Flixotide

Leaflet attached to the packaging: patient information

Flixotide, 50 g/inhalation dose, inhalation aerosol, suspension
Flixotide, 125 g/inhalation dose, inhalation aerosol, suspension
Fluticasone propionate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Flixotide and what is it used for
• 2. Important information before using Flixotide
• 3. How to use Flixotide
• 4. Possible side effects
• 5. How to store Flixotide
• 6. Contents of the packaging and other information

1. What is Flixotide and what is it used for

Flixotide, 50 µg/inhalation dose and Flixotide, 125 µg/inhalation dose, inhalation aerosol, suspension belong to the group of medicines used in bronchial asthma. The active substance of the medicine, fluticasone propionate, is a corticosteroid with local anti-inflammatory action in the lungs. The medicine is indicated for the prophylactic treatment of bronchial asthma:

• In adults:
• mild asthma - in patients who require daily symptomatic treatment with bronchodilators;
• moderate asthma - unstable or worsening asthma, despite regular use of preventive medicines or only bronchodilators;
• severe asthma - in patients with severe chronic bronchial asthma and those who require oral steroids to control asthma symptoms. Starting treatment with fluticasone propionate in many people allows for a reduction in the dose or complete discontinuation of oral steroids.
• In childrenwho require prophylactic treatment, including patients who have not responded to other available preventive medicines.

2. Important information before using Flixotide

When not to use Flixotide

Warnings and precautions

If asthma symptoms worsen or asthma control deteriorates, i.e.if wheezing worsens or it is necessary to use a larger number of inhalations of a rapid-acting inhalation medicine to facilitate breathing, the patient should continue using the medicine and contact their doctor immediately, who will assess the patient's condition and recommend appropriate treatment. Flixotide should not be used to interrupt a sudden asthma attack. For this purpose, a rapid-acting bronchodilator (e.g. salbutamol) should be used, which the patient should always carry with them. Care should be taken not to confuse Flixotide with an inhalation medicine used as needed. The doctor should periodically check the patient's inhalation technique to ensure that the release of the medicine from the inhaler is properly synchronized with the performance of a deep, calm breath. During inhalation, the patient should be sitting or standing. The inhaler is designed for use in an upright position. With long-term use of Flixotide, suppression of the natural production of steroid hormones by the adrenal glands may occur. This may cause a decrease in bone mass, cataracts, glaucoma, weight gain, rounding of the face (moon face), high blood pressure, and slowing of growth in children and adolescents. The doctor will regularly monitor whether the patient is experiencing any of these side effects and ensure that the patient is using the smallest dose of Flixotide that provides adequate control of asthma. During treatment with fluticasone propionate at recommended doses, adrenal cortical function usually remains normal. Nevertheless, in people who have previously been treated with oral steroids, symptoms of impaired adrenal cortical function may occur. Long-term treatment with high doses of inhaled steroids may cause suppression of adrenal cortical function. Children and adolescents under the age of 16 who receive large doses (usually ≥1000 micrograms per day) of fluticasone propionate are at particular risk. Very rarely, side effects may occur when taking large doses of Flixotide for a long time or when treatment is suddenly stopped or the dose is reduced. Side effects may also occur in the event of infections or during periods of severe stress (e.g. accident or surgery). The symptoms are not usually characteristic and may include: abdominal pain, fatigue, loss of appetite, nausea and vomiting, weight loss, headache, confusion, low blood pressure, decreased blood glucose levels, and seizures. To prevent these symptoms, the doctor may prescribe additional corticosteroids to be taken at that time. Due to the possibility of impaired adrenal cortical function, patients who are switching from oral steroid treatment to inhaled fluticasone propionate should be under special care, and adrenal cortical function should be monitored. When fluticasone propionate is introduced, the reduction of systemic steroid doses should be gradual, and patients should carry a "steroid card" informing them of the need for additional systemic steroids in stressful situations. Replacement of oral steroids with inhaled steroids may reveal symptoms of allergy, such as allergic rhinitis or rash, which were previously treated with systemic steroids. The doctor will recommend appropriate treatment. Very rare cases of increased blood glucose levels have been reported (see section 4), and the doctor should take this into account when prescribing Flixotide to patients with a history of diabetes. Do not stop treatment with fluticasone propionate abruptly. If the patient is currently being treated or has been treated for tuberculosis, they should inform their doctor. If the patient experiences blurred vision or other vision disturbances that may be caused by cataracts or glaucoma, they should contact their doctor.

