Flixotide disk

Package leaflet: information for the patient

Flixotide Disk, 50 µg/inhalation dose, powder for inhalation
Flixotide Disk, 100 µg/inhalation dose, powder for inhalation
Flixotide Disk, 250 µg/inhalation dose, powder for inhalation
Flixotide Disk, 500 µg/inhalation dose, powder for inhalation
Fluticasone propionate
Please read this leaflet carefully before using the medicine, 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 pass it on to others. The 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 of the leaflet:

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

1. What Flixotide Disk is and what it is used for

Flixotide Disk 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.
Flixotide Disk is indicated for:

• Prevention of bronchial asthma attacks in adults and children over 4 years of age

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 alone;
Severe asthma – in patients with severe chronic bronchial asthma requiring oral steroid therapy to control asthma symptoms. Initiating inhaled fluticasone propionate allows many patients to reduce or completely discontinue oral steroid treatment.
In children requiring preventive medication, including those inadequately controlled with other available preventive medicines.

• Treatment of chronic obstructive pulmonary disease (COPD)

Fluticasone propionate is indicated in the treatment of COPD in combination with a long-acting beta-agonist such as salmeterol.
For this indication, only Flixotide Disk 250 µg/inhalation dose and 500 µg/inhalation dose powder for inhalation are appropriate.

2. Important information before using Flixotide Dysk

When not to use Flixotide Dysk

• if the patient has severe allergy to milk proteins
• if the patient is allergic to fluticasone propionate or to lactose monohydrate, an excipient of the medicine.

Warnings and precautions
If asthma symptoms worsen or asthma control deteriorates, i.e. if wheezing increases or if a higher number of inhalations of a fast-acting inhaled medicine used as needed to relieve breathing difficulties becomes necessary, the patient should continue taking the medicine and contact the doctor immediately, who will assess the patient's health condition and recommend appropriate treatment.
Flixotide Dysk should not be used to relieve sudden asthma attacks. For this purpose, a fast-acting bronchodilator medicine (e.g. salbutamol) should be used as needed, which the patient should always carry with them. Care should be taken not to confuse Flixotide Dysk with a rescue inhaled medicine.
When Flixotide Dysk is used for a long time, suppression of the natural production of steroid hormones by the adrenal glands may occur. This may lead to reduced bone mass, cataract, glaucoma, increased body weight, rounding of the face (moon-shaped face), elevated blood pressure, and slowed growth in children and adolescents.
The doctor will regularly check whether any of these adverse effects occur and will ensure that the patient uses the lowest dose of Flixotide Dysk that provides effective control of asthma and COPD.
While using fluticasone propionate at recommended doses, adrenal cortex function usually remains 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 suppression of adrenal cortex function. 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 Dysk 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 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, low blood glucose levels, 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 cortex 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.
When introducing fluticasone propionate into treatment, the reduction of systemic corticosteroid 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 medicines may unmask allergy symptoms such as allergic rhinitis or rash, which were previously controlled 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 COPD patients for the development of pneumonia, as clinical symptoms of pneumonia and COPD exacerbation often overlap.
Very rare cases of increased blood glucose levels have been reported (see section 4), and the doctor should consider this when prescribing Flixotide Dysk 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 that may be caused by cataract or glaucoma, they should contact the doctor.

Flixotide Dysk and other medicines
Inform the doctor about all medicines currently taken 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 currently or recently used medicines such as:

• corticosteroids in tablet or injectable form
• 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 Dysk can be used with these medicines. Some of these medicines may enhance the effect of Flixotide Dysk, and the doctor may wish to closely monitor the patient taking such medicines (including certain HIV medicines: ritonavir, cobicistat).
Only medicines prescribed by the doctor should be used together with Flixotide Dysk.

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 the doctor before using this medicine.
The doctor will assess whether the patient can take Flixotide Dysk during this period.

Driving and operating machinery
It is unlikely that adverse effects associated with the use of Flixotide Dysk will affect the ability to drive or operate machinery.

Important information about certain ingredients of Flixotide Dysk
Each dose of Flixotide Dysk contains approximately 12.5 mg of lactose. In individuals with lactose intolerance, this amount of lactose usually does not cause problems. However, if the patient has previously been diagnosed with intolerance to certain sugars, they should contact the doctor before taking the medicine.

3 How to use Flixotide Dysk
This medicine should always be used as directed by the doctor. Do not take a higher dose than recommended. If in doubt, consult the doctor.
Flixotide Dysk is intended for inhalation only.
The doctor will adjust the dose according to the individual patient's response to treatment and determine the lowest dose that ensures effective symptom control.
It is very important to use Flixotide Dysk every day until the doctor advises otherwise. Therapeutic effect occurs 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.

Children over 4 years of age
50 µg to 100 µg twice daily. The initial dose depends on the severity of the disease.
Children under 4 years of age
Flixotide Dysk is not intended for use in children under 4 years of age.

Chronic obstructive pulmonary disease (COPD):
Adults
500 µg twice daily, corresponding to 1 dose of Flixotide Dysk, 500 µg/dose inhalation, twice daily or 2 doses of Flixotide Dysk, 250 µg/dose inhalation, twice daily, in combination with a long-acting beta-agonist such as salmeterol.
Only Flixotide Dysk, inhalation powder with strengths of 250 µg/inhalation dose and 500 µg/inhalation dose, are suitable for this dose.
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 be re-evaluated clinically.

Special patient groups
There is no need to adjust the dose in elderly patients or in patients with renal or hepatic impairment.

