FORBEST 1 mg /2 Ml Roztwór Do Nebulizacji

Treść ulotki

1. Forbest Adults 1 mg/1 ml solution for nebulisation, Children 0.5 mg/1 ml solution for nebulisation
   1. What is Forbest and what is it used for
   2. What you need to know before using Forbest
   3. How to use Forbest
   4. Possible side effects
   5. How to store Forbest
   6. Contents of the pack and other information
2. Forbest Adults 2 mg/2 ml solution for nebulisation, Children 1 mg/2 ml solution for nebulisation
   1. What is Forbest and what is it used for
   2. What you need to know before using Forbest
   3. How to use Forbest
   4. Possible side effects
   5. How to store Forbest
   6. Contents of the pack and other information

Forbest Adults 1 mg/1 ml solution for nebulisation, Children 0.5 mg/1 ml solution for nebulisation

Flunisolide

Read this leaflet carefully before you start 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 Forbest is and what it is used for
• 2. What you need to know before you use Forbest
• 3. How to use Forbest
• 4. Possible side effects
• 5. How to store Forbest
• 6. Contents of the pack and other information

1. What is Forbest and what is it used for

The active ingredient of Forbest 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 rhinitis (inflammation of the nasal mucosa).

2. What you need to know before using Forbest

Do not use Forbest

• 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 breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using Forbest.

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

• 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 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 Forbest for a long 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 appropriate therapy.
• If you use Forbest 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 the mucous membranes.
• If you are using medicines for the treatment of respiratory diseases administered by inhalation (inhaled corticosteroids such as Forbest), 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 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 Forbest, 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 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 Forbest while continuing systemic treatment, gradually reducing the latter, monitoring adrenal function and modifying the dose of Forbest according to the results obtained. During periods of stress or severe asthma attack, if you have switched from systemic treatment to Forbest, 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 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 endobronchial topical therapy (administered directly into the bronchi) is recommended.

The effect of Forbest is not immediate, so this medicine is not effective during ongoing asthma crises. Follow a regular use of this medicine for several days.
If your nose is very congested (blocked) or if you have abundant secretions, your doctor may
advise you to take medicines that resolve these conditions (blocked nose or excessive
secretions) first, so that Forbest can come into direct contact with the mucous membranes.
The use of Forbest 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 Forbest, carries the risk of systemic effects from
absorption (general undesirable effects).

Children
Take care if you need to administer Forbest 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 administered by
inhalation (inhaled corticosteroids such as Forbest) 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 Forbest
Tell your doctor if you are taking or have recently taken other medicines, including
medicines obtained without a prescription.
Some medicines may increase the effects of Forbest 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 if necessary
and under direct medical supervision.

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

Forbest contains propylene glycol
This medicine contains 518 mg of propylene glycol per 1 ml of Forbest Adults or Forbest
Children. This amount is equivalent to 7.4 mg/Kg per container and 14.8 mg/Kg per recommended daily dose
in adults (70 Kg) and to 26 mg/Kg per container and 52 mg/Kg per recommended daily dose
in children aged  4 years (20 Kg) (See section 3 “how to use Forbest”).

3. How to use Forbest

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

For inhalation use
Therecommended dosein adults is: 1 container of Forbest Adulti (equal to 1 mg), twice a day.

Use in children: 1 container of Forbest Bambini (equal to 0.5 mg), twice a day.
Use of this medicine in children under 4 years of age is not recommended.

Instructions for use
For use with pneumatic electric nebulizers, use Forbest as is (undiluted)
or, preferably, diluted with sterile saline solution indicatively in a ratio of
1 to 1 (1 ml of Forbest + 1 ml of sterile saline solution) or 1 to 2 (1 ml of Forbest + 2 ml
of sterile saline solution).
For use with ultrasonic electric nebulizers, use the dilution of Forbest with
sterile saline solution in a ratio of 1 to 3 (1 ml of Forbest + 3 ml of sterile saline
solution).

If you use more Forbest than you should
In case of ingestion/accidental intake of an excessive dose of Forbest, 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 hormonal 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 Forbest
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 (mainly in children).

Only some patients with very sensitive airways have experienced cough and hoarseness; sometimes a mild and
transient burning sensation of the nasal mucosa may occur. Rarely, fungal infections in the mouth or
throat have been observed, which disappeared rapidly after appropriate local therapy.
These infections can be prevented or minimised if patients carefully rinse their mouths after each administration.
Other side effects observed are: nasal irritation, epistaxis, nasal congestion, rhinorrhea, sore throat,
hoarseness and irritation of the nasal cavity and mouth. If severe, these side effects may require
discontinuation of therapy.
Only in cases 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 corticosteroid-dependent patients was the appearance of
nasal congestion and nasal polyps, due to the reduction of systemic corticosteroid therapy. Patients
should nevertheless be kept under strict control in the case of prolonged treatments, in order to ascertain
promptly the possible 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. 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 Forbest

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.
Keep the medicine in its original packaging to protect it from light.
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 Forbest contains

• The active ingredient is flunisolide. One single-dose container of Forbest Adulti contains 1 mg of flunisolide. One single-dose container of Forbest Bambini contains 0.5 mg of flunisolide.
• The other ingredients are: propylene glycol, sodium chloride, water for injections.

Description of the appearance of Forbest and contents of the pack
Forbest is presented as a solution for nebulization.
The pack of Forbest Adulti contains 30 single-dose containers of 1 mg/1 ml, divided
into 6 aluminum pouches.
The pack of Forbest Bambini contains 30 single-dose containers of 0.5 mg/1 ml,
divided into 6 aluminum pouches.

