Aerflu

.
Some medicines can increase the effects of AERFLU, and your doctor may want to monitor you closely if you are taking these medicines (including some medicines used to treat HIV: ritonavir, cobicistat).

Package leaflet: information for the user

AERFLU 0.1% nebulizer solution

Flunisolide
Equivalent medicine
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What AERFLU is and what it is used for
2. What you need to know before using AERFLU
3. How to use AERFLU
4. Possible side effects
5. How to store AERFLU
6. Package contents and other information

1. What AERFLU is and what it is used for

AERFLU contains the active substance flunisolide, an anti-inflammatory drug belonging to the group of other medications used in aerosol form for respiratory obstructive syndromes (lung diseases characterized by closure of the small bronchi).
AERFLU is indicated for the treatment of allergic respiratory tract disorders such as bronchial asthma, asthmatic chronic bronchitis, and chronic and seasonal rhinitis.

2. What you should know before taking AERFLU

Do not take AERFLU

• If you are allergic to flunisolide or to any of the other ingredients of this medicine (listed in section 6).
• If you have active or quiescent (latent) pulmonary tuberculosis.
• If you suffer from bacterial, viral, or fungal infections.
• If you are pregnant or breastfeeding (see section "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before taking AERFLU.
Prolonged use of this medicine, especially if long-term, may lead to sensitization phenomena (an excessive immune response when the body comes into contact with foreign substances: this is the basis of allergy) and, exceptionally, to the classic systemic (affecting the whole body) adverse effects of corticosteroids. In such cases, treatment must be discontinued and appropriate therapy initiated.
Whenever corticosteroids are used, it must be borne in mind that they may mask symptoms of infection, and during their use, new infectious processes may develop.
Recommended doses must not be exceeded. Increasing the dose, in fact, does not improve the therapeutic efficacy of the medicine and increases the risk of systemic effects due to absorption.
The switch from systemic steroid therapy (oral, intramuscular, intravenous, subcutaneous) to flunisolide therapy must be carried out cautiously if there is reason to suspect impaired adrenal function (the adrenal glands, located above the kidneys, produce substances similar to corticosteroids, which may suppress their activity); abrupt discontinuation of systemic treatment should generally be avoided (because suppressed adrenal glands do not have time to resume functioning immediately).
If you are undergoing systemic corticosteroid therapy, treatment requires special precautions and close medical supervision, since recovery of adrenal function, suppressed by prolonged systemic corticosteroid therapy, is slow. It is essential that the disease be relatively stabilized by systemic treatment before switching.
Initially, AERFLU should be administered while continuing systemic treatment; subsequently, systemic therapy should be gradually reduced, with regular patient monitoring and adjustment of AERFLU dosage according to clinical response.
During periods of stress or severe asthma attack, if undergoing this transition, you may require additional (supplemental) systemic steroid treatment. You should also undergo periodic checks of adrenal function, including early morning measurements of cortisol levels under resting conditions.
If you are steroid-dependent (long-term corticosteroid users who cannot discontinue therapy), a gradual and controlled transition from oral to topical (local) endobronchial therapy is advisable.
The effect of AERFLU, as with all inhaled corticosteroids, is not immediate.
Therefore, it should be noted that AERFLU is not effective during acute asthma attacks, and regular use over several days is recommended.
Recommended doses must not be exceeded. Increasing the dose does not improve therapeutic efficacy and increases the risk of systemic absorption effects.
Flunisolide, like all corticosteroids, should be used with caution—or preferably avoided—if you have active or quiescent tuberculosis of the respiratory tract, untreated fungal, bacterial, or viral infections, or ocular herpes simplex.
Due to the inhibitory effect of corticosteroids on wound healing processes (slowed healing), flunisolide should be used cautiously if you have a history of or recent nasal trauma, nasal septum ulceration, or recurrent epistaxis.
Although microbial imbalance (alteration in the quality and quantity of normal bacteria in the body) has been rarely reported, it is advisable to monitor, especially during prolonged treatment, for possible changes in microbial flora of the upper airways and, if necessary, initiate concomitant antimicrobial therapy.
Systemic effects may occur with inhaled corticosteroids, particularly when prescribed at high doses for prolonged periods. These effects are less likely than with oral corticosteroids. Possible systemic effects include growth retardation in children and adolescents, reduced bone mineral density, cataract, glaucoma, and, more rarely, a range of psychological or behavioral effects such as psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (particularly in children). It is therefore important that the inhaled corticosteroid dose be the lowest possible dose that maintains effective asthma control.
It is important to take the dose as indicated in the package leaflet or as prescribed by your doctor. Do not increase or decrease the dose without first consulting your doctor.
If you have marked nasal congestion or excessive secretions, preliminary treatment with topical vasoconstrictors may be indicated to allow the nasal spray to reach and contact the mucosa effectively.

