Flixotide

Package Leaflet: Information for the Patient

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

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

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

Contents of the Package Leaflet:

• 1. What Flixotide is and what it is 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 pack and other information

1. What Flixotide is and what it is used for

Flixotide, 50 μg/inhalation dose and Flixotide, 125 μg/inhalation dose, inhalation aerosol, suspension belong to a group of medicines called corticosteroids, which are used to treat asthma. The active substance in Flixotide, fluticasone propionate, is a corticosteroid with local anti-inflammatory action in the lungs. Flixotide is used to prevent asthma symptoms in patients with 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 asthma medications or only bronchodilators;
• Severe asthma - in patients with severe chronic asthma and those who require oral steroids to control asthma symptoms. Starting treatment with fluticasone propionate in many patients allows for a reduction in the dose or complete discontinuation of oral steroids.
• In childrenwho require preventive treatment, including patients who have not responded to other available preventive medications.

2. Important information before using Flixotide

When not to use Flixotide

• If you are allergic to fluticasone propionate or to 1,1,1,2-tetrafluoroethane (HFA 134a), an excipient in Flixotide.

Warnings and precautions

If your asthma symptoms worsen or your asthma control deteriorates, i.e.if your wheezing worsens or you need to use more inhalations of a fast-acting reliever inhaler, you should continue to use your Flixotide and consult your doctor immediately, who will assess your condition and recommend appropriate treatment. Flixotide should not be used to relieve an acute asthma attack. For this purpose, a fast-acting reliever inhaler (e.g., salbutamol) should be used, which you should always carry with you. Be careful not to confuse Flixotide with a reliever inhaler. Your doctor should periodically check your 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, you should be sitting or standing. The inhaler is designed for use in an upright position. If you use Flixotide for a long time, suppression of natural steroid hormone production by the adrenal glands may occur. This may lead to a decrease in bone mass, cataracts, glaucoma, weight gain, rounded face (moon face), high blood pressure, and slowed growth in children and adolescents. Your doctor will regularly monitor you for any of these side effects and ensure that you are using the smallest effective dose of Flixotide to control your asthma. During treatment with fluticasone propionate at recommended doses, adrenal function usually remains normal. However, in patients previously treated with oral steroids, signs of adrenal insufficiency may occur. Long-term treatment with high doses of inhaled steroids may lead to adrenal insufficiency. Children and adolescents under 16 years of age who receive high doses (usually ≥1000 micrograms per day) of fluticasone propionate are at particular risk. Very rare side effects may occur with high doses of Flixotide used for a long time or when treatment is suddenly stopped or the dose is reduced. Side effects may also occur with infections or during periods of high 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, your doctor may prescribe additional corticosteroids during this time. Due to the possibility of adrenal insufficiency, patients who are being transferred from oral steroids to inhaled fluticasone propionate should be closely monitored, and their adrenal function should be monitored. When fluticasone propionate is introduced, the reduction in the dose of oral steroids should be gradual, and patients should carry a "steroid card" informing them of the need for additional oral steroids in stressful situations. Replacement of oral steroids with inhaled steroids may reveal allergic reactions, such as allergic rhinitis or eczema, which were previously controlled by oral steroids. Your doctor will recommend appropriate treatment. Very rare cases of increased blood glucose levels (see section 4) have been reported, and your doctor should take this into account when prescribing Flixotide to patients with a history of diabetes. Do not stop treatment with fluticasone propionate suddenly. If you are currently being treated or have been treated for tuberculosis, tell your doctor. If you experience blurred vision or other vision disturbances that may be caused by cataracts or glaucoma, consult your doctor.

Flixotide and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription. It is especially important to tell your doctor if you are taking or have recently taken any of the following medicines:

• Oral corticosteroids
• Ritonavir or cobicistat-containing medicines used to treat HIV
• Ketoconazole or itraconazole used to treat fungal infections.

Your doctor will assess whether Flixotide can be used with these medicines. Some of them may enhance the effect of Flixotide, and your doctor may want to monitor your condition closely when taking such medicines (including some HIV medicines: ritonavir, cobicistat). Only use other medicines with Flixotide if your doctor has recommended them.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before using this medicine. Your doctor will assess whether you can use Flixotide during this time.

Driving and using machines

It is unlikely that side effects associated with Flixotide will affect your ability to drive or use machines.

3. How to use Flixotide

Always use this medicine exactly as your doctor has told you. Do not exceed the recommended dose. If you are unsure, ask your doctor. Flixotide inhalation aerosol is for inhalation use only. Your doctor will adjust the dose according to your individual response to treatment and determine the smallest effective dose that controls your 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 the elderly), are recommended to use a spacer. It is very important to use Flixotide every day, until your doctor tells you to stop. The therapeutic effect occurs within 4 to 7 days. Adults and children over 16 years old
100 μg to 1000 μg twice daily. The initial dose depends on the severity of the disease:

• Mild asthma: 100 μg to 250 μg twice daily;
• Moderate asthma: 250 μg to 500 μg twice daily;
• Severe asthma: 500 μg to 1000 μg twice daily.

