Flixotide

Package leaflet: Information for the patient

Flixotide, 50 µg per inhalation dose, inhalation aerosol, suspension
Flixotide, 125 µg per inhalation dose, inhalation aerosol, suspension
Fluticasone propionate
Please read carefully the entire leaflet before use, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

• in adults:
  • mild asthma – in patients requiring daily symptomatic treatment with bronchodilators;
  • moderate asthma – unstable or worsening asthma despite regular use of preventive anti-asthma medicines or bronchodilators alone;
  • severe asthma – in patients with severe forms of chronic bronchial asthma requiring oral steroids to control asthma symptoms. Initiating fluticasone propionate treatment allows many patients to reduce or completely discontinue oral steroid therapy.
• in children requiring preventive treatment, including patients inadequately controlled with other available preventive medicines.

2. Information before using Flixotide

When not to use Flixotide

• if the patient is allergic to fluticasone propionate or to 1,1,1,2-tetrafluoroethane (HFA 134a), an excipient in Flixotide.

Warnings and precautions
If asthma symptoms worsen or asthma control deteriorates, i.e. if wheezing increases or a higher number of inhalations of a fast-acting inhaled medicine used as needed to relieve breathing difficulties becomes necessary, the patient should continue using the medicine and contact a doctor immediately. The doctor will assess the patient's health condition and recommend appropriate treatment.
Flixotide must not be used to relieve sudden asthma attacks. For this purpose, a fast-acting bronchodilator (e.g. salbutamol) should be used as needed, which the patient should always carry with them. Care should be taken not to confuse Flixotide with the reliever inhaler.
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 a deep, calm inhalation. During inhalation, the patient should be sitting or standing. The inhaler is designed for use in an upright position.
Long-term use of Flixotide may lead to suppression of the natural production of steroid hormones by the adrenal glands. This may cause reduced bone mass, cataract, glaucoma, increased body weight, facial rounding (moon-shaped face), elevated blood pressure, slowed growth in children and adolescents. The doctor will regularly monitor whether any of these adverse effects occur and ensure that the patient uses the lowest dose of Flixotide that maintains asthma control.
During treatment with fluticasone propionate at recommended doses, adrenal cortex function is usually normal. However, patients previously treated with oral steroids may experience symptoms of impaired adrenal cortex function. Long-term treatment with high doses of inhaled steroids may cause adrenal suppression. Children and adolescents under 16 years of age receiving high doses of fluticasone propionate (usually ≥1000 micrograms per day) are at particular risk. Very rarely, adverse effects may occur when high doses of Flixotide are used long-term or when treatment is abruptly stopped or the dose reduced. Adverse effects may also occur during infections or periods of severe stress (e.g. accident or surgery). Symptoms are usually non-specific and may include: abdominal pain, fatigue, loss of appetite, nausea and vomiting, weight loss, headache, confusion, low blood pressure, decreased blood glucose concentration, and seizures. To prevent these symptoms, the doctor may prescribe additional corticosteroids for use during this time.
Due to the risk of impaired adrenal cortex function, patients switching from oral corticosteroids to inhaled fluticasone propionate should remain under special supervision, and adrenal cortex function should be monitored.
After initiating treatment with fluticasone propionate, the reduction of systemic steroid doses should be gradual, and patients should carry a "steroid card" indicating the need for additional systemic steroids during periods of stress.
Switching from oral steroids to inhaled steroids may unmask allergy symptoms such as allergic rhinitis or rash, previously suppressed by systemic steroids. The doctor will recommend appropriate treatment.
Very rare cases of increased blood glucose levels (see section 4) have been reported, and the doctor should consider this when prescribing Flixotide to patients with a history of diabetes.
Treatment with fluticasone propionate must not be stopped suddenly.
If the patient is currently being treated or has previously been treated for tuberculosis, this should be reported to the doctor.
If the patient experiences blurred vision or other visual disturbances, which may be due to cataract or glaucoma, they should contact their doctor.

Flixotide and other medicines
Tell the doctor about all medicines currently or recently used, as well as any medicines the patient plans to take, including those available without a prescription.
It is especially important to inform the doctor if the patient is currently or recently using any of the following medicines:

• corticosteroids in tablets or injections
• ritonavir or medicines containing cobicistat, used in the treatment of HIV
• ketoconazole or itraconazole, used in the treatment of fungal infections.

