FLUTIXONE

Patient Information Leaflet

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

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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 (conditions with reduced airflow in the lungs). The active substance, fluticasone propionate, is a corticosteroid (adrenal cortex hormone) with local anti-inflammatory action in the lungs.

Flutixon is indicated:

• for 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 steroids to control asthma symptoms. Initiating fluticasone propionate allows many patients to reduce or completely discontinue oral steroid doses;
• for treatment of symptoms of chronic obstructive pulmonary disease (COPD).

Flutixon should not be used to relieve sudden asthma attacks or wheezing. For such episodes, a fast-acting bronchodilator (e.g. salbutamol) should be used immediately, which the patient should always carry with them. Be careful not to confuse Flutixon with a rescue inhaler medicine.

2. Important information before using Flutixon

When not to use Flutixon

• if the patient is allergic (hypersensitive) to fluticasone propionate or any of the other ingredients of Flutixon.

Warnings and precautions
Before starting treatment with Flutixon, consult a 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 rash, previously controlled by oral corticosteroids; in such a case, consult a doctor;
• if treatment is suddenly stopped or the dose reduced, or during periods of increased stress, infection, or 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, the doctor may prescribe additional corticosteroids during this time;
• when high doses of Flutixon are used 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, or growth retardation in children and adolescents; if such symptoms occur, consult a 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 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.

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 a 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 or recently taken, including those obtained without a prescription, as well as any medicines planned for use. Only medicines recommended by a 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, e.g.:

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

Some medicines may enhance the effect of Flutixon, and the doctor may wish to closely monitor the patient 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 have a child, she should consult a doctor before using this medicine.
Pregnancy
Do not use Flutixon during pregnancy without consulting a doctor.
Breastfeeding
Do not use Flutixon during breastfeeding without consulting a doctor.

Driving and operating machinery
Flutixon has no effect on the ability to drive vehicles 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 as directed by the physician. In case of 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 as directed, until your doctor advises otherwise.
Therapeutic effect occurs within 4 to 7 days.
If symptoms of the disease worsen or if treatment effectiveness decreases – in asthma
or COPD – (if wheezing increases or if more frequent use is required of a fast-acting inhaled medicine for relief of breathing),
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 over 16 years of age :
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 in elderly patients or in patients with renal or hepatic impairment.
Use of a higher than recommended dose of Flutixon
If a higher than recommended dose of Flutixon has been used, contact your doctor or pharmacist immediately.
Prolonged use of doses higher than recommended may lead to suppression of endogenous steroid hormone production by the adrenal glands.
Missed dose of Flutixon
If a dose of Flutixon is missed, take it as soon as possible, then continue treatment as directed by the doctor.
Do not use a double dose to make up for a missed dose.
Discontinuation of Flutixon
Flutixon should be taken until your doctor advises stopping.
Do not stop using Flutixon abruptly, as symptoms of the disease may worsen.
In case of any doubts regarding the use of the medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Flutixon may cause adverse effects, although not everyone experiences them.
The following adverse effects may occur during treatment with Flutixon:
Very common (occur in more than 1 in 10 people)

• white patches in the mouth and throat (thrush). Rinsing the mouth with water (without swallowing) after each inhalation may be helpful. Your doctor may also recommend 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 effect). You should inform your doctor if any of the following symptoms occur during treatment with fluticasone propionate; these may be signs of a lung infection:
  • fever or chills
  • increased mucus production
  • worsening cough or increased breathing difficulties
• 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 such symptoms occur, or appear suddenly after inhalation, a fast-acting inhaled bronchodilator should be used immediately, treatment with Flutixon should be discontinued and medical advice sought, as this may indicate hypersensitivity to this medicine.
• Flutixon may interfere with the body's production of steroid hormones, especially when high doses are used for prolonged periods. Symptoms include: slowed growth in children and adolescents; decreased bone mass; eye disorders (cataract, glaucoma); weight gain; increased blood pressure; rounding (‘moon face’) of the face (Cushing's syndrome).
• increased blood sugar (glucose) levels (hyperglycaemia),
• joint pain,
• indigestion,
• anxiety, sleep disturbances and behavioural 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 effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Flutixon

Store below 30°C.
Keep in a place inaccessible and out of sight 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 must 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 Flutixon contains
The active substance is fluticasone propionate. Each hard capsule contains 125 or 250 micrograms (µg) of fluticasone propionate.
Other ingredients:
Flutixon 125 µg: anhydrous lactose, monohydrate lactose, HPMC #3 capsule (hypromellose).
Flutixon 250 µg: anhydrous lactose, monohydrate lactose, 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:
60 capsules or 120 capsules in blister packs with a cardboard carton, supplied 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 using the inhalation device
Your doctor or pharmacist should instruct you on how to use Flutixon as an inhalation powder in hard capsules.

How to use the inhaler:

1. Remove the cap.
2. Hold the base of the inhaler firmly and open it by twisting the mouthpiece in the direction of the arrow.

3. Place the capsule into the capsule-shaped compartment located in the base of the inhaler. The capsule should 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), while 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. Swallowing these fragments is not harmful. The likelihood of this occurring is minimal if the capsule is not pierced more than once, storage conditions are maintained, and the capsule is removed from the blister immediately before use (see step 3).

6. Breathe out deeply.
7. Place the mouthpiece in your mouth and tilt your head slightly backward. Close your lips around the mouthpiece and inhale quickly and steadily. While the capsule rotates in the inhaler chamber and the powder disperses, a characteristic rattling sound should be heard. If no sound is 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 rattling sound, hold your breath as long as comfortable, then remove the inhaler from your 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 powder residue, wipe the mouthpiece and capsule compartment with a dry cloth or clean soft brush.