FLUTIXONE

Patient Information Leaflet

Flutixon, 125 micrograms/inhalation dose, inhalation powder in hard capsules
Flutixon, 250 micrograms/inhalation dose, inhalation powder in hard capsules
Fluticasoni propionas
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

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

1. What Flutixon is and what it is used for

Flutixon belongs to a group of medicines used in obstructive respiratory diseases (diseases with reduced airflow in the lungs). The active substance, fluticasone propionate, is a corticosteroid (a corticosteroid hormone) with local anti-inflammatory action in the lungs.

Flutixon is indicated:

• for the prevention of asthma attacks in adults and children over 16 years of age:
  • 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 steroid treatment to control asthma symptoms. Initiating fluticasone propionate treatment enables many patients to reduce or completely discontinue oral steroid doses;
• for the treatment of symptoms of chronic obstructive pulmonary disease (COPD).

Flutixon should not be used to relieve sudden asthma attacks or wheezing. For this purpose, a fast-acting bronchodilator (e.g. salbutamol) should be used as needed, which the patient should always carry with them. Take care not to confuse Flutixon with a rescue inhaler used on an as-needed basis.

2. Important information before using Flutixon

When not to use Flutixon

• if the patient has a known hypersensitivity (allergy) to fluticasone propionate or to any of the other components of Flutixon.

Warnings and precautions
Before starting treatment with Flutixon, consult your doctor or pharmacist.
When to exercise special caution when using Flutixon

• during the first months after switching treatment from oral corticosteroids to inhaled Flutixon, because the change in therapy may reveal allergy symptoms such as allergic rhinitis or skin rash, previously controlled by oral corticosteroids; in such a case, consult your doctor;
• in case of sudden interruption of treatment or dose reduction, as well as during periods of increased stress, infection, severe injury (e.g. due to an accident), recent surgery, or planned surgery, additional adverse effects may occur, such as: stomach pain, fatigue, loss of appetite, nausea, diarrhea, weight loss, headache, or drowsiness, low blood potassium levels, low blood pressure, or seizures; to prevent these symptoms, your doctor may prescribe additional corticosteroids during this time;
• when using high doses of Flutixon for a prolonged period, suppression of natural steroid hormone production by the adrenal glands may occur, which could lead to decreased bone mass, glaucoma, weight gain, facial rounding (moon-shaped face), increased blood pressure, growth retardation in children and adolescents; if such symptoms are observed, consult your doctor;
• if symptoms such as fatigue, loss of appetite, nausea, vomiting, weight loss, abdominal pain, headache, low blood glucose (sugar) levels, seizures, loss of consciousness, or low blood pressure occur, as these may indicate adrenal insufficiency or acute adrenal crisis; in such cases, seek immediate medical attention;
• in patients with active or past history of pulmonary tuberculosis;
• in patients with a history of diabetes; in diabetic patients, more frequent monitoring of blood glucose levels and adjustment of previously used antidiabetic medications may be necessary;
• if the patient experiences blurred vision or other visual disturbances, medical advice should be sought immediately.

During treatment with Flutixon, asthma exacerbations or asthma-related adverse effects may occur. If asthma symptoms worsen after starting Flutixon or are not adequately controlled, the patient should continue treatment and contact their doctor.

Children
Flutixon is not intended for use in children under 16 years of age.

Flutixon and other medicines
Inform your doctor about all medicines currently used or recently used, including those obtained without a prescription, as well as any medicines you plan to use. Only those medicines recommended by your doctor should be used with Flutixon.
Inform your doctor if you have recently taken corticosteroids (orally or by injection).
Some medicines taken concurrently with Flutixon may increase the risk of adverse effects, for example:

• certain antiviral drugs (e.g. ritonavir – used in the treatment of HIV infection);
• certain antifungal drugs (e.g. ketoconazole, itraconazole).

