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 all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask 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.

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 asthma attacks in adults and children aged over 4 years

In adults:
Mild asthma – in patients requiring daily symptomatic treatment with bronchodilators;
Moderate asthma – unstable or worsening asthma despite regular use of preventive asthma medicines 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 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 powders for inhalation are appropriate.

2. Important information before using Flixotide Disk

When not to use Flixotide Disk

• if the patient has been diagnosed with 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
a higher number of inhalations of a fast-acting inhaled medicine for breathing is needed as required,
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 Disk must 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
have available. Care must be taken not to confuse Flixotide Disk with a rescue inhaled medicine.
Long-term use of Flixotide Disk 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 Disk 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 Disk are used long-term or when treatment is suddenly stopped or the dose
is reduced. 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 taken during this time.
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 systemically acting steroid doses
should be done gradually, 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 reveal allergic symptoms such as: allergic rhinitis or
eczema, 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 may 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 Disk 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 caused by cataracts
or glaucoma, the patient should contact the doctor.
Flixotide Disk and other medicines
The patient should inform the doctor about all medicines currently taken or recently used, as well as about
medicines planned for use, including those available without a prescription.
It is especially important to inform the doctor about any of the following medicines currently or recently used:

• 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 Disk can be used with these medicines. Some of these medicines
may enhance the effect of Flixotide Disk, and the doctor may wish to closely monitor the patient taking such
medicines (including certain HIV medicines: ritonavir, cobicistat).
Flixotide Disk 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 the doctor before using this medicine.
The doctor will assess whether the patient can take Flixotide Disk during this period.
Driving and operating machinery
It is unlikely that adverse effects associated with the use of Flixotide Disk will affect the ability to drive
or operate machinery.
Important information about certain ingredients of Flixotide Disk
Each dose of Flixotide Disk contains approximately 12.5 mg of lactose. In individuals with lactose intolerance,
this amount of lactose usually does not cause any problems. If the patient has previously been diagnosed
with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.
3 How to use Flixotide Disk
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 Disk 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 providing effective symptom control.
It is very important to use Flixotide Disk 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 Disk medicines are 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 Disk, 500 µg/inhalation dose, twice daily or
2 doses of Flixotide Disk, 250 µg/inhalation dose, twice daily, in combination with a long-acting beta-agonist
such as salmeterol.
Only Flixotide Disk, powder for inhalation 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 no improvement occurs, the patient should be re-evaluated clinically.
Special patient groups
There is no need to adjust the dosage in elderly patients or in patients with impaired renal or hepatic function.
Instructions for using the Disk 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 Disk or improper use of the inhaler device may result in the medicine not producing the expected improvement in asthma or COPD.
• The Disk inhaler is packaged in foil, which should be removed before first use and discarded.
• The Disk inhaler, when first removed from the Flixotide Disk medicine packaging, is in the closed position.

• The Disk inhaler contains the medicine in the form of individual powder doses for inhalation.
• The Disk 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. When the counter shows 0, the inhaler is empty.

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

1. OPENING: To open the Disk 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 met and a click is heard.

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

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

• Place the mouthpiece in the mouth; inhale deeply from the Disk inhaler through the mouth, not through the nose.
• Hold breath, remove the Disk 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 the medicine or taste it, even if they are using the Disk inhaler correctly.

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

Rinsing the mouth with water and spitting it out after inhalation of the medicine helps prevent hoarseness
and oral candidiasis.
Cleaning
To clean the mouthpiece of the Disk inhaler, wipe it with a dry, soft cloth.
Use of a higher than recommended dose of Flixotide Disk
If a higher than recommended dose of Flixotide Disk is used, contact the doctor or pharmacist immediately
for advice.
It is important to take the medicine doses as prescribed by the doctor. Do not increase or decrease the dose
without consulting the 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.
Missing a dose of Flixotide Disk
It is very important to take the prescribed 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 Disk
It is very important to take Flixotide Disk daily until the doctor advises stopping. Do not stop taking
Flixotide Disk abruptly, 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 gets them.
Below are the adverse reactions observed in patients using the medicine
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 characterised 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 characterised 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 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 – they may be signs of a 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 ):

• 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 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 ):

• 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 ):

• Oesophageal candidiasis.

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

• Flixotide Disk, powder for inhalation, 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 reactions are more likely to occur in children.

Adverse reactions with unknown frequency ( frequency cannot be estimated from the 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, tell your doctor, pharmacist, or nurse. Adverse reactions 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
Tel: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorisation holder or its representative.

5. How to store Flixotide Dysk

Store at a temperature not exceeding 30°C.
Keep the medicine 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. 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. Each 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, placed in a multi-layer foil within a plastic container (the Disk inhaler device), fitted with a mouthpiece and a dose counter, wrapped in foil, and presented 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 more detailed information, 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 }