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 you.

• 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. The medicine may harm other people, even if their symptoms are similar.
• 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. Starting inhaled 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 treatments.

• 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.
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 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 greater number of inhalations of a fast-acting inhaled medicine to ease breathing is required as needed,
the patient should continue using the medicine and contact the doctor immediately, who will assess
the patient's health condition and recommend appropriate treatment.
Flixotide Disk should not be used to relieve sudden breathlessness 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 should be taken not to confuse Flixotide Disk
with a rescue inhaled medicine.
Long-term use of Flixotide Disk may lead to suppression of natural steroid hormone production
by the adrenal glands. This may cause reduced 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 uses the lowest dose of Flixotide Disk providing effective 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 suppress adrenal cortex function. Children and adolescents under 16 years of age receiving high
(usually ≥1000 micrograms per day) doses of fluticasone propionate constitute a group 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 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, decreased blood glucose concentration, and seizures. To prevent these symptoms,
the doctor may prescribe additional corticosteroids to be used during this time.
Due to the possibility of impaired adrenal cortex function, patients in whom oral corticosteroids
are replaced by inhaled fluticasone propionate should remain under special supervision,
and adrenal cortex function should be monitored.
When introducing fluticasone propionate into treatment, tapering of systemic steroids 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 medicines may reveal allergy symptoms such as:
allergic rhinitis or rash, which were 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 signs of developing 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 cataract
or glaucoma, the patient should contact the doctor.

Flixotide Disk 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 particularly important to inform the doctor about currently or recently used medicines such as:

• 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 them 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).
Only medicines prescribed by the doctor should be used together with Flixotide Disk.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans 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 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 exclusively for inhalation use.
The doctor will adjust the dose according to the patient's individual response to treatment and determine
the lowest dose ensuring 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, 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 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 kidney or liver function.

Instructions for using the Disk 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 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 removed for the first time from the Flixotide Disk medicine packaging, is in the closed position.

• The Disk inhaler contains the medicine in the form of individual doses of inhalation powder.
• 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 to warn that only a few doses of medicine remain in the inhaler. If the counter shows 0, this means the inhaler is empty.

Using the Disk inhaler
Moving the slider of the Disk inhaler opens a small hole in the mouthpiece, and the dose of medicine
is ready for inhalation. Closing the Disk inhaler causes the slider to return automatically 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. Push the thumb away from you until it stops, until a click is heard.

2. DOSE SETTING: Hold the Disk inhaler with the mouthpiece facing toward you. It can be held in either hand. Push the slider fully away from you until a characteristic sound is heard. The Disk inhaler is ready for use. Each time the lever is moved, the next dose of powder becomes available 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 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 comfortable without causing discomfort, then perform a calm exhalation.
• Patients may not feel or taste the medicine, even if using the Disk inhaler correctly.

4. CLOSING:
   • To close the Disk inhaler, insert the thumb into the housing indentation and slide it toward you.
   • A "click" 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 thrush.
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 use 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 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 Disk
It is very important to take Flixotide Disk every day 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 will experience 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 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, who will advise on appropriate treatment.

Lung inflammation (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 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 thrush (painful, creamy-white lesions) in the mouth and throat, difficulty 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 oral thrush.

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 be helpful.
• Lung inflammation 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 (thrush of the esophagus).

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 over a long period. Symptoms include slowed growth in children and adolescents, reduced bone mass, cataracts, glaucoma, weight gain, 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 used 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, inform your doctor, pharmacist, or nurse. Adverse reactions can 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 reactions helps provide more information on the safety of the 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 the medicine out of 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 indicated 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. Such measures 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 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 further 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 }