Euroflu

Package leaflet: Information for the user

EUROFLU 2mg/2ml adults nebuliser solution, 1mg/2ml children nebuliser solution

Flunisolide
Equivalent medicine
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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What EUROFLU is and what it is used for

EUROFLU contains flunisolide, a corticosteroid anti-inflammatory medicine belonging to the group of
other medicines used for obstructive respiratory syndromes (lung diseases with closure of the small bronchi) for aerosol administration.
EUROFLU is indicated for the treatment of allergic respiratory diseases such as bronchial asthma, chronic asthmatic bronchitis, and chronic and seasonal rhinitis.

2. What you should know before taking EUROFLU

Do not take EUROFLU

• 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 untreated fungal, bacterial, or viral infections.
• If you are in the first trimester of pregnancy or if you are breastfeeding (see "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before taking EUROFLU.
The use of this product, especially if prolonged, may lead to sensitization phenomena (excessive body response upon contact with foreign substances) and systemic side effects (affecting the whole body) typical 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 certain symptoms of infection and that new infectious processes may develop during their use.
Do not exceed the recommended doses. Increasing the dose does not improve the therapeutic efficacy of the product but increases the risk of systemic effects due to absorption.
If adrenal dysfunction is suspected, switching from systemic steroid therapy (oral, intramuscular, intravenous, subcutaneous) to flunisolide therapy must be done with caution. The adrenal glands are two glands located above the kidneys that produce substances similar to corticosteroids, and prolonged corticosteroid therapy may suppress their function. Moreover, abrupt discontinuation of systemic treatment should generally be avoided (because suppressed adrenal glands do not have time to resume functioning immediately).
If you are already undergoing systemic corticosteroid therapy, you will require special precautions and close medical monitoring, as recovery of adrenal function suppressed by prolonged systemic corticosteroid therapy is slow. The disease must be relatively "stable" before initiating the switch. Initially, EUROFLU should be administered while continuing systemic treatment, which should then be gradually reduced, with regular patient monitoring and adjustment of EUROFLU dosage according to clinical response.
If undergoing such a transition, patients may require additional systemic steroid treatment during periods of stress or severe asthma attacks. You should also undergo periodic checks of adrenal cortical function, including early morning measurements of cortisol levels under resting conditions.
If you are a steroid-dependent patient (long-term corticosteroid use), a gradual and controlled transition from oral to topical (local) endobronchial therapy is advisable.
The effect of EUROFLU, like all inhaled corticosteroids, is not immediate.
Therefore, it should be noted that EUROFLU is not effective during acute asthma attacks, and regular use over several days is recommended.
Flunisolide, like all corticosteroids, should be used with caution—or 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 (delayed healing), flunisolide should be used cautiously if you have had previous or recent nasal trauma, nasal septum ulceration, or recurrent epistaxis.
Although microbial imbalance (dysbiosis—alteration in the quality and quantity of normal body bacteria) has been rarely reported, it is advisable, especially during prolonged treatment, to monitor possible changes in the 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 Cushing's syndrome, Cushingoid appearance, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, and glaucoma.
Rarely, a range of psychological and behavioral effects may occur, including psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, and behavioral disorders (mainly in children).
It is important to take the dose exactly as indicated in the package leaflet or as prescribed by your doctor. Do not increase or decrease the dose without first consulting your doctor.
With prolonged topical use at high doses, the possibility of adrenal suppression (inhibition of adrenal gland function—glands located above the kidneys) and mucosal atrophy (thinning of mucous membranes lining internal organs) should be considered.
If significant nasal congestion or abundant secretions are present, preliminary treatment with topical vasoconstrictors may be indicated to allow EUROFLU to contact the mucosa effectively.
Contact your doctor if you experience blurred vision or other visual disturbances.

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 doses of inhaled corticosteroids.

Other medicines and EUROFLU
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
No interactions with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of EUROFLU is not recommended during the first three months of pregnancy. During the remainder of pregnancy and while breastfeeding, EUROFLU should be administered only when clearly necessary and under direct medical supervision.

