness)
- rounded face (moon face) (Cushing's syndrome)
- adrenal gland suppression, which may cause 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 following inhaler use).
Frequency not known
- nosebleeds
- blurred vision.
Reporting of adverse effects
If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects 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 Flusonal Accuhaler 500 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 Flusonal Accuhaler 500 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 should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a pharmacy’s SIGRE collection point. If in doubt, ask your pharmacist how to dispose of unused medicines and containers. This helps protect the environment.
6. Contents of the pack and other information
Composition of Flusonal Accuhaler 500 micrograms/inhalation
- The active substance is 500 micrograms of fluticasone propionate per inhalation (blister).
- The other component is lactose monohydrate (contains milk proteins).
Nature of the product and pack contents
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
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 most recent revision of this leaflet: January 2022.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/