Active ingredients: Flunisolide
Forbest Adults 1 mg / 1 ml solution to be sprayed
Forbest Children 0.5 mg / 1 ml solution to be sprayed
Forbest package inserts are available for pack sizes: - Forbest Adults 1 mg / 1 ml solution for nebulisation, Forbest Children 0.5 mg / 1 ml solution for nebulisation
- Forbest Adults 2 mg / 2 ml solution for nebulisation, Forbest Children 1 mg / 2 ml solution for nebulisation
Indications Why is Forbest used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Anti-inflammatory, anti-asthmatic glycocorticoid
THERAPEUTIC INDICATIONS
Allergic diseases of the respiratory tract: bronchial asthma, chronic asthmatic bronchitis; chronic and seasonal rhinitis.
Contraindications When Forbest should not be used
Individual hypersensitivity to the active substance or to any of the excipients. Active or quiescent pulmonary tuberculosis. Bacterial, viral or fungal infections.
Generally contraindicated in pregnancy and lactation (see "Special warnings")
Precautions for use What you need to know before taking Forbest
Flunisolide, like all corticosteroids, should be used with caution, if not avoided, in patients with active, or dormant, tuberculous infections of the respiratory tract or with untreated fungal, bacterial or viral infections or with herpes simplex eyes. .
Due to the inhibitory effect of corticosteroids on scarring, it is advisable to use flunisolide with caution in patients with previous or recent nasal trauma, with nasal septal ulcer or with recurrent epistaxis.
Although dysmicrobisms have rarely been reported, it is advisable to check, especially for prolonged treatments, the possible variation of the microbial flora of the upper airways by instituting, if necessary, a cover therapy.
The effect of FORBEST, as with all inhaled corticosteroids, is not immediate.
It should therefore be borne in mind that FORBEST is not effective in ongoing asthma crises and that it is advisable to stick to regular use of the product for several days. It is not recommended to give to children under four years of age. In case of prolonged topical use and at high doses, it is good to keep in mind the possibility of inhibition of adrenal activity and mucosal atrophy, although it has not been demonstrated in clinical experience an absorption of the product sufficient to produce general effects.
In patients with marked nasal congestion or with abundant secretions, a preliminary treatment with topical vasoconstrictors may be indicated to allow the aerosol to come into contact with the mucosa.
Rarely, a range of psychological and behavioral effects may occur, including psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioral disturbances (predominantly in children).
It is important to take the dose as directed in the package leaflet or as prescribed by your doctor. You should not increase or decrease the dose without first consulting your doctor.
Interactions Which drugs or foods may change the effect of Forbest
Not known.
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Warnings It is important to know that:
The use, especially if prolonged, of the product, can give rise to sensitization phenomena and exceptionally to the classic systemic undesirable effects of the drug. In this case it is necessary to interrupt the treatment and institute a suitable therapy.
Whenever corticosteroids are used, it should be borne in mind that they can mask some symptoms of infection and that during their use new infectious processes can be established.
Transfer from systemic steroid therapy to flunisolide therapy should be done with caution if there is reason to suspect the presence of adrenal functional changes; abrupt discontinuation of systemic treatment is generally to be avoided.
The conduct of treatment in patients already under systemic corticotherapy requires special precautions and close medical surveillance, since the reactivation of adrenal function, suppressed by prolonged systemic corticoid therapy, is slow. In any case, it is necessary that the disease is relatively "stabilized" with systemic treatment.
Initially FORBEST should be administered while continuing the systemic treatment, subsequently this should be progressively reduced by checking the patient at regular intervals and modifying the dosage of FORBEST according to the results obtained. During times of stress or severe asthma attack, patients undergoing such a switch will need to have additional systemic steroid treatment. In these patients, periodic checks of adrenocortical function should also be performed, including early morning measurements of cortisol levels in conditions of rest.
In steroid-dependent patients, a gradual and controlled transition from oral to topical endobronchial therapy is recommended.
The effect of FORBEST, as with all inhaled corticosteroids, is not immediate.
It should therefore be borne in mind that FORBEST is not effective in ongoing asthma crises and that it is advisable to stick to regular use of the product for several days.
The recommended doses should not be exceeded. In fact, any increase, in addition to not improving the therapeutic efficacy of the product, entails the risk of systemic effects from absorption.
Pregnancy and breastfeeding
The product is not recommended in the first three months of pregnancy; in the further period and during lactation, the product should be administered only in cases of real need and under the direct supervision of the doctor.
For those who carry out sporting activities: the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
Dose, Method and Time of Administration How to use Forbest: Posology
Adults
FORBEST 1 mg / 1 ml: one container (equal to 1 mg) twice a day
Children
FORBEST 0.5 mg / 1 ml: one container (equal to 0.5 mg) twice a day
It is not recommended to give to children under four years of age.
