Flixotide inhaler 50, 125 and 250 mcg – fluticasone propionate to prevent asthma attacks

Flixotide is a pressurised inhalation suspension containing fluticasone propionate, an inhaled corticosteroid (steroid). In Serbia it is available in three strengths – 50, 125 and 250 micrograms per dose – and is manufactured by Glaxo Wellcome S.A. (Spain).

According to the package leaflet, Flixotide reduces swelling and irritation in the walls of the small airways and has an anti-inflammatory effect. It is used for the regular prevention (prophylaxis) of asthma attacks, which is why it is called a “preventer”. Flixotide does not help with a sudden asthma attack – a different, fast-acting reliever medicine is used for that.

What is Flixotide used for and how should the inhaler be used correctly?

Key facts about the medicine

What is Flixotide used for?

According to the summary of product characteristics, inhaled fluticasone propionate is used in the prophylaxis of asthma:

• mild asthma – patients who need intermittent symptomatic bronchodilator treatment on a regular daily basis;
• moderate asthma – unstable or worsening asthma despite current prophylactic therapy or a bronchodilator alone;
• severe asthma – severe chronic asthma and patients whose control depends on systemic corticosteroids; after starting inhaled fluticasone propionate many of them can considerably reduce or stop oral corticosteroids.

The 50 microgram strength is also intended for children who need prophylactic therapy; the 125 and 250 microgram strengths are intended for adults and children over 16 years.

How is it used and dosed?

The medicine is used only by inhalation through the mouth, regularly, twice a day, even when there are no symptoms. The effect starts after 4 to 7 days of regular use. Dosing according to the leaflet:

• The dose is gradually reduced to the lowest dose that maintains asthma control.
• If the daily dose exceeds 1000 micrograms (in people over 16), the medicine is used with a spacer (e.g. Volumatic), which reduces side effects in the mouth and throat. A spacer also helps people who find it hard to coordinate pressing the inhaler with breathing in.
• Before first use, or if the inhaler has not been used for a week or more, shake it and release one dose (or two doses) into the air.
• To use: sit or stand upright, shake the inhaler 4–5 times, breathe out fully, close your lips around the mouthpiece and press the canister just after starting a slow, deep breath; hold your breath for a few seconds. Wait about half a minute before a second dose.
• Rinse your mouth with water after use. Clean the mouthpiece with a dry cloth at least once a week; never put the metal canister in water.

Special patient groups

• Children: regular checks of height are recommended in children on long-term inhaled corticosteroids; children aged 4 to 16 use only the 50 microgram strength.
• Elderly patients and liver or kidney impairment: according to the SmPC no dose adjustment is needed.
• Patients switched from oral corticosteroids: special medical supervision is needed; in stressful situations (injury, surgery) additional steroids may be required.

Contraindications – when the medicine must not be used

Do not use Flixotide:

• if you are allergic (hypersensitive) to fluticasone propionate or to the excipient norflurane (HFA 134a).

Warnings and precautions

Talk to your doctor before use if:

• you have ever been treated for tuberculosis;
• you are taking corticosteroid tablets at the same time or have just finished such treatment;
• you notice blurred vision or other visual disturbances.

If the medicine no longer works as well as before or you need your reliever more often than usual, see your doctor. If your breathing suddenly gets worse, this can be life-threatening – seek medical help urgently. Long-term use of high doses may affect the body’s own steroid production, so the doctor prescribes the lowest dose that maintains control. Pneumonia and bronchitis have been reported in patients with chronic obstructive pulmonary disease (COPD).

Interactions with other medicines, food and drink

Tell your doctor or pharmacist about all medicines you take, including herbal and non-prescription medicines. Particularly important are:

• HIV protease inhibitors (e.g. ritonavir) and medicines containing cobicistat – they may increase the effect of fluticasone propionate, so closer monitoring may be needed;
• medicines for fungal infections, such as ketoconazole.

Flixotide can be used at any time of day, with or without food.

Pregnancy and breast-feeding

• Pregnancy: there are limited data on use in pregnant women; the doctor considers use only if the expected benefit to the mother outweighs any possible risk to the foetus.
• Breast-feeding: use during breast-feeding is assessed by the doctor according to benefit and risk.

Driving and using machines

Flixotide is unlikely to affect the ability to drive or use machines.

