Flunisolide EG

Package leaflet: Information for the user

FLUNISOLIDE EG 1 mg/ml nebulising solution

Generic medicine
Read this entire 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 yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform 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 FLUNISOLIDE EG is and what it is used for

The active substance of FLUNISOLIDE EG is flunisolide, a substance belonging to a group of
medicinal products called glucocorticoids.
This medicine is used in the treatment of certain allergic respiratory diseases such as:

• bronchial asthma (airway obstruction and breathing attacks)
• chronic asthmatic bronchitis (asthma arising 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 to any of the other ingredients of this medicine (listed in section 6);
• if you have active or quiescent pulmonary tuberculosis (a lung infection caused by active or inactive mycobacteria);
• if you have a bacterial, viral, or fungal infection;
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to 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 the 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) on the nasal septum or recurrent nosebleeds (epistaxis), as this medicine may slow down wound healing.
• If you use FLUNISOLIDE EG for a long time, because this medicine may alter the natural microbial flora of the airways. In such cases, a covering therapy (restoration of the natural microbial flora) may be necessary. Prolonged use of the medicine may also lead to sensitization phenomena and, occasionally, adverse effects (see section "Possible side effects"). In this case, stop treatment and consult your doctor to initiate appropriate therapy.
• If you use FLUNISOLIDE EG for prolonged periods and at high doses (higher than recommended), because it may cause reduced activity of the gland regulating the stress response (adrenal gland) and reduced natural growth of mucosal tissues.
• If you are using medicines for respiratory diseases administered by inhalation (inhaled corticosteroids such as FLUNISOLIDE EG), because these medicines may cause systemic adverse effects due to hormonal imbalance. Some of these effects include Cushing's syndrome (excess hormones in the bloodstream), cushingoid appearance (facial or trunk swelling), adrenal suppression (reduced function of the gland regulating 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 side effects may occur, including psychomotor hyperactivity (restlessness), sleep disturbances, anxiety, depression, aggression, behavioral disorders (particularly in children).
• If you are switching from systemic steroid therapy, for example oral, to treatment with FLUNISOLIDE EG, because alterations in the function of the gland regulating the stress response (adrenal gland) may already be present. Generally, systemic treatment should not be stopped abruptly. If you are receiving systemic treatment, you require medical supervision and special precautions, as recovery of adrenal function (the gland regulating the stress response) is slow. In this case, your respiratory disease should also be relatively "stabilized" through systemic therapy. Initially, your doctor will instruct you to use FLUNISOLIDE EG while continuing systemic treatment, gradually reducing the latter, monitoring adrenal function, and adjusting the dose of FLUNISOLIDE EG according to the results obtained. During periods of stress or severe asthma attacks, if you have switched from systemic treatment to FLUNISOLIDE EG, you will need supplemental systemic steroid therapy. Additionally, you should undergo periodic checks of adrenal-cortical function (the gland regulating the stress response), including early morning measurements of cortisol levels (a hormone) under resting conditions.
• If you are on continuous treatment with steroid medicines, because in this case a gradual and controlled transition from oral (by mouth) to topical endobronchial administration (directly into the bronchi) is recommended. The effect of FLUNISOLIDE EG is not immediate; therefore, this medicine is not effective during ongoing asthma attacks. Follow a regular dosing schedule for several days.

The use of FLUNISOLIDE EG may mask certain symptoms of infection and may also lead to new infections.
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. Exceeding the recommended doses, besides not improving the therapeutic efficacy of FLUNISOLIDE EG, increases the risk of systemic effects due to absorption (general adverse effects).
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
Be cautious when administering FLUNISOLIDE EG to children under 4 years of age, as this medicine is not recommended for this age group.
Be cautious when using medicines for respiratory diseases administered via the airways (inhaled corticosteroids such as FLUNISOLIDE EG) in children, because these medicines may cause systemic adverse effects due to hormonal imbalance. Some of these effects include growth retardation in children and adolescents.
Rarely, a series of psychological and behavioral adverse effects may occur, including psychomotor hyperactivity (restlessness), sleep disturbances, anxiety, depression, aggression, behavioral disorders.

