Forbest

Patient Information Leaflet

Forbest Adults 1 mg/1 ml nebulizer solution, Children 0.5 mg/1 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, 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 you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact 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 using Forbest
3. How to use Forbest
4. Possible side effects
5. How to store Forbest
6. Package contents and other information

1. What Forbest is and what it is used for

The active substance in Forbest 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 breathing attacks)
chronic asthmatic bronchitis (asthma arising 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 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 Forbest.
Contact your doctor if you experience blurred vision or other visual disturbances.
Be especially careful 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 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) in the nasal septum or recurrent nosebleeds (epistaxis), as this medicine may slow down wound healing.
• If you use Forbest for a long time, because this medicine may alter the natural microbial flora of the airways. In such cases, adjunctive 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 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 reduced activity of the gland regulating the stress response (adrenal gland) and reduced natural mucosal growth.
• If you are using medicines for respiratory diseases administered by inhalation (inhaled corticosteroids such as Forbest), 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 (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 series of psychological and behavioral adverse effects may occur, including psychomotor hyperactivity (restlessness), sleep disturbances, anxiety, depression, aggression, behavioral disorders (especially in children).
• If you are switching from systemic steroid therapy, for example oral administration, to treatment with Forbest, 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 adrenal function recovery (the gland regulating the stress response) is slow. In this case, your disease (respiratory) should also be relatively "stabilized" through systemic therapy. Initially, your doctor will instruct you to start using Forbest while continuing systemic treatment, gradually reducing the latter, monitoring adrenal function, and adjusting 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 additional systemic steroid treatment. In addition, 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 (directly administered into the bronchi) is advisable.

The effect of Forbest is not immediate; therefore, this medicine is not effective during ongoing asthma attacks. Use this medicine regularly for several days.
If you have severe nasal congestion (blockage) or excessive secretions, your doctor may advise you to first take medicines that resolve these conditions (blocked nose or excessive secretions), so that Forbest can come into direct contact with the mucous membranes.
The use of Forbest 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, in addition to not improving the therapeutic efficacy of Forbest, increases the risk of systemic effects due to absorption (general adverse effects).

Children
Be cautious when administering Forbest 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 Forbest) 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 Forbest
Inform your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of Forbest, and your doctor may want to monitor you closely if you are taking these medicines (including certain medicines for the treatment of HIV: 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. During the later stages of pregnancy and while 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.

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 exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For inhalation use
Recommended dose in adults: 1 container of Forbest Adults (equivalent to 1 mg), twice daily.
Use in children: 1 container of Forbest Children (equivalent to 0.5 mg), twice daily.
The use of this medicine is not recommended in children below 4 years of age.

Instructions for use
For use with electric pneumatic nebulizers, use Forbest undiluted or, preferably, diluted with sterile physiological solution in an approximate ratio of 1 to 1 (1 ml of Forbest + 1 ml of sterile physiological solution) or 1 to 2 (1 ml of Forbest + 2 ml of sterile physiological solution).
For use with electric ultrasonic nebulizers, dilute Forbest with sterile physiological solution in a ratio of 1 to 3 (1 ml of Forbest + 3 ml of sterile physiological solution).

If you use more Forbest than you should
If you accidentally ingest or take an excessive dose of Forbest, 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 an endocrine 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 Forbest
Do not use a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 disturbances (mainly in children).

Only some patients with highly sensitive airways have experienced cough and hoarseness; occasionally a mild and transient burning sensation of the nasal mucosa may occur. Rarely, fungal infections in the mouth or throat have been observed, which rapidly resolved following appropriate local therapy.
These infections can be prevented or minimized if patients thoroughly rinse their mouth after each administration.
Other observed side effects include: nasal irritation, epistaxis, nasal congestion, rhinorrhea, sore throat, hoarseness, and irritation of the oral cavity and mouth. If severe, these side effects may require discontinuation of treatment.
Only in case of inappropriate use, and even then to a limited extent, typical effects of systemically administered corticosteroids may occur.
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 due to acute adrenal insufficiency.
Following the instructions provided in this leaflet reduces the occurrence of adverse 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 may also report side effects directly via 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 stated on the carton and vial. The expiry date refers to the last day of that month. The expiry date applies to the product in its original, unopened packaging, correctly stored.
Store the medicine in its original container to protect it from light.
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 Forbest contains

• The active substance is flunisolide. One single-dose container of Forbest Adults contains 1 mg of flunisolide. One single-dose container of Forbest Children contains 0.5 mg of flunisolide.
• The other components are: propylene glycol, sodium chloride, water for injections.