The doctor will assess whether Flixotide can be used with these medicines. Some of these medicines may increase the effect of Flixotide, and the doctor may wish to closely monitor the patient (including certain HIV medicines: ritonavir, cobicistat).
Flixotide should only be used with medicines prescribed by the doctor.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine. The doctor will assess whether the patient can use Flixotide during this period.

Driving and operating machinery
It is unlikely that adverse 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 exactly as prescribed by your doctor. Do not take a higher dose than recommended. If in doubt, consult your doctor.
Flixotide in the form of an inhalation aerosol is intended exclusively for inhalation use.
The doctor will adjust the dose according to the individual patient's response to treatment and will determine the lowest dose that provides effective control of symptoms.
To facilitate the use of the medicine and to prevent possible adverse effects in the mouth and throat in 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), the use of a spacer device is recommended.
It is very important to use Flixotide every day until your doctor advises otherwise.
Therapeutic effect occurs within 4 to 7 days.

Adults and children over 16 years of age
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 of age
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, the dose may 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 form of an inhalation aerosol does not match the dose prescribed by the doctor for the child, consider using other available pharmaceutical forms of Flixotide (e.g. Flixotide Disk).

Children from 1 to 4 years of age
50 µg to 100 µg twice daily.
The medicine should be administered using a paediatric spacer device with a face mask (e.g. Babyhaler).

Special patient groups
Dosage adjustment is not required in elderly patients or in patients with impaired renal or hepatic function.

Instructions for use of the inhaler

• Your doctor, nurse, or pharmacist should instruct you on how to use the inhaler correctly. They should periodically check that you are using the inhaler properly. Incorrect use of Flixotide or improper use of the inhaler may result in the medicine not providing the expected improvement in asthma.
• The medicine is contained in a pressurized canister within a plastic housing with a mouthpiece.

Checking the inhaler

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

2. To ensure the inhaler is working, shake it vigorously, point the mouthpiece away from you, and release one puff into the air. If the inhaler has not been used for one week or longer, remove the mouthpiece cap, shake the inhaler vigorously, and release two puffs into the air.

Using the inhaler
It is important to begin breathing slowly and as calmly as possible even before using the inhaler.

1. Use the inhaler while standing or sitting. The inhaler is designed to be used in an upright position.
2. Remove the mouthpiece cap (as shown in Figure 1). Check the mouthpiece inside and outside to ensure it is clean and free of foreign objects.
3. Shake the inhaler 4 or 5 times to remove any foreign particles and to ensure the contents are evenly mixed.

It is important not to rush through steps 4–7.

4. Hold the inhaler upright with your fingers, placing your thumb under the base of the inhaler, below the mouthpiece. Breathe out fully, as deeply as possible.

5. Place the mouthpiece in your mouth and close your lips tightly around it. Do not bite the mouthpiece.

6. Immediately after starting to inhale through your mouth, press down on the inhaler to release Flixotide, then continue to inhale slowly and deeply.

7. Hold your breath, remove the inhaler from your mouth, and remove your finger from the canister. 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 approximately half a minute before repeating steps 3–7.
9. Rinsing your mouth with water and spitting it out after inhalation helps prevent hoarseness and oral thrush.
10. After inhalation, always replace the mouthpiece cap to prevent dust from entering. Push the cap firmly into place. If you do not hear a click when attaching the cap, remove it, turn it around, and try again. Do not use excessive force.

Cleaning the inhaler
To prevent blockage, clean the inhaler at least once a week. To clean the inhaler:
Remove the mouthpiece cap.
Do not remove the metal canister from the plastic housing during cleaning or at any other time.
Wipe the mouthpiece inside and outside, and the outside of the plastic housing, with a dry cloth or tissue.
Replace the mouthpiece cap. A click should be heard when the cap is properly attached. If no click is heard, remove the cap, turn it around, and try again. Do not use excessive force.
Do not immerse the metal canister in water.

Overdose of Flixotide
If more than the recommended dose of Flixotide has been used, contact your doctor or pharmacist immediately for advice.
It is important to use the prescribed dose exactly as directed. 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 cortex function.
Long-term use of higher than recommended doses of fluticasone propionate may lead to adrenal cortex insufficiency.

