Active ingredients: Beclometasone (Beclometasone dipropionate)
PRONTINAL 0.8 mg / 2 ml suspension for nebuliser
Indications Why is Prontinal used? What is it for?
Prontinal is a medicine that contains beclomethasone dipropionate, an active substance that belongs to a group of medicines called corticosteroids.
Prontinal is used to control breathing difficulties due to narrowing of the bronchial tubes (bronchostenosis) and asthma, which cause symptoms such as cough and shortness of breath.
Furthermore Prontinal is used for rhinitis (allergic or vasomotor) or for problems (inflammatory and / or allergic) of the nasal cavities and nasopharyngeal tract.
Contraindications When Prontinal should not be used
Do not use Prontinal:
- if you are allergic to the active substance or any of the other ingredients of this medicine.
- if you have active or quiescent local viral and tuberculous infections.
- if you are in the first trimester of pregnancy or if you are breast-feeding your baby (see Pregnancy and breast-feeding subsection).
Precautions for use What you need to know before taking Prontinal
Talk to your doctor or pharmacist before using Prontinal.
Inhaled corticosteroids, particularly when prescribed in high doses and for prolonged periods, can cause the same undesirable effects that occur after the use of systemically administered corticosteroids such as by mouth. Such undesirable effects occur less often. likelihood of using low-dose and short-term inhaled corticosteroids versus treatment with oral corticosteroids.
Possible systemic effects include:
- Cushing's syndrome (a condition in which the body produces too much cortisol, a hormone produced by the adrenal ghinadoles),
- Cushingoid aspect,
- suppression of the activity of the adrenal glands (glands located above the kidneys and which produce vital hormones)
- growth retardation in children and adolescents,
- reduction in bone mineral density,
- cataract,
- Glaucoma (eye disease often associated with increased pressure in the eye)
Rarely, a range of psychological and behavioral effects may occur, including:
- psychomotor hyperactivity,
- sleep disorders,
- anxiety,
- depression,
- aggression,
- behavioral disorders (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. Infections of the nasal cavities or sinuses should be treated with appropriate therapy, but are not specific contraindications to the use of Prontinal.
Although Prontinal is able to control seasonal allergic rhinitis in most cases, excessive stimulation by allergens may require appropriate additional therapy.
Switching from systemic cortisone therapy (e.g. tablets) to inhaled cortisone therapy
The transition from continuous treatment with systemic steroids (for example tablets) to inhalation therapy requires special precautions, especially if there is reason to suppose that the functionality of the adrenal glands is impaired.
Initially, your doctor will tell you to perform both therapies and, subsequently, will begin to progressively reduce the systemic cortisone. During times of stress or severe asthma attack your doctor will prescribe supplementary systemic steroid treatment. To date, no evidence has shown that Prontinal therapy can lead to a reduction in blood cortisol levels. This reduction was observed only in patients who received twice the maximum recommended dose of beclomethasone dipropionate administered by pressurized aerosol.
Children and adolescents
In early childhood Prontinal should only be administered if clearly needed and under direct medical supervision.
In children using PRONTINAL, height should be measured regularly as long-term treatment with inhaled corticosteroids may result in a slowdown in growth. In this case, consult your doctor as your therapy may need to be changed.
Interactions Which drugs or foods may change the effect of Prontinal
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
This is especially important if you are using systemic (e.g. tablets) or nasal medications that contain cortisone, as this may increase the risk of adrenal gland impairment (adrenal suppression).
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Do not administer in the first trimester of pregnancy. In the second and third trimester of pregnancy and during lactation, Prontinal should only be administered if clearly needed and under direct medical supervision.
Driving and using machines
Prontinal does not affect the ability to drive or use machines.
PRONTINAL contains sodium
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, ie it is essentially "sodium-free"
Dose, Method and Time of Administration How to use Prontinal: Posology
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Adults
The recommended dose is one single-dose container per session 1-2 times a day.
Children
The recommended dose is half the contents of a single-dose container per session 1-2 times a day. The container bears a graduation corresponding to half the dose.
Shake vigorously before use.
Instructions for use of the single-dose container
To use, perform the following operations:
- Flex the single-dose container in both directions
- Detach the single-dose container from the strip first above and then in the center
- Shake vigorously by shaking and inverting the container to make the suspension homogeneous. Repeat this operation, until the entire contents are completely redispersed and mixed
- Open the single-dose container by turning the flap in the direction indicated by the arrow
- By exerting moderate pressure on the walls of the single-dose container, release the medicine in the prescribed quantity and place it in the nebulizer ampoule
- In case of use of half the dose, the container can be closed by turning over and pressing the cap The closed container must be stored at a temperature between 2 ° C and 8 ° C (in the refrigerator) and the remaining quantity must be used within 12 hours of first opening.
