FLUGENIX 500 mcg/2 ml Nebulizer suspension

Зміст інструкції

1. Flugenix 500 mcg/2ml Suspension for nebulisation, 2mg/2ml Suspension for nebulisation
   1. What is Flugenix and what is it used for
   2. What you need to know before you use Flugenix
   3. How to use Flugenix
   4. Possible side effects
   5. How to store Flugenix
   6. Contents of the pack and other information

Flugenix 500 mcg/2ml Suspension for nebulisation, 2mg/2ml Suspension for nebulisation

Fluticasone propionate

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

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

Contents of this leaflet:

• 1. What Flugenix is and what it is used for
• 2. What you need to know before you use Flugenix
• 3. How to use Flugenix
• 4. Possible side effects
• 5. How to store Flugenix
• 6. Contents of the pack and other information

1. What is Flugenix and what is it used for

This medicine is indicated in the control of asthma and conditions of broncho-stenosis
(reduction of the calibre of a bronchus).

2. What you need to know before you use Flugenix

Do not use Flugenix

• if you are allergic to fluticasone propionate or to any of the other ingredients of this medicine (listed in section 6); Warnings and precautionsTalk to your doctor or pharmacist before using Flugenix if:
• you have active or quiescent tuberculosis (TB, a contagious disease caused by a bacterium)
• you are a diabetic patient
• you suffer from a respiratory disease called Chronic Obstructive Pulmonary Disease (COPD) are switching from oral steroid therapy to inhaled fluticasone. In this case, you must be treated with particular attention by the doctor, who will have to regularly monitor your adrenal function and gradually discontinue oral therapy following the introduction of inhaled therapy. It is therefore advisable to carry with you a card indicating that you may require supplementary corticosteroid therapy during periods of stress. If your breathing becomes labored (bronchospasm with increased dyspnea) following the use of Flugenix, stop taking the medicine and consult your doctor immediately. In fact, fluticasone propionate administered by nebulization is not indicated alone for treating the symptoms of an acute bronchospasm attack. Flugenix Suspension for nebulization

does not replace emergency therapy which instead occurs with corticosteroids administered
orally or intravenously.
Replacing systemic corticosteroid therapy with inhaled corticosteroids can
trigger allergic diseases.
Asthma treatment should normally be carried out as part of a therapeutic plan
adapted to the severity of the disease; your response to therapy should be verified by
the doctor, both clinically and through lung function tests.
The need to resort more frequently to drugs to control asthma symptoms indicates a worsening of disease control; in this circumstance your therapeutic plan must be modified by the doctor.
A sudden worsening of asthma is potentially life-threatening and, in this case, the
doctor must consider the possibility of increasing the dosage of
corticosteroids.
It is important that you take the dose as prescribed by the doctor. Do not increase or
decrease the dose without asking your doctor for advice. Do not abruptly stop
treatment with fluticasone propionate.
With the use of inhaled glucocorticoids (such as fluticasone propionate), particularly when
prescribed at high doses for prolonged periods, systemic effects (on the whole
organism) can occur. These effects are less likely to occur than with treatment with
glucocorticoids administered orally.
Possible systemic effects include Cushing's disease (a clinical condition characterized
by an excess of glucocorticoids in the blood leading to obesity, lack of expression in the
face, red skin, extensive stretch marks and thick hair, especially on the face), cushingoid appearance
(typical of people affected by Cushing's disease), adrenal suppression (reduction of
adrenal function), growth retardation in children and adolescents, reduced bone mineral
density, cataract (clouding of the lens located inside the eye),
glaucoma (serious eye disease) and, more rarely, a series of psychological or
behavioral effects including psychomotor hyperactivity, irritability, sleep disorders, anxiety,
depression or behavioral disorders (particularly in children) (see section 4
“Possible side effects”). It is therefore important that the dose of inhaled corticosteroid is the lowest dose possible with which effective control of
asthma is maintained.
It is recommended to regularly check the height of children receiving prolonged therapies
with corticosteroids via inhalation.
Very rare cases of acute adrenal crises have occurred in children exposed to doses higher than
those recommended (approximately 1,000 micrograms per day) for prolonged periods (several months
or years).
Contact your doctor if you experience blurred vision or other visual disturbances, which may be caused by
cataract or glaucoma.

