VENTOFLU 2 mg /2 Ml Solution For Nebulization

Зміст інструкції

1. VENTOFLU 0.1% solution for nebulisation, 0.05% solution for nebulisation
   1. What is VENTOFLU and what is it used for
   2. What you need to know before you take VENTOFLU
   3. How to take VENTOFLU
   4. Possible side effects
   5. How to store VENTOFLU
   6. Contents of the pack and other information

VENTOFLU 0.1% solution for nebulisation, 0.05% solution for nebulisation

Flunisolide
Generic medicine

Read this leaflet carefully before you start to take 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 others, even if their symptoms are the same as yours, as it may 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 VENTOFLU is and what it is used for
• 2. What you need to know before you take VENTOFLU
• 3. How to take VENTOFLU
• 4. Possible side effects
• 5. How to store VENTOFLU
• 6. Contents of the pack and other information

1. What is VENTOFLU and what is it used for

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

2. What you need to know before you take VENTOFLU

Do not take VENTOFLU

• 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 (unmanifest) 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
Talk to your doctor or pharmacist before taking VENTOFLU.
The use, especially if prolonged, of the product can lead to sensitization phenomena
(the body's excessive response when it comes into contact with foreign substances, which is the basis
of allergy) and to systemic side effects (affecting the whole body) typical of the
medicine. In this case, treatment should be discontinued and appropriate therapy instituted.
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.
Transferring from systemic steroid therapy (oral, intramuscular, intravenous,
subcutaneous) to therapy with flunisolide must be done with caution if there is reason to
suspect the presence of adrenal dysfunction (the adrenal glands are two glands located
above the kidneys, they produce substances similar to corticosteroids, which, for this reason, can block them;
abrupt discontinuation of systemic treatment is generally to be avoided (because the blocked adrenals
do not have time to start working immediately).
Conducting treatment in patients already on systemic corticosteroids requires particular precautions
and close medical supervision, given that reactivation of adrenal function, suppressed by prolonged corticosteroid therapy, is slow. It is in any case
necessary that the disease is relatively "stabilized" with systemic treatment. Initially
VENTOFLU should be administered while continuing systemic treatment, subsequently this should be
progressively reduced, monitoring the patient at regular intervals and modifying the dosage
of VENTOFLU according to the results obtained.
During periods of stress or severe asthma attacks, patients undergoing this transition
will need additional (supplementary) steroid treatment. In these patients
periodic checks of adrenocortical function should also be performed, including
morning measurements of cortisol levels at rest.
In steroid-dependent patients (who have been receiving corticosteroids for a long time and cannot do without them) a gradual and controlled transition from oral to topical (local)
endobronchial therapy is recommended.
The effect of VENTOFLU, like all corticosteroids administered by inhalation, is not
immediate.
Therefore, it is important to remember that VENTOFLU is not effective in ongoing asthma crises and that it is
advisable to adhere to a regular use of the product for several days.
Do not exceed the recommended doses. Any increase in the dose, in fact, in addition to not
improving the therapeutic efficacy of the product, carries the risk of systemic effects from
absorption.
Flunisolide, like all corticosteroids, must be used with caution, if not avoided, in patients
with active or quiescent tuberculosis of the respiratory tract or with untreated infections from
fungi, bacteria or viruses or with herpes simplex in the eyes.
Due to the inhibitory effect exerted by corticosteroids on cicatricial processes (slowing down
healing), flunisolide should be used with caution in patients with 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.
In case of prolonged and high-dose topical use, it is good to keep in mind the possibility of inhibition
of adrenal activity (blockage of the function of the adrenal glands, glands located above the kidneys) and
of atrophy of the mucous membranes (reduction of the thickness of the mucous membranes, structures that line the internal organs).
Systemic effects with inhaled corticosteroids can occur, particularly when prescribed
at high doses for prolonged periods. These effects are less likely to occur than with
treatment with oral corticosteroids. Possible systemic effects include Cushing's syndrome,
Cushingoid appearance, adrenal suppression, growth retardation in children and adolescents,
reduction in bone mineral density, cataracts, glaucoma.
A number of psychological and behavioral effects may occur, including psychomotor hyperactivity,
sleep disorders, anxiety, depression, aggression, behavioral disorders
(especially in children).
Do not increase or decrease the dose without first consulting your doctor.
Very rare cases of acute adrenal crises (reduction of the activity of the adrenal glands) have occurred in boys exposed to doses higher than those recommended (about 1000 mcg/day) for
prolonged periods (several months or years). The symptoms of adrenal insufficiency are initially
non-specific and include anorexia (loss of appetite, abdominal pain, weight loss, fatigue,
headache, nausea, vomiting; specific symptoms in case of treatment with inhaled corticosteroids
include hypoglycemia (low blood sugar) with reduced state of
consciousness and/or convulsions. Situations that could potentially lead to an adrenal crisis are: trauma, surgery, infections and rapid reduction of the dosage.
Patients receiving high doses should be closely evaluated and the dose gradually
reduced.
Monitoring of adrenal reserve may also be necessary.
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, may
occur following treatment with inhaled corticosteroids at high doses for prolonged periods.

