Flutixone neb

Package leaflet: Information for the user

Flutixon Neb, 0.5 mg/2 ml, suspension for nebulization
Flutixon Neb, 2 mg/2 ml, suspension for nebulization
Fluticasone propionate
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as 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 a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Flutixon Neb is and what it is used for
2. What you need to know 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 Flutixon Neb is and what it is used for

The active substance in Flutixon Neb is fluticasone propionate, which belongs to a group of medicines
called corticosteroids (a group of synthetic hormones often referred to 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, only a very small dose is required.
Flutixon Neb helps prevent and treat asthma attacks in adults and children aged over 16 years who require regular treatment.
For this reason, the medicine is sometimes referred to as a "preventer" medicine.
The medicine must be used regularly, every day. Flutixon Neb also helps treat asthma attacks in children aged 4 years and older.
Flutixon Neb is not effective in stopping sudden asthma attacks accompanied by breathing difficulties.

• Other medicines (called bronchodilators) are used to treat sudden asthma attacks.
• If you are taking more than one medicine, take care not to confuse them.

2. Important information before using Flutixon Neb

When not to use Flutixon Neb:

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

• if the patient has ever been treated for tuberculosis;
• if the patient has ever had oral fungal infection (thrush);
• if the patient is taking Flutixon Neb concurrently with steroid tablets, or has recently stopped taking steroid tablets. In both cases, the patient should carry a "steroid card" until the doctor advises that it is no longer necessary;
• if the patient has diabetes (Flutixon Neb may increase blood sugar levels).

If in doubt about using Flutixon Neb, consult your doctor, pharmacist, or nurse.
If breathing difficulties or wheezing worsen immediately after using Flutixon Neb, stop using the medicine immediately and contact your doctor.

Flutixon Neb and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including over-the-counter and herbal medicines. Remember to bring this medicine with you if hospitalization is required.
In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

• certain medicines known as "protease inhibitors" (e.g. ritonavir),
• antifungal medicines (e.g. ketoconazole).
  If in doubt, consult your doctor or pharmacist before using Flutixon Neb.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, is planning to become pregnant, or is breastfeeding, she should consult her doctor or pharmacist before using this medicine.

3. How to use Flutixon Neb

Flutixon Neb is available in two different strengths. This medicine should always be used as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist. Do not increase or decrease the dose without consulting a doctor.

How to use the medicine

• Shake well before use. Hold the ampoule horizontally at the marked area, flick the other end several times, and shake for 1 minute.
• Do not inject or swallow the liquid. Flutixon Neb is intended for use with a pneumatic nebulizer. Use with ultrasonic nebulizers is not recommended.
• The pneumatic nebulizer produces a fine mist, which is then inhaled through a mouthpiece or face mask.
• Avoid contact of the liquid or nebulized mist with the eyes. To protect the eyes, it is recommended to wear protective glasses or goggles.
• Each small plastic ampoule (Nebule®) contains a small amount of liquid.
• The liquid is placed into the nebulizer. A fine mist is generated and then inhaled through a mouthpiece or face mask. Use of a mouthpiece is recommended to minimize the risk of skin changes on the face with long-term administration via face mask. If a face mask is preferred by the patient or used for administering the medicine to a child, the facial skin should be protected with cream or thoroughly washed after inhalation.
• The nebulizer should be used in a well-ventilated room, as some of the aerosol may be released into the air and inhaled by others.
• Therapeutic effect occurs after several days; therefore, 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 daily.
• Flutixon Neb 0.5 mg/2 ml contains 500 micrograms per dose.
• Flutixon Neb 2.0 mg/2 ml contains 2000 micrograms per dose.

Children (aged 4 to 16 years)

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

If a patient is receiving long-term, high-dose inhaled steroids, an additional steroid dose may be required during periods of stress, such as a car accident or prior to surgical procedures. A doctor may recommend taking additional steroid medicines in such situations.
Patients receiving long-term, high-dose steroids, including Flutixon Neb, should not abruptly stop taking the medicine without prior consultation with a doctor. Abrupt discontinuation may cause symptoms such as: vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar levels, and seizures.

How to use the nebulizer

1. The ampoules are contained in sealed foil packaging. Each package contains a blister of 5 ampoules. Open the packaging immediately before use. After removal from the foil pack, store the ampoules below 25°C, protect from light, and use within 1 month. Do not freeze.
2. To open, hold the top part of the ampoule after removing it from the foil packaging, then twist the body of the ampoule.

3. Insert the open end of the ampoule into 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 a higher dose is required.

