LUNIBRON 30 мг/30 мл Раствор для небулайзера

Содержание инструкции

1. Lunibron 2 mg/2 ml solution for nebulisation, 1 mg/2 ml solution for nebulisation
   1. What is Lunibron and what is it 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
2. Lunibron 30 mg/30 ml solution for nebulization
   1. What is Lunibron and what is it 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

Lunibron 2 mg/2 ml solution for nebulisation, 1 mg/2 ml solution for nebulisation

Flunisolide

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 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 Lunibron is and what it is used for
• 2. What you need to know before you use 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 is Lunibron and what is it used for

The active ingredient of Lunibron 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 Lunibron

Do not use Lunibron

• 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 microbes);
• 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 Lunibron.

Contact your doctor if you experience blurred vision or other visual disturbances
Take special care with Lunibron:

• If you have an untreated infection of the respiratory tract, 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 had or recently had nasal trauma with a wound (ulcer) to the nasal septum or with recurrent bleeding (epistaxis), as this medicine slows down wound healing.
• If you use Lunibron for a long period of time, as this medicine can alter the natural microbial flora of the airways. In this case, covering therapy (restoration of the natural microbial flora) may be necessary. Prolonged use of the medicine can also lead to sensitization phenomena and, sometimes, to undesirable effects (see section “Possible side effects”). In this case, stop treatment and consult your doctor to establish suitable therapy.
• If you use Lunibron for prolonged periods and at high doses (higher than those recommended), as it can cause a reduction in the activity of the gland that regulates the stress response (adrenal gland) and a reduction in the natural growth of the mucous membranes.
• If you are using medicines for the treatment of respiratory diseases taken by inhalation (inhaled corticosteroids such as Lunibron), as these medicines can cause general undesirable effects caused by 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, reduction in bone mineral density, cataract (loss of visual clarity) 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 (especially in children).
• If you are switching from systemic steroid therapy, for example by mouth, to therapy with Lunibron, as alterations of 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 gland function (the gland that regulates the stress response) is slow. In this case, it is also necessary that your disease (respiratory) is relatively "stabilized" by systemic therapy. Initially, your doctor will advise you to use Lunibron while continuing systemic treatment, gradually reducing the latter, monitoring adrenal function and modifying 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 should have supplementary systemic steroid treatment. You should also undergo periodic checks of corticosurrenal function (the gland that regulates the stress response), including measurements of cortisol levels (a hormone) 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 topical endobronchial therapy (administered directly into the bronchi) is recommended.

The effect of Lunibron is not immediate, so this medicine is not effective during ongoing asthma crises. Follow a regular use of this medicine for several days.
The use of Lunibron can mask some symptoms of infection and can also lead to new
infections.
decrease the dose without first consulting your doctor. Exceeding the recommended doses, in addition to
not improving the therapeutic efficacy of Lunibron, carries the risk of systemic effects from
absorption (general undesirable effects).

Children
Take care if you need to administer Lunibron 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 Lunibron) in children, as these medicines can
cause general undesirable effects caused by 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 Lunibron
Tell your doctor if you are taking or have recently taken other medicines, including medicines
obtained without a prescription.
Some medicines can increase the effects of Lunibron 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 with
breast milk, ask your doctor or pharmacist for advice 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 when absolutely necessary and
under the direct control of your doctor.

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

Lunibron contains propylene glycol
This medicine contains propylene glycol which can cause skin irritation.

3. How to use Lunibron

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

Adults:
Single-dose containers of 2 mg/2ml:
1 ml, corresponding to half a dose, equal to 1 mg, twice a day

Use in children:
Single-dose containers of 1 mg/2ml:
1 ml, corresponding to half a dose, equal to 500 micrograms, twice a day

INSTRUCTIONS FOR USE

• A.Open the container by applying slight pressure on the cannula.
• B.withdraw the contents in the prescribed quantity using a syringe or by inverting the open container and tapping on the bottom with a finger.
• C.To withdraw only “1 ml”, empty it up to the mark indicated on the container .

Lunibron must be used with electric nebulizers for both outpatient and home use. The
solution should be used as is without dilution.
Lunibron can be used during therapies with bronchodilators, chemotherapeutic agents and with
corticosteroids in the replacement phase of oral corticosteroid therapy.

If you use more Lunibron than you should
In case of ingestion/accidental intake of an excessive dose of Lunibron, immediately
inform your doctor or go to the nearest hospital.
Administration of large quantities of the medicine in a short period of time may
determine the suppression of a system of hormone-regulating glands that regulate various
functions of the body including sleep, response to stress, appetite, body temperature and
growth. In this case, immediately return to the recommended dose.

If you forget to use Lunibron
Do not use a double dose to make up for a 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 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 available data):

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

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

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
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 which is stated on the package and the bottle. The
expiry date refers to the last day of that month. The expiry date refers to the product
in intact packaging, correctly stored.
Store the medicine in the original package 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 a refrigerator, must be used within 12 hours. The excess
product not used within 12 hours 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 Lunibron contains
The active ingredient is flunisolide

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

The other ingredients 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 presented as a solution for nebulization.
The pack contains 15 single-dose containers of 2 ml

Marketing Authorisation Holder and Manufacturer
MAH:
NEOPHARMED GENTILI S.p.A – Via San Giuseppe Cottolengo 15 – 20143 Milano

Manufacturer:
Special Product’s Line - via Campobello, 15 - Pomezia (ROMA), and
Fisiopharma Srl - Industrial Area - Palomonte (SA).