Flixotide and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are available without a prescription. It is especially important to inform the doctor about any of the following medicines that are being taken or have been taken recently:

• corticosteroids in tablets or injections
• ritonavir or medicines containing cobicistat, used to treat HIV
• ketoconazole or itraconazole, used to treat fungal infections.

The doctor will assess whether Flixotide can be used with these medicines. Some of them may enhance the effect of Flixotide, and the doctor may want to closely monitor the condition of the patient taking such medicines (including some HIV medicines: ritonavir, cobicistat). Only medicines that have been recommended by the doctor should be used with Flixotide.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine. The doctor will assess whether the patient can take Flixotide during this period.

Driving and using machines

It is unlikely that side effects associated with the use of Flixotide will affect the ability to drive or operate machinery.

3. How to use Flixotide

This medicine should always be used as directed by the doctor. Do not take a higher dose than recommended. In case of doubts, consult a doctor. Flixotide in the form of an inhalation aerosol is intended for inhalation use only. The doctor will adjust the dose of the medicine according to the individual patient's response to treatment and determine the smallest dose that provides effective control of symptoms. To facilitate the use of the medicine and prevent potential side effects in the mouth and throat, patients treated with inhaled steroids, especially those who have difficulty coordinating inhalation with the release of the medicine from the inhaler (e.g. children and elderly patients), are advised to use a spacer. It is very important to use Flixotide every day, until the doctor recommends otherwise. The therapeutic effect occurs within 4 to 7 days. Adults and children over 16 years old
From 100 µg to 1000 µg twice a day. The initial dose of the medicine depends on the severity of the disease:

• mild asthma: from 100 µg to 250 µg twice a day;
• moderate asthma: from 250 µg to 500 µg twice a day;
• severe asthma: from 500 µg to 1000 µg twice a day.

Children over 4 years old
From 50 µg to 100 µg twice a day. The initial dose of the medicine depends on the severity of the disease. If the symptoms of asthma are not properly controlled with this dose, it can be increased to 200 µg twice a day.
The maximum allowed dose for use in children is 200 µg twice a day. If the dose of fluticasone propionate in the form of an inhalation aerosol does not match the dose prescribed by the doctor for the child, it is possible to consider using other available pharmaceutical forms of Flixotide (e.g. Flixotide Disk).
Children from 1 to 4 years old
From 50 µg to 100 µg twice a day. The medicine should be administered using a spacer with a face mask (e.g. Babyhaler).
Special patient groups
There is no need to change the dosage in elderly patients or in patients with renal or hepatic impairment.

Instructions for using the inhaler

• The doctor, nurse, or pharmacist should instruct the patient on how to properly use the inhaler. They should periodically check that the patient is using the inhaler correctly. Using Flixotide contrary to the doctor's recommendation or improper use of the inhaler may cause the medicine to not produce the expected improvement in asthma.
• The medicine is contained in a pressure container, in a plastic casing with a mouthpiece.

Checking the inhaler

• 1. Before the first use, check that the inhaler is working. Remove the cap from the mouthpiece of the inhaler by gently pressing the sides of the cap with your thumb and index finger.

• 2. To make sure the inhaler is working, shake it vigorously, point the mouthpiece away from you, and release a dose of the medicine into the air. If the inhaler has not been used for a week or longer, remove the mouthpiece cap, shake the inhaler vigorously, and release two doses of the medicine into the air.

Using the inhaler
It is essential to start breathing in slowly, as slowly as possible, before using the inhaler.

• 1. Inhale while standing or sitting. The inhaler is designed for use in an upright position.
• 2. Remove the cap from the mouthpiece of the inhaler (as shown in figure 1). Check the mouthpiece outside and inside to ensure it is clean and free of foreign objects.
• 3. Shake the inhaler 4 or 5 times to ensure that any foreign objects are removed and the contents of the inhaler are evenly mixed.

and so that the contents of the inhaler are evenly mixed.