Instructions for using the Dysk inhaler device

• The doctor, nurse, or pharmacist should instruct the patient on the correct use of the inhaler device. They should periodically check whether the patient is using the inhaler correctly. Incorrect use of Flixotide Dysk or improper use of the inhaler device may result in the medicine not producing the expected improvement in asthma or COPD.
• The Dysk inhaler is packaged in foil, which should be removed before first use and discarded.
• The Dysk inhaler removed for the first time from the Flixotide Dysk packaging is in the closed position.

• The Dysk inhaler contains the medicine in the form of individual doses of inhalation powder.
• The Dysk inhaler is equipped with a dose counter indicating how many doses of medicine remain in the inhaler. The counter displays the dose number down to 0. Numbers from 5 to 0 appear in red as a warning that only a few doses of medicine remain in the inhaler. If the counter shows 0, this means the inhaler is empty.

Using the Dysk inhaler
When the slider of the Dysk inhaler is moved, a small opening appears in the mouthpiece and the dose of medicine is ready for inhalation. When the Dysk inhaler is closed, the slider automatically returns to its original position, and the outer cover protects the Dysk when not in use. To use, follow the steps below:

1. OPENING: To open the Dysk inhaler, hold the cover with one hand and place the thumb of the other hand in the indentation of the housing. Slide the thumb away from you until resistance is felt and a click is heard.

2. DOSE SETTING: Hold the Dysk inhaler with the mouthpiece facing toward you. It can be held in either hand. Slide the slider fully away from you until a characteristic sound is heard. The Dysk inhaler is ready for use. Each time the lever is moved, the next dose of powder is prepared for inhalation. Do not play with the slider, as this will open the next dose and reduce the number of available doses.

3. INHALING: Before starting inhalation (breathing in) of the medicine, carefully read the instructions below.
   • Hold the Dysk inhaler at a distance from the mouth and breathe out calmly and deeply. Do not exhale into the Dysk inhaler.

• Place the mouthpiece in the mouth; inhale deeply from the Dysk inhaler through the mouth, not through the nose.
• Hold the breath, remove the Dysk inhaler from the mouth. Breath-holding should last approximately 10 seconds, or as long as comfortable, then breathe out calmly.
• Patients may not feel or taste the medicine, even if using the Dysk inhaler correctly.

4. CLOSING:
   • To close the Dysk inhaler, insert the thumb into the indentation of the housing and slide it toward you.
   • A "click" is heard when closing the Dysk inhaler. The dose-setting slider automatically returns to its original position. The Dysk inhaler is ready for reuse.

Rinsing the mouth with water and spitting it out after inhalation helps prevent hoarseness and oral thrush.

Cleaning
To clean the mouthpiece of the Dysk inhaler, wipe it with a dry, soft cloth.

Taking more than the recommended dose of Flixotide Dysk
If more than the recommended dose of Flixotide Dysk has been taken, contact the doctor or pharmacist immediately for advice.
It is important to take the medicine exactly as prescribed by the doctor. Do not increase or decrease the dose without consulting the 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 Dysk
It is very important to take the recommended dose daily 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 treatment with Flixotide Dysk
It is very important to take Flixotide Dysk daily until the doctor advises stopping. Do not stop taking Flixotide Dysk suddenly, as symptoms of the disease may worsen and hormonal disturbances in the body may occur.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Below are the adverse reactions observed in patients using
Flixotide Disk.

Allergic reactions: seek immediate medical help
Allergic reactions to Flixotide Disk, 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 Disk, 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. The doctor will advise on appropriate treatment.

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

• Oral and pharyngeal candidiasis (painful, creamy-white lesions), 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 reactions ( may occur in 1 to 10 out of 100 patients ):

• Hoarseness, voice loss. Rinsing the mouth with water and spitting it out after each inhalation may be helpful.
• Lung infection 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 ):

• Esophageal candidiasis.

Very rare adverse reactions ( may occur in fewer than 1 out of 10,000 patients ):

• Flixotide Disk, inhalation powder, may suppress the body's normal production of steroid hormones, especially when high doses are used for a prolonged period. Symptoms include slowed growth 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 (hyperglycemia). In diabetic patients, more frequent monitoring of blood glucose levels and adjustment of previously prescribed antidiabetic medications may be necessary.
• Joint pain.
• Indigestion.
• Anxiety, sleep disturbances, and behavioral changes, including psychomotor hyperactivity and irritability. These are more likely to occur in children.

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

• Depression and aggression. These 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, tell your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Reporting adverse reactions helps to provide more information on the safety of this medicine.
Adverse reactions can also be reported to the marketing authorization holder or its representative.

5. How to store Flixotide Dysk

Store at a temperature not exceeding 30°C.
Keep out of the sight and reach of children.
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 batch number of the medicine is shown on the packaging following: 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. Contents of the pack and other information

What Flixotide Disk contains

• The active substance is micronized fluticasone propionate. One dose of the medicine contains 50, 100, 250 or 500 µg (micrograms) of micronized fluticasone propionate, respectively.
• The other ingredient is lactose monohydrate (which contains milk proteins).

What Flixotide Disk looks like and contents of the pack
Flixotide Disk is a powder for inhalation.
The pack contains 60 doses of the medicine as powder, contained in multi-layer foil within a plastic container (the Disk inhaler device), fitted with a mouthpiece and a dose counter, wrapped in foil, and packaged in a cardboard box.

Marketing Authorisation Holder: Manufacturer:
GlaxoSmithKline Trading Services Limited 1. Glaxo Wellcome Production
12 Riverwalk Zone Industrielle No. 2
Citywest Business Campus 23, rue Lavoisier
Dublin 24 27000, Evreux
D24 YK11 France
Ireland

For further information, please contact the local representative of 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 }