Active ingredients: Levodropropizina
FLUIBRON DRY COUGH 60 mg / ml oral drops, solution
Fluibron dry cough package inserts are available for pack sizes:- FLUIBRON DRY COUGH 60 mg / ml oral drops, solution
- FLUIBRON DRY COUGH 30 mg / 5 ml syrup
Why is Fluibron dry cough used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Cough suppressant.
THERAPEUTIC INDICATIONS
Symptomatic cough therapy
Contraindications When Fluibron should not be used dry cough
Hypersensitivity to the active substance or to any of the excipients. Administration of the drug should be avoided in patients with bronchial hypersecretion and reduced mucociliary function (Kartagener's syndrome, ciliary dyskinesia).
Pregnancy and breastfeeding (see section "Special warnings").
Precautions for use What you need to know before taking Fluibron dry cough
The effect of administering the specialty to children under 24 months has not been fully studied and in any case the drug should be used with caution in patients of this age.
It is recommended to use with caution in patients with severe renal insufficiency (creatinine clearance below 35 ml / min).
In light of the evidence that sensitivity to various drugs is altered in the elderly, special caution should be used when levodropropizin is administered to elderly patients.
It is advisable to use caution even in case of simultaneous intake of sedative drugs in particularly sensitive individuals (see section "Interactions").
Interactions Which drugs or foods can modify the effect of Fluibron dry cough
Animal pharmacology studies have shown that levodropropizine does not potentiate the effect of active substances on the nervous system (eg benzodiazepines, alcohol, phenytoin, imipramine). In animals, levodropropizine does not modify the activity of oral anticoagulants, such as warfarin or even it interferes with the hypoglycemic action of insulin. In clinical pharmacology studies the combination with benzodiazepine does not modify the EEG picture. However, caution should be exercised in case of concomitant use of sedative drugs in particularly sensitive individuals (see section "Precautions for" use ").
Clinical studies show no interaction with drugs used in the treatment of bronchopulmonary diseases such as β2 agonists, methylxanthines and derivatives, corticosteroids, antibiotics, mucoregulators and antihistamines
Warnings It is important to know that:
The antitussive drugs are symptomatic and should be used only while awaiting the diagnosis of the triggering cause and / or the effect of the therapy of the underlying disease. Therefore, do not use for prolonged treatments. After a short period of treatment without appreciable results, consult your doctor.
The medicine contains methyl para-hydroxybenzoate, which is known to cause hives. In general, para-hydroxybenzoates can cause delayed reactions, such as contact dermatitis and rarely immediate reactions with manifestations of urticaria and bronchospasm.
FLUIBRON DRY COUGH 60 mg / ml oral drops, solution does not affect low-calorie or controlled diets and can also be administered to diabetic patients
FLUIBRON DRY COUGH 60 mg / ml oral drops, solution does not contain gluten; therefore the medicine is not contraindicated for subjects suffering from celiac disease.
Pregnancy and breastfeeding.
Since the active ingredient in animals crosses the placental barrier and is present in breast milk, the use of the drug is contraindicated in women who are presumed or confirmed pregnant and during breastfeeding.
Effects on ability to drive and use machines
No studies on the ability to drive and / or use machines have been performed. However, since the product may, although rarely, cause drowsiness (see section "Undesirable effects"), use with caution in patients intending to drive vehicles. or operate machinery, informing them of this possibility
Dosage and method of use How to use Fluibron dry cough: Dosage
Adults: 20 drops (corresponding to 60 mg) up to 3 times a day at intervals of at least 6 hours. Children: up to 3 daily administrations spaced by at least 6 hours, as per the following scheme
In the opinion of the doctor, the above dosages can be doubled up to a maximum of 20 drops three times a day.
The drops should preferably be diluted in half a glass of water. In the absence of information on the effect of food on absorption, it is advisable to take the drug between meals.
Duration of treatment
Treatment should be continued until the cough subsides or as directed by the doctor. However, if after 2 weeks of therapy the cough is still present, it is advisable to stop the treatment and ask your doctor for advice. In fact, cough is a symptom and the causative pathology should be studied and treated.
Instructions for Use
The vial has a child resistant closure. To open, press on the cap and at the same time turn anticlockwise until it opens. To dispense the drops, press lightly on the container.
Overdose What to do if you have taken too much Fluibron dry cough
In case of overdose with evident clinical manifestations, immediately institute symptomatic therapy and apply the usual emergency measures (gastric lavage, activated charcoal meal, parenteral administration of liquid, etc.) if necessary.
Side Effects What are the side effects of Fluibron dry cough
The experience derived from the marketing of products containing levodropropizin in more than 30 countries around the world shows that the occurrence of undesirable effects is a very rare event. Based on the estimate of patients exposed to levodropropizin, derived from the number of packs sold, and considering the number of spontaneous reports, fewer than one in every 500,000 patients experienced adverse reactions Most of these reactions are not serious and symptoms have resolved with discontinuation of therapy and, in some cases, with specific drug treatment.
