Flugenix

Package leaflet: Information for the user

Flugenix 500 mcg/2ml Nebuliser Suspension, 2mg/2ml Nebuliser Suspension

Fluticasone propionate
Please read all of this leaflet carefully before you start using this medicine because 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 other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including 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 using 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 Flugenix is and what it is used for

This medicinal product is indicated for the control of asthma and conditions involving bronchospasm (reduction in the diameter of a bronchus).

2. What you should know before using 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 precautions Talk to your doctor or pharmacist before using Flugenix if:
• you have active or quiescent tuberculosis (TB, an infectious disease caused by bacteria)
• you are diabetic
• you suffer from a respiratory disease called chronic obstructive pulmonary disease (COPD) and are switching from oral steroid therapy to inhaled fluticasone. In this case, you must be carefully managed by your doctor, who should regularly monitor your adrenal function and gradually withdraw oral therapy following the initiation of inhaled treatment. It is therefore advisable to carry a medical alert card indicating that you might require additional corticosteroid therapy during periods of stress. If you experience shortness of breath (bronchospasm with worsening dyspnea) after using Flugenix, stop taking the medicine and consult your doctor immediately. Fluticasone propionate administered by nebulization is not indicated alone for the treatment of symptoms of an acute bronchospasm attack. Flugenix Nebuliser Suspension

does not replace emergency therapy, which instead requires corticosteroids administered
orally or intravenously.
Switching from systemic corticosteroid therapy to inhaled corticosteroids may trigger allergic
diseases.
Asthma treatment should normally be carried out within a therapeutic plan tailored to the severity
of the disease; your response to treatment must be assessed by the doctor, both clinically and
through pulmonary function tests.
The need to use asthma control medications more frequently indicates worsening disease
control; in such circumstances, your therapeutic plan should be revised by your doctor.
Sudden worsening of asthma may be life-threatening, and in such cases your doctor should
consider increasing the dose of corticosteroids.
It is important that you take the prescribed dose exactly as directed by your doctor. Do not
increase or decrease the dose without consulting your doctor. Do not stop treatment with
fluticasone propionate abruptly.
With the use of inhaled glucocorticoids (such as fluticasone propionate), particularly when
prescribed at high doses for prolonged periods, systemic effects (on the whole body) may occur.
Such effects are less likely than with oral glucocorticoid therapy.
Possible systemic effects include Cushing's syndrome (a clinical condition characterized by excess
glucocorticoids in the blood leading to obesity, expressionless face, red skin, widespread
stretch marks, and excessive hair growth, especially on the face), Cushingoid appearance (typical
of Cushing's syndrome), adrenal suppression, growth retardation in children and adolescents,
reduced bone mineral density, cataract (clouding of the lens inside the eye), glaucoma (a serious
eye disease), and, more rarely, a range of psychological or behavioral effects including
psychomotor hyperactivity, irritability, sleep disorders, anxiety, depression, or behavioral
disturbances (particularly in children) (see section 4 “Possible side effects”). It is therefore
important that the inhaled corticosteroid dose be the lowest possible dose at which effective
asthma control is maintained.
Regular monitoring of height is recommended in children receiving prolonged inhaled
corticosteroid therapy.
Very rare cases of acute adrenal crisis have been reported in children exposed to doses higher
than 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
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• ketoconazole, a medicine used to treat fungal infections. Some medicines may increase the effects of Flugenix. Your doctor may want to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat). Flugenix with food and drink Flugenix can be used at any time of day, with or without food.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
It is unlikely that Flugenix will affect your ability to drive vehicles or operate machinery.

3. How to use Flugenix

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor, nurse, or pharmacist.
You should be aware that treatment with this medicine is for preventive purposes and the medicine must 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 swallow the liquid.
Use Flugenix Nebuliser Suspension only by inhalation via a nebuliser. Do not use Flugenix Nebuliser Suspension with ultrasonic nebulisers.

• The nebuliser produces a fine mist which is inhaled through a mouthpiece or a face mask.
• Each plastic container holds liquid.
• The liquid is placed into the nebuliser. The nebuliser then generates a fine mist which is inhaled through a mask or mouthpiece. Using a mouthpiece helps prevent the medicine from affecting the skin of the face, which may occur if a mask is used for prolonged periods. If you prefer to use a mask, or if you are using a mask for your child, you should protect the facial skin with a cream or wash the face thoroughly after treatment. If a mask is used, nasal inhalation may occur. Use the nebuliser in a well-ventilated room, as the mist released into the air may be partially inhaled by others nearby.
  Your doctor will prescribe the appropriate dosage for this medicine based on an assessment of the severity of your asthma and your individual response. Your doctor may gradually reduce your dose if your respiratory function becomes stabilised.

Adults and adolescents aged over 16 years
The usual recommended dose is 250 mcg (half a container of 500 mcg) twice daily. The dose should then be adjusted to achieve asthma control (500–2000 mcg twice daily), or reduced according to individual response, until the lowest effective maintenance dose is reached. For treatment of exacerbation episodes, a higher dose (at the upper end of the recommended dose range) is recommended for 7 days following the exacerbation. After this, dose reduction should be considered.