Other medicines and Flugenix
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or
may take any other medicines, including medicines obtained without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• ketoconazole, a medicine used to treat fungal infections. Some medicines can increase the effects of Flugenix. Your doctor may want to keep you under close observation if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat). Flugenix with food and drinkYou can use Flugenix at any time of the day, with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
It is unlikely that Flugenix will affect your ability to drive vehicles or use machinery.

3. How to use Flugenix

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor, nurse or pharmacist.
You should be informed that treatment with this medicine is for preventive purposes and the medicine
should be taken regularly even in the absence of symptoms.
It takes 4-7 days for this medicine to take effect and it is very important that you use it
regularly.

Do not inject or ingest the liquid.
Take Flugenix Suspension for nebulization only by means of aerosol generated by a
nebulizer. Do not use Flugenix Suspension for nebulization with ultrasonic nebulizers.

• The nebulizer produces a mist that is inhaled through a mouthpiece or an inhalation mask
• Each plastic container contains liquid
• The liquid is placed in the nebulizer. This generates a fine mist that is inhaled through a mask or a mouthpiece. Using a mouthpiece prevents the medicine from having effects on the skin of the face, which can happen if you use a mask for a long period of time. If you prefer to use a mask, or if you are using a mask for your child, it is necessary to protect the skin of the face with a cream or to wash your face thoroughly after treatment. If you use a mask, nasal inhalation may occur. Use the nebulizer in a well-ventilated room as the mist released into the air may also be breathed in by others. The doctor will prescribe the appropriate dosage for this medicine, following an assessment of the severity of asthma and your individual response. The doctor may gradually reduce your dose if your respiratory function is stabilized. Adults and adolescents over 16 years of ageThe normally recommended dose is 250 mcg (half a 500 mcg container) 2 times a day. Subsequently, the dosage should be adjusted until asthma control is achieved (500-2000 mcg 2 times a day), or reduced according to individual response, until the minimum effective maintenance dose is reached. For the treatment of exacerbation episodes, it is recommended to adopt a high dose (at the upper limit of the recommended dose range) for a period of 7 days following the exacerbation itself. Subsequently, the opportunity to reduce the dosage should be considered. Children (from 4 to 16 years of age)The recommended dose is 250 mcg (half a 500 mcg container) 2 times a day. Patients should be treated with an initial dose of fluticasone propionate for nebulization appropriate for the severity of their illness. Subsequently, the dosage should be adjusted until asthma control is achieved, or reduced according to individual response, until the minimum effective maintenance dose is reached. In the treatment of asthma exacerbation episodes, the recommended dosage is 1 mg 2 times a day (2 containers of 500 mcg 2 times a day) for up to 7 days of treatment. Subsequently, the dosage should be adjusted according to individual response. It is recommended that the height of children treated with steroids, including Flugenix Suspension for nebulization, be regularly checked by the doctor.

If you are using high doses of an inhaled steroid for a long time, you may sometimes need to use
supplemental doses of steroids, for example during stressful circumstances, such as
a car accident or before surgery. The doctor may decide to prescribe you a steroid supplement during that period.
Patients who have been treated with high doses of steroids, including Flugenix Suspension for nebulization,
for a long period, should not suddenly stop taking the medicine without first
informing the doctor. Sudden discontinuation of treatment can cause discomfort and symptoms such as
vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar
levels(hypoglycemia) and changes in weight.
Instructions for use
Use Flugenixby aerosol generated by a pneumatic nebulizer (JET),
according to the doctor's instructions.
Also refer to the instructions for use recommended by the nebulizer manufacturer.
Administration of Flugenix with ultrasonic nebulizers is not recommended.
Since many nebulizers operate with continuous flow, the nebulized drug is likely to be
released into the environment; therefore, it is advisable that Flugenix be administered in a well
ventilated room.

Flugenix Suspension for nebulizationis not for injectable use.

In school-age children:
the use of a mouthpiece is mainly recommended.