Lunibron 30 mg/30 ml solution for nebulization

Flunisolide

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 for you only. Do not pass it on to others, even if they have the same symptoms as you, 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 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 is Lunibron and what is it used for

The active ingredient of Lunibron 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 Lunibron

Do not use Lunibron

• 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 Lunibron.

Contact your doctor if you experience blurred vision or other visual disturbances
Take special care with Lunibron:

• 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) to the nasal septum or with recurrent bleeding (epistaxis), as this medicine slows down wound healing.
• If you use Lunibron for a long period of time, as this medicine may alter the natural microbial flora of the airways. In this case, covering therapy (restoration of the natural microbial flora) may be necessary. Prolonged use of the medicine can also lead to sensitization and, sometimes, to undesirable effects (see section “Possible side effects”). In this case, stop treatment and consult your doctor to establish appropriate therapy.
• If you use Lunibron for prolonged periods and at high doses (higher than 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 Lunibron), as these medicines can cause general undesirable effects caused by 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, cataracts (loss of vision transparency) and glaucoma (damage to the optic nerve). Rarely, a number of psychological and behavioral undesirable effects may occur, including psychomotor hyperactivity (mania), sleep disturbances, anxiety,depression, aggression, behavioral disorders (especially in children).
• If you are switching from systemic steroid therapy, for example by mouth, to therapy with Lunibron, as alterations of 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 gland 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 Lunibron while continuing systemic treatment, gradually reducing the latter, monitoring adrenal function and modifying 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 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 topical endobronchial therapy (administered directly into the bronchi) is recommended.

The effect of Lunibron is not immediate, so this medicine is not effective during ongoing asthma crises. Follow a regular use of this medicine for several days.
The use of Lunibron may mask some symptoms of infection and may also lead to new infections.
decrease the dose without first consulting your doctor. Exceeding the recommended doses, in addition to not improving the therapeutic efficacy of Lunibron, carries the risk of systemic effects from absorption (general undesirable effects).

Children
Take care if you need to administer Lunibron to children under 4 years of age, as this medicine is not recommended in this age group.
Take care if you use medicines for the treatment of respiratory diseases taken by inhalation in children, as these medicines can cause general undesirable effects caused by hormonal imbalance. Some of these effects include growth retardation in children and adolescents.
Rarely, a number of psychological and behavioral undesirable effects may occur, including psychomotor hyperactivity (mania), sleep disturbances, anxiety, depression, aggression, behavioral disorders
Other medicines and Lunibron
Tell your doctor if you are taking or have recently taken any other medicines, including over-the-counter medicines.
Some medicines may increase the effects of Lunibron 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 for advice before using this medicine.
This medicine is not recommended in the first three months of pregnancy. In the subsequent period and during breastfeeding, use this medicine only in cases of actual need and under the direct control of the doctor.

Driving and using machines
No effects on the ability to drive vehicles or use machines 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 adults (70 Kg).
This medicine contains 207.2 mg of propylene glycol per 20 micrograms/Kg dose, equivalent to 10.4 mg/Kg in children aged  4 years (20 Kg).

3. How to use Lunibron

Use this medicine following the instructions of your doctor or pharmacist exactly. If you
have any 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 Lunibron corresponds to 40 microliters and 40 micrograms of Flunisolide.
To determine the dose, expressed in drops, based on body weight, refer to the
following table
Correlation weight, number of drops and mg of Flunisolide
Kg
FROM 5 8 11 14 17 20 23 26 29 32 35 38 >
TO 7 10 13 16 19 22 25 28 31 34 37 40 40
drops 356891112141517182025
mg 0.120.200.240.320.36 0.44 0.48 0.56 0.60 0.68 0.72 0.801.0
Instructions for use

• 1) To open the bottle, apply pressure to the dropper cap and twist it counterclockwise simultaneously.
• 2) After use, close the bottle by screwing the cap clockwise

Lunibron must be used with electric nebulizers, including ultrasonic nebulizers, and can be diluted with
physiological solution.
Lunibron can be used during therapies with bronchodilators, chemotherapeutic agents and with
corticosteroids in the replacement phase of oral corticosteroid therapy.

If you use more Lunibron than you should
In case of ingestion/accidental intake of an excessive dose of Lunibron, immediately
notify your doctor or go to the nearest hospital.
Administration of large quantities of the medicine in a short period of time may
determine the suppression of a system of hormone glands that regulate various functions
of the body including sleep, response to stress, appetite, body temperature and
growth. In this case, immediately return to the recommended dose.

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

Reporting of side effects
If you get any side effects, talk to 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 Lunibron

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 package and the bottle. The
expiry date refers to the last day of that month. The expiry date refers to the product
in intact packaging, correctly stored.
Store the medicine in its original packaging to protect it from light.
Use the medicine within 30 days of opening the bottle and discard any excess that has not
been used.
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 Lunibron contains

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

Description of the appearance of Lunibron and contents of the pack
Lunibron is presented as a solution for nebulization.
The pack contains a 30 ml multidose container with a dropper closure system.

Marketing Authorisation 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)