Overdose What to do if you have taken too much Prontinal
If you use more Prontinal than you should
In case of accidental ingestion / intake of an overdose of Prontinal, notify your doctor immediately or go to the nearest hospital.
If you forget to take PRONTINAL
Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of Prontinal, ask your doctor or pharmacist.
Side Effects What are the side effects of Prontinal
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some patients may experience a "fungal infection (thrush) in the mouth or throat following the administration of beclomethasone dipropionate for aerosol. Patients who have had a previous infection may develop this complication more easily. The frequency with which this occurs appears to be be related to the administered dose.
Should this occur, initiate appropriate antifungal therapy without stopping treatment with beclomethasone dipropionate.
The occurrence of such fungal infections can be minimized by rinsing the mouth regularly after each application.
In patients with very sensitive airways the use of the drug could give rise to cough and hoarseness.
Effects due to the passage of the drug into the bloodstream may occur particularly when administered in high doses and / or for prolonged periods.
Such events may include:
- suppression of the activity of the adrenal glands (glands located above the kidneys that produce vital hormones),
- growth retardation in children and adolescents,
- reduction in bone mineral density,
- cataracts and glaucoma (see section Warnings and precautions).
Allergic reactions including rash, hives (red spots on the skin), itching, erythema (redness of the skin) and swelling of the eyelids, lips and throat have also been reported with this class of drugs.
Undesirable effects, with an unknown frequency, which may occur are:
- psychomotor hyperactivity
- sleep disorders
- anxiety
- depression
- aggression
- behavior disorders (mainly in children).
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
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 after "exp".
The expiry date refers to the product in intact packaging, correctly stored.
Store the product in an upright position, as indicated on the package.
The single-dose containers outside the protective bag can be stored for up to 3 months.
In case of use of half the dose, the re-closed container must be stored at a temperature between 2 ° C and 8 ° C (in the refrigerator) and used within 12 hours.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What Prontinal contains
The active ingredient is beclomethasone dipropionate
Each 2 ml single-dose container contains 0.8 mg of beclomethasone propionate
The other ingredients are: Sodium chloride; Polysorbate 20; Sorbitan monolaurate; Water for injections.
What Prontinal looks like and contents of the pack
Prontinal is a suspension for nebuliser
Box of 20 single-dose containers of 2 ml.
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
PRONTINAL 0,8 MG / 2 ML SUSPENSION FOR NEBULIZER
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100ml Nebulizer Suspension contains:
Active principle: beclomethasone dipropionate 0.040 g.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Suspension for nebulizer.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Control of the evolution of asthmatic disease and bronchostenosis conditions. Allergic and vasomotor rhinitis, inflammatory and allergic affections of the nasal cavities and of the rhino-pharyngeal tract.
04.2 Posology and method of administration
Adults: one single-dose container per session 1-2 times a day.
Children: half the contents of a single-dose container per session 1-2 times a day.
The container bears a graduation corresponding to half the dose.
Shake vigorously before use.
To use, perform the following operations:
1) Flex the single-dose container in both directions.
2) Detach the single-dose container from the strip first above and then in the center.
3) Shake vigorously by shaking and inverting the container to make the suspension homogeneous. Repeat this operation, until the entire contents are completely redispersed and mixed.
4) Open the single-dose container by rotating the flap in the direction indicated by the arrow.
5) By exerting moderate pressure on the walls of the single-dose container, release the medicine in the prescribed quantity and put it in the nebulizer ampoule.
6) In case of using half dose, the container can be closed by turning over and pressing the cap. The re-closed container must be stored at a temperature between 2 ° C and 8 ° C (in the refrigerator) and the remaining quantity must be used within 12 hours of first opening.
In early childhood Prontinal should only be administered if clearly needed.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Local active or quiescent viral and tuberculous infections.
contraindicated in the first trimester of pregnancy and during lactation (see par. 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, disturbances sleep, 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.
Infections of the nasal cavities or sinuses must be treated with appropriate therapy, but are not specific contraindications to the use of PRONTINAL.
Although PRONTINAL is able to control seasonal allergic rhinitis in most cases, an abnormally high allergen stimulus may require appropriate additional therapy.
The transfer of patients on continuous general steroid treatment to PRONTINAL therapy requires precautions if there is reason to suppose that adrenal function is impaired. However, PRONTINAL should initially be administered while continuing the systemic treatment; subsequently this must be progressively reduced by checking the patient at regular intervals (in particular periodic tests of the cortico-adrenal function should be carried out) and by modifying the dosage of PRONTINAL according to the results obtained. During times of stress or severe asthmatic attack, patients undergoing this transition will need to have additional systemic steroid treatment.
So far PRONTINAL therapy has not resulted in a reduction in plasma cortisol levels. This reduction was observed only in patients who received twice the maximum recommended dose of beclomethasone dipropionate administered by pressurized aerosol.
