Lunibron

Package leaflet: Information for the patient

Lunibron 2 mg/2 ml nebulising solution, 1 mg/2 ml nebulising solution

Flunisolide
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lunibron is and what it is used for

The active substance of Lunibron is flunisolide, a substance that belongs to a group of medicines 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 should know before using Lunibron

Do not use Lunibron

• 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 (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 Lunibron.
Contact your doctor if you experience blurred vision or other visual disturbances.
Exercise particular caution with Lunibron:

• If you have an untreated respiratory tract 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 ulceration of the nasal septum or recurrent nosebleeds (epistaxis), as this medicine may slow wound healing.
• If you use Lunibron for a long period of time, because this medicine may alter the natural microbial flora of the airways. In such cases, concomitant therapy to restore 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”). If this occurs, stop treatment and consult your doctor to establish appropriate therapy.
• If you use Lunibron 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 mucosal growth.
• If you are taking medicines for respiratory diseases administered by inhalation (inhaled corticosteroids such as Lunibron), 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 (swelling of the face or trunk), 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 range of psychological and behavioral adverse 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 therapy with Lunibron, because alterations in the gland regulating the stress response (adrenal gland) may be ongoing. 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" using systemic therapy. Initially, your doctor will instruct you to use Lunibron while continuing systemic treatment, gradually reducing the latter, monitoring adrenal function, and adjusting the dose of Lunibron according to the results obtained. During periods of stress or severe asthma attack, if you have switched from systemic treatment to Lunibron, you will need supplementary 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 therapy to topical endobronchial therapy is recommended.

The effect of Lunibron is not immediate; therefore, this medicine is not effective during ongoing asthma attacks. Use this medicine regularly for several days as directed.
The use of Lunibron 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, in addition to not improving the therapeutic efficacy of Lunibron, increases the risk of systemic effects due to absorption (general adverse effects).

Children
Be cautious if administering Lunibron to children under 4 years of age, as this medicine is not recommended for this age group.
Be cautious when using inhaled respiratory medicines (inhaled corticosteroids such as Lunibron) 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 range of psychological and behavioral adverse effects may occur, including psychomotor hyperactivity (restlessness), sleep disturbances, anxiety, depression, aggression, behavioral disorders.

Other medicines and Lunibron
Inform your doctor if you are currently taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of Lunibron, and your doctor may wish 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 to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
This medicine is not recommended during the first three months of pregnancy. During the later stages of pregnancy and while breastfeeding, use this medicine only if clearly needed and under direct medical supervision.

Driving vehicles and using machinery
No effects on the ability to drive vehicles or use machinery are known.

Lunibron contains propylene glycol
This medicine contains propylene glycol, which may cause skin irritation.

3. How to use Lunibron

Use this medicine exactly as prescribed 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:
Single-dose containers 2 mg/2ml:
1 ml, corresponding to half the dose, equal to 1 mg, twice daily
Use in children:
Single-dose containers 1 mg/2ml:
1 ml, corresponding to half the dose, equal to 500 micrograms, twice daily

INSTRUCTIONS FOR USE

A. Open the container by applying slight pressure on the nozzle.
B. Withdraw the prescribed amount using a syringe or by inverting the opened container and gently tapping the bottom with a finger.
C. To withdraw one “ml”, empty the container up to the mark indicated on it.
Lunibron must be used with electric nebulizers, both for outpatient and home use.
The solution should be used undiluted.
Lunibron may be used during therapies with bronchodilators, chemotherapeutic agents, and corticosteroids in the replacement phase of oral corticosteroid therapy.

If you use more Lunibron than you should
In case of accidental ingestion/overdose, contact your doctor immediately or go to the nearest hospital.
Administration of large amounts of the medicine within a short period of time may lead to suppression of a hormonal 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 Lunibron
Do not use a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
Contact your doctor if you experience any of the following side effects:
Frequency not known (frequency cannot be estimated from the available data):

• blurred vision
• psychomotor hyperactivity;
• sleep disorders;
• anxiety and depression;
• aggression;
• behavioural disorders (mainly in children).

