Flixotide

Package leaflet: Information for the patient

Flixotide, 0.5 mg/2 ml, suspension for nebuliser
Flixotide, 2 mg/2 ml, suspension for nebuliser
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. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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, suspension for nebuliser, belongs 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.
Indications
Adults and adolescents aged over 16 years:
The medicine is used preventively in severe bronchial asthma in patients requiring high doses of inhaled or oral corticosteroids. Initiating inhaled fluticasone propionate allows many patients to reduce or completely discontinue oral corticosteroids.
Children aged 4 to 16 years:
Treatment of acute exacerbations of bronchial asthma.

2. Information before using Flixotide

When not to use Flixotide

• if the patient is allergic to fluticasone propionate or to any of the other ingredients of this medicine (listed in section 6).

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 reliever medicine is required, 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 must not be used to relieve sudden breathing difficulties. For this purpose, a fast-acting, short-duration bronchodilator should be used, which the patient should always carry with them.
Flixotide is intended for daily, regular use.
Flixotide must not be used as a substitute for oral or intravenous steroids in life-threatening conditions.
Prolonged use of Flixotide may lead to suppression of the natural production of steroid hormones by the adrenal glands. This may result in decreased bone mass, cataracts, glaucoma, weight gain, facial rounding (moon-shaped face), increased 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 provides adequate asthma control.
While using fluticasone propionate at recommended doses, adrenal cortex function usually remains normal. However, patients previously treated with oral steroids may experience symptoms of impaired adrenal cortex function. 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 when high doses of Flixotide 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, injury, 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 for use during this time.
Due to the risk of impaired adrenal cortex function, patients who are switching from oral corticosteroids to inhaled fluticasone propionate should remain under special supervision, and adrenal cortex function should be monitored.
When starting treatment with fluticasone propionate, doses of systemic corticosteroids should be reduced gradually. Patients should carry a "steroid card" indicating the need for additional systemic corticosteroids during periods of stress.
Switching from oral steroids to inhaled therapy may reveal allergic symptoms such as allergic rhinitis or rash, previously suppressed by systemic steroids. The doctor will recommend appropriate treatment.
Very rare cases of increased blood glucose levels have been reported (see section 4), and the doctor should consider this when prescribing Flixotide to patients with a history of diabetes.
Treatment with fluticasone propionate must not be stopped suddenly.
If the patient is currently being treated or has previously been treated for tuberculosis, they should inform their doctor.
If the patient experiences blurred vision or other visual disturbances that may be due to cataracts or glaucoma, they should contact their doctor.

Flixotide and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription, as well as any medicines the patient plans to take.
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 can be used together with these medicines. Some of these medicines may increase the effects of Flixotide, and the doctor may wish to closely monitor the patient taking such medicines (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 can use Flixotide during this period.

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

3. How to use Flixotide

This medicine should always be used exactly as prescribed by your doctor. Do not take a higher dose than recommended. If in doubt, consult your doctor.
Flixotide for nebulising suspension is intended for inhalation only and is not intended for oral administration or injection.
The medicine should be administered as an aerosol produced by a pneumatic nebuliser, in accordance with your doctor's instructions.
The use of ultrasonic nebulisers for inhalation of Flixotide, suspension for nebulisation, is not recommended.
As inhaled delivery of the medicine depends on many factors, follow the instructions provided by the nebuliser manufacturer.
Inhalation via a mouthpiece is recommended to avoid the risk of developing atrophic skin changes on the face during prolonged administration of propionate fluticasone using a face mask. If a face mask is used, the facial skin in contact with the mask should be protected with cream or thoroughly washed after inhalation.

Dosage
Adults and adolescents over 16 years of age – 0.5 to 2.0 mg twice daily, strictly according to the doctor’s instructions.
Children and adolescents aged 4 to 16 years – 1.0 mg twice daily, strictly according to the doctor’s instructions.
Flixotide 2 mg/2 ml, suspension for nebulisation, must not be used in children under 16 years of age. There are no clinical data available on recommended dosing in this age group.
Special patient groups: there is no need to reduce the dose in elderly patients or in patients with renal or hepatic impairment.

Instructions for use
Before use, shake the container well by inverting it several times. To open, twist and detach the upper, movable part of the container.
Inhalation via a mouthpiece is recommended (see nebuliser user manual).

• Dilution: Flixotide, suspension for nebulisation, may be diluted with 0.9% sodium chloride injection solution to facilitate administration of small volumes of the medicine or when prolonged administration is required.
  Any unused suspension must be discarded from the nebuliser.
  Depending on the nebuliser design, aerosol may escape from the device into the surrounding environment.
  Therefore, nebulisation should not be performed in enclosed rooms without adequate ventilation. This is particularly important in hospital wards where several patients may be using nebulisers simultaneously.

Overdose of Flixotide
If more than the recommended dose of Flixotide has been used, contact your doctor or pharmacist immediately for advice.
It is important to use the medicine exactly as prescribed by your doctor. Do not increase or decrease the dose without consulting your doctor.
Administration of higher than recommended doses of propionate fluticasone may cause transient suppression of adrenal cortex function.
Long-term use of higher than recommended doses of propionate fluticasone may lead to adrenal cortex insufficiency.

Missed dose of Flixotide
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 according to instructions.
Do not take a double dose to make up for a missed dose.

Stopping Flixotide
It is very important to take Flixotide daily until your doctor advises you to stop. Do not stop taking Flixotide suddenly, as symptoms of the disease may worsen and hormonal disturbances in the body may occur.
If you have any further questions about the use of 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 uncommonly (may occur in 1 to 10 out of 1,000 patients using 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 fewer than 1 out of 10,000 patients using the medicine), and in a small number of patients these reactions may develop into a serious condition, even life-threatening, 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 (possibly leading to collapse or loss of consciousness). ➔ If such symptoms occur, stop using the medicine immediately and contact your doctor without delay, who will advise appropriate treatment.

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

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

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 inhalation may be helpful.
• Pneumonia has been reported in patients with chronic obstructive pulmonary disease (COPD).
• Easy bruising.

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

• Oesophageal candidiasis.

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

• Flixotide may suppress the normal production of steroid hormones by the body, particularly when high doses are used over a long 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 (hyperglycaemia). In diabetic patients, 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 occurring 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 you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can also 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
Phone: +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 authorization holder or its representative.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Flixotide

Store below 30 °C. Protect from light, do not freeze.
Keep out of sight and reach of children.
Store in an upright position. Shake before use.
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 is indicated on the packaging after: Lot.
After opening the sachet, store the medicinal product in plastic containers, protected from light, for no longer than 28 days.
The medicine should be discarded if not used immediately after opening the plastic container.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Flixotide, nebuliser suspension contains

• The active substance is fluticasone propionate (micronised). 2 ml of suspension (1 plastic container) contains 0.5 mg or 2 mg (milligrams) of fluticasone propionate (micronised), respectively.
• Other ingredients are: polysorbate 20, sorbitan laurate, sodium dihydrogen phosphate dihydrate, disodium phosphate anhydrous, sodium chloride, water for injections.

What Flixotide, nebuliser suspension looks like and contents of the pack
10 containers (2 sachets containing 5 containers each) in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Manufacturer:
GlaxoSmithKline (Ireland) Limited GlaxoSmithKline Trading Services Limited
12 Riverwalk 12 Riverwalk,
Citywest Business Campus Citywest Business Campus
Dublin 24 Dublin 24,
Ireland Ireland
For further information, please contact the Marketing Authorisation Holder's representative:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. (0-22) 576 9000
{Logo of the Marketing Authorisation Holder}