Possible side effects

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

• Very common (more than 1 in 10 patients): thrush (fungal infection) of the mouth and throat.
• Common (up to 1 in 10): sore tongue and throat, hoarseness; in COPD patients – pneumonia or bronchitis and bruising.
• Uncommon (up to 1 in 100): allergic reactions – rash, redness, itching, hives.
• Rare (up to 1 in 1,000): thrush of the oesophagus.
• Very rare (up to 1 in 10,000): severe allergic reactions (swelling of the face, lips, tongue or throat), sleep problems, restlessness and irritability (more common in children), joint pain, indigestion, increased blood sugar, effects on the body’s steroid production (slowed growth in children, Cushing’s syndrome, cataract, glaucoma).
• Not known: depression, restlessness or nervousness (more common in children), nosebleeds, blurred vision.

Mouth and throat symptoms can be reduced by brushing your teeth and rinsing your mouth and throat with water (spitting it out) immediately after inhalation.

Overdose, missed dose and stopping treatment

• Overdose: if you use more than the recommended dose, seek medical advice immediately. According to the SmPC, short-term overdose may temporarily suppress adrenal function, which normalises within a few days; long-term use of excessive doses requires monitoring and gradual dose reduction.
• Missed dose: take the next dose at the usual time; do not take a double dose.
• Stopping treatment: do not stop even if you feel better, unless your doctor advises it. Sudden withdrawal after long-term high doses may cause vomiting, drowsiness, nausea, headache, tiredness, loss of appetite, low blood sugar and muscle cramps.

Related information

For soothing an irritated throat and hoarseness, see also the category Throat problems – products in this category do not replace the medicine prescribed for you.

Composition, pack and manufacturer

• Active substance: fluticasone (as fluticasone propionate) – 50, 125 or 250 micrograms per released dose.
• Excipient: norflurane (HFA 134a), propellant.
• Appearance and pack: white to off-white suspension in an aluminium-alloy pressurised canister with metering valve, actuator (mouthpiece) and dust cap; 50 mcg – 120 doses, 125 mcg and 250 mcg – 60 doses.
• Manufacturer: Glaxo Wellcome S.A., Avda. de Extremadura 3, Aranda de Duero, Burgos, Spain. Marketing authorisation holder: Evropa Lek Pharma d.o.o., Bore Stankovića 2, Belgrade.
• Authorisations: 50 mcg – 001953860 2024 of 5 May 2025; 125 mcg – 000457267 2023 and 250 mcg – 000457268 2023 of 4 April 2024.

Storage

• Store below 30 °C in the original package to protect from light; do not refrigerate or freeze.
• A cold canister may work less well – if the inhaler is very cold, remove the metal canister and warm it in your hands for a few minutes (never by any other means).
• The canister is pressurised: do not expose to temperatures above 50 °C, do not pierce, break or burn it, even when empty.
• Keep out of the sight and reach of children.

Frequently asked questions

Does Flixotide help during an asthma attack?

No. Flixotide is a “preventer” used regularly, every day, to prevent attacks. For a sudden attack of breathlessness a different fast-acting reliever prescribed by the doctor is used.

Which Flixotide strength can children use?

Children aged 4 to 16 use only the 50 microgram strength (usually 50 mcg twice daily, maximum 200 mcg twice daily). The 125 and 250 microgram strengths are not suitable for children under 16.

Why should I rinse my mouth after inhalation?

Thrush of the mouth and throat is very common and hoarseness is common. Brushing your teeth and rinsing your mouth and throat with water straight after the dose reduces these problems.

How long does Flixotide take to work?

According to the leaflet, several days of regular use are needed (4 to 7 days according to the SmPC) before the effect develops. That is why regular use is important even when there are no symptoms.

Sources

• ALIMS – Summary of Product Characteristics, Flixotide®, 50 micrograms/dose, pressurised inhalation suspension (SmPC, Serbian)
• ALIMS – Package leaflet, Flixotide®, 50 micrograms/dose (PIL, Serbian)
• ALIMS – Summary of Product Characteristics, Flixotide®, 125 micrograms/dose (SmPC, Serbian)
• ALIMS – Package leaflet, Flixotide®, 125 and 250 micrograms/dose (PIL, Serbian)
• ALIMS – Summary of Product Characteristics, Flixotide®, 250 micrograms/dose (SmPC, Serbian)
• ALIMS – Package leaflet, Flixotide®, 250 micrograms/dose (PIL, Serbian)

Sources checked on: 25 October 2026.