It is essential not to rush the actions described in points 4-7.

• 4. Hold the inhaler upright with your fingers, with your thumb on the base of the inhaler, under the mouthpiece. Take a deep breath out, as deep as possible.

• 5. Put the mouthpiece in your mouth and seal it with your lips. Do not bite the mouthpiece.

• 6. Immediately after starting to breathe in, press the inhaler to release the Flixotide medicine, and then continue with a calm, deep breath.

• 7. Hold your breath, remove the inhaler from your mouth, and take your finger off the inhaler base. Hold your breath for a few seconds or as long as is comfortable, then breathe out slowly.

• 8. If the doctor has prescribed two inhalations of the medicine, wait about half a minute before repeating the actions described in points 3-7.
• 9. Rinsing the mouth with water and spitting it out after inhalation helps prevent hoarseness and thrush.
• 10. After inhalation, always put the cap back on the mouthpiece to prevent dust from entering it. Put the cap back on by clicking it into place. If you do not hear a click when putting the cap back on, remove it, turn it upside down, and try again. Do not use too much force.

Cleaning the inhaler
To prevent the inhaler from clogging, it should be cleaned at least once a week. To clean the inhaler:

• Remove the cap from the mouthpiece.
• Do not remove the metal container from the plastic casing during cleaning or at any other time.
• Clean the mouthpiece inside and outside and the plastic casing outside with a dry cloth or tissue.
• Put the cap back on the mouthpiece. When put back correctly, you will hear a click. If you do not hear a click when putting the cap back on, remove it, turn it upside down, and try again. Do not use too much force.
• Do not immerse the metal container in water.

Using a higher than recommended dose of Flixotide

In the event of using a higher than recommended dose of Flixotide, you should contact your doctor or pharmacist immediately for advice. It is essential to use the recommended doses of the medicine. Do not increase or decrease the dose without consulting your doctor. Using higher than recommended doses of fluticasone propionate may cause transient suppression of adrenal cortical function. Long-term use of higher than recommended doses of fluticasone propionate may lead to adrenal cortical insufficiency.

Missing a dose of Flixotide

It is crucial to take the recommended dose of the medicine every day to ensure the best effect of the treatment. If a dose is missed, take the medicine as soon as possible. Continue treatment as before. Do not take a double dose to make up for the missed dose.

Stopping treatment with Flixotide

It is essential to take Flixotide every day until the doctor recommends stopping the treatment. Do not stop taking Flixotide abruptly, as the symptoms of the disease may worsen, and hormonal disturbances may occur in the body. If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Flixotide can cause side effects, although not everybody gets them. The following side effects have been observed in patients taking Flixotide.

Allergic reactions: seek medical help immediately

Allergic reactionsto Flixotide, which occur uncommonly (may affect 1 to 10 in 1000 patients taking the medicine). They are characterized by symptoms such as:

• Hives or redness of the skin.

Allergic reactionsto Flixotide, which occur very rarely (may affect less than 1 in 10,000 patients taking the medicine), and in a small number of patients, these reactions may develop into a serious, life-threatening condition if not treated. They are characterized by symptoms such as:

• Swelling (mainly of the face, lips, tongue, or throat), which can cause difficulty swallowing or breathing.
• Sudden onset of breathing difficulties or severe worsening of wheezing (bronchospasm).
• Sudden feeling of weakness or dizziness (which can lead to falling or loss of consciousness).

In the event of such symptoms, stop using the medicine and contact your doctor immediately, who will recommend appropriate treatment.

Pneumonia (lung infection) in patients with chronic obstructive pulmonary disease (COPD) (common side effect)

Tell your doctorif any of the following symptoms occur while using Flixotide - they may be symptoms of a lung infection:

• Fever or chills.
• Increased production of sputum or change in its color.
• Worsening of cough or increased breathing difficulties.

Other side effects:
Very common side effects(may affect more than 1 in 10 patients taking the medicine):

• Thrush (painful, creamy-white patches) in the mouth and throat, difficulty swallowing. Rinsing the mouth with water and spitting it out after each inhalation may be helpful. The doctor may also recommend an antifungal medicine to treat thrush.