Only some patients with very sensitive airways have developed cough and hoarseness. Rarely, fungal infections in the mouth or throat have been observed, which rapidly disappeared with appropriate local treatment. These infections can be prevented or minimized if patients rinse their mouth thoroughly after each administration.
Following nasal use of the product, mild transient burning and tingling may occur, which could be so intense as to require discontinuation of treatment. Other side effects observed with nasal use of Flunisolide, in decreasing order of frequency, are: nasal irritation, epistaxis, nasal congestion, rhinorrhea, sore throat, hoarseness, and throat irritation. If severe, these side effects may require discontinuation of therapy.
Only with inappropriate use may there occur, albeit to a limited extent, the typical effects of corticosteroids administered systemically.
The most common adverse effect 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 adrenocortical insufficiency such as hypotension and weight loss), thus avoiding, in the latter case, severe acute adrenal insufficiency events.
Following the instructions provided in this leaflet reduces the occurrence of side effects.
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
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lunibron

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle. The expiry date refers to the last day of that month. The expiry date applies to the product in its original packaging, stored correctly.
Store the medicine in its original packaging to protect it from light.
Use the medicine within 24 hours after opening the container. The remaining half, stored at a temperature between 2°C and 8°C in the refrigerator, must be used within 12 hours. Any unused product remaining after 12 hours must 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 Lunibron contains
The active substance is flunisolide.

• One single-dose container 2 mg/2 ml of Lunibron contains 1 mg of flunisolide per 1 ml
• One single-dose container 1 mg/2 ml of Lunibron contains 0.5 mg of flunisolide per 1 ml

The other components are: propylene glycol, sodium chloride, citric acid, sodium citrate, water for
injections

Description of the appearance of Lunibron and contents of the pack
Lunibron is a solution for nebulization.
Pack contains 15 single-dose containers of 2 ml each.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
NEOPHARMED GENTILI S.p.A. – Via San Giuseppe Cottolengo 15 – 20143 Milan, Italy
Manufacturers:
Special Product’s Line - Via Campobello, 15 - Pomezia (ROME), and
Fisiopharma Srl - Industrial Area - Palomonte (SA).

Patient Information Leaflet

Lunibron 30 mg/30 ml nebulizer solution

Flunisolide
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lunibron is and what it is used for

The active substance of Lunibron is flunisolide, a substance belonging to a group of medicines called glucocorticoids.
This medicine is used in the treatment of certain allergic respiratory diseases, such as:
bronchial asthma (airway obstruction and respiratory attacks)
chronic asthmatic bronchitis (asthma arising from bronchial inflammation)
chronic and seasonal allergic rhinitis (inflammation of the nasal mucosa), including hay fever.

2. What you should know before using Lunibron

Do not use Lunibron

• 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 Lunibron.
Contact your doctor if you experience blurred vision or other visual disturbances.
Exercise particular caution with Lunibron:

• If you have an untreated respiratory tract infection caused by viruses, bacteria, or fungi, or an eye infection caused by herpes simplex virus. In such 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 recurrent nosebleeds (epistaxis), as this medicine may slow down wound healing.
• If you use Lunibron for a long period of time, because this medicine may alter the natural microbial flora of the airways. In such cases, additional therapy (to restore the natural microbial flora) may be necessary. Prolonged use of the medicine may also lead to sensitization phenomena and, occasionally, to adverse effects (see section "Possible side effects"). In such cases, discontinue treatment and consult your doctor to initiate appropriate therapy.
• If you use Lunibron for prolonged periods and at high doses (higher than recommended), because it may reduce the activity of the gland regulating the stress response (adrenal gland) and impair the natural growth of mucosal tissues.
• If you are using medicines for respiratory diseases administered by inhalation (inhaled corticosteroids such as Lunibron), because these medicines may cause general 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, decreased bone mineral density, cataract (loss of lens transparency), and glaucoma (optic nerve damage). Rarely, a series of psychological and behavioral adverse 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 therapy with Lunibron, because alterations in the gland regulating the stress response (adrenal gland) may be ongoing. 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 Lunibron while continuing systemic treatment, gradually reducing the latter, monitoring adrenal function, and adjusting the dose of Lunibron based on results. During periods of stress or severe asthma attack, if you have switched from systemic treatment to Lunibron, you will need supplementary 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 therapy (administered directly into the bronchi) is advisable.

The effect of Lunibron is not immediate; therefore, this medicine is not effective during ongoing asthma attacks. Use this medicine regularly for several days as directed.
The use of Lunibron may mask some 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 Lunibron, increases the risk of systemic effects due to absorption (general adverse effects).