Dilution of the ampoule contents
Do not dilute the ampoule contents unless otherwise directed by a doctor.

• If dilution is prescribed by a doctor, transfer the contents of the ampoule into the nebulizer.
• Add the volume of sterile sodium chloride injection solution as prescribed by the doctor.
• Close the nebulizer chamber and gently mix the contents. If dilution is required, only sterile sodium chloride injection solution should be used.

After using the nebulizer

• After first opening, the contents of the ampoule should be used within 24 hours. Store in the refrigerator (2–8°C) and protect from light.
• Any unused solution remaining in the nebulizer should be discarded.
• Clean the nebulizer according to the manufacturer's instructions.

Use of more than the recommended dose of Flutixon Neb
If more than the recommended dose is used, contact a doctor immediately.

Missed 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 the patient feels better, unless otherwise instructed by a doctor. If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Stop using the medicine immediately and contact your doctor if any of the following symptoms occur.
The patient may require immediate 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 a rash or hives;
• 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, itchy rash, feeling of weakness or dizziness, collapse;
• Worsening of breathing difficulties or wheezing immediately after using the inhaler.

Other possible adverse effects:
Very common (may affect more than 1 in 10 people)

• Oral and pharyngeal candidiasis (thrush)

Common (may affect up to 1 in 10 people)

• Hoarseness;
• Bruising;
• Oral or pharyngeal disorders can be reduced by performing certain actions immediately after each dose. These include brushing teeth, rinsing the mouth and throat with water, and spitting it out. If oral or pharyngeal disorders occur, inform your doctor. However, do not stop using the medicine unless your doctor advises otherwise.

Rare (may affect up to 1 in 1,000 people)

• Oesophageal candidiasis (thrush)

Very rare (may affect up to 1 in 10,000 people)

• Sleep disturbances, feelings of anxiety, nervousness, overexcitement, irritability. The likelihood of these symptoms is higher in children;
• Blood sugar (glucose) levels may increase;
• Flutixon Neb affects steroid production in the body (suppression of adrenal cortex function). This risk is higher in patients receiving long-term high doses of the medicine. This may result in:
• Slowed growth in children and adolescents;
• Cushing's syndrome. This occurs when steroid levels in the body are too high and may lead to bone weakening and eye problems (such as cataracts or glaucoma associated with increased intraocular pressure). To prevent these effects, the doctor will ensure the patient uses the lowest effective steroid dose that controls disease symptoms.

Adverse effects with unknown frequency

• Depression or aggression. The likelihood of these symptoms is higher in children;
• Nosebleeds.

Contact your doctor immediately if:

• Breathing difficulties or wheezing do not improve or worsen after 7 days of starting Flutixon Neb treatment;
• The patient, including children receiving high doses of inhaled steroids, experiences general malaise with symptoms such as abdominal pain, diarrhoea, headache, or drowsiness. These symptoms may occur during infections such as viral illness or gastrointestinal upset. It is important not to stop steroid treatment suddenly, as this may worsen asthma symptoms or cause disturbances in the body's hormonal balance.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, e-mail:
[email protected]
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Flutixon Neb

Keep the medicine out of sight and reach of children.
There are no special storage temperature requirements for this medicine.
Store ampoules in the foil packaging and within the cardboard box to protect from light. Do not freeze.
After first opening the foil packaging: use within 1 month, store below 25°C and protect from light. Do not freeze.
After first opening an ampoule: use within 24 hours, store in a refrigerator (2°C - 8°C) and protect from light.
If the foil packaging 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 specified month.
Do not use the medicine if discoloration of the solution is observed. Store in an upright position.
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 Neb contains

• The active substance is fluticasone propionate.
• Each 0.5 mg/2 ml ampoule contains 0.5 mg fluticasone propionate in 2 ml of suspension. 1 ml of suspension contains 0.25 mg fluticasone propionate.
• Each 2 mg/2 ml ampoule contains 2 mg fluticasone propionate in 2 ml of suspension. 1 ml of suspension contains 1 mg fluticasone propionate.
  The other ingredients are: Polysorbate 20, sorbitan laurate, disodium dihydrogen phosphate dihydrate, anhydrous disodium hydrogen phosphate, 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 cardboard box contains 10 ampoules in two foil sachets. Each sachet contains a blister with 5 ampoules.

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

Manufacturer:
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland
GENETIC S.P.A.
Nucleo Industriale,
Contrada Canfora, 84084 Fisciano (SA)
Italy

This medicinal product is authorised in the European Economic Area member states under the following names:
Poland: Flutixon Neb
Portugal: Fluticasona Adamed