FLIXOTIDE DYSK

Package leaflet: Information for the patient

Flixotide Disk, 50 µg/inhalation, powder for inhalation
Flixotide Disk, 100 µg/inhalation, powder for inhalation
Flixotide Disk, 250 µg/inhalation, powder for inhalation
Flixotide Disk, 500 µg/inhalation, 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, 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. It 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.

Table of contents:

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 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 asthma requiring oral steroids to control asthma symptoms. Initiating inhaled fluticasone propionate allows many patients to reduce or completely discontinue oral steroid therapy.
In children requiring preventive treatment, including those inadequately controlled with other available preventive medicines.

• 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.
Only Flixotide Disk, powder for inhalation, 250 µg/inhalation and 500 µg/inhalation, are appropriate for this indication.

2. Important information before using Flixotide Dysk

When not to use Flixotide Dysk

• if the patient has a 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 more puffs of a fast-acting inhaled medicine used as needed are required, 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 Dysk should 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 carry with them. Care must be taken not to confuse Flixotide Dysk with a reliever inhaled medicine.
Long-term use of Flixotide Dysk may lead to suppression of the natural production of steroid hormones by the adrenal glands. This may cause reduced bone mass, cataracts, 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 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 suppress 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 with long-term use of high doses of Flixotide Dysk or with sudden 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, 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 steroid treatment is 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 systemically acting 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 medicines 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 pneumonia cases has been reported in clinical trials among 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 signs 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 cataracts or glaucoma, they should contact the doctor.

Flixotide Dysk and other medicines
Inform the doctor about all medicines currently taken 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 taking or has recently taken 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 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 with Flixotide Dysk.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a 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 excipients in 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 consult a 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 use 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 medicines are not intended for use in children under 4 years of age.

Chronic obstructive pulmonary disease (COPD):
Adults
500 µg twice daily, equivalent to 1 dose of Flixotide Dysk, 500 µg/inhalation dose, twice daily, or 2 doses of Flixotide Dysk, 250 µg/inhalation dose, 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 administering 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 impaired kidney or liver function.

Instructions for using the Dysk inhaler device

• The doctor, nurse, or pharmacist should instruct the patient on how to properly use 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 and discarded before first use.
• The Dysk inhaler, when first removed from the Flixotide Dysk medicine 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 to warn that only a few doses remain in the inhaler. When the counter shows 0, 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 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 it stops, until a click is heard.

2. DOSE PREPARATION: Hold the Dysk inhaler with the mouthpiece facing towards 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 opens the next dose and reduces the number of available inhalation doses.

3. INHALATION: Before starting inhalation (breathing in) of the medicine, carefully read the instructions below.
   • Hold the Dysk inhaler at a certain 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 breath, remove the Dysk inhaler from the mouth. Breath-holding should last approximately 10 seconds or as long as is 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 housing indentation and slide it toward you.
   • A "click" sound 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 is taken, contact a 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 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 may occur.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Below are the adverse effects observed in patients using Flixotide Disk.

Allergic reactions: seek medical help immediately
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 a 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 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 while using Flixotide Disk – 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 effects:
Very common adverse effects ( may occur in more than 1 out of 10 patients ):

• 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 ):

• 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 1,000 patients ):

• Not applicable (no specific effects listed under this frequency in the source text).

Rare adverse effects ( may occur in 1 to 10 out of 10,000 patients ):

• Oesophageal candidiasis.

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

• Flixotide Disk, powder for inhalation, may suppress the normal production of steroid hormones by the body, 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, 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 previously prescribed antidiabetic medication 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 the 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 not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse effects can also 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of this medicine.
Adverse effects can also be reported to the marketing authorisation holder or its representative.

5. How to store Flixotide Dysk

Store below 30°C.
Keep out of sight and reach of children.
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 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 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 medicine in the form of powder, contained in a multi-layer foil,
in a plastic container (the Disk inhaler device), fitted with a mouthpiece and a dose counter,
wrapped in foil, and packed 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 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 }