Flixotide

Patient Information Leaflet

Flixotide, 250 µg/inhalation dose, inhalation aerosol, suspension
Fluticasone propionate
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to 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, 250 µg/inhalation dose, inhalation aerosol, suspension, belongs to a group of medicines used in obstructive respiratory diseases. The active substance, fluticasone propionate, is a corticosteroid with local anti-inflammatory action in the lungs.
The medicine is indicated for:

• Prevention of bronchial asthma attacks in adults and children over 16 years of age:
  • Mild asthma – in patients requiring daily symptomatic treatment with bronchodilators;
  • Moderate asthma – unstable or worsening asthma despite regular use of preventive asthma medications or bronchodilators alone;
  • Severe asthma – in patients with severe forms of chronic bronchial asthma requiring oral steroid therapy to control asthma symptoms. Initiating treatment with fluticasone propionate enables many patients to reduce or completely discontinue oral steroid therapy;
• Treatment of chronic obstructive pulmonary disease (COPD). Fluticasone propionate is indicated for the treatment of COPD in combination with a long-acting beta-agonist such as salmeterol.

The inhalation aerosol, suspension, Flixotide with a dose of 250 µg/inhalation is appropriate for use in this indication.

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),

a pharmaceutical excipient in Flixotide.
Warnings and precautions
If asthma symptoms worsen or asthma control deteriorates, i.e. if wheezing increases or if a greater number of inhalations of a fast-acting inhaled medicine used as needed to ease breathing becomes necessary, the patient should continue taking the medicine and contact a doctor immediately, who will assess the patient's health condition and recommend appropriate treatment.
Flixotide must not be used to relieve sudden breathing difficulties. For this purpose, a fast-acting bronchodilator (e.g. salbutamol) should be used as needed, which the patient should always have available. Care should be taken not to confuse Flixotide with the reliever inhaled medicine.
The doctor should periodically check the patient's inhalation technique to ensure that the release of medicine from the inhaler is properly synchronized with taking a deep, calm breath. During inhalation, the patient should be sitting or standing. The inhaler is designed for use in an upright position.
Prolonged use of Flixotide may lead to suppression of the body's natural production of steroid hormones by the adrenal glands. This may cause reduced bone mass, cataract, glaucoma, increased body weight, rounding of the face (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 will ensure that the patient uses the lowest dose of Flixotide that maintains control of asthma and COPD.
During treatment with fluticasone propionate at recommended doses, adrenal cortex function is usually normal. However, in patients previously treated with oral steroids, symptoms of impaired adrenal cortex function may occur. Long-term treatment with high doses of inhaled steroids may cause adrenal cortex suppression. Children and adolescents under 16 years of age receiving high (usually ≥1000 micrograms per day) doses of fluticasone propionate are at particular risk. Very rarely, adverse effects may occur when high doses of Flixotide are used for a prolonged period or when treatment is suddenly stopped or the dose reduced. Adverse effects may also occur during infections or periods of severe stress (e.g. accident or surgical procedure). 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 to be taken during this time.
Due to the possibility of impaired adrenal cortex function, patients in whom oral steroid treatment is being switched to inhaled fluticasone propionate should remain under special medical supervision, and adrenal cortex function should be monitored.
When fluticasone propionate is introduced into treatment, 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.
Replacing oral steroids with inhaled steroids may unmask allergy symptoms such as allergic rhinitis or rash, previously suppressed by systemic steroids. The doctor will recommend appropriate treatment.
An increased number of reports of pneumonia cases have been observed in clinical trials in patients with chronic obstructive pulmonary disease (COPD) receiving fluticasone propionate at a dose of 500 micrograms (see section 4). The doctor should monitor patients with COPD for the development of pneumonia, as clinical symptoms of pneumonia and COPD exacerbation often overlap.
Very rare cases of increased blood glucose concentration have been reported (see section 4), 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 caused by cataract or glaucoma, the patient should contact the doctor.
Flixotide and other medicines
Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
It is especially important to inform the doctor about current or recent use of 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 monitor the patient closely (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 child, she should consult her doctor before using this medicine. The doctor will assess whether the patient can take 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 effects occur within 4 to 7 days.

Asthma:
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.

Chronic obstructive pulmonary disease (COPD):
Adults
500 µg twice daily, corresponding to 2 doses of Flixotide inhalation aerosol, suspension 250 µg/inhalation dose, in combination with a long-acting beta-agonist such as salmeterol.
Only Flixotide inhalation aerosol, suspension with a strength of 250 µg/inhalation dose, is suitable for use in this indication.
The medicine must be used daily to achieve optimal benefit, which may take from three to six months.
If there is no improvement, the patient should consult the doctor for a clinical reassessment.