Instructions for Use
For use with pneumatic electric nebulizers, Forbest solution to be nebulized can be used as it is (undiluted) or, preferably, diluted with sterile physiological solution approximately in the ratio 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 ultrasonic electric nebulizers, it is recommended to dilute Forbest with sterile physiological solution in the ratio 1 to 3 (1 ml of Forbest + 3 ml of sterile physiological solution).
As known, the administration of drugs in solution by means of electric nebulizers involves a residue of solution which, adhering to the walls of the phial or to the bottom, is not dispensed.
Taking this into account, it is necessary, during the preparation phase, to consider the need to integrate the non-payable part.
Overdose What to do if you have taken too much Forbest
Administration of large quantities of flunisolide over a short period of time may result in suppression of hypothalamic-pituitary-adrenal function. In this case the administered dose should be reduced immediately to the recommended dose.
Side Effects What are the side effects of Forbest
Only a few patients, with very sensitive airways, presented cough and hoarseness; sometimes a slight and transient burning of the nasal mucosa may occur.Fungal infections in the mouth or throat have rarely been observed and disappeared rapidly after appropriate local therapy. These infections can be prevented or minimized if patients rinse their mouth thoroughly after each administration.
Other side effects observed are: nasal irritation, epistaxis, stuffy nose, rhinorrhea, sore throat, hoarseness and irritation of the oral cavity and jaws. If severe, these side effects may require discontinuation of therapy.
Only in case of incongruous use can the typical effects of systemically administered corticosteroids occur, albeit to a lesser extent.
The most common undesirable effect found in corticosteroid patients was the onset of nasal congestion and nasal polyps, due precisely to the reduction of systemic corticotherapy. possible appearance of systemic manifestations (osteoporosis, peptic ulcer, signs of secondary adrenocortical insufficiency such as hypotension and weight loss) in order to avoid in the latter case very serious accidents from acute hypoadrenalism.
Side effects that may arise, with unknown frequency, are psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioral disturbances (mainly in children).
Compliance with the instructions contained in the package leaflet reduces the occurrence of undesirable effects.
It is important to inform the doctor or pharmacist of any undesirable effect, even if not described in the package leaflet.
Expiry and Retention
Expiry: see the expiry date indicated on the package.
The expiry date indicated refers to the product in intact and correctly stored packaging.
Storage: Store the product in the original packaging to protect it from light.
Warning: Do not use the product beyond the expiration date indicated on the package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN
COMPOSITION
FORBEST Adults 1 mg / 1 ml solution to be sprayed
A single-dose container of 1 ml contains:
Active principle
Flunisolide 1 mg
FORBEST Children 0.5 mg / 1 ml solution to be sprayed
A single-dose container of 1 ml contains:
Active principle
Flunisolide 0.5 mg
Excipients: Propylene glycol, Sodium chloride, Water for injections.
PHARMACEUTICAL FORM AND CONTENT
Solution to be sprayed in the following packs:
Pack of 30 single-dose containers of 1 mg / 1 ml, divided into 6 aluminum bags
Pack of 30 single-dose containers of 0.5 mg / 1 ml, divided into 6 aluminum sachets
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
FORBEST
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
FORBEST Adults 1 mg / 1 ml solution to be sprayed
A single-dose container of 1 ml contains
Active principle:
Flunisolide 1 mg
FORBEST Children 0.5 mg / 1 ml solution to be nebulised
A single-dose container of 1 ml contains
Active principle:
Flunisolide 0.5 mg
FORBEST Adult 2 mg / 2 ml solution to be sprayed
A single-dose container of 2 ml contains
Active principle:
Flunisolide 2 mg
FORBEST Children 1 mg / 2 ml solution to be nebulised
A single-dose container of 2 ml contains
Active principle:
Flunisolide 1 mg
For excipients see section 6.1
03.0 PHARMACEUTICAL FORM
Solution to be sprayed.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Allergic diseases of the respiratory tract: bronchial asthma, chronic asthmatic bronchitis; chronic and seasonal rhinitis.
04.2 Posology and method of administration
Adults
FORBEST 1 mg / 1 ml: one container (equal to 1 mg) twice a day
FORBEST 2 mg / 2 ml: half container (equal to 1 mg) twice a day
Children
FORBEST 0.5 mg / 1 ml: one container (equal to 0.5 mg) twice a day
FORBEST 1 mg / 2 ml: half container (equal to 0.5 mg) twice a day
It is not recommended to give to children under four years of age.