Common side effects(may affect 1 to 10 in 100 patients taking the medicine):

• Hoarseness, loss of voice. Rinsing the mouth with water and spitting it out after each inhalation may be helpful.
• Pneumonia has been reported in patients with COPD - see above.
• Bruising easily.

Rare side effects(may affect 1 to 10 in 10,000 patients taking the medicine):

• Thrush of the esophagus.

Very rare side effects(may affect less than 1 in 10,000 patients taking the medicine):

• Flixotide may have a suppressive effect on the normal production of steroid hormones by the body, particularly when taking large doses of the medicine for a long time. Symptoms include slowing of growth in children and adolescents, decreased bone mass, cataracts, glaucoma, weight gain, rounding of the face (moon face), high blood pressure, and other symptoms.
• Increased blood glucose levels (hyperglycemia). In patients with diabetes, it may be necessary to monitor blood glucose levels more frequently and adjust the dose of antidiabetic medicines being taken.
• Joint pain.
• Nausea.
• Anxiety, sleep disturbances, and changes in behavior, including hyperactivity and irritability. The occurrence of these side effects is more likely in children.

Side effects with unknown frequency(frequency cannot be estimated from the available data):

• Depression and aggression. The occurrence of these side effects is more likely in children.
• Nosebleeds.
• Blurred vision.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder or its representative. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Flixotide

The medicine should be stored out of sight and reach of children. Store at a temperature not exceeding 30°C. Do not freeze. The container contains a pressurized suspension. Do not expose to temperatures above 50°C, protect from direct sunlight. Do not pierce or damage the container, even if it appears to be empty. As with most inhalation medicines in pressurized containers, the effectiveness of this medicine may be reduced if the inhaler is cold. After each use, put the cap back on the mouthpiece. Do not force the cap on. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month stated. The batch number of the medicine is stated on the packaging after: Lot. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Flixotide contains

• The active substance of the medicine is fluticasone propionate (micronized). One dose contains 50 or 125 µg (micrograms) of fluticasone propionate, micronized.
• The other ingredient is 1,1,1,2-tetrafluoroethane (HFA 134a). The propellant gas (HFA 134a) does not contain freons.

This medicine contains fluorinated greenhouse gases. Flixotide, 50 µg/inhalation dose, inhalation aerosol, suspension - 120 doses. Each inhaler contains 10.6 g of HFC-134a (also known as 1,1,1,2-tetrafluoroethane or HFA 134a), which is equivalent to 0.0152 tons of CO2 equivalent (GWP = 1430). Flixotide, 125 µg/inhalation dose, inhalation aerosol, suspension - 60 doses. Each inhaler contains 8 g of HFC-134a (also known as 1,1,1,2-tetrafluoroethane or HFA 134a), which is equivalent to 0.0114 tons of CO2 equivalent (GWP = 1430). Flixotide, 125 µg/inhalation dose, inhalation aerosol, suspension - 120 doses. Each inhaler contains 12 g of HFC-134a (also known as 1,1,1,2-tetrafluoroethane or HFA 134a), which is equivalent to 0.0172 tons of CO2 equivalent (GWP = 1430).

What Flixotide looks like and contents of the pack

Flixotide, 50 g/inhalation dose, inhalation aerosol, suspension- 120 doses of the medicine in an aluminum container under pressure, closed with a metering valve, with a plastic inhaler in a cardboard box.
Flixotide, 125 g/inhalation dose, inhalation aerosol, suspension- 60 or 120 doses of the medicine in an aluminum container under pressure, closed with a metering valve, with a plastic inhaler in a cardboard box.

Manufacturer:

Glaxo Wellcome Production
Zone Industrielle No. 2
23, rue Lavoisier
27000, Evreux
France
Glaxo Wellcome S.A.
Avenida de Extremadura 3
09400 Aranda de Duero
Burgos
Spain
To obtain more detailed information, please contact the representative of the marketing authorization holder:

Marketing authorization holder:

GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. (22) 576-90-00
{Logo of the marketing authorization holder}

Date of last revision of the leaflet: January 2025