Package leaflet: Information for the user

VENTOFLU 0.1% nebulizing solution, 0.05% nebulizing 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, 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 you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What VENTOFLU is and what it is used for
What you need to know before using VENTOFLU
How to use VENTOFLU
Possible side effects
How to store VENTOFLU
Contents of the pack and other information

1. What VENTOFLU is and what it is used for

VENTOFLU contains flunisolide, a corticosteroid anti-inflammatory drug belonging to the group
of other medications for obstructive respiratory syndromes (lung diseases with obstruction of the
small bronchi) for aerosol use.
VENTOFLU is indicated for the treatment of allergic respiratory disorders such as bronchial
asthma, chronic asthmatic bronchitis, and chronic and seasonal rhinitis.

2. What you should know before taking VENTOFLU

Do not take VENTOFLU

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 pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before taking VENTOFLU.
Prolonged use of this product, especially if prolonged, may lead to sensitization phenomena (excessive immune response upon exposure to foreign substances, which is the basis of allergy) 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 should be borne in mind that they may mask signs of infection, and new infectious processes may develop during their use.
The transition from systemic steroid therapy (oral, intramuscular, intravenous, subcutaneous) to flunisolide therapy must be carried out cautiously, especially if there is reason to suspect adrenal functional impairment (the adrenal glands, located above the kidneys, produce substances similar to corticosteroids, which may be suppressed by corticosteroid therapy; abrupt discontinuation of systemic treatment should generally be avoided, as suppressed adrenal glands cannot resume immediate function).
Patients already on systemic corticosteroid therapy require special precautions and close medical supervision, as recovery of adrenal function, suppressed by prolonged systemic corticosteroid treatment, is slow. The disease must first be relatively "stabilized" with systemic treatment. Initially, VENTOFLU should be administered while continuing systemic therapy, which should then be gradually reduced, with regular patient monitoring and adjustment of VENTOFLU dosage according to clinical response.
During periods of stress or severe asthma attacks, patients undergoing this transition may require additional systemic steroid treatment. In these patients, periodic monitoring of adrenal function, including early morning cortisol levels measured under resting conditions, is also recommended.
In steroid-dependent patients (those receiving long-term corticosteroids and unable to discontinue them), a gradual and controlled transition from oral to topical (local) endobronchial therapy is advisable.
The effect of VENTOFLU, as with all inhaled corticosteroids, is not immediate.
Therefore, it should be noted that VENTOFLU is not effective during acute asthma attacks, and regular use over several days is recommended.
Recommended doses must not be exceeded. Increasing the dose may not improve therapeutic efficacy and may increase the risk of systemic effects due to absorption.
Flunisolide, like all corticosteroids, should be used cautiously—or preferably avoided—in patients with active or quiescent tuberculous respiratory infections, untreated fungal, bacterial, or viral infections, or ocular herpes simplex.
Due to the inhibitory effect of corticosteroids on wound healing (delayed healing), flunisolide should be used cautiously in patients with previous or recent nasal trauma, nasal septum ulcers, or recurrent epistaxis.
Although microbial imbalance (alteration in the quality and quantity of normal body flora) has been rarely reported, monitoring of the microbial flora of the upper airways is advisable, especially during prolonged treatment, with preventive therapy instituted if necessary.
With prolonged topical use at high doses, suppression of adrenal activity (impaired function of the adrenal glands located above the kidneys) and mucosal atrophy (thinning of mucous membranes lining internal organs) should be considered.
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, cataract, and glaucoma.
A range of psychological and behavioral effects may occur, including psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, and behavioral disturbances (especially in children).
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.
Very rare cases of acute adrenal crisis (reduced adrenal gland function) have been reported in adolescents exposed to doses higher than recommended (approximately 1000 mcg/day) for prolonged periods (several months or years). Initial symptoms of adrenal insufficiency are nonspecific and include anorexia (loss of appetite), abdominal pain, weight loss, fatigue, headache, nausea, and vomiting. Specific symptoms associated with inhaled corticosteroid therapy include hypoglycemia (low blood sugar) with reduced consciousness and/or seizures. Situations that could potentially trigger an adrenal crisis include trauma, surgery, infections, and rapid dose reduction.
Patients receiving high doses should be closely monitored, and the dose should be gradually reduced.
Monitoring of adrenal reserve may also be necessary.

