EUROFLU 0.1% Раствор для небулайзера

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1. EUROFLU 2mg/2ml adults nebulizer solution, 1mg/2ml children nebulizer solution
   1. What is EUROFLU and what is it used for?
   2. What you need to know before you take EUROFLU
   3. How to take EUROFLU
   4. Possible side effects
   5. How to store EUROFLU
   6. Contents of the pack and other information

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

Flunisolide
Generic medicine

Read this leaflet carefully before you start to take 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 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 you take EUROFLU
• 3. How to take EUROFLU
• 4. Possible side effects
• 5. How to store EUROFLU
• 6. Contents of the pack and other information

1. What is EUROFLU and what is it used for?

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

2. What you need to know before you take EUROFLU

Do not take EUROFLU

• If you are allergic to flunisolide or any of the other ingredients of this medicine (listed in section 6).
• If you have active or quiescent (not manifest) 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
Consult your doctor or pharmacist before taking EUROFLU.
Use, especially if prolonged, of the product, may lead to sensitization phenomena
(excessive response of the body when it comes into contact with foreign substances) and systemic side effects (affecting the whole body) typical of the medicine. In this case it is necessary to
interrupt treatment and institute appropriate therapy.
Whenever corticosteroids are used, it is important to remember that they can mask some
symptoms of infection and that new infectious processes can occur during their use.
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Do not exceed the recommended doses. Increasing the dose, in fact, in addition to not improving
the therapeutic efficacy of the product, involves the risk of systemic effects from absorption.
In case of suspected presence of adrenal dysfunction, transfer from systemic steroid therapy (oral, intramuscular, intravenous, subcutaneous) to therapy with flunisolide
must be carried out with caution if the presence of adrenal dysfunction is suspected
(the adrenal glands are two glands located above the kidneys that produce substances similar to corticosteroids and
that for this reason, can block them, furthermore the abrupt suspension of systemic treatment is, in general, to be avoided (because the blocked adrenal glands do not have time to start functioning
immediately).
If you are already on systemic corticosteroid therapy, you will then need special precautions and close
medical supervision, as the reactivation of adrenal function, suppressed by
prolonged systemic corticosteroid therapy, is slow. It is in any case necessary that the disease is
relatively “stabilized” with systemic treatment. Initially EUROFLU should be administered
continuing systemic treatment, subsequently, this should be gradually reduced
monitoring the patient at regular intervals and modifying the dosage of EUROFLU according to
the results obtained.
If undergoing such a transition, during periods of stress or severe asthma attack, patients will
need additional (supplemental) steroid treatment. You should also undergo periodic checks of adrenal function, including measurements taken
early in the morning of cortisol levels in a resting state.
If you are a steroid-dependent patient (have been taking corticosteroids for a long time and a gradual transition is recommended
from oral to topical (local) endobronchial therapy.
The effect of EUROFLU, as with all corticosteroids administered by inhalation, is not
immediate.
Therefore, it is important to remember that EUROFLU is not effective in ongoing asthma crises and that it is
advisable to adhere to a regular use of the product for several days.
Flunisolide, like all corticosteroids, should be used with caution, if not avoided, in patients with
active or quiescent tuberculosis infections of the respiratory tract or with untreated infections from fungi, from
Due to the inhibitory effect exerted by corticosteroids on cicatricial processes (slowing down
healing), it is advisable to use flunisolide with caution if you have previous or recent nasal trauma,
with ulceration of the nasal septum or with recurrent epistaxis.
Although rarely reported dysmicrobism (alteration of the quality and quantity of bacteria
normally present in our body), it is advisable to check, especially for prolonged treatments,
the possible variation of the microbial flora of the upper airways, instituting, if necessary,
a covering therapy.
Systemic effects with inhaled corticosteroids can occur, particularly when prescribed to
high doses for prolonged periods. These effects are less likely to occur than treatment
with oral corticosteroids. Possible systemic effects include Cushing's syndrome, Cushingoid appearance,
adrenal suppression, growth retardation in children and adolescents, reduced
bone mineral density, cataracts, glaucoma.
Rarely, a series of psychological and behavioral effects can occur including
psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioral disorders
(mainly in children).
you must increase or decrease the dose without first consulting your doctor.
In case of prolonged and high-dose topical use, it is good to keep in mind the possibility of inhibition
of adrenal activity (blocking the functions of the adrenal glands, glands located above the kidneys) and
atrophy of the mucous membranes (reduction of the thickness of the mucous membranes, structures that line the internal organs).
In case of marked nasal congestion or abundant secretions, a preliminary
treatment with topical vasoconstrictors may be indicated to allow EUROFLU to come into contact with the
mucosa.
Contact your doctor if you experience blurred vision or other visual disturbances.
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Children and adolescents
It is not advisable to administer to children under four years of age.
Possible systemic effects, including growth retardation in children and adolescents, can occur
following treatment with inhaled corticosteroids at high doses for prolonged periods.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Taking EUROFLU is not recommended during the first three months of pregnancy; in the further
period and during breastfeeding EUROFLU should be administered only in cases of actual need and
under the direct control of the doctor.

