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FLUSONAL ACCUHALER 500 micrograms/inhalation, powder for inhalation

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About the medicine

How to use FLUSONAL ACCUHALER 500 micrograms/inhalation, powder for inhalation

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Flusonal Accuhaler 500 micrograms/inhalation, powder for inhalation

fluticasone propionate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

  1. What is Flusonal Accuhaler 500 micrograms/inhalation and what is it used for
  2. What you need to know before you use Flusonal Accuhaler 500 micrograms/inhalation
  3. How to use Flusonal Accuhaler 500 micrograms/inhalation
  4. Possible side effects
  5. Storing Flusonal Accuhaler 500 micrograms/inhalation
  6. Pack contents and further information

1. What is Flusonal Accuhaler 500 micrograms/inhalation and what is it used for

Fluticasone propionate belongs to a group of medicines called corticosteroids. Corticosteroids are used to treat asthma because of their anti-inflammatory action. They reduce inflammation and irritation in the walls of the small airways in the lungs and thus reduce respiratory problems. 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.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you use Flusonal Accuhaler 500 micrograms/inhalation

Do not use Flusonal Accuhaler 500 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 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 for adequate control of 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 administration of 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 in acute attacks but as habitual long-term treatment, and withdrawal of the medicine should be gradual.

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 of age.

Using Flusonal Accuhaler 500 micrograms/inhalation with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might 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 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 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 some 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 500 micrograms/inhalation

Follow the instructions for administration of Flusonal Accuhaler 500 micrograms/inhalation exactly as 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 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 1000 micrograms twice a day).

  • CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD):

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

The content of the applications of Flusonal 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 Flusonal Accuhaler 500 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 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 action 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 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.

Oval-shaped inhaler with an arrow indicating the direction of opening and a finger placement area labeled

OPEN

The device contains 60 individual doses of the medicine in powder form. The dose indicator shows how many doses are left.

Inhaler device with external casing, dose indicator, finger hole, and lever, showing full and empty levels

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 dose is prepared to be inhaled. When the device is closed, the lever automatically returns to its original position, and it is ready for the next dose that is needed. The external casing protects the device when it is not in use.

A.

Open:

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

Hand holding a vaginal applicator with a white arrow indicating the direction of insertion

B.

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 prepared for inhalation. This is shown by the dose counter. Do not manipulate the lever, as doses will be prepared that will be wasted.

Hands holding an auto-injector device with a white arrow indicating the direction of rotation

C.

Inhale:

-

Before starting to inhale a dose, read this entire section carefully.

-

Keep the device away from your mouth. Expel the air as much as you reasonably can – DO NOT DO IT INSIDE THE DEVICE.

-

Place the mouthpiece on your lips. Take air progressively and intensely – THROUGH THE DEVICE, NOT THROUGH THE NOSE.

-

Remove the device from your mouth.

-

Hold your breath for about 10 seconds or as long as possible.

-

Expel the air slowly.

Patient holding a mouth inhaler with both hands and applying the lips around the mouthpiece

D.

Close:

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

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

Hand holding an auto-injector device with a white arrow indicating the direction of application

  • Rinse:

Then, 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 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 500 micrograms/inhalation than you should

If you have used more Flusonal 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 use Flusonal 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 stop using Flusonal Accuhaler 500 micrograms/inhalation

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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, spitting it out 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 500 micrograms/inhalation, stop using this medicine and inform your doctor immediately:

  • sudden appearance 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 difficulty breathing
  • 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 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 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 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 500 micrograms/inhalation

Do not store above 30°C. Keep in the original packaging to protect 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 Flusonal 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 via wastewater or household waste. Place the packaging and medicines that 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 that you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

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 Package Contents

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

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/

Online doctors for FLUSONAL ACCUHALER 500 micrograms/inhalation, powder for inhalation

Discuss questions about FLUSONAL ACCUHALER 500 micrograms/inhalation, powder for inhalation, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
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  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
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Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

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He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

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  • general family medicine concerns
Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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Doctor

Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
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  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
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Additional care areas:

  • Preventive consultations and check-up planning.
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  • Test interpretation and diagnostic guidance.
  • Structured support for undiagnosed complaints.
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  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
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Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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€70
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Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

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She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
  • Personalised preventive care and wellness consultations.
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  • Support in managing multiple coexisting conditions.
  • Remote prescription management and medical documentation.

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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€55

Frequently Asked Questions

Is a prescription required for FLUSONAL ACCUHALER 500 micrograms/inhalation, powder for inhalation?
FLUSONAL ACCUHALER 500 micrograms/inhalation, powder for inhalation requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in FLUSONAL ACCUHALER 500 micrograms/inhalation, powder for inhalation?
The active ingredient in FLUSONAL ACCUHALER 500 micrograms/inhalation, powder for inhalation is fluticasone. This information helps identify medicines with the same composition but different brand names.
How much does FLUSONAL ACCUHALER 500 micrograms/inhalation, powder for inhalation cost in pharmacies?
The average pharmacy price for FLUSONAL ACCUHALER 500 micrograms/inhalation, powder for inhalation is around 31.47 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures FLUSONAL ACCUHALER 500 micrograms/inhalation, powder for inhalation?
FLUSONAL ACCUHALER 500 micrograms/inhalation, powder for inhalation is manufactured by Glaxosmithkline S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of FLUSONAL ACCUHALER 500 micrograms/inhalation, powder for inhalation online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether FLUSONAL ACCUHALER 500 micrograms/inhalation, powder for inhalation is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to FLUSONAL ACCUHALER 500 micrograms/inhalation, powder for inhalation?
Other medicines with the same active substance (fluticasone) include FLIXOTIDE 250 micrograms/inhalation, pressurized inhaler suspension, FLIXOTIDE 50 micrograms/inhalation, pressurized inhaler suspension, FLIXOTIDE ACCUHALER 100 micrograms/inhalation, powder for inhalation. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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