Children over 4 years old
50 μg to 100 μg twice daily. The initial dose depends on the severity of the disease. If asthma symptoms are not adequately controlled with this dose, it can be increased to 200 μg twice daily.
The maximum recommended dose for children is 200 μg twice daily. If the dose of fluticasone propionate in the inhalation aerosol does not match the dose prescribed by your doctor for your child, you may consider using other available pharmaceutical forms of Flixotide (e.g., Flixotide Disk).
Children from 1 to 4 years old
50 μg to 100 μg twice daily. The medicine should be administered using a spacer with a face mask (e.g., Babyhaler).
Special patient groups
No dose adjustment is needed in elderly patients or in patients with renal or hepatic impairment.

Instructions for using the inhaler

• Your doctor, nurse, or pharmacist should instruct you on how to use the inhaler properly. They should check your technique periodically to ensure you are using the inhaler correctly. Not using Flixotide as recommended by your doctor or not using the inhaler correctly may mean that the medicine does not work as well as expected and may cause side effects.
• The medicine is contained in a pressurized container, in a plastic actuator with a mouthpiece.

Checking the inhaler

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

• 2. To ensure the inhaler is working, shake it vigorously, point the mouthpiece away from you, and release a dose into the air. If the inhaler has not been used for a week or more, remove the mouthpiece cap, shake the inhaler vigorously, and release two doses 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 (as shown in figure 1). Check the mouthpiece for foreign objects.
• 3. Shake the inhaler 4 or 5 times to ensure that any foreign objects are removed and the contents are well mixed.

and that the inhaler contents are evenly mixed.

It is essential not to rush through the steps 4-7.

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

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

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

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

• 8. If your doctor has prescribed two inhalations, wait about half a minute before repeating the steps 3-7.
• 9. Rinsing your mouth with water and spitting it out after inhalation helps prevent hoarseness and thrush.
• 10. After inhalation, always replace the cap on the mouthpiece to prevent dust from entering. Replace the cap by pushing it back into place. If you do not hear a click, remove the cap, turn it around, and try again. Do not use too much force.

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

• Remove the cap from the mouthpiece.
• Do not remove the metal canister from the plastic actuator during cleaning or at any other time.
• Clean the mouthpiece inside and outside and the plastic actuator outside with a dry cloth or tissue.
• Replace the cap on the mouthpiece. When the cap is properly replaced, you will hear a click. If you do not hear a click when replacing the cap, remove it, turn it around, and try again. Do not use too much force.
• Do not immerse the metal canister in water.

Using a higher dose of Flixotide than recommended

If you use a higher dose of Flixotide than recommended, consult your doctor or pharmacist for advice immediately. It is essential to use the recommended dose. Do not increase or decrease the dose without consulting your doctor. Using higher doses of fluticasone propionate than recommended may cause temporary suppression of adrenal function. Long-term use of higher doses of fluticasone propionate than recommended may lead to adrenal insufficiency.

Missing a dose of Flixotide

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

Stopping treatment with Flixotide

It is essential to use Flixotide every day until your doctor tells you to stop. Do not stop using Flixotide suddenly, as your asthma symptoms may worsen, and hormonal disturbances may occur in your body. If you have any further questions about using this medicine, ask 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 reported in patients using Flixotide:

Allergic reactions: seek medical help immediately

Allergic reactionsto Flixotide, which occur uncommonly (may affect up to 1 in 100 patients using the medicine). They are characterized by symptoms such as:

• Hives or skin rash.

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

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

If you experience any of these symptoms, stop using the medicine and seek medical help immediately.

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

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

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

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

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

Common side effects(may affect up to 1 in 10 patients using the medicine):

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

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

• Thrush of the esophagus.

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

• Flixotide may suppress the normal production of steroid hormones in the body, particularly with long-term use of high doses. Symptoms include slowed growth in children and adolescents, decreased bone mass, cataracts, glaucoma, weight gain, rounded face (moon face), high blood pressure, and other signs of Cushing's syndrome.
• Increased blood glucose levels (hyperglycemia). In patients with diabetes, more frequent monitoring of blood glucose levels and adjustment of the dose of antidiabetic medicines may be necessary.
• Joint pain.
• Nausea.
• Anxiety, sleep disturbances, and behavioral changes, including hyperactivity and irritability. These effects are more likely to occur in children.

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

• Depression and aggression. These effects are more likely to occur in children.
• Nosebleeds.
• Blurred vision.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration 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

Keep this medicine out of the sight and reach of children. Store in 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 burn the container, even if it appears to be empty. As with most inhalation medicines in pressurized containers, the effectiveness of this medicine may be less if the inhaler is cold. After inhalation, replace the cap 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 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Flixotide contains

• The active substance is fluticasone propionate (micronized). Each 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 chlorofluorocarbons (CFCs).

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

What Flixotide looks like and contents of the pack

Flixotide, 50 μg/inhalation dose, inhalation aerosol, suspension- 120 doses of the medicine in an aluminum container under pressure, sealed with a metering valve, fitted with a plastic actuator, in a cardboard box.
Flixotide, 125 μg/inhalation dose, inhalation aerosol, suspension- 60 or 120 doses of the medicine in an aluminum container under pressure, sealed with a metering valve, fitted with a plastic actuator, 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
For more information, 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 Warszawa
tel. (22) 576-90-00
{Logo of the marketing authorization holder}

Date of last revision of the leaflet: January 2025