ASMAFLU 0.1% Solution for nebulization

Зміст інструкції

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

Asmaflu 0.1 % solution for nebulization

Asmaflu adults solution for nebulization

Asmaflu children solution for nebulization

flunisolide

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

1. What Asmaflu is and what it is used for

Asmaflu contains the active ingredient flunisolide.
Asmaflu belongs to a group of medicines called glucocorticosteroids which are hormones
that perform numerous activities, with an important function in controlling
inflammation.
Asmaflu is indicated in allergic conditions of the respiratory tract:

• bronchial asthma, an inflammatory disease characterized by an obstruction of the bronchi;
• chronic asthmatic bronchitis, a persistent inflammatory disease of the bronchi, accompanied by breathing difficulties;
• rhinitis, inflammation of the inside of the nose, persistent (chronic) and seasonal.

2. What you need to know before you take Asmaflu

Do not take Asmaflu

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you have an infectious disease called active or quiescent pulmonary tuberculosis;
• if you have infections from microorganisms such as bacteria, viruses or fungi;
• if you are pregnant and breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Asmaflu if:

• you have herpes simplex infections of the eyes;
• if you have previous or recent nasal trauma, with lesions of the nasal septum that do not tend to heal (ulcers) or with recurrent nosebleeds (epistaxis);
• if you have a change in the microorganisms (microbial flora) present in the nose and throat (upper airways) which manifests especially in prolonged treatments, contact your doctor who will prescribe a covering therapy.

The effect of Asmaflu, as with all glucocorticosteroids administered by inhalation,
is not immediate.
Therefore, keep in mind that Asmaflu is not effective in ongoing asthma attacks and that it is
advisable to adhere to a regular use of the medicine for several days.
It is important that your doctor prescribes the minimum effective dose of inhaled glucocorticosteroids
for asthma control and regularly reviews the dosage. In fact, possible
general effects on the body (such as suppression of the activity of the glands called
adrenal glands, even acute, growth retardation in children and adolescents, reduction of mineral
bone density, cataracts and glaucoma) may occur following treatment with
inhaled glucocorticosteroids at high doses for prolonged periods.
The doctor must carefully evaluate your conditions and decrease the dose of the medicine if
there are situations that could potentially determine a crisis of the glands
called adrenal glands such as: trauma, surgery, infections and rapid reduction of
the dosage of the medicine. If you are treated with high doses, the doctor must carefully evaluate your
conditions and gradually decrease the dose.
The doctor may decide to prescribe you tests to check the activity of the adrenal glands.
If you have marked nasal congestion or abundant secretions, the doctor may prescribe a
preliminary treatment with medicines that reduce the size of the blood vessels in the nose
(topical vasoconstrictors) to allow the nasal spray to come into contact with the mucosa.
Rarely, a series of psychological and behavioral effects may occur
including psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression,
behavioral disorders (mainly in children).
doctor.
Do not increase or decrease the dose without first consulting your doctor. Do not exceed the recommended doses.
Increasing the doses, in fact, in addition to not improving the therapeutic efficacy of the
product, involves the risk of general adverse effects on the body.
The use, especially if prolonged, of the medicine can lead to sensitization phenomena and
exceptionally, adverse effects involving the whole organism (systemic) can occur. In this case, the doctor will make you interrupt the
treatment and establish a suitable therapy.
Whenever you use glucocorticosteroids, keep in mind that these medicines can
mask some symptoms of infection and that new infectious processes can occur during their use.
The doctor will take particular precautions if you are to be transferred from a therapy with
glucocorticosteroids that reach the whole organism (systemic) to a therapy with Asmaflu.
To carry out this transfer it is necessary that the disease is relatively
"stabilized".
Under strict medical control, you will initially have to take Asmaflu continuing systemic treatment,
subsequently, this will be progressively reduced at regular intervals, modifying the dosage of Asmaflu
according to the results obtained.
During periods of stress or severe asthma attack, if you have undergone such a transfer, the
doctor will prescribe you a supplementary treatment of systemic glucocorticosteroids. In these
cases, the doctor will have you undergo periodic checks of the functionality of the glands
called adrenal glands, including measurements taken first thing in the morning of the levels of a
hormone called cortisol in resting conditions.
If you are a patient dependent on glucocorticosteroids, the doctor will prescribe you a gradual and controlled transfer
from oral to local therapy.
For those who play sports: the use of the drug without therapeutic necessity constitutes
doping and can still determine positivity to anti-doping tests.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
Asmaflu is not recommended in children under four years of age.
Very rare cases of acute insufficiency of two glands called adrenal glands have been reported in
children exposed to doses higher than those recommended (about 1000 micrograms/day) for
prolonged periods (several months or years). The symptoms of adrenal insufficiency initially
are nonspecific and include loss of appetite, abdominal pain, weight loss, fatigue, headache, nausea, vomiting.
Specific symptoms in case of treatment with inhaled glucocorticosteroids include
reduction of blood sugar values (hypoglycemia) with reduction of consciousness and/or convulsions.
Growth retardation in children and adolescents may occur following treatment with high doses for prolonged periods. Behavioral disturbances have also been observed.