Missed dose of Flixotide
It is very important to take the prescribed dose daily to ensure maximum treatment effectiveness.
If a dose is missed, take it as soon as possible. Continue treatment as before.
Do not take a double dose to make up for a missed dose.

Stopping Flixotide
It is very important to take Flixotide every day until your doctor advises you to stop. Do not stop taking Flixotide suddenly, as symptoms may worsen and hormonal disturbances in the body may occur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Below are the adverse reactions observed in patients taking
Flixotide.

Allergic reactions: seek medical help immediately
Allergic reactions to Flixotide, which occur uncommonly (may occur in 1 to 10 out of 1,000
patients taking the medicine). These are characterized by symptoms such as:

• Skin rash (urticaria) or redness.

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

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

If any of these symptoms occur, stop using the medicine immediately and contact your doctor
without delay, who will advise appropriate treatment.

Pneumonia (lung infection) in patients with chronic obstructive pulmonary disease (COPD)
(common adverse reaction)
Tell your doctor if any of the following symptoms occur while using Flixotide – these may be signs of lung infection:

• Fever or chills.
• Increased mucus production, change in mucus colour.
• Worsening cough or increased breathing difficulties.

Other adverse reactions:
Very common adverse reactions (may occur in more than 1 out of 10 patients taking the
medicine):

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

Common adverse reactions (may occur in 1 to 10 out of 100 patients taking the medicine):

• Hoarseness, loss of voice. Rinsing the mouth with water and spitting it out after each inhalation may help.
• Pneumonia has been reported in patients with COPD – see above.
• Easy bruising.

Uncommon adverse reactions (may occur in 1 to 10 out of 10,000 patients taking the medicine):

• Oesophageal candidiasis.

Rare adverse reactions (may occur in fewer than 1 out of 10,000 patients
taking the medicine):

• Flixotide may suppress the body's normal production of steroid hormones, especially when high doses are used for prolonged periods. Symptoms include growth suppression in children and adolescents, reduced bone mass, cataracts, glaucoma, weight gain, high blood pressure, and a rounded (moon-shaped) face (Cushing's syndrome).
• Increased blood sugar (glucose) levels (hyperglycaemia). In diabetic patients, more frequent monitoring of blood glucose levels and adjustment of the dose of currently used antidiabetic medicines may be necessary.
• Joint pain.
• Indigestion.
• Anxiety, sleep disturbances, and behavioural changes, including psychomotor hyperactivity and irritability. These reactions are more likely to occur in children.

Adverse reactions with unknown frequency (frequency cannot be estimated
from available data):

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder or its representative.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Flixotide

Keep this medicine out of sight and reach of children.
Store at a temperature not exceeding 30 °C.
Do not freeze.
The container holds a pressurised suspension. Do not expose to temperatures above 50°C and protect from direct sunlight. Do not pierce, damage, or burn the container, even if it appears to be empty.
As with most inhaled medicines in pressurised containers, the effectiveness of this medicine may be reduced if the inhaler is cold.
Replace the cap on the mouthpiece immediately after inhalation. 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 stated month.
The medicine's batch number is shown on the packaging after: Lot.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Flixotide contains

• The active substance is fluticasone propionate (micronised). One dose contains 50 or 125 µg (micrograms) of micronised fluticasone propionate.
• 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/inhaled 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), corresponding to 0.0152 tonnes of CO₂ equivalent (global warming potential GWP = 1430).
Flixotide, 125 µg/inhaled 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), corresponding to 0.0114 tonnes of CO₂ equivalent (global warming potential GWP = 1430).
Flixotide, 125 µg/inhaled 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), corresponding to 0.0172 tonnes of CO₂ equivalent (global warming potential GWP = 1430).

What Flixotide looks like and contents of the pack
Flixotide, 50 µg/inhaled dose, inhalation aerosol, suspension – 120 doses of medicine in an aluminium pressurised container closed with a metering valve and fitted with a plastic actuator, in a cardboard box.
Flixotide, 125 µg/inhaled dose, inhalation aerosol, suspension – 60 or 120 doses of medicine in an aluminium pressurised container closed with a metering valve and fitted with a plastic actuator, in a cardboard box.

Marketing Authorisation Holder:
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

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 further information, contact the representative of the Marketing Authorisation Holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
Poland
Tel: (22) 576-90-00
{Logo of the Marketing Authorisation Holder}