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
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, 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 someone else, 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.

Leaflet 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/inhalation dose and Flixotide, 125 µg/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 prophylactic 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 asthma medications or bronchodilators only;
  • severe asthma – in patients with severe forms of chronic bronchial asthma requiring oral steroids to control asthma symptoms. Starting treatment with fluticasone propionate allows many patients to reduce or completely discontinue oral steroid therapy.
• in children requiring preventive medication, 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 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 should not be used to relieve sudden breathlessness. 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 actuation of the inhaler is properly synchronized with a slow, deep inhalation. The patient should be sitting or standing during inhalation. 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 decreased 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 is using the lowest dose of Flixotide that maintains asthma control.
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 function may occur. Long-term treatment with high doses of inhaled steroids may cause adrenal 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 with long-term use of high doses of Flixotide or with abrupt discontinuation or dose reduction. Adverse effects may also occur during infections or periods of severe stress (e.g. accident or surgery). Symptoms are usually nonspecific 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 used during such times.
Due to the possibility of impaired adrenal function, patients in whom oral corticosteroids are being replaced by inhaled fluticasone propionate should remain under special supervision, and adrenal cortex function should be monitored.
After initiating treatment with fluticasone propionate, tapering of systemic corticosteroid doses should be gradual, and patients should carry a "steroid card" indicating the need for additional systemic corticosteroids during periods of stress.
Replacing oral steroids with inhaled corticosteroids may unmask allergic conditions such as allergic rhinitis or eczema, 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 should not be stopped abruptly.
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
Inform the doctor about all medicines currently or 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 closely monitor the patient (including certain HIV medicines: ritonavir, cobicistat).
Flixotide should only be used with medicines prescribed by a 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 may 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 the doctor. Do not take a higher dose than recommended. If in doubt, consult your doctor.
Flixotide as 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 as an inhalation aerosol does not match the dose prescribed by the doctor for the child, consideration should be given to using other available pharmaceutical forms of Flixotide (e.g. Flixotide Disk).

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

Special patient groups
There is no need to adjust the dosage in elderly patients or in patients with impaired kidney or liver function.

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. Using Flixotide incorrectly or not as prescribed by the doctor 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 works. Remove the cap from the mouthpiece by gently pressing the sides of the cap with 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 steadily as possible even before using the inhaler.

1. Use the inhaler while standing or sitting. The inhaler is designed for use in an upright position.
2. Remove the cap from the inhaler mouthpiece (as shown in Figure 1). Check the mouthpiece inside and outside to ensure it is clean and free from 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 under the base of the inhaler, below the mouthpiece. Breathe out deeply, as fully as possible.

5. Place the mouthpiece in your mouth and seal 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 inhaler canister. Hold your breath for several 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 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 cap on the mouthpiece to prevent dust from entering. Push the cap firmly into place. If you do not hear a click when replacing 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 cap from the mouthpiece.
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 cap on the mouthpiece. A click should be heard when the cap is properly in place. 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.

Taking more Flixotide than recommended
If more Flixotide than recommended has been taken, 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 cortex insufficiency.

Missing a 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 the medicine as soon as possible. Continue treatment as before.
Do not take a double dose to make up for a missed dose.

Stopping Flixotide treatment
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 doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Below are the adverse effects observed in patients using the medicine
Flixotide.
Allergic reactions: seek medical help immediately
Allergic reactions to Flixotide, which occur fairly 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 less 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 a doctor without delay,
who will advise on appropriate treatment.
Pneumonia (lung infection) in patients with chronic obstructive pulmonary disease (COPD)
(common adverse effect)
Tell your doctor if any of the following symptoms occur during treatment with Flixotide – these may be symptoms of a lung infection:

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

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

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

Common adverse effects (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 be helpful.
• Pneumonia has been reported in patients with COPD – see above.
• Easy bruising.

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

• Oesophageal candidiasis.

Very rare adverse effects (may occur in less 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 a prolonged period. Symptoms include growth retardation 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 sugar (glucose) levels (hyperglycaemia). In patients with diabetes, 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 effects are more likely to occur in children.

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

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

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, tell your doctor, pharmacist, or nurse. Adverse
effects can be reported directly to the Department of Monitoring of 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 effects can also be reported to the marketing authorisation holder or representative of the marketing authorisation holder.
Reporting adverse effects 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.
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 following EXP.
The expiry date refers to the last day of the stated month.
The medicine's batch number is shown on the packaging following: Lot.
Medicines should 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). Each 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/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), equivalent to 0.0152 tonnes of CO₂-equivalent (global warming potential 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), equivalent to 0.0114 tonnes of CO₂-equivalent (global warming potential 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), equivalent to 0.0172 tonnes of CO₂-equivalent (global warming potential GWP = 1430).

What Flixotide looks like and contents of the pack
Flixotide, 50 µg/inhalation 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/inhalation 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:
Manufacturer:
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

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 local representative of the Marketing Authorisation Holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warszawa
tel. (22) 576-90-00
{Logo of the Marketing Authorisation Holder}