Other medicines and Asmaflu
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including medicines obtained without a prescription.
Some medicines can increase the effects of Asmaflu and the doctor may want to keep you
under close observation if you are taking these medicines (including some
medicines for the treatment of HIV: ritonavir, cobicistat).
No interactions between flunisolide and other medicines are known.

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

Driving and operating machinery
No effects on the ability to drive vehicles and operate machinery are known.

3. How to take Asmaflu

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Use in adults
Asmaflu 0.1 % solution for nebulisation
The recommended dose is: 1 mg (25 drops) 2 times a day.
Each drop contains 40 micrograms of flunisolide.
Asmaflu adults solution for nebulisation
The recommended dose is: half the contents of one container of Asmaflu adults 2 times a day.

Use in children and adolescents
Asmaflu 0.1 % solution for nebulisation
The recommended dose is: 500 micrograms (12-13 drops) 2 times a day.
Each drop contains 40 micrograms of flunisolide.
It is not advisable to administer to children under four years of age.
Asmaflu children solution for nebulisation
The recommended dose is: half the contents of one container of Asmaflu children 2 times a day.
It is not advisable to administer to children under four years of age.
Asmaflu must be used with electric nebulisers and must not be diluted.
As is known, the administration of medicines in solution by means of electric nebulisers
involves a residue of solution which, adhering to the walls of the vial or at the bottom, is not
delivered.
Taking this into account, it is necessary, during preparation, to consider the need to supplement the
non-deliverable part.

If you take more Asmaflu than you should
The administration of large quantities of flunisolide in a short period of time may
determine the suppression of some important hormonal functions (hypothalamic-pituitary-adrenal function). In this case the doctor must reduce the dose administered, bringing it
to the recommended dose.

If you forget to take Asmaflu
Do not take a double dose to make up for a missed dose.

If you stop taking Asmaflu
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed:

• cough and hoarseness in patients with very sensitive airways;
• sometimes mild and transient burning inside (mucosa) of the nose;
• rarely fungal infections in the mouth or throat that disappear quickly after appropriate local therapy. These infections can be prevented or minimized by rinsing the mouth thoroughly after each administration;
• nasal irritation, nosebleeds (epistaxis), nasal congestion, runny nose (rhinorrhea), sore throat, hoarseness and irritation of the oral cavity and throat. If severe, these side effects may require discontinuation of therapy;
• only in case of excessive use of the medicine, even if to a limited extent, you may experience the typical effects of glucocorticosteroids administered systemically

Commonly, nasal congestion and nasal polyps have been observed in patients who have been taking glucocorticosteroids for a long time
(corticosteroid-dependent).
In the case of prolonged treatments, patients should be kept under strict medical supervision in order to
promptly ascertain the possible appearance of manifestations involving the whole
organism (osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency
such as hypotension and weight loss).
At high doses used for long periods, suppression of the activity of the
glands called adrenal glands, reduction of bone mineral density, opacity
of the eye (cataract) and prolonged damage to the optic nerve (glaucoma) may occur.
Side effects that may occur with unknown frequency are:

• psychomotor hyperactivity;
• sleep disturbances;
• anxiety;
• depression;
• aggression;
• behavioral disturbances; blurred vision.

Additional side effects in children and adolescents

• growth retardation;
• behavioral disturbances.

undesirable.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at the address
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 Asmaflu

Asmaflu 0.1 % solution for nebulization
Store at a temperature not exceeding 25°C in the original package to protect the
medicine from light.
Use the medicine within 30 days of first opening the bottle. The excess medicine
must be discarded.
Asmaflu adults solution for nebulization
Asmaflu children solution for nebulization
Store in the original package to protect the medicine from light.
Use the medicine within 12 hours of first opening the container. The excess
medicine must be discarded.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after the words
“Expiry”.
The expiry date refers to the last day of that month.
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 Asmaflu contains

Asmaflu 0.1%solution for nebulisation

• The active ingredient is flunisolide. 100 ml of solution contains 100 mg of flunisolide.
• The other ingredients are propylene glycol, sodium chloride, water for injections.

Asmaflu adults solution for nebulisation

• The active ingredient is flunisolide. One 2 ml container of solution contains 2 mg of flunisolide.
• The other ingredients are propylene glycol, sodium chloride, water for injections.

Asmaflu children solution for nebulisation

• The active ingredient is flunisolide. One 2 ml container of solution contains 1 mg of flunisolide
• The other ingredients are propylene glycol, sodium chloride, water for injections.

Description of the appearance of Asmaflu and contents of the pack

Asmaflu 0.1%solution for nebulisation
Solution for nebulisation. Bottle of 30 ml of 0.1% solution.
One drop contains 40 micrograms of flunisolide.

Asmaflu adults solution for nebulisation
Solution for nebulisation.
Pack of 15 containers of 2 ml solution 2 mg/2 ml

Asmaflu children solution for nebulisation
Solution for nebulisation.
Pack of 15 containers of 2 ml solution 1 mg/2 ml
Marketing authorisation holder
Genetic S.p.A. – Via G.Della Monica, 26 – Castel San Giorgio (SA)
Manufacturer

Asmaflu 0.1%solution for nebulisation
Genetic S.p.A. – Contrada Canfora – Fisciano (SA)
or

Asmaflu adults solution for nebulisation

Asmaflu children solution for nebulisation
Genetic S.p.A. – Contrada Canfora – Fisciano (SA )