In younger children:
the use of a facial inhalation mask is recommended.
Before using Flugenix, carefully mix the contents of the container by holding the container
horizontally from the lower end, tapping the opposite end several times and shaking it.
Repeat this operation several times so that all the contents of the container are completely
mixed.
To open the container, rotate the tab to the opening.
If you use an inhalation mask, you must protect your face with protective creams and after use you must
wash your face thoroughly. For prolonged use, it is advisable to use a mouthpiece.
After each administration, rinse your mouth with water to reduce the appearance of fungal infections
of the mouth and throat (oropharyngeal candidiasis) and hoarseness (see section 4).
Dilution

Do not dilute the contents of the vial unless your doctor has told you to do so

• If your doctor has told you to dilute the suspension, empty the contents of Flugenix into the nebulizer ampoule. Add the amount of saline solution for injectable use that your doctor has told you to use. If you use more Flugenix than you shouldIn case of ingestion/accidental intake of an excessive dose of Flugenix, immediately inform your doctor or go to the nearest hospital. Acute inhalation of Flugenix in doses higher than those recommended can lead to temporary suppression of adrenal function (see symptoms in “Warnings and precautions”). Emergency interventions are not necessary as adrenal function returns to normal in a few days.

However, if doses higher than those recommended are used for prolonged periods, some
degree of adrenal suppression may occur. The doctor may request to perform tests
to verify the degree of functioning of the adrenal gland.

If you forget to use Flugenix
Do not use a double dose to make up for the missed dose.

If you stop using Flugenix
Do not stop treatmenteven if you feel better unless your doctor prescribes it. In this
case, do not stop Flugenix abruptly. If you have any doubts about the use of this medicine, consult
your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking it and contact your doctor immediately if you experience any of the following
symptoms after taking Flugenix:

• allergic reactions characterized by skin rashes (cutaneous hypersensitivity);
• swelling of the face, lips, mouth, tongue or throat that may cause difficulty swallowing (angioedema);
• difficulty breathing (dyspnea and/or bronchospasm, paradoxical bronchospasm).

Other side effects include:
Very common(may affect more than 1 in 10 people)

• thrush in the mouth and throat (painful, raised, yellowish-cream colored patches)

Common(may affect up to 1 in 10 people)

• bruising
• hoarseness. Mouth and throat problems can be reduced with some specific precautions, such as brushing your teeth or rinsing your mouth with water immediately after inhaling the dose. Also, pneumonia (lung infection) has been reported in patients with Chronic Obstructive Pulmonary Disease (COPD). Very rare(may affect up to 1 in 10,000)
• thrush (candidiasis) in the esophagus;
• anxiety, sleep disorders and behavioral disorders, including hyperactivity and irritability (mainly in children)
• increased blood sugar (glucose) levels (hyperglycemia)
• slowing of growth in young people;
• Cushing's syndrome, a condition characterized by an excess of steroid hormones in the bloodstream, which manifests with a rounded face;
• thinning of the bones
• eye problems such as cataracts (clouding of the eye's lens) and glaucoma (increased pressure inside the eye)
• effects on the adrenal gland (a small gland located next to the kidney).

Not known(frequency cannot be estimated from available data):

• depression, aggression. These effects are more likely to occur in children;
• blurred vision;
• nosebleeds.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the website
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Flugenix

• Keep this medicine out of the sight and reach of children.
• Do not store at a temperature above 25°C. Store the product in an upright position in the original packaging to protect it from light and frost .
• After opening the aluminum pouch, the single-dose containers must be used within one month.
• Opened containers must be placed in a refrigerator and stored at a temperature between 5°C ± 3°C and used within 24 hours of opening.
• Do not freeze.

Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Flugenix contains

• The active ingredient is fluticasone propionate. One single-dose container of 2 ml contains 0.5 mg of fluticasone propionate.
• The other ingredients are: Polysorbate 20, Sorbitan monolaurate, Disodium phosphate monohydrate, Disodium phosphate anhydrous, Sodium chloride, Water for injections. Description of the appearance of Flugenix and contents of the packThe vials of Flugenix are packaged in a strip of 5 vials in an aluminum pouch. Each pack contains 10 or 20 vials of 2 ml. MARKETING AUTHORISATION HOLDERGenetic S.p.A. Via G. Della Monica, 26 - Castel San Giorgio (SA) MANUFACTURERGenetic S.p.A. Contrada Canfora - Fisciano (SA)