Flutixon Neb

Leaflet accompanying the packaging: patient information

Flutixon Neb, 0.5 mg/2 ml, nebulizer suspension

Flutixon Neb, 2 mg/2 ml, nebulizer suspension

Fluticasone propionate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Flutixon Neb and what is it used for
• 2. Important information before using Flutixon Neb
• 3. How to use Flutixon Neb
• 4. Possible side effects
• 5. How to store Flutixon Neb
• 6. Package contents and other information

1. What is Flutixon Neb and what is it used for

The active substance of Flutixon Neb is fluticasone propionate, which belongs to a group of medicines called corticosteroids (a group of synthetic hormones commonly referred to as steroids). Flutixon Neb works by reducing swelling and irritation of the lungs. The medicine has an anti-inflammatory effect. Since the medicine is inhaled directly into the lungs, a very small dose of the medicine is required. Flutixon Neb helps prevent and treat asthma attacks in adults and children over 16 years of age who require regular treatment. For this reason, the medicine is sometimes referred to as a "preventive medicine". The medicine requires regular use, every day. Flutixon Neb also helps treat asthma attacks in children aged 4 and older.

Flutixon Neb is not effective in stopping a sudden asthma attack with shortness of breath.

• Other medicines (called bronchodilators) are used to treat sudden asthma attacks.
• If the patient is taking more than one medicine, they should be careful not to mix up the medicines.

2. Important information before using Flutixon Neb

When not to use Flutixon Neb:

Warnings and precautions

Before starting to use Flutixon Neb, the patient should discuss it with their doctor, pharmacist, or nurse:

In case of any doubts before using Flutixon Neb, the patient should consult their doctor, pharmacist, or nurse.

If breathing difficulties or wheezing worsen immediately after using Flutixon Neb, the patient should stop using the medicine and contact their doctor immediately.

Flutixon Neb and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking, or have recently taken, and about medicines they plan to take, including those that are available without a prescription. This also applies to herbal medicines. The patient should remember to take this medicine with them if they need to go to the hospital.

In particular, the patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• certain medicines known as "protease inhibitors" (e.g., ritonavir),
• antifungal medicines (e.g., ketoconazole). If the patient has any further doubts before using Flutixon Neb, they should consult their doctor or pharmacist.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

3. How to use Flutixon Neb

Flutixon Neb comes in two different strengths. This medicine should always be used as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist. The patient should not increase or decrease the dose of the medicine without consulting their doctor.

How to use the medicine

• Shake before use.Holding the ampoule horizontally at the marked point, snap the other end of the ampoule several times and shake for 1 minute.
• Do not inject or swallow the liquid.Flutixon Neb is intended for use with a pneumatic nebulizer. It is not recommended to use the medicine with ultrasonic nebulizers.
• The pneumatic nebulizer produces a fine mist that is then inhaled through a mouthpiece or face mask.
• Avoid getting the liquid or mist produced by the nebulizer into the eyes.To protect the eyes, it is recommended to wear protective goggles or glasses.
• Each small plastic ampoule (Nebule) contains a small amount of liquid.
• The liquid is introduced into the nebulizer. A fine mist is produced, which is then inhaled through a mouthpiece or face mask. It is recommended to inhale the medicine through a mouthpiece to avoid the risk of skin changes on the face in the case of long-term use with a face mask. If the patient prefers to use a face mask or administers the medicine to a child using a face mask, the skin of the face should be protected with cream or washed thoroughly after inhalation.
• The nebulizer should be used in well-ventilated areas, as part of the aerosol enters the air and can be inhaled by others.
• The effect of the medicine occurs after several days, so it is very important to use the medicine regularly.

Adults and children over 16 years of age

• The usual initial dose is 0.5 to 2.0 mg (500 to 2000 micrograms) twice a day.
• Flutixon Neb 0.5 mg/2 ml contains a dose of 500 micrograms.
• Flutixon Neb 2.0 mg/2 ml contains a dose of 2000 micrograms.

Children (aged 4 to 16 years)

• The usual initial dose is 1 mg (1000 micrograms) twice a day. It is recommended that the doctor regularly monitor the growth of children treated with steroids, including Flutixon Neb.

If the patient is using long-term high doses of inhaled steroids, it may be necessary to administer an additional dose of steroid in a stressful situation, such as a car accident or before surgery. The doctor may recommend taking additional steroid medicines

in such a situation.

Patients taking long-term high doses of steroids, including Flutixon Neb, should not stop using the medicine abruptly without consulting their doctor. Stopping the medicine abruptly may cause

feeling unwell and symptoms such as vomiting, drowsiness, nausea, headaches, fatigue, loss of appetite, low blood sugar levels, and seizures.

How to use the nebulizer

• 1. The ampoules are in a heat-sealed foil package. Each package contains a blister pack of 5 ampoules. The package should be opened just before use. After removing the ampoules from the foil package, they should be stored at a temperature below 25°C, protected from light, and used within 1 month. Do not freeze.
• 2. To open, hold the top part of the ampoule after removing it from the foil package, and then twist the body of the ampoule.

• 3. Place the open end of the ampoule in the nebulizer chamber, then slowly squeeze the ampoule to empty its contents.

• 4. Close the nebulizer and follow the manufacturer's instructions.
• 5. Repeat steps 2 to 4 if it is necessary to increase the dose.