Driving and operating machinery
The effects on the ability to drive and operate machinery are not known
For those who engage in sports, the use of the drug without therapeutic need constitutes doping and may
anyway determine positivity to doping tests.

3. How to take EUROFLU

Take this medicine following exactly the instructions of 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 2mg/2ml adults, corresponding to 1 mg, twice a day. Each drop contains 40 micrograms of flunisolide.

Children:
The recommended dose is 1 ml (25 drops) of EUROFLU 1mg/2ml children, corresponding to 500 micrograms, twice a day. Each drop contains 20 micrograms of flunisolide.
It is not advisable to administer to children under 4 years of age.
To use the single-dose vial, perform the following operations:
a) open the vial by applying slight pressure to the cannula,
b) withdraw the contents of the vial in the prescribed amount using a syringe or by inverting the open vial and tapping on the bottom with a finger.
To withdraw one ml, empty it up to the mark indicated on the vial.
EUROFLU must be used with electric nebulizers, both for outpatient and home use.
The solution should be used as is without dilution. At the end of nebulization, a small part of the solution adheres to the walls or bottom of the ampoule and cannot be dispensed; this must be taken into account when evaluating the administered dose.

Use in children
It is not advisable to administer EUROFLU to children under four years of age.

If you take more EUROFLU than you should
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The administration of large quantities of flunisolide in a short period of time may determine the suppression of hypothalamic-pituitary-adrenal function. In this case, the administered dose should be reduced immediately to the recommended dose.
In case of ingestion/accidental intake of an excessive dose of EUROFLU, immediately notify your doctor 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 everyone will experience them.
Only some patients, with very sensitive airways, have reported cough and hoarseness (lowering
of voice tone); sometimes a mild and transient burning sensation of the nasal mucosa may occur.
Rarely, fungal infections (from fungi) have been observed in the mouth or throat, which have disappeared
rapidly after appropriate local therapy. These infections can be prevented or minimized if patients
carefully rinse their mouth after each administration.
Other side effects observed are: nasal irritation, epistaxis (bleeding from the nose), nasal
congestion, rhinorrhea (excessive mucus production from the nose), sore throat, hoarseness and irritation of the
oral cavity and pharynx (the space separating the mouth from the pharynx). If severe, these side effects
may require discontinuation of therapy.
The most common side effect found in patients dependent on corticosteroids was the appearance of
nasal congestion and nasal polyps (benign formations), due precisely to the reduction of
systemic corticosteroid therapy. Patients should nevertheless be kept under strict control in the event of
prolonged treatments, in order to promptly ascertain the possible appearance of systemic manifestations
(osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency such as
hypotension (low blood pressure) and weight loss) in order to avoid in the latter
event serious incidents from acute adrenal insufficiency (reduced adrenal function).
Side effects that may occur, with unknown frequency, are psychomotor hyperactivity,
sleep disturbances, anxiety, depression, aggression, behavioral disorders (especially in
children).
Side effect that may occur, with unknown frequency, is blurred vision. It’s important to
It is important to inform your doctor or pharmacist of any side effect, even
different from those listed above.
Tell your doctor if you are taking or have recently taken other medicines, including over-the-counter medicines.
Some medicines may increase the effects of EUROFLU and your doctor may want to keep you
under close observation if you are taking these medicines (including some medicines for
HIV treatment: ritonavir, cobicistat).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through
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 sight and reach of children.
Do not use this medicine after the expiry date which is reported on the label after Expiry. The expiry
date refers to the last day of that month.
This date refers to the product in intact packaging, correctly stored.
Store in the original packaging to protect the medicine from light.
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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 EUROFLU contains
EUROFLU 2mg/2ml adults nebulizer solution

• The active ingredient is flunisolide. 100 ml of nebulizer solution contains 100 mg of flunisolide. 1 vial contains 2 ml of solution, equivalent to 2 mg of flunisolide. 1 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 nebulizer solution
• The active ingredient is flunisolide. 100 ml of nebulizer solution contains 50 mg of flunisolide. 1 vial contains 2 ml of solution, equivalent to 1 mg of flunisolide. 1 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 contents of the pack
Nebulizer solution.

EUROFLU 2mg/2ml adults nebulizer solution: pack of 15 vials of 2 ml
EUROFLU 1mg/2ml children nebulizer solution: pack of 15 vials of 2 ml
Marketing Authorisation Holder
EURO-PHARMA S.r.l.
Via Garzigliana 8 – Torino

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