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

Other medicines and VENTOFLU
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.

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.
VENTOFLU is not recommended during the first three months of pregnancy. During the remainder of pregnancy and while breastfeeding, VENTOFLU should be used only if clearly necessary and under direct medical supervision.

Driving and using machines
The effect of this medicine on the ability to drive vehicles or operate machinery is 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 VENTOFLU

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 VENTOFLU 0.1%, corresponding to 1 mg, twice daily. Each drop contains 40 micrograms of flunisolide.

Children: The recommended dose is 1 ml (25 drops) of VENTOFLU 0.05% for children, corresponding to 500 micrograms, twice daily. Each drop contains 20 micrograms of flunisolide.

Administration of this medicine is not recommended in children under 4 years of age.

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 from the vial using a syringe or by inverting the opened vial and gently tapping the bottom with a finger.
To withdraw exactly 1 ml, empty the vial up to the mark indicated on it.

VENTOFLU 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 may remain 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
VENTOFLU is not recommended for children under four years of age.

If you take more VENTOFLU than you should
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 VENTOFLU, contact your doctor immediately or go to the nearest hospital.

If you have any doubts about how to use VENTOFLU, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Only some patients with very sensitive airways have experienced cough and hoarseness (lowering of voice pitch); 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 resolved 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.
Another common side effect is pneumonia (lung infection) in patients with COPD (common adverse reaction). Inform your doctor if you experience any of the following symptoms while taking flunisolide, as they could be signs of a lung infection:

fever or chills
increased mucus production, changes in mucus colour
increased cough or worsening breathing difficulties

Patients should be kept under close medical supervision during prolonged treatment to promptly detect any possible onset of systemic manifestations (such as osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency, including hypotension (low blood pressure) and weight loss), in order to avoid, in the latter case, serious incidents of acute adrenal insufficiency (reduced adrenal gland function). At high doses used for long periods, Cushing's syndrome, Cushingoid appearance (moon face, obesity, red striae on the abdominal skin, swelling), adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataract, and glaucoma may occur.
Adverse reactions that may occur with unknown frequency include psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, and behavioural disturbances (mainly in children).
Following the instructions contained in this leaflet reduces the occurrence of side effects. It is important to inform your doctor or pharmacist about any side effect, even if different from those listed above.

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 national reporting system at the website: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VENTOFLU

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 intact packaging and properly stored.
Store in the original packaging to protect the medicine from light.
Do not store above 25°C.
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 VENTOFLU Contains
VENTOFLU 2 mg/2 ml adults nebulizing solution

The active substance is flunisolide. 100 ml of nebulizing solution contain 100 mg of flunisolide. Each 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.

VENTOFLU 1 mg/2 ml children nebulizing solution

The active substance is flunisolide. 100 ml of nebulizing solution contain 50 mg of flunisolide. Each 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 VENTOFLU and Contents of the Package
Nebulizing solution.
VENTOFLU 2 mg/2 ml adults nebulizing solution: pack of 15 vials of 2 ml
VENTOFLU 1 mg/2 ml children nebulizing solution: pack of 15 vials of 2 ml

Marketing Authorization Holder
BIOMEDICA FOSCAMA INDUSTRIA CHIMICO-FARMACEUTICA S.p.A.
Via dei Castelli Romani, 22
00071 Pomezia (RM), Italy

Manufacturer
ESSETI FARMACEUTICI S.r.l.
Via Campobello, 15
00040 Pomezia (Rome), Italy