Some drugs may enhance the effect of Flutixon, and your doctor may wish to closely monitor your condition while taking such drugs (including certain HIV medications: ritonavir, cobicistat).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Pregnancy
Flutixon should not be used during pregnancy without consulting a doctor.
Breastfeeding
Flutixon should not be used during breastfeeding without consulting a doctor.

Driving and operating machinery
Flutixon has no effect on the ability to drive or operate machinery.

Flutixon contains lactose
Each dose of Flutixon contains approximately 25 mg of lactose. In individuals with lactose intolerance, this amount of lactose usually does not cause any symptoms.

3. How to use Flutixon

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
Flutixon is intended exclusively for inhalation via an inhaler. Do not swallow the capsules.
Detailed instructions for using the medicine are provided at the end of this leaflet.
It is important to use Flutixon daily, unless otherwise advised by your doctor.
The therapeutic effect occurs within 4 to 7 days.
If symptoms of the disease worsen or if treatment efficacy deteriorates – in asthma
or COPD – (e.g. increased wheezing, or if a higher number of inhalations of a fast-acting bronchodilator is needed as required),
do not increase the number of inhalations of Flutixon. You should contact your doctor immediately,
who will recommend appropriate treatment.
Warning: Strictly adhere to the prescribed dosage.
Bronchial asthma:
Adults and children aged above 16 years:
The dose depends on the severity of the disease and the individual patient's response to treatment:
Mild asthma: 125 micrograms twice daily, i.e. 1 inhalation of Flutixon 125
micrograms twice daily.
Moderate asthma: 125 micrograms to 250 micrograms twice daily, i.e. 1 to 2
inhalations of Flutixon 125 micrograms twice daily or 1 inhalation of Flutixon 250
micrograms twice daily.
Severe asthma: 250 micrograms to 500 micrograms twice daily, i.e. 2 to 4 inhalations of Flutixon 125 micrograms
twice daily or 1 to 2 inhalations of Flutixon 250 micrograms
twice daily.
Once asthma symptoms are under control, the doctor may reduce the dose according to the treatment response, aiming to achieve optimal efficacy with the lowest possible daily dose.
Flutixon is not intended for use in children under 16 years of age.
Chronic obstructive pulmonary disease (COPD):
Adults
250 micrograms twice daily, i.e. 2 inhalations of Flutixon 125 micrograms twice
daily or 1 inhalation of Flutixon 250 micrograms twice daily.
Improvement occurs after approximately 6 months of treatment. If no improvement is observed, the doctor should re-evaluate the patient clinically.
To achieve optimal effect, Flutixon should be used daily.
Special patient groups:
No dosage adjustment is necessary for elderly patients or for patients with renal or hepatic impairment.
Use of a higher than recommended dose of Flutixon
If a higher than recommended dose of Flutixon is used, contact your doctor or pharmacist immediately.
Prolonged use of doses higher than recommended may lead to suppression of adrenal steroid hormone production.
Missed dose of Flutixon
If a dose of Flutixon is missed, take it as soon as possible, then continue treatment as prescribed by the doctor.
Do not take a double dose to make up for a missed dose.
Stopping Flutixon treatment
Flutixon should be taken until your doctor advises to stop.
Do not stop using Flutixon abruptly, as symptoms of the disease may worsen.
If in doubt about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Flutixon can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur during treatment with Flutixon:

Very common (occur in more than 1 in 10 people)

• White deposits in the mouth and throat (thrush). Rinsing the mouth with water (without swallowing) after each inhalation may be helpful. Your doctor may also prescribe additional treatment for thrush.

Common (occur in more than 1 in 100 and less than 1 in 10 people)

• Hoarseness, loss of voice. Rinsing the mouth with water (without swallowing) after each inhalation may be helpful.
• Pneumonia (lung infection) in patients with COPD (common adverse reaction). Inform your doctor if any of the following symptoms occur during treatment with fluticasone propionate; these may be signs of lung infection:
  • Fever or chills
  • Increased mucus production
  • Worsening cough or increased breathing difficulty
• Easy bruising.

