FLUNISOLIDE 1 mg /Ml Solution For Nebulization

Зміст інструкції

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

FLUNISOLIDE EG 1 mg/ml solution for nebulisation

Equivalent medicine
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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is FLUNISOLIDE EG and what it is used for

The active ingredient of FLUNISOLIDE EG is flunisolide, a substance that belongs to a group of
medicines called glucocorticoids.
This medicine is used in the treatment of some allergic diseases of the respiratory tract such as:

• bronchial asthma (obstruction of the airways and respiratory crises)
• chronic asthmatic bronchitis (asthma originating from inflammation of the bronchi)
• chronic and seasonal allergic rhinitis (inflammation of the nasal mucosa), including hay fever.

2. What you need to know before using FLUNISOLIDE EG

Do not use FLUNISOLIDE EG

• if you are allergic to flunisolide or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from active or quiescent pulmonary tuberculosis (lung infection caused by active or inactive microorganisms);
• if you have a bacterial, viral or fungal infection;
• if you are pregnant or if you are breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using FLUNISOLIDE EG.

Take special care with FLUNISOLIDE EG:

• If you have an untreated respiratory infection, such as tuberculosis, caused by viruses, bacteria or fungi, or an eye infection caused by herpes simplex virus. In these cases, you should not use this medicine.
• If you have or have recently had nasal trauma with a wound (ulcer) in the nasal septum or with recurrent bleeding (epistaxis), as this medicine slows down wound healing.
• If you use FLUNISOLIDE EG for a long period of time, as this medicine may alter the natural microbial flora of the airways. In this event, covering therapy (restoration of the natural microbial flora) may be necessary. Prolonged use of the medicine may also lead to sensitization phenomena and, sometimes, to undesirable effects (see section “Possible side effects”). In this case, discontinue treatment and consult your doctor to establish appropriate therapy.
• If you use FLUNISOLIDE EG for prolonged periods and at high doses (higher than those recommended), as it may cause a reduction in the activity of the gland that regulates the stress response (adrenal gland) and a reduction in the natural growth of mucous membranes.
• If you are using medicines for the treatment of respiratory diseases taken by inhalation (inhaled corticosteroids such as FLUNISOLIDE EG), as these medicines can cause general undesirable effects due to hormonal imbalance. Some of these effects include Cushing's syndrome (excess hormones in the bloodstream), cushingoid appearance (swelling of the face or trunk), adrenal suppression (suppression of the function of the gland that regulates the stress response), growth retardation in children and adolescents, reduced bone mineral density, cataract (loss of lens transparency) and glaucoma (damage to the optic nerve). Rarely, a series of psychological and behavioral undesirable effects may occur, including psychomotor hyperactivity (mania),sleep disturbances, anxiety, depression, aggression, behavioral disorders (especiallyin children).
• If you are switching from systemic steroid therapy, for example by mouth, to therapy with FLUNISOLIDE EG, as alterations in the gland that regulates the stress response (adrenal gland) may be in progress. Generally, systemic treatment should not be stopped abruptly. If you are receiving systemic treatment, you need medical supervision and special precautions, because the recovery of adrenal function (the gland that regulates the stress response) is slow. In this case, it is also necessary that your illness (respiratory) is relatively "stabilized" by systemic therapy. Initially, your doctor will advise you to use FLUNISOLIDE EG while continuing systemic treatment, gradually reducing the latter, monitoring adrenal function and modifying the dose of FLUNISOLIDE EG according to the results obtained. During periods of stress or severe asthma attack, if you have switched from systemic treatment to FLUNISOLIDE EG, you will need supplementary steroid treatment. You should also undergo periodic checks of cortico-adrenal function (the gland that regulates the stress response), including measurements of cortisol (a hormone) levels in the morning in a resting state.
• If you are undergoing continuous treatment with steroid medicines, as in this case a gradual and controlled transition from oral (by mouth) to endobronchial topical (administered directly into the bronchi) therapy is recommended. The effect of FLUNISOLIDE EG is not immediate, so this medicine is not effective during ongoing asthma attacks. Follow a regular use of this medicine for several days.

The use of FLUNISOLIDE EG may mask some symptoms of infection and may also lead to new
infections.
the dose without first consulting your doctor. Exceeding the recommended doses, in addition to not improving
the therapeutic efficacy of FLUNISOLIDE EG, carries the risk of systemic effects from absorption (general
undesirable effects).
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
Take care if you need to administer FLUNISOLIDE EG to children under 4 years of age, as this
medicine is not recommended in this age group.
Take care if you are using medicines for the treatment of respiratory diseases taken by inhalation
(inhaled corticosteroids such as FLUNISOLIDE EG) in children, as these medicines can cause
general undesirable effects due to hormonal imbalance. Some of these effects include growth retardation in
children and adolescents.
Rarely, a series of psychological and behavioral undesirable effects may occur, including psychomotor
hyperactivity (mania), sleep disturbances, anxiety, depression, aggression,
behavioral disorders.
Other medicines and FLUNISOLIDE EG
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 FLUNISOLIDE EG and your 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).