Description of the appearance of Forbest and package contents
Forbest is a solution for nebulization.
The package of Forbest Adults contains 30 single-dose containers of 1 mg/1 ml, divided into 6 aluminum foil pouches.
The package of Forbest Children contains 30 single-dose containers of 0.5 mg/1 ml, divided into 6 aluminum foil pouches.
Marketing Authorization Holder
NEOPHARMED GENTILI S.p.A. – Via San Giuseppe Cottolengo 15 – 20143 Milan
Manufacturer
Genetic S.p.A. - Contrada Canfora Zona Industriale - 84084 Fisciano (SA) - Italy

Patient information leaflet

Forbest Adults 2 mg/2 ml nebulizer solution, Children 1 mg/2 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 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 Forbest is and what it is 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

1. What Forbest is and what it is used for

The active substance of Forbest 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 breathing attacks)
chronic asthmatic bronchitis (asthma arising 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 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 an infection caused by bacteria, viruses, or fungi;
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before using Forbest.
Contact your doctor if you experience blurred vision or other visual disturbances.
Exercise particular caution 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 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 Forbest for a prolonged period, 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. Long-term 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 Forbest 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 tissue.
• If you are using medicines for respiratory diseases administered by inhalation (inhaled corticosteroids such as Forbest), 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 transparency of the lens), and glaucoma (damage to the optic nerve). 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 treatment with Forbest, 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, it is also necessary that your (respiratory) disease be relatively "stabilized" through systemic therapy. Initially, your doctor will instruct you to use Forbest while continuing systemic treatment, gradually reducing the latter, monitoring adrenal function, and adjusting 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 additional systemic steroid treatment. Furthermore, you should undergo periodic checks of adrenal-cortical function (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 (administered directly into the bronchi) is advisable.

The effect of Forbest is not immediate; therefore, this medicine is not effective during ongoing asthma attacks. Use this medicine regularly for several days as directed.
If your nose is severely congested (blocked) or if you have excessive secretions, your doctor may advise you to take other medicines first to resolve these conditions (blocked nose or excessive secretions), so that Forbest can come into direct contact with the mucous membranes.
The use of Forbest 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 will not improve the therapeutic efficacy of Forbest and may increase the risk of systemic absorption effects (general adverse effects).

Children
Be cautious when administering Forbest 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 via inhalation (inhaled corticosteroids such as Forbest) 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 Forbest
Inform your doctor if you are currently taking or have recently taken any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of Forbest, and your doctor may wish to monitor you closely if you are taking these medicines (including certain medicines for the treatment of HIV: Ritonavir, Cobicistat).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are 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 strictly necessary and under direct medical supervision.

Driving and using machines
No effects on the ability to drive vehicles or use 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 corresponds 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 exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The 2 ml container is resealable: use the remaining half (1 ml) within 12 hours (see "How to store Forbest").
For inhalation use
Recommended dose in adults: half a container of Forbest Adults (equivalent to 1 mg), twice daily.
Use in children: half a container of Forbest Children (equivalent to 0.5 mg), twice daily.
The use of this medicine is not recommended in children under 4 years of age.
Instructions for use
For use with electric or pneumatic nebulizers, use Forbest as it is (undiluted), or preferably diluted with sterile physiological solution, approximately in a 1 to 1 ratio (1 ml Forbest + 1 ml sterile physiological solution) or 1 to 2 ratio (1 ml Forbest + 2 ml sterile physiological solution).
For use with electric ultrasonic nebulizers, dilute Forbest with sterile physiological solution in a 1 to 3 ratio (1 ml Forbest + 3 ml sterile physiological solution).
If you use more Forbest 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 an endocrine system that regulates 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 Forbest
Do not use a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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; occasionally a mild and transient burning sensation of the nasal mucosa may occur. Rarely, fungal infections in the mouth or throat have been observed, which rapidly resolved following appropriate local treatment. These infections can be prevented or minimized if patients thoroughly rinse their mouth after each administration.
Other observed side effects include: nasal irritation, epistaxis, nasal congestion, rhinorrhea, sore throat, hoarseness, and irritation of the oral cavity and mouth. If severe, these side effects 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 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 always be closely monitored 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 acute adrenal insufficiency events.
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 Forbest

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 vial. The expiry date refers to the last day of that month. The expiry date applies to the product in its original sealed packaging and properly stored.
The 2 ml container is resealable: use the remaining half (1 ml) within 12 hours. Discard any unused medicine 12 hours after the first opening.
Keep the medicine in its original packaging to protect it from light.
Do not dispose of medicines 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 Forbest contains

• The active substance is flunisolide. One single-dose container of Forbest Adults contains 2 mg of flunisolide. One single-dose container of Forbest Children contains 1 mg of flunisolide.
• The other components are: propylene glycol, sodium chloride, water for injections.

Description of the appearance of Forbest and contents of the pack
Forbest is a solution for nebulization.
The pack of Forbest Adults contains 15 single-dose containers of 2 mg/2 ml, divided into 3 aluminum foil pouches.
The pack of Forbest Children contains 15 single-dose containers of 1 mg/2 ml, divided into 3 aluminum foil pouches.
Marketing Authorization Holder
NEOPHARMED GENTILI S.p.A. – Via San Giuseppe Cottolengo 15 – 20143 Milan, Italy
Manufacturer
Genetic S.p.A. - Contrada Canfora Zona Industriale - 84084 Fisciano (SA) - Italy