Marketing authorization holder
NEOPHARMED GENTILI S.p.A – Via San Giuseppe Cottolengo 15 – 20143 Milano

Manufacturer
Genetic S.p.A. - Contrada Canfora Zona Industriale - 84084 Fisciano (SA) - Italy

Forbest Adults 2 mg/2 ml solution for nebulisation, Children 1 mg/2 ml solution for nebulisation

Flunisolide

Read this leaflet carefully before you start 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 Forbest is and what it is used for
• 2. What you need to know before you use Forbest
• 3. How to use Forbest
• 4. Possible side effects
• 5. How to store Forbest
• 6. Contents of the pack and other information

1. What is Forbest and what is it used for

The active ingredient of Forbest 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 rhinitis (inflammation of the nasal mucosa).

2. What you need to know before using Forbest

Do not use Forbest

• 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 Forbest.

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

• 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 wound (ulcer) to the nasal septum or with recurrent bleeding (epistaxis), as this medicine slows down wound healing.
• If you use Forbest for a long time, as this medicine can alter the natural microbial flora of the airways. In this case, coverage 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, discontinue treatment and consult your doctor to establish appropriate therapy.
• If you use Forbest 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 Forbest), 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 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 Forbest, 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 Forbest while continuing systemic treatment, gradually reducing the latter, monitoring adrenal function and modifying the dose of Forbest according to the results obtained. During periods of stress or severe asthma attack, if you have switched from systemic treatment to Forbest, you should have 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 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 endobronchial topical therapy (administered directly into the bronchi) is recommended.

The effect of Forbest is not immediate, so this medicine is not effective during ongoing asthma crises. Follow a regular use of this medicine for several days.
If your nose is very congested (blocked) or if you have abundant secretions, your doctor may
advise you to take medicines that resolve these conditions (blocked nose or excessive
secretions) first, so that Forbest can come into direct contact with the mucous membranes.
The use of Forbest 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 Forbest, carries the risk of systemic effects from
absorption (general undesirable effects).

Children
Take care if you need to administer Forbest 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 Forbest) 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 Forbest
Tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Some medicines can increase the effects of Forbest 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 in cases of actual need
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.

Forbest contains propylene glycol
This medicine contains 518 mg of propylene glycol per 1 ml of Forbest Adults or Forbest
Children. This amount is equivalent to 14.8 mg/Kg for the recommended daily dose in adults
(70 Kg) and 52 mg/Kg for the recommended daily dose in children aged  4 years (20 Kg) (See
section 3 “how to use Forbest”).

3. How to use Forbest

Use this medicine following the instructions of your doctor or pharmacist exactly. If you
have any doubts, consult your doctor or pharmacist.
The 2 ml container is resealable: use the remaining half equal to 1 ml within 12 hours (see “how
to store Forbest”)

For inhalation use
Therecommended dosein adults is: half a container of Forbest Adulti (equal to 1 mg), twice a
day.

Use in children: half a container of Forbest Bambini (equal to 0.5 mg), twice a day.
The use of this medicine in children under 4 years of age is not recommended.

Instructions for use
For use with pneumatic electric nebulizers, use Forbest as is (undiluted)
or, preferably, diluted with sterile saline solution indicatively in a ratio
of 1 to 1 (1 ml of Forbest + 1 ml of sterile saline solution) or 1 to 2 (1 ml of Forbest + 2
ml of sterile saline solution).
For use with ultrasonic electric nebulizers, use the dilution of Forbest with
sterile saline solution in a ratio of 1 to 3 (1 ml of Forbest + 3 ml of sterile saline
solution).

If you use more Forbest than you should
In case of ingestion/accidental intake of an excessive dose of Forbest, 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 hormonal gland system that regulates various functions
of the body including sleep, stress response, appetite, body temperature and
growth. In this case, immediately return to the recommended dose.

If you forget to use Forbest
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 everyone 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 (mainly in children).

Only some patients with very sensitive airways have experienced cough and hoarseness; sometimes a mild and
transient burning sensation of the nasal mucosa may occur. Fungal infections in the mouth or throat have
been rarely observed and have disappeared quickly after appropriate local therapy. These infections can be
prevented or minimised if patients carefully rinse their mouth after each administration.
Other side effects observed are: nasal irritation, nosebleeds, nasal congestion, rhinorrhea, sore throat,
hoarseness and irritation of the nasal cavity and mouth. If severe, these side effects may require
discontinuation of therapy.
Only in case of inappropriate use, even to a limited extent, can typical effects of
corticosteroids administered systemically occur.
The most common side effect found in corticosteroid-dependent patients was the appearance of
nasal congestion and nasal polyps, due to the reduction of systemic corticosteroid therapy. Patients
should nevertheless be kept under strict control in case of prolonged treatments, in order to promptly
ascertain the possible 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
very serious incidents due to acute adrenal insufficiency.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell 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. Reporting side effects can help provide more information on
the safety of this medicine.

5. How to store Forbest

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 pack and on 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.
The 2 ml container is resealable: use the remaining half equal to 1 ml within 12 hours. Discard the product
exceeding the amount not used within 12 hours of first opening.
Store the medicine in the original packaging to protect it from light.
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 Forbest contains

• The active ingredient is flunisolide. One single-dose container of Forbest Adulti contains 2 mg of flunisolide. One single-dose container of Forbest Bambini contains 1 mg of flunisolide.
• The other ingredients are: propylene glycol, sodium chloride, water for injections.

Description of the appearance of Forbest and contents of the pack
Forbest is presented as a solution for nebulization.
The pack of Forbest Adulti contains 15 single-dose containers of 2 mg/2 ml, divided
into 3 aluminium pouches.
The pack of Forbest Bambini contains 15 single-dose containers of 1 mg/2 ml,
divided into 3 aluminium pouches.

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

Manufacturer
Genetic S.p.A. - Contrada Canfora Zona Industriale - 84084 Fisciano (SA) - Italy