Driving and using machines
The effects of EUROFLU 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 regardless.

3. How to take EUROFLU

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 ml (25 drops) of EUROFLU 2 mg/2 ml for adults, corresponding to 1 mg, twice daily. Each drop contains 40 micrograms of flunisolide.
Children:
The recommended dose is 1 ml (25 drops) of EUROFLU 1 mg/2 ml for children, corresponding to 500 micrograms, twice daily. Each drop contains 20 micrograms of flunisolide.
Administration to children under 4 years of age is not recommended.
To use the single-dose vial, follow these steps:
a) open the vial by applying slight pressure on the neck,
b) withdraw the prescribed amount of solution using a syringe or by inverting the opened vial and tapping the bottom gently with a finger.
To withdraw exactly 1 ml, empty the vial up to the mark indicated on it.
EUROFLU must be used with electric nebulizers, both for clinical and home use.
The solution should be used undiluted. After nebulization, a small amount of solution remains adhering to the walls or bottom of the vial and cannot be delivered; this should be taken into account when evaluating the administered dose.
Use in children
Administration of EUROFLU to children under four years of age is not recommended.
If you take more EUROFLU than you should
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Administration of large amounts of flunisolide over a short period of time may lead to suppression of hypothalamic-pituitary-adrenal function. In such cases, the administered dose should be immediately reduced to the recommended dose.
In case of accidental ingestion/overdose of EUROFLU, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of EUROFLU, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 disappeared rapidly after appropriate local treatment. These infections can be prevented or minimized if patients thoroughly rinse their 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 area separating the mouth from the pharynx). If severe, these side effects may require discontinuation of therapy.
The most common side effect observed in corticosteroid-dependent patients has been the onset of nasal congestion and nasal polyps (benign growths), due to the reduction of systemic corticosteroid therapy. Patients should nevertheless be kept under close monitoring during prolonged treatments, in order to promptly detect any possible systemic manifestations (osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency such as hypotension (low blood pressure) and weight loss), thus avoiding, in the latter case, severe incidents due to acute adrenal insufficiency (reduced adrenal gland function).
Side effects that may occur, with unknown frequency, include psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, and behavioural disorders (mainly in children).
A side effect that may occur, with unknown frequency, is blurred vision. Following the instructions provided in this leaflet reduces the risk of side effects.
It is important to inform your doctor or pharmacist about any side effect you may experience, even if different from those listed above.
Inform your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of EUROFLU, and your doctor may wish to monitor you closely if you are taking these medicines (including certain medicines for the treatment of HIV: ritonavir, cobicistat).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via
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 EUROFLU

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 packaging, correctly stored.
Store in the original packaging to protect the medicine from light.
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Do not dispose of any medicine 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 EUROFLU contains
EUROFLU 2 mg/2 ml adults nebulizing solution

• The active substance is flunisolide. 100 ml of nebulizing solution contains 100 mg of flunisolide. One vial contains 2 ml of solution, equivalent to 2 mg of flunisolide. One drop contains 40 micrograms of flunisolide.
• The other components are: propylene glycol, sodium chloride, citric acid, sodium citrate, water for injections.

EUROFLU 1 mg/2 ml children nebulizing solution

• The active substance is flunisolide. 100 ml of nebulizing solution contains 50 mg of flunisolide. One vial contains 2 ml of solution, equivalent to 1 mg of flunisolide. One drop contains 20 micrograms of flunisolide.
• The other components are: propylene glycol, sodium chloride, citric acid, sodium citrate, water for injections.

Description of the appearance of EUROFLU and package contents
Nebulizing solution.
EUROFLU 2 mg/2 ml adults nebulizing solution: pack of 15 vials of 2 ml
EUROFLU 1 mg/2 ml children nebulizing solution: pack of 15 vials of 2 ml

Marketing Authorization Holder
EURO-PHARMA S.r.l.
Via Garzigliana 8 – Turin

Manufacturer
ESSETI Farmaceutici S.r.l. - Via Campobello, 15 - 00071 Pomezia (RM).
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