Children
Be cautious when administering Lunibron to children under 4 years of age, as this medicine is not recommended in this age group.
Be cautious when using medicines for respiratory diseases administered by inhalation (inhaled corticosteroids such as Lunibron) in children, because these medicines may cause general 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 Lunibron
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 Lunibron, and your doctor may wish 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.

Lunibron contains propylene glycol
This medicine contains 518 mg of propylene glycol per 1 mg dose, equivalent to 7.4 mg/kg in an adult (70 kg).
This medicine contains 207.2 mg of propylene glycol per 20 microgram/kg dose, equivalent to 10.4 mg/kg in a child aged ≥ 4 years (20 kg).

3. How to use Lunibron

Use this medicine exactly as directed 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 Lunibron 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

| Kg | 5–7 | 8–10 | 11–13 | 14–16 | 17–19 | 20–22 | 23–25 | 26–28 | 29–31 | 32–34 | 35–37 | 38–40 | >40 | |----------|------|------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-----| | Drops | 3| 5| 6 | 8 | 9 | 11| 12| 14| 15| 17| 18| 20| 25| | mg |0.12|0.20|0.24|0.32|0.36|0.44|0.48|0.56|0.60|0.68|0.72|0.80|1.0|

Instructions for use

1. To open the bottle, press and simultaneously twist the dropper cap counterclockwise.
2. After use, close the bottle by screwing the cap clockwise.
   Lunibron should be used with electric nebulizers, including ultrasonic ones, and may be diluted with
   physiological saline solution.
   Lunibron may be used during treatment with bronchodilators, chemotherapeutic agents, and
   corticosteroids in the replacement phase of oral corticosteroid therapy.
   If you use more Lunibron than you should
   In case of accidental ingestion/overdose of Lunibron, contact your doctor immediately or go to the nearest hospital.
   Administration of large amounts of the medicine within a short period of time may
   lead to suppression of a hormonal gland system regulating various body functions, including sleep, stress response, appetite, body temperature, and growth. In such a case, return immediately to the recommended dose.
   If you forget to use Lunibron
   Do not take a double dose to make up for the missed dose.
   If you have any doubts about using this medicine, consult 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:
Frequency not known (frequency cannot be estimated from the available data):

• blurred vision
• psychomotor hyperactivity;
• sleep disorders;
• anxiety and depression;
• aggression;
• behavioural disorders (mainly in children).

Only some patients with highly sensitive airways have experienced cough and hoarseness. Fungal infections in the mouth or throat have rarely been observed, which quickly resolved with appropriate local treatment. These infections can be prevented or minimized if patients rinse their mouth thoroughly after each administration.
Following nasal use of the product, mild transient burning sensation and tingling may occur, which could be so intense as to require discontinuation of treatment. Other side effects observed with nasal use of Flunisolide, in decreasing order of frequency, are: nasal irritation, epistaxis, nasal congestion, rhinorrhea, sore throat, hoarseness and throat irritation. If severe, these side effects may require discontinuation of therapy.
Only with inappropriate use may the typical effects of systemically administered corticosteroids occur, albeit to a limited extent.
The most common adverse effect 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 treatments, 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 incidents of acute adrenal insufficiency.
Following the instructions contained in this leaflet reduces the occurrence of side effects.
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 Lunibron

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle.
The expiry date refers to the last day of that month. The expiry date applies to the product in its
original, unopened packaging, when stored correctly.
Store the medicine in its original packaging to protect it from light.
Use the medicine within 30 days after opening the bottle and discard any unused portion.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Lunibron contains

• The active substance is flunisolide. A multidose container of Lunibron contains 30 mg of flunisolide. One drop of Lunibron contains 40 micrograms of flunisolide.
• The other components are: sodium chloride, propylene glycol, purified water, hydrochloric acid 1N solution.

Description of the appearance of Lunibron and contents of the package
Lunibron is a solution for nebulization.
The package contains one 30 ml multidose container with dropper closure system.
Marketing Authorization Holder
NEOPHARMED GENTILI S.p.A. – Via San Giuseppe Cottolengo 15 – 20143 Milan
Manufacturer
Valeas S.p.A. - Via Vallisneri, 10 - 20133 Milan
Lachifarma S.r.l. Laboratorio Chimico Farmaceutico Salentino - S.S. 16 – Zona Industriale 73010
Zollino (LE)