04.3 Contraindications
Individual hypersensitivity to the active substance or to any of the excipients. Active or quiescent pulmonary tuberculosis. Bacterial, viral or fungal infections.
Generally contraindicated in pregnancy and lactation (see section 4.6)
04.4 Special warnings and appropriate precautions for use
Systemic effects may occur with inhaled corticosteroids, particularly when prescribed in high doses for prolonged periods. These effects are less likely to occur than with oral corticosteroid treatment. Possible systemic effects include Cushing's syndrome, Cushingoid aspect, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, glaucoma and more rarely a range of psychological or behavioral effects including psychomotor hyperactivity, sleep disturbances , anxiety, depression or aggression (particularly in children). It is therefore important that the dose of inhaled corticosteroid is the lowest possible dose with which effective control of asthma is maintained.
The use, especially if prolonged, of the product, can give rise to sensitization phenomena and exceptionally to the classic systemic undesirable effects of the drug. In this case it is necessary to interrupt the treatment and institute a suitable therapy.
Whenever corticosteroids are used, it should be borne in mind that they can mask some symptoms of infection and that during their use new infectious processes can be established.
The recommended doses should not be exceeded. This increase, in fact, in addition to not improving the therapeutic efficacy of the product, involves the risk of systemic effects from absorption.
Transfer from systemic steroid therapy to flunisolide therapy should be done with caution if there is reason to suspect the presence of adrenal functional changes; abrupt discontinuation of systemic treatment is generally to be avoided.
The conduct of treatment in patients already under systemic corticotherapy requires special precautions and close medical surveillance, since the reactivation of adrenal function, suppressed by prolonged systemic corticoid therapy, is slow. In any case, it is necessary that the disease is relatively "stabilized" with systemic treatment.
Initially FORBEST should be administered while continuing the systemic treatment, subsequently this should be progressively reduced by checking the patient at regular intervals and modifying the dosage of FORBEST according to the results obtained. During times of stress or severe asthma attack, patients undergoing such a switch will need to have additional systemic steroid treatment. In these patients, periodic checks of adrenocortical function should also be performed, including early morning measurements of cortisol levels in conditions of rest.
In steroid-dependent patients, a gradual and controlled transition from oral to topical endobronchial therapy is recommended.
In case of prolonged topical use and at high doses, it is good to keep in mind the possibility of inhibition of adrenal activity and mucosal atrophy, although it has not been demonstrated in clinical experience an absorption of the product sufficient to produce general effects.
In patients with marked nasal congestion or with abundant secretions, a preliminary treatment with topical vasoconstrictors may be indicated to allow the aerosol to come into contact with the mucosa.
Flunisolide, like all corticosteroids, should be used with caution, if not avoided, in patients with active, or dormant, tuberculous infections of the respiratory tract or with untreated fungal, bacterial or viral infections or with herpes simplex eyes. .
Due to the inhibitory effect of corticosteroids on scarring, it is advisable to use flunisolide with caution in patients with previous or recent nasal trauma, with nasal septal ulcer or with recurrent epistaxis.
Although dysmicrobisms have rarely been reported, it is advisable to check, especially for prolonged treatments, the possible variation of the microbial flora of the upper airways by instituting, if necessary, a cover therapy.
The effect of FORBEST, as with all inhaled corticosteroids, is not immediate.
It should therefore be borne in mind that FORBEST is not effective in ongoing asthma crises and that it is advisable to stick to regular use of the product for several days.
It is not recommended to give to children under four years of age.
04.5 Interactions with other medicinal products and other forms of interaction
Not known.
04.6 Pregnancy and lactation
The product is not recommended in the first three months of pregnancy; in the further period and during lactation, the product should be administered only in cases of real need and under the direct supervision of the doctor.
04.7 Effects on ability to drive and use machines
You don't notice.
04.8 Undesirable effects
Only a few patients, with very sensitive airways, presented cough and hoarseness; sometimes a slight and transient burning of the nasal mucosa may occur. Fungal infections in the mouth or throat have rarely been observed and disappeared rapidly after appropriate local therapy. These infections can be prevented or minimized if patients rinse their mouth thoroughly after each administration.
Other side effects observed are: nasal irritation, epistaxis, stuffy nose, rhinorrhea, sore throat, hoarseness and irritation of the oral cavity and jaws. If severe, these side effects may require discontinuation of therapy.
Only in case of incongruous use can the typical effects of systemically administered corticosteroids occur, albeit to a lesser extent.
The most common undesirable effect found in corticosteroid patients was the onset of nasal congestion and nasal polyps, due precisely to the reduction of systemic corticotherapy. possible appearance of systemic manifestations (osteoporosis, peptic ulcer, signs of secondary adrenocortical insufficiency such as hypotension and weight loss) in order to avoid in the latter case very serious accidents from acute hypoadrenalism.
