Flutixone neb

Package leaflet: Information for the user

Flutixon Neb, 0.5 mg/2 ml, suspension for nebulisation
Flutixon Neb, 2 mg/2 ml, suspension for nebulisation
Fluticasoni propionas
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this 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 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.
Because the medicine is inhaled directly into the lungs, only a very small dose is needed.
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 called a "preventer". 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 a sudden asthma attack with 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 (oral thrush);
• if the patient is taking Flutixon Neb at the same time as steroid tablets, or has recently stopped taking steroid tablets. In both cases, the patient should carry a "steroid card" until the doctor informs them that it is no longer necessary;
• if the patient has diabetes (Flutixon Neb may increase blood sugar levels).

If in any doubt before using Flutixon Neb, consult your doctor, pharmacist, or nurse.
If breathing difficulties or wheezing worsen immediately after using Flutixon Neb, use of the medicine must be stopped immediately and the doctor should be contacted.

Flutixon Neb and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use, including those obtained without a prescription. This also applies to herbal medicines. Remember to take this medicine with you in case hospitalization becomes necessary.
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 any further doubt before using Flutixon Neb, consult your doctor or pharmacist.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, 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 your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Do not increase or decrease the dose without consulting your doctor.

How to use the medicine

• Shake before use. Hold the vial horizontally at the marked spot, 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 getting the liquid or nebulized mist into the eyes. To protect the eyes, it is recommended to wear protective glasses or goggles.
• Each small plastic vial (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. Inhalation via mouthpiece is recommended to reduce the risk of skin changes on the face associated with long-term use of the medicine with a face mask. If the patient prefers to use a face mask or if administering the medicine to a child using a face mask, 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 escape into the air and could be inhaled by others.
• The effect of the medicine 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 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 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 before a surgical procedure. Your doctor may recommend taking additional steroid medicines in such situations.
Patients receiving long-term, high-dose steroids, including Flutixon Neb, should not stop taking the medicine abruptly without first consulting their doctor. Sudden discontinuation of the medicine 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 vials are packed in sealed foil pouches. Each pack contains a blister of 5 vials. Open the packaging immediately before use. After removal from the foil pack, store the vials below 25°C, protect from light, and use within 1 month. Do not freeze.
2. To open, hold the top part of the vial after removing it from the foil pack, then twist the body of the vial.

3. Place the open end of the vial into the nebulizer chamber, then slowly squeeze the vial to empty its contents.

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

Dilution of the vial contents
Do not dilute the vial contents unless otherwise instructed by your doctor.

• If your doctor instructs you to dilute the vial contents, empty the vial into the nebulizer.
• Add the volume of sterile sodium chloride injection solution recommended by your doctor.
• Close the nebulizer chamber and gently mix the contents. If dilution is recommended, use only sterile sodium chloride injection solution.

After using the nebulizer

• After first opening the vial, use the contents within 24 hours. Store in the refrigerator (2–8°C) and protect from light.
• Discard any unused solution remaining in the nebulizer.
• 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 of Flutixon Neb is used, contact your doctor immediately.

Missed dose of Flutixon Neb

• Take the next dose at the usual 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 advises otherwise. 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 experiences 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 fewer than 1 in 100 patients) – symptoms include skin rash, redness of the skin, itching, or skin blisters resembling rash or hives;
• Severe allergic reactions (may occur in fewer 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 occur in more than 1 in 10 patients)

• Oral and pharyngeal candidiasis (thrush)

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

• 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 otherwise instructed by your doctor.

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

• Oesophageal candidiasis (thrush)

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

• 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 is more likely 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 steroid dose that controls disease symptoms.

Adverse effects of unknown frequency

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

Contact your doctor immediately if:

• After 7 days of starting treatment with Flutixon Neb, breathing difficulties or wheezing have not improved or worsen;
• In patients, including children, receiving high doses of inhaled steroids, there is a general feeling of being unwell with symptoms such as abdominal pain, diarrhoea, headache, or drowsiness. These symptoms may occur during infections, such as viral infections or gastrointestinal upset. It is important not to suddenly stop using the steroid, 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, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, e-mail: [email protected]
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store Flutixon Neb

Keep the medicine out of the sight and reach of children.
There are no special requirements regarding storage temperature.
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 box following EXP. The expiry date refers to the last day of the stated month.
Do not use the medicine if discolouration of the solution is observed. Store in an upright position.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will 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 pouches. Each pouch 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 countries under the following names:
Poland: Flutixon Neb
Portugal: Fluticasona Adamed