Other medicines and VENTOFLU
Tell 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 are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Taking VENTOFLU is not recommended during the first three months of pregnancy; in the further
period and during breastfeeding VENTOFLU should only be administered 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 in any case determine positivity to anti-doping tests.

3. How to take VENTOFLU

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

Children: The recommended dose is 1 ml (25 drops) of VENTOFLU 0.05% children,
corresponding to 500 micrograms, twice a day. Each drop contains 20 micrograms of
flunisolide.
It is not advisable to administer this medicine to children under 4 years of age.
To use the single-dose vial, perform the following operations:
a) open the vial by exerting slight pressure on the cannula,
b) take the contents of the vial in the prescribed quantity with the aid of a syringe or
by inverting the open vial and tapping on the bottom with a finger.
To take one ml, empty it up to the mark indicated on the vial.
VENTOFLU 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 delivered, this
must be taken into account when evaluating the administered dose.

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

If you take more VENTOFLU than you should
The administration of large quantities of flunisolide in a short period of time may determine
suppression of the hypothalamic-pituitary-adrenal function. In this case, the dose
administered must be reduced immediately to the recommended dose.
In case of accidental ingestion/intake of an excessive dose of VENTOFLU, immediately notify
your doctor or go to the nearest hospital.
If you have any doubts about the use of VENTOFLU, 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 (candidiasis) 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 to the reduction of
systemic corticosteroid therapy.
Another common side effect is pneumonia (lung infection) in patients with COPD
(common undesirable effect). Inform your doctor if you experience any of the following symptoms while
taking flunisolide, as they could be symptoms of a lung infection:

• fever or chills.
• increased mucus production, changes in mucus color.
• increased cough or greater difficulty breathing. Patients should still be closely monitored in the case 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 case very serious incidents from acute adrenal insufficiency (reduction of adrenal function). At high doses used for long periods, Cushing's syndrome, Cushingoid appearance (moon face, obesity, red striae on the skin of the abdomen, swelling), adrenal suppression, growth retardation in children and adolescents, reduced bone mineral density, cataract and glaucoma may occur. Undesirable effects that may occur, with unknown frequency, are psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioral disturbances (predominantly in children).

It is important to inform your doctor or pharmacist of any side effects, even
if different from those listed above.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
consult your doctor or pharmacist. You can also report side effects directly
through the national reporting system at 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 which is stated on the label after Expiry. The date
of expiry refers to the last day of that month.
This expiry date applies to the product in its intact packaging and when correctly stored.
Store in the original packaging to protect the medicine from light.
Do not store at a temperature above 25°C.
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 VENTOFLU contains

VENTOFLU 2 mg/2 ml 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 ingredients are: propylene glycol, sodium chloride, citric acid, sodium citrate, water for injections.

VENTOFLU 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 ingredients are: propylene glycol, sodium chloride, citric acid, sodium citrate, water for injections.

Description of the appearance of VENTOFLU and contents of the pack
Nebulizer solution.
VENTOFLU 2 mg/2 ml adults nebulizer solution: pack of 15 vials of 2 ml
VENTOFLU 1 mg/2 ml children nebulizer solution: pack of 15 vials of 2 ml

Marketing Authorisation 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 (Roma)