04.9 Overdose
Administration of large quantities of flunisolide over a short period of time may result in suppression of hypothalamic-pituitary-adrenal function. In this case the administered dose should be reduced immediately to the recommended dose.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other drugs for obstructive respiratory tract syndromes by aerosol - glucocorticoids; ATC code: R03BA03
Flunisolide is a synthetic fluorinated corticosteroid, characterized from a pharmacodynamic point of view by a high anti-inflammatory activity for topical application.
Administered to the animal by inhalation at therapeutic doses, it does not present systemic effects either of a corticomimetic type, in a glucocorticoid or mineralocorticoid sense, or of an inhibitory type on the pituitary-adrenal axis.
05.2 Pharmacokinetic properties
Flunisolide is rapidly absorbed through the mucous membranes of the respiratory tract; however, due to its rapid metabolism (its main metabolite is practically inactive pharmacologically), the systemic activity is negligible.
05.3 Preclinical safety data
In acute toxicity tests, for intramuscular administration and buccal inhalation of flunisolide in various animal species, at doses between 500 and 5000 mcg / animal, and for intramuscular administration at doses of 520 and 1040 mg / kg in rats and mice, no no toxic symptoms were observed.
Likewise, no abnormal findings were observed in the subacute toxicity tests, lasting 40 days, in which doses of 1250-2500 mcg / animal per day were administered to the rabbit, via oral inhalation, and in the chronic toxicity tests, duration of 120 days, in which per die doses of flunisolide of 150, 300 and 350 mcg / animal were administered to the rabbit via intranasal and to the dog, by endobronchial inhalation, doses of 1250, 2000 and 2500 mcg / animal. Treatment with flunisolide was also well tolerated locally.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Propylene glycol, sodium chloride, water for injections.
06.2 Incompatibility
Not known.
06.3 Period of validity
2 years.
Forbest Adults 1 mg / 1 ml solution to be nebulised - Forbest Children 0.5 mg / 1 ml solution to be nebulised, 30 sterile single-dose containers without external mark:
the content of 1 ml must be used completely and immediately after opening as the container cannot be closed again.
Forbest Adults 2 mg / 2 ml solution to be nebulised - Forbest Children 1 mg / 2 ml solution to be nebulised, 15 sterile single-dose containers with external mark:
the remaining half of the 2 ml contents must be used within 12 hours of first opening the resealable container. Excess product not used within 12 hours must be thrown away.
06.4 Special precautions for storage
Keep the containers in the original packaging to protect the product from light
06.5 Nature of the immediate packaging and contents of the package
Single-dose polyethylene container.
Pack of 30 single-dose containers of 1 mg / 1 ml divided into 6 aluminum bags
Pack of 30 single-dose containers of 0.5 mg / 1 ml divided into 6 aluminum sachets
Pack of 15 single-dose containers of 2 mg / 2 ml divided into 3 aluminum bags
Pack of 15 single-dose containers of 1 mg / 2 ml divided into 3 aluminum bags
06.6 Instructions for use and handling
- For use with pneumatic electric nebulizers, Forbest solution to be nebulized can be used as it is (undiluted) or, preferably, diluted with sterile physiological solution approximately in the ratio 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 ultrasonic electric nebulizers, it is recommended to dilute Forbest with sterile physiological solution in the ratio 1 to 3 (1 ml of Forbest + 3 ml of sterile physiological solution).
As known, the administration of drugs in solution by means of electric nebulizers involves a residue of solution which, adhering to the walls of the phial or to the bottom, is not dispensed.
Taking this into account, it is necessary, during the preparation phase, to consider the need to integrate the non-payable part.
07.0 MARKETING AUTHORIZATION HOLDER
VALEAS SPA - Via Vallisneri, 10 - 20133 Milan
08.0 MARKETING AUTHORIZATION NUMBER
FORBEST Adults 1 mg / 1 ml solution to be sprayed
30 single-dose containers of 1 ml - AIC n ° 036364 038
FORBEST Children 0.5 mg / 1 ml solution to be nebulised
30 single-dose containers of 1 ml - AIC n ° 036364 040
* FORBEST Adult 2 mg / 2 ml solution to be sprayed
15 single-dose containers of 2 ml - AIC n ° 036364 026
* FORBEST Children 1 mg / 2 ml solution to be sprayed
15 single-dose containers of 2 ml - AIC n ° 036364 014
* Not commercially
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
May 2010
10.0 DATE OF REVISION OF THE TEXT
14/7/2011
