Flutixon Neb

Package Leaflet: Information for the Patient

Flutixon Neb, 0.5 mg/2 ml, Nebuliser Suspension

Flutixon Neb, 2 mg/2 ml, Nebuliser Suspension

Fluticasone Propionate

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the Package 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. Contents of the pack 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 known as steroids). Flutixon Neb works by reducing swelling and irritation in 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 you are taking more than one medicine, be careful not to confuse them.

2. Important information before using Flutixon Neb

When not to use Flutixon Neb:

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

Warnings and precautions

Before starting treatment with Flutixon Neb, discuss with your doctor, pharmacist, or nurse:

• if you have ever been treated for tuberculosis;
• if you have ever had a fungal infection of the mouth;
• if you are taking Flutixon Neb at the same time as oral steroids. Also, if you have recently stopped taking oral steroids. In both cases, you should carry a "steroid card" until your doctor tells you it is no longer necessary;
• if you have diabetes (Flutixon Neb may cause an increase in blood sugar levels).

If you have any further questions before using Flutixon Neb, ask your doctor, pharmacist, or nurse. If breathing difficulties or wheezing worsen immediately after using Flutixon Neb, stop using the medicine and contact your doctor immediately.

Flutixon Neb and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription. This also includes herbal medicines. Remember to take this medicine with you if you need to go to the hospital. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• certain medicines known as "protease inhibitors" (e.g. ritonavir),
• antifungal medicines (e.g. ketoconazole). If you have any further questions before using Flutixon Neb, ask your doctor or pharmacist.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice 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 your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. Do not increase or decrease the dose of the medicine without consulting your doctor.

How to use the medicine

• Shake before use.Holding the ampoule horizontally at the marked point, snap the other end of the ampoule 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 your eyes.To protect your 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 when using a face mask for a long time. If you prefer to use a face mask or give the medicine to a child using a face mask, protect the skin of the face with a cream or wash it thoroughly after inhalation.
• The nebulizer should be used in well-ventilated areas, as part of the aerosol may enter the air and be inhaled by others.
• The effect of the medicine occurs after a few days, so it is very important to use the medicine regularly.

Adults and children over 16 years of age

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

If you are using Flutixon Neb for a long time and taking high doses of inhaled steroids, you may need to take an additional dose of steroid in stressful situations, such as a car accident or before surgery. Your doctor may recommend taking additional steroid medicines

in such situations.

Patients taking Flutixon Neb for a long time and taking high doses of steroids 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 foil pouch. Each pouch contains a blister pack of 5 ampoules. The pouch should be opened just before use. After removing the ampoule from the foil pouch, store it in a temperature below 25°C, protect it from light, and use it within 1 month. Do not freeze.
• 2. To open, hold the top part of the ampoule after removing it from the foil pouch, then twist the ampoule body.

• 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 you need to increase the dose.

Diluting the ampoule contents

Do not dilute the ampoule contents unless your doctor has told you to do so.

• if your doctor has told you to dilute the ampoule contents, empty the contents of the ampoule into

the nebulizer,

• add the prescribed volume of sterile sodium chloride solution for injection,
• close the nebulizer cup and gently mix the contents. If dilution of the ampoule contents is required, use only sterile sodium chloride solution for injection.

After using the nebulizer

• After first opening the ampoule, use the contents within 24 hours. Store in the refrigerator (2-8°C) and protect from light.
• Discard any unused solution in the nebulizer.
• Clean the nebulizer according to the manufacturer's instructions.

Using a higher dose of Flutixon Neb than recommended

If you have used a higher dose of Flutixon Neb than recommended, inform your doctor immediately.

Missing a dose of Flutixon Neb

• Take the next dose at the scheduled time.
• Do not take a double dose to make up for a missed dose.

Stopping treatment with Flutixon Neb

• Do not stop using Flutixon Neb even if you feel better, unless your doctor has told you to do so. If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Stop using the medicine and contact your doctor immediately if you

experience any of the following symptoms.You may need urgent medical attention.

• allergic reactions (may occur in less than 1 in 100 patients) - symptoms include skin rash, redness of the skin, 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 in swallowing or breathing, itching rash, feeling weak or faint, or anaphylaxis;
• 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;
• bruising;
• the occurrence of disorders of the mouth or throat can be limited by performing certain actions after each dose. These include brushing your teeth, rinsing your mouth and throat with water, and spitting it out. If you experience disorders of the mouth or throat, tell your doctor. However, do not stop using the medicine unless your doctor tells you to.

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 anxious, agitated, 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 (suppression of adrenal cortex function). The likelihood of this effect is higher in patients taking high doses of the medicine for a long time. 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, your doctor will ensure that you are using the smallest dose of steroid that controls your symptoms.

Side effects with unknown frequency

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

Contact your 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, a feeling of being unwell occurs with symptoms such as stomach pain, diarrhea, headaches, or drowsiness. These symptoms may occur with infections, such as viral infections or gastrointestinal upset. It is important not to stop using the steroid abruptly, as this may worsen asthma symptoms or disrupt the body's hormonal balance.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, you can help provide more information on the safety of this medicine.

5. How to store Flutixon Neb

Keep the medicine out of the sight and reach of children. There are no special storage instructions for the medicine. The ampoules should be stored in the foil pouch and carton to protect them from light. Do not freeze. After opening the foil pouch: use within 1 month, store in 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 pouch has not been opened, do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month. Do not use the medicine if the solution has changed color. Store in an upright position. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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 contents of the pack

Flutixon Neb is a white, opaque suspension in plastic ampoules. Each carton 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 package leaflet:September 2018