Other medicines and FLUNISOLIDE EG
Inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of FLUNISOLIDE EG, and your doctor may need to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
This medicine is not recommended during the first three months of pregnancy. In the subsequent period and during breastfeeding, use this medicine only if clearly needed and under direct medical supervision.

Driving and using machines
No effects on the ability to drive vehicles 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 exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose, unless otherwise prescribed by the doctor, is:
Adults: 25 drops (equivalent to 1 mg), twice daily.
Use in children: 20 micrograms/kg, twice daily.
1 drop of FLUNISOLIDE EG corresponds to 40 microliters and 40 micrograms of Flunisolide.
To determine the dose in drops according to body weight, refer to the following table:
Correlation between weight, number of drops, and mg of Flunisolide

FLUNISOLIDE EG should be used with electric nebulizers, including ultrasonic ones, and may be diluted with
physiological solution.
FLUNISOLIDE EG can be used during treatments with bronchodilators, chemotherapeutic agents, and corticosteroids in the replacement phase of oral corticosteroid therapy.
If you use more FLUNISOLIDE EG than you should
In case of accidental ingestion/overdose of FLUNISOLIDE EG, inform your doctor immediately or go to the nearest hospital.
Administration of large amounts of the medicine within a short period of time may cause suppression of an endocrine gland system regulating various body functions, including sleep, stress response, appetite, body temperature, and growth. In such case, return immediately to the recommended dose.
If you forget to use FLUNISOLIDE EG
Do not use a double dose to make up for a forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Contact your doctor if you experience any of the following adverse reactions:
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 experience any of the following symptoms while taking flunisolide, as they could indicate a lung infection:
  • fever or chills
  • increased mucus production, changes in mucus color
  • worsening cough or increased breathing difficulties

Frequency not known (frequency cannot be estimated from the available data):

• Psychomotor hyperactivity;
• Sleep disorders;
• Anxiety and depression;
• Aggressiveness;
• Behavioural disturbances (mainly in children);
• Blurred vision.

Only some patients with very sensitive airways have experienced cough and hoarseness. Fungal infections in the mouth or throat have rarely been observed, which rapidly resolve with appropriate local therapy. These infections can be prevented or minimized if patients thoroughly rinse their mouth after each administration.
Following nasal use of the product, mild transient burning sensation and itching may occur, which could be so intense as to require discontinuation of treatment. Other adverse reactions observed with nasal use of flunisolide, in decreasing order of frequency, are: nasal irritation, epistaxis (nosebleeds), nasal congestion, rhinorrhea (runny nose), sore throat, hoarseness, and throat irritation. If severe, these adverse reactions may require discontinuation of therapy.
Only in case of inappropriate use, although to a limited extent, typical effects of systemically administered corticosteroids may occur.
The most common adverse reaction observed in corticosteroid-dependent patients has been the onset of nasal congestion and nasal polyps, due to the reduction of systemic corticosteroid therapy. Patients should nevertheless be kept under close monitoring during prolonged treatment in order to promptly detect any possible systemic manifestations (osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency such as hypotension and weight loss), thus avoiding, in the latter case, severe acute adrenal insufficiency events.
Adherence to the instructions contained in the package leaflet reduces the occurrence of adverse reactions.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, 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 stated on the packaging. The expiry date refers to the last
day of that month.
Store the medicine in the original packaging to protect it from light and at a temperature not exceeding
25°C.
The opened package must be used within 30 days. Any remaining product should be discarded.
Do not dispose of any medicine 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 FLUNISOLIDE EG contains
The active substance is flunisolide.
100 ml of solution contain 100 mg of flunisolide (1 drop contains 40 micrograms of flunisolide).
The other components are: propylene glycol (E1520), sodium chloride, purified water.
Description of the appearance of FLUNISOLIDE EG and contents of the pack
Pack containing one 30 ml bottle with dropper.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milan, Italy
Manufacturer
GENETIC S.p.A., Industrial Area, Contrada Canfora - 84084 Fisciano (SA), Italy