Children (aged 4 to 16 years)
The recommended dose is 250 mcg (half a container of 500 mcg) twice daily. Patients should be treated with an initial dose of fluticasone propionate for nebulisation appropriate to the severity of their disease. The dose should then be adjusted to achieve asthma control, or reduced according to individual response, until the lowest effective maintenance dose is reached. For the treatment of asthma exacerbation episodes, the recommended dosage is 1 mg twice daily (2 containers of 500 mcg twice daily) for up to 7 days. After this, the dose should be adjusted according to individual response. It is recommended that the height of children treated with steroids, including Flugenix Nebuliser Suspension, be regularly monitored by a doctor.

If you have been using high doses of inhaled steroids for a long time, you may sometimes need additional steroid doses, for example during stressful situations such as a road accident or before surgery. Your doctor may decide to prescribe additional steroid treatment during such periods.
Patients who have been treated with high doses of steroids, including Flugenix Nebuliser Suspension, for a prolonged period should not stop taking the medicine suddenly without first informing their doctor. Abruptly stopping treatment may cause discomfort and symptoms such as vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar levels (hypoglycaemia), and weight changes.

Instructions for use
Use Flugenix via aerosol generated by a pneumatic (JET) nebuliser, as directed by your doctor.
Also refer to the instructions for use recommended by the nebuliser manufacturer.
Administration of Flugenix with ultrasonic nebulisers is not recommended.
Since many nebulisers operate with a continuous flow, the nebulised medicine may be released into the environment; therefore, it is advisable to administer Flugenix in a well-ventilated room.
Flugenix Nebuliser Suspension is not for injection.

In school-aged children:
Use of a mouthpiece is primarily recommended.
In younger children:
Use of a face mask for inhalation is recommended.

Before using Flugenix, mix the contents of the container thoroughly by holding it horizontally from the bottom end, tapping the opposite end several times, and shaking it. Repeat this process several times to ensure the entire contents are completely mixed.
To open the container, twist the tab until it opens.

If you use a face mask for inhalation, protect the face with protective creams and wash your face thoroughly after use. For prolonged use, a mouthpiece is recommended.
After each administration, rinse your mouth with water to reduce the risk of fungal infections of the mouth and throat (oropharyngeal candidiasis) and hoarseness (see section 4).

Dilution
Do not dilute the vial contents unless your doctor has instructed you to do so.

• If your doctor has instructed you to dilute the suspension, empty the contents of Flugenix into the nebuliser chamber. Add the amount of physiological saline solution for injection that your doctor has prescribed.

If you use more Flugenix than you should
In case of accidental ingestion/overdose of Flugenix, contact your doctor immediately or go to the nearest hospital. Acute inhalation of Flugenix in doses higher than recommended may cause temporary suppression of adrenal function (for symptoms, see “Warnings and precautions”). Emergency interventions are not necessary, as adrenal function returns to normal within a few days.
However, if doses higher than recommended are used for prolonged periods, some degree of adrenal suppression may occur. Your doctor may request tests to assess adrenal gland function.

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

If you stop using Flugenix
Do not stop treatment, even if you feel better, unless instructed by your doctor. If so, do not stop Flugenix abruptly.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking the medicine and contact your doctor immediately if you experience any of the
following symptoms after taking Flugenix:

• allergic reactions characterised by skin rashes (skin hypersensitivity);
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing (angioedema);
• breathing difficulties (dyspnoea and/or bronchospasm, paradoxical bronchospasm).

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

• oral and throat thrush (raised, painful, yellow-cream coloured patches)

Common (may affect up to 1 in 10 people)

• bruising

• hoarseness (dysphonia). Mouth and throat problems may be reduced by taking certain specific precautions, such as brushing your teeth or rinsing your mouth with water immediately after inhaling the dose. In addition, pneumonia (lung infection) has been reported in patients with chronic obstructive pulmonary disease (COPD).
  Very rare (may affect up to 1 in 10,000 people)

• oesophageal candidiasis (thrush in the oesophagus);

• anxiety, sleep disorders and behavioural disorders, including hyperactivity and irritability (mainly in children);

• increased blood sugar (glucose) levels (hyperglycaemia);

• slowed growth in children and adolescents;

• Cushing's syndrome, a condition characterised by an excess of steroid hormones in the bloodstream, manifesting as a rounded facial appearance;

• thinning of the bones;

• eye problems such as cataract (clouding of the eye's lens) and glaucoma (increased internal pressure of the eye);

• effects on the adrenal gland (a small gland located next to the kidney).

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 above 25°C. Store the product in an upright position in the original packaging to protect it from light and freezing.
• After opening the aluminium pouch, the single-dose containers must be used within one month.
• Opened containers must be stored in the refrigerator at a temperature between 5°C ± 3°C and used within 24 hours of opening.
• Do not freeze.

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

6. Package contents and other information

What Flugenix contains

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