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist before using this medicine.
This medicine is not recommended in the first three months of pregnancy. In the following period and during
breastfeeding, use this medicine only if absolutely necessary and under the direct
control of your doctor.

Driving and operating machinery
No effects on the ability to drive or operate machinery are known.
FLUNISOLIDE EG contains 520 mg of propylene glycol (E1520) in 25 drops equivalent to 1 ml of
medicine.

3. How to use FLUNISOLIDE EG

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have doubts
consult your doctor or pharmacist.
The recommended dose, unless otherwise prescribed by your doctor, is:

Adults: 25 drops (equivalent to 1 mg), twice a day.

Use in children: 20 micrograms/kg, twice a day.
1 drop of FLUNISOLIDE EG corresponds to 40 microliters and 40 micrograms of Flunisolide.
To determine the dose, expressed in drops, based on body weight, refer to the table
below
Weight, number of drops and mg of Flunisolide correlation
FLUNISOLIDE EG must be used with electric nebulizers, including ultrasonic ones, and can be diluted with
physiological solution.
FLUNISOLIDE EG can be used during therapies with bronchodilators, chemotherapeutic agents and with
corticosteroids in the replacement phase of oral corticosteroid therapy.

If you use more FLUNISOLIDE EG than you should
In case of ingestion/accidental intake of an excessive dose of FLUNISOLIDE EG, immediately
inform your doctor or go to the nearest hospital.

Administering large amounts of the medicine in a short period of time may determine the
suppression of a system of hormonal glands that regulate various functions of the organism including
sleep, response to stress, appetite, body temperature and growth. In this case, immediately
return to the recommended dose.

If you forget to use FLUNISOLIDE EG
Do not use a double dose to make up for a missed dose.
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.
Contact your doctor if you experience any of the following side effects:

common(may affect up to 1 in 10 people)

• pneumonia (lung infection), in patients with chronic obstructive pulmonary disease (COPD) Inform your doctor if you have any of the following symptoms while taking flunisolide, they could be symptoms of a lung infection:
• fever or chills
• increased mucus production, changes in mucus color.
• increased cough or greater difficulty breathing frequency not known(the frequency cannot be estimated from the available data):
• psychomotor hyperactivity;
• sleep disorders;
• anxiety and depression;
• aggression;
• behavioral disturbances (especially in children),
• blurred vision.

Only some patients with very sensitive airways have experienced cough and hoarseness. Rarely, fungal infections in the mouth or throat have been observed, which disappeared quickly after appropriate local therapy.
These infections can be prevented or minimized if patients carefully rinse their mouth after each administration.
Following the rhinal use of the product, mild transient burning as well as a stinging sensation may occur which could be so intense as to force discontinuation of treatment. Other side effects observed following rhinal use of Flunisolide are in decreasing order: nasal irritation, epistaxis (nosebleeds), nasal congestion, rhinorrhea (runny nose), sore throat, hoarseness and throat irritation. If severe, these side effects may require discontinuation of therapy.
Only in case of inappropriate use can, even to a limited extent, the effects typical of corticosteroids administered systemically occur.
The most common side effect found in corticosteroid-dependent patients has been the appearance of nasal congestion and nasal polyps, due precisely to the reduction of systemic corticosteroid therapy. Patients should nevertheless be kept under strict control in the case of prolonged treatments, in order to promptly ascertain the eventual appearance of systemic manifestations (osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency, such as hypotension and weight loss) in order to avoid in the latter event serious incidents from acute adrenal insufficiency.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https:// 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 FLUNISOLIDE EG

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 packaging. The expiry date refers to the last day of that month.
Store the medicine in its original packaging to protect it from light and at a temperature not exceeding
25°C.
The opened package must be used within 30 days. Excess product must be discarded.
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 FLUNISOLIDE EG contains
The active ingredient is flunisolide.
100 ml of solution contains 100 mg of flunisolide (1 drop contains 40 micrograms of flunisolide).
The other ingredients are: propylene glycol (E1520), sodium chloride, purified water.

Description of the appearance of FLUNISOLIDE EG and contents of the pack
Pack containing a 30 ml bottle, with dropper.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milano
Manufacturer
GENETIC S.p.A., Nucleo Industriale, Contrada Canfora - 84084 Fisciano (SA)