Uncommon (occur in more than 1 in 1,000 and less than 1 in 100 people)

• Skin hypersensitivity reactions (e.g. rash).

Very rare (occur in less than 1 in 10,000 people)

• Swelling of the face, lips, tongue or throat causing difficulty in breathing or swallowing (angioedema),
• Severe hypersensitivity reactions (anaphylactic reactions),
• Breathing difficulties, wheezing, cough, shortness of breath (paradoxical bronchospasm). If any of these symptoms occur, or appear suddenly after inhalation, immediately use a fast-acting inhaled bronchodilator, discontinue use of Flutixon and contact your doctor, as this may indicate hypersensitivity to this medicine.
• Flutixon may impair the body's production of steroid hormones, particularly when high doses are used for prolonged periods. Symptoms include: slowed growth in children and adolescents; decreased bone mass; eye disorders (cataracts, glaucoma); weight gain; increased blood pressure; facial rounding ("moon face") (Cushing's syndrome).
• Increased blood glucose levels (hyperglycaemia),
• Joint pain,
• Indigestion,
• Anxiety, sleep disturbances, and behavioral changes, including increased activity and irritability (mainly in children).

Frequency not known (frequency cannot be estimated from available data)

• Blurred vision.

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Flutixon

Store below 30°C.
Keep out of sight and reach of children.
Do not use Flutixon after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
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 packaging and other information

What Flutixon contains
The active substance is fluticasone propionate. Each hard capsule contains 125 or 250 micrograms (µg) of fluticasone propionate, respectively.
Other ingredients:
Flutixon 125 µg: anhydrous lactose, monohydrate lactose, HPMC #3 capsule (hypromellose).
Flutixon 250 µg: anhydrous lactose, monohydrate lact游戏副本, HPMC #3 capsule (hypromellose), black ink.

What Flutixon looks like and contents of the pack
125 µg hard capsule: colourless, containing white or almost white powder.
250 µg hard capsule: colourless, with a black ring, containing white or almost white powder.
Pack sizes available:
60 capsules or 120 capsules in blister packs with a cardboard carton, together with an inhaler.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Instructions for use of the inhalation device
A doctor or pharmacist should instruct the patient on how to use Flutixon as a powder for inhalation in hard capsules.

Instructions for using the inhaler:

1. Remove the cap.
2. Firmly hold the base of the inhaler and open it by twisting the mouthpiece in the direction indicated by the arrow.

3. Place the capsule into the capsule-shaped compartment located in the base of the inhaler. The capsule must be removed from the blister immediately before use.

4. Twist the mouthpiece back to the closed position.
5. Press the buttons down fully (only once), holding the inhaler in an upright position.
   WARNING: At this moment, the capsule may break apart, and small fragments may enter the mouth or throat during inhalation. Ingestion of these fragments is not harmful. The likelihood of this occurring is minimal provided the capsule is not pierced more than once, storage conditions are maintained, and the capsule is removed from the blister immediately before use (see point 3).

6. Breathe out deeply.
7. Place the mouthpiece in the mouth and tilt the head slightly backwards. Close lips tightly around the mouthpiece and take one quick, steady breath. While the capsule rotates inside the inhaler chamber and the powder disperses, a characteristic clicking or rattling sound should be heard. If this sound is not heard, the capsule may be stuck in the compartment. In this case, open the inhaler and gently dislodge the capsule. DO NOT attempt to dislodge the capsule by repeatedly pressing the buttons.

8. After hearing the characteristic sound (rattling), hold your breath as long as comfortably possible, then remove the inhaler from the mouth and breathe out. Open the inhaler and check whether any powder remains in the capsule. If powder remains, repeat the steps described in points 6 to 8.
9. After use, open the inhaler, remove the empty capsule, close the mouthpiece, and replace the cap.

Cleaning the inhaler:
To remove any residual powder, wipe the mouthpiece and the capsule compartment with a dry cloth or clean soft brush.