Special patient groups
There is no need to adjust 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 use the inhaler correctly. They should periodically check that the patient is using the inhaler properly. Incorrect or off-label use of Flixotide or improper use of the inhaler may result in the medicine not producing the expected improvement in asthma or COPD.
• 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 pressing 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 dose 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 doses into the air.

Using the inhaler
It is important to begin breathing slowly and as gently as possible 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.

Important: Do not rush through steps 4–7.

4. Hold the inhaler upright with your fingers, placing your thumb at the base of the inhaler, below the mouthpiece. Breathe out deeply, as fully 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 a slow, deep inhalation.

7. Hold your breath, remove the inhaler from your mouth, and remove your finger from the top of the inhaler. Hold your breath for several seconds, or as long as comfortable without causing discomfort, then breathe out slowly.

8. If your doctor has prescribed two inhalations, wait approximately half a minute before repeating steps 3–7.
9. Rinsing the 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. Press the cap firmly into place. If you do not hear a click when placing 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.
Clean 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 properly fitted. If no click is heard, remove the cap, turn it over, 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 take the prescribed dose exactly as directed by your doctor. Do not increase or decrease the dose without consulting your doctor.
Taking 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 insufficiency.

Missed dose of Flixotide
It is very important to take the prescribed dose every day 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 using the medicine
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 using 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 using the medicine), and in a small number of patients these reactions may
progress to a serious, even life-threatening condition if not treated. They are characterized by
symptoms such as:

• Swelling (mainly of the face, lips, mouth, tongue, or throat), which may cause difficulty swallowing or breathing.
• Sudden onset of breathing difficulties or sudden worsening of wheezing (bronchospasm).
• Sudden feeling of weakness or dizziness (possibly leading to collapse or loss of consciousness). If any of these symptoms occur, stop using the medicine immediately and contact your doctor without delay, who will advise on appropriate treatment.

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

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

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

• Oral or pharyngeal candidiasis (painful, creamy-yellow lesions in the mouth and throat), difficulty 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 using 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 using the medicine):

• Esophageal candidiasis.

Very rare adverse reactions (may occur in fewer than 1 out of 10,000 patients
using 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, decreased bone mass, cataracts, glaucoma, weight gain, high blood pressure, and a rounded (moon-shaped) face (Cushing's syndrome).
• Increased blood glucose levels (hyperglycemia). In diabetic patients, more frequent monitoring of blood glucose levels and adjustment of antidiabetic medication doses may be necessary.
• Joint pain.
• Indigestion.
• Anxiety, sleep disturbances, and behavioral changes, including psychomotor hyperactivity and irritability. These reactions are more likely to occur in children.

Adverse reactions with unknown frequency (frequency cannot be determined 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, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 the medicine out of the sight and reach of children.
Store at a temperature not exceeding 30 °C.
Do not freeze.
The container holds a pressurized suspension. Do not expose it to temperatures above 50 °C and protect it from direct sunlight. Do not pierce, damage, or burn the container, even if it appears to be empty.
As with most pressurized inhalation medicines, the effectiveness of this medicine may be reduced if the inhaler is cold.
After inhalation, always 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 stated month.
The batch number of the medicine 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. This will help protect the environment.

6. Package contents and other information

What Flixotide contains

• The active substance is fluticasone propionate (micronized). One dose contains 250 µg (micrograms) of micronized 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.
60 doses
Each inhaler contains 8 g of HFC-134a (also known as 1,1,1,2-tetrafluoroethane or
HFA 134a), equivalent to 0.0114 tonnes of CO₂-equivalent (global warming potential GWP = 1430).
120 doses
Each inhaler contains 12 g of HFC-134a (also known as 1,1,1,2-tetrafluoroethane or
HFA 134a), equivalent to 0.0172 tonnes of CO₂-equivalent (global warming potential GWP = 1430).

What Flixotide looks like and contents of the pack
Pressurized inhalation aerosol, suspension – 60 or 120 doses of medicine in an aluminum container under pressure, closed with a metering valve and fitted with a plastic actuator, packed in a cardboard box.

Marketing Authorisation Holder: Manufacturer:
GlaxoSmithKline Trading Services Limited Glaxo Wellcome Production
12 Riverwalk Zone Industrielle No. 2
Citywest Business Campus 23, rue Lavoisier
Dublin 24 27000, Evreux
D24 YK11 France
Ireland
Glaxo Wellcome S.A.
Avenida de Extremadura 3
09400 Aranda de Duero
Burgos
Spain

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