Children and adolescents
Administration to children under four years of age is not recommended.
Possible systemic effects, including growth retardation in children and adolescents, may occur following prolonged treatment with high-dose inhaled corticosteroids.

Other medicines and AERFLU
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of AERFLU, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Use of AERFLU is not recommended during the first three months of pregnancy. During the remainder of pregnancy and while breastfeeding, AERFLU should be administered only if clearly needed and under direct medical supervision.

Driving and operating machinery
The effects of AERFLU on the ability to drive vehicles or operate machinery are unknown.
For individuals engaged in sports, using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take AERFLU

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults:
The recommended dose is 1 mg (25 drops) of AERFLU twice daily.

Children:
The recommended dose is 500 micrograms (12–13 drops) of AERFLU twice daily.
AERFLU is not recommended for children under four years of age.

AERFLU must be used with electric nebulizers and must not be diluted.
The dropper pipette is marked with a line at 0.5 ml, corresponding to 12–13 drops. Each drop contains 40 micrograms of flunisolide.

It is known that administration of drug solutions via electric nebulizers results in residual solution remaining adherent to the walls or bottom of the vial, which is not delivered.
Therefore, when preparing the dose, it is necessary to take into account the need to compensate for this non-delivered portion.

Use in children
AERFLU is not recommended for children under four years of age.

If you take more AERFLU than you should
Administration of large amounts of flunisolide within a short period of time may cause suppression of the hypothalamic-pituitary-adrenal function. In such cases, the administered dose should be immediately reduced to the recommended dose.

If you have any doubts about the use of AERFLU, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Only some patients, with particularly sensitive airways, have experienced cough and hoarseness (lowering of voice tone); occasionally, a mild and transient burning sensation of the nasal mucosa may occur.
Rarely, fungal infections (due to fungi) in the mouth or throat have been observed, which rapidly disappeared following appropriate local treatment. These infections can be prevented or minimized by thoroughly rinsing the mouth after each administration. Other observed side effects include: nasal irritation, epistaxis (nosebleed), nasal congestion, rhinorrhea (excessive mucus production from the nose), sore throat, hoarseness, and irritation of the oral cavity and pharynx (the space connecting the mouth to the pharynx). If severe, these side effects may require discontinuation of therapy.
Only with inappropriate use, and even then to a limited extent, may typical effects of systemically administered corticosteroids occur.
The most common side effect observed in corticosteroid-dependent patients has been the onset of nasal congestion and nasal polyps (benign growths), due precisely to the reduction of systemic corticosteroid therapy. You must therefore be kept under close monitoring during prolonged treatments, in order to promptly detect any possible onset of systemic manifestations (osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency, such as hypotension (lowering of blood pressure) and weight loss), so as to avoid, in the latter case, severe acute adrenal insufficiency events (reduced adrenal gland function).
Side effects that may occur with unknown frequency include psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, and behavioral disorders (mainly in children).
Side effects that may occur with uncommon frequency (may affect up to 1 in 100 people):
Blurred vision.
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: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AERFLU

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after "Exp". The expiry date refers to the last day of that month.
This date applies to the product in its original, undamaged packaging and properly stored.
Store in the original packaging to protect the medicine from light.
Do not store above 25°C.
Use the medicine within 30 days of first opening the bottle. Any remaining medicine should be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What AERFLU contains

• The active substance is flunisolide. 100 ml of nebulizing solution contain 100 mg of flunisolide. One drop contains 40 micrograms of flunisolide. The other components are: propylene glycol, sodium chloride, purified water.

Description of the appearance of AERFLU and contents of the pack
Nebulizing solution. 30 ml vial of 0.1% solution.
Marketing Authorization Holder
S.F. GROUP S.R.L., Via Tiburtina 1143, 00156 Rome
Manufacturer
FARMILA -THEA Farmaceutici S.p.A. - Via E. Fermi, 50 - Settimo Milanese (MI)