04.5 Interactions with other medicinal products and other forms of interaction
Not known.
04.6 Pregnancy and lactation
Do not administer in the first trimester of pregnancy. In the further period, during breastfeeding, PRONTINAL should only be administered in case of real need and under direct medical supervision.
04.7 Effects on ability to drive and use machines
Nobody.
04.8 Undesirable effects
Following aerosol administration of beclomethasone dipropionate, candidiasis of the mouth or throat may occur in some patients. Patients with medical history or laboratory data indicating a previous infection may more easily develop this complication. The incidence of candidiasis appears to be related to the dose administered. The condition generally responds to appropriate topical antifungal therapy without interruption of beclomethasone dipropionate.
The occurrence of such fungal infections can be minimized by rinsing the mouth regularly after each application.
In patients with very sensitive airways the use of the product could give rise to cough and hoarseness.
Systemic effects may occur with inhaled corticosteroids particularly when given at high doses for prolonged periods. Such events may include adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts and glaucoma (see section 4.4). Hypersensitivity reactions including rash, hives, pruritus, erythema and edema of the eyes, face, lips and throat have also been reported with this class of drugs.
Psychiatric disorders that can arise, with unknown frequency, are psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, behavior disorders (mainly in children).
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
Patients must be closely monitored during prolonged treatments so that, in the event that excessive use of the preparation induces alterations in adrenal function, the treatment can be interrupted and the patient promptly protected from the effects of adrenal suppression by means of appropriate systemic therapy.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Therapeutic drug category: glucocorticoids; other drugs for obstructive airway disorders.
ATC code: R03BA01.
PRONTINAL contains beclomethasone 17,21-dipropionate as the active ingredient, a cortisone with a strong anti-inflammatory and anti-allergic topical activity on the nasal and bronchial mucosa. Beclomethasone dipropionate (BDP) is a synthetic corticosteroid, exclusively for topical use, with powerful anti-inflammatory activity, reduced mineralocorticoid activity and absence of systemic effects. In the skin vasoconstriction test according to Mc Kenzie BDP is 5000 times more active than hydrocortisone, 625 times more active than alcohol betamethasone, 5 times more active than fluocinolone acetonide and 1.39 times more active than betamethasone valerate.
It has intense and prolonged anti-inflammatory activity against croton oil, carrageenan, formalin, egg white and dextran edema and the granulomatous reaction from a foreign body, with superior efficacy to that of other corticosteroids.
By aerosol PRONTINAL is indicated in the therapy of bronchial asthma, allergic and vasomotor rhinitis and inflammatory manifestations of rhino-pharyngeal affections. well known of corticotherapy.
05.2 Pharmacokinetic properties
Kinetic studies with radiolabelled beclomethasone dipropionate have shown that after inhalation of a high dose only 20-25% is absorbed. Part of the administered dose is swallowed and excreted in the faeces. The fraction absorbed into the circulation is metabolised by the liver to monopropionate and beclomethasone alcohol and subsequently excreted in the form of inactive metabolites in the bile and urine.
05.3 Preclinical safety data
Acute toxicity: LD50 (mouse per os)> 4000 mg / kg; LD50 (rat per os)> 4000 mg / kg; LD50 (mouse for IM) 400 mg / kg; LD50 (rat for IM) 420 mg / kg.
Chronic toxicity: rat by spraying (180 days), dog by spraying (90 days). The administration did not cause any alteration of body weight, blood count and trophism of the respiratory tract mucosa. Liver and kidney functions remained normal.
Genetic toxicity: administration by nebulization to pregnant rats and rabbits did not cause signs of toxicity on the mother, nor on the fetuses, nor abortions, nor a decrease in the number of births.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Sodium chloride, polysorbate 20, sorbitan monolaurate, water for injections.
06.2 Incompatibility
Not known.
06.3 Period of validity
2 years.
06.4 Special precautions for storage
Store the product in an upright position, as indicated on the package.
The single-dose containers outside the protective bag can be stored for up to 3 months.
In case of use of half the dose, the re-closed container must be stored at a temperature between 2 ° C and 8 ° C (in the refrigerator) and used within 12 hours.
06.5 Nature of the immediate packaging and contents of the package
Inner packaging: single-dose polyethylene containers with half-dose graduation, resealable, in PET / Al / PE heat-sealed sachets. External packaging: printed cardboard box.
Box of 20 single-dose containers of 2 ml
06.6 Instructions for use and handling
No special instructions
07.0 MARKETING AUTHORIZATION HOLDER
Dompé Pharmaceuticals S.p.A. - Via San Martino 12 - 20122 Milan
08.0 MARKETING AUTHORIZATION NUMBER
032798023
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 16.12.1999
Renewal date: 12.1.2010
10.0 DATE OF REVISION OF THE TEXT
January 2015