Diluting the ampoule contents

The contents of the ampoule should not be diluted, unless the doctor recommends otherwise.

the nebulizer,

• and the prescribed volume of sterile sodium chloride solution for injection should be added,
• then the nebulizer cup should be closed and the contents gently mixed. If dilution of the ampoule contents is recommended, only sterile sodium chloride solution for injection should be used.

After using the nebulizer

• After opening the ampoule for the first time, its contents should be used within 24 hours. Store in the refrigerator (2-8°C) and protect from light.
• Any unused solution in the nebulizer should be discarded.
• The nebulizer should be cleaned according to the manufacturer's instructions.

Using a higher dose of Flutixon Neb than recommended

If a higher dose of Flutixon Neb than recommended is used, the doctor should be informed immediately.

Missing a dose of Flutixon Neb

• The next dose should be taken at the scheduled time.
• A double dose should not be taken to make up for a missed dose.

Stopping the use of Flutixon Neb

• The use of Flutixon Neb should not be stopped, even if the patient feels better, unless the doctor recommends otherwise. If the patient has any further doubts about using this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Flutixon Neb can cause side effects, although not everybody gets them.

The patient should stop using the medicine and contact their doctor immediately if they experience

any of the following symptoms.The patient may need immediate medical attention.

• allergic reactions (may occur in less than 1 in 100 patients) - symptoms include skin rash, skin redness, itching, or skin blisters resembling hives or urticaria;
• severe allergic reactions (may occur in less than 1 in 10,000 patients) - symptoms include swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing, itching rash, feeling weak or faint, or collapse;
• breathing difficulties or wheezing worsen immediately after using the inhaler.

Other possible side effects:

Very common(may occur in more than 1 in 10 patients)

• thrush in the mouth and throat

Common(may occur in less than 1 in 10 patients)

• hoarseness;
• bruises;
• the occurrence of disorders of the mouth or throat can be limited by performing certain actions immediately after taking each dose. These include brushing teeth, rinsing the mouth and throat with water, and spitting it out. If disorders of the mouth or throat occur, the patient should inform their doctor. However, the patient should not stop using the medicine unless the doctor recommends otherwise.

Rare(may occur in less than 1 in 1,000 patients)

• thrush (candidiasis) of the esophagus

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

• sleep disturbances, feeling restless, anxious, overexcited, or irritable. The likelihood of these symptoms is higher in children;
• blood sugar levels (glucose) may be increased;
• Flutixon Neb affects the production of steroids by the body (inhibition of adrenal cortex function). The likelihood of this effect is higher in patients taking long-term high doses of the medicine. This may cause:
• slow growth in children and young people;
• Cushing's syndrome. This occurs when the level of steroids in the body is too high and can lead to weakened bones and eye problems (such as cataracts or glaucoma, associated with high pressure in the eye). To prevent these symptoms, the doctor will ensure that the patient is using the smallest dose of steroid that controls the symptoms of the disease.

Side effects with unknown frequency

• depression or aggression. The likelihood of these symptoms is higher in children;
• nosebleeds.

The patient should contact their doctor immediately if:

• after 7 days of using Flutixon Neb, breathing difficulties or wheezing do not improve or worsen;
• in patients, including children, taking high doses of inhaled steroids, they experience feeling unwell with symptoms such as abdominal pain, diarrhea, headaches, or drowsiness. These symptoms may occur with infections, such as viral infections or gastrointestinal upset. It is essential not to stop using the steroid abruptly, as this may worsen the symptoms of asthma or disrupt the body's hormonal balance.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Flutixon Neb

The medicine should be stored out of sight and reach of children.

There are no special recommendations for the storage temperature of the medicine.

The ampoules should be stored in the foil package and in the cardboard box to protect them from light. Do not freeze.

After opening the foil package: use within 1 month, store at a temperature below 25°C, and protect from light. Do not freeze.

After opening the ampoule: use within 24 hours, store in the refrigerator (2°C - 8°C), and protect from light.

If the foil package has not been opened, the medicine should not be used after the expiry date stated on the box after EXP. The expiry date refers to the last day of the specified month.

The medicine should not be used if the solution has changed color.

Store in an upright position.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Flutixon Neb contains

• The active substance of Flutixon Neb is fluticasone propionate.
• Each 0.5 mg/2 ml ampoule contains 0.5 mg of fluticasone propionate in 2 ml of suspension. 1 ml of suspension contains 0.25 mg of fluticasone propionate.
• Each 2 mg/2 ml ampoule contains 2 mg of fluticasone propionate in 2 ml of suspension. 1 ml of suspension contains 1 mg of fluticasone propionate. The other ingredients of the medicine are: Polysorbate 20, sorbitan laurate, sodium dihydrogen phosphate dihydrate, disodium phosphate anhydrous, sodium chloride, water for injections.

What Flutixon Neb looks like and what the package contains

Flutixon Neb is a white, non-transparent suspension in plastic ampoules.

Each cardboard box contains 10 ampoules in two foil pouches. Each pouch contains a blister pack of 5 ampoules.

Marketing authorization holder:

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Manufacturer:

Adamed Pharma S.A.

ul. Marszałka Józefa Piłsudskiego 5

95-200 Pabianice

GENETIC S.P.A.

Nucleo Industriale,

Contrada Canfora, 84084 Fisciano (SA)

Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland: Flutixon Neb

Portugal: Fluticasona Adamed

Date of last revision of the leaflet:September 2018