The adverse reactions found, all very rare (incidence
Skin and appendages: urticaria, erythema, rash, pruritus, angioedema, skin reactions. A single case of epidermolysis with fatal outcome has been reported.
Digestive system: gastric and abdominal pain, nausea, vomiting, diarrhea. Two single cases of glossitis and aphthous stomatitis have been reported, respectively. One case of cholestatic hepatitis and one case of hypoglycemic coma have been reported in an elderly patient treated concomitantly with oral hypoglycemic agents.
General conditions: allergic and anaphylactoid reactions, general malaise. Single cases of generalized edema, syncope and asthenia have been reported, respectively.
Nervous system: dizziness, vertigo, tremors, paraesthesia. A single case of tonic-clonic seizure and one case of a petit mal attack have been reported. Cardiovascular system: palpitations, tachycardia, hypotension. One case of cardiac arrhythmia (atrial bigeminy) has been reported.
Psychiatric disorders: nervousness, drowsiness, sense of depersonalization.
Respiratory system: dyspnoea, cough, edema of the respiratory tract.
Musculoskeletal system: asthenia and weakness of the lower limbs. Few cases of eyelid edema have been reported, most of which refer to angioneurotic edema, considering the concomitant presence of urticaria.
A single case of mydriasis and a case of bilateral vision loss have been reported. In both cases the reaction resolved after discontinuation of the drug.
A single case of somnolence, hypotonia and vomiting has been reported in a neonate following the nursing mother's intake of levodropropizin. Symptoms appeared after the feed and resolved spontaneously by suspending breastfeeding for a few feedings.
Only occasionally some adverse reactions were of a serious nature. These include some cases of skin reactions (urticaria, pruritus), the case of cardiac arrhythmia, already mentioned above, the case of hypoglycemic coma, as well as some cases of allergic / anaphylactoid reactions involving edema, dyspnoea, vomiting, diarrhea. As already mentioned, a single case of epidermolysis, which occurred abroad in a polytreated elderly patient, had a fatal outcome.
Compliance with the instructions contained in the package leaflet reduces the risk 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 printed on the package.
The expiry date indicated refers to the product in unopened packaging, correctly stored The medicine must be stored at a temperature not exceeding 25 ° C
The shelf life after first opening the bottle is 21 weeks.
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.
Warning: do not use the medicine after the expiry date shown on the package.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN.
COMPOSITION
100ml of solution contain:
Active ingredient: levodropropizina 6 g
Excipients: Propylene glycol, xylitol, sodium saccharinate, methyl para-hydroxybenzoate, wild fruit flavor, anise flavor, anhydrous citric acid, purified water
PHARMACEUTICAL FORM AND CONTENT
Oral drops, solution FLUIBRON DRY COUGH 60 mg / ml oral drops, solution - 1 bottle of 30 ml (1 ml contains 20 drops)
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
SEDATUSS 60 MG / ML ORAL DROPS, SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml of solution contain:
Active ingredient: levodropropizina 6 g.
For excipients, see section "List of excipients".
03.0 PHARMACEUTICAL FORM
Oral drops, solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptomatic cough therapy.
04.2 Posology and method of administration
Adults: 20 drops (corresponding to 60 mg) up to 3 times a day at intervals of at least 6 hours unless otherwise prescribed by the doctor.
Children: up to 3 daily doses spaced by at least 6 hours, as per the following scheme
In the opinion of the doctor, the above dosages can be doubled up to a maximum of 20 drops three times a day.
The drops should preferably be diluted in half a glass of water.
Treatment should be continued until the cough subsides or as directed by the doctor. However, if the cough is still present after 2 weeks of therapy, it is advisable to stop the treatment and ask your doctor for advice. In fact, cough is a symptom and the causative pathology should be studied and treated.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients. The administration of the drug should be avoided in patients with bronchorrhea and with reduced mucociliary function (Kartagener's syndrome, ciliary dyskinesia).
Pregnancy and breastfeeding (see "Pregnancy and breastfeeding").
04.4 Special warnings and appropriate precautions for use
The observation that the pharmacokinetic profiles of levodropropizin are not markedly altered in the elderly suggests that dose adjustments or modification of the dosing intervals may not be required in the elderly. However, in light of the evidence that sensitivity to various drugs is altered in the elderly, special caution should be used when levodropropizin is administered to elderly patients.
The effect of administering the product to children under 24 months has not been fully studied and in any case the drug should be used with caution in patients of this age.
Caution is advised in patients with severe renal insufficiency (creatinine clearance below 35 ml / min).
It is advisable to use caution even in case of simultaneous intake of sedative drugs in particularly sensitive individuals (see paragraph "Interactions").
The medicine contains methyl para-hydroxybenzoate, which is known to cause hives. In general, para-hydroxybenzoates can cause delayed reactions, such as contact dermatitis and rarely immediate reactions with manifestation of urticaria and bronchospasm.
Antitussive drugs are symptomatic and should only be used pending diagnosis of the underlying cause and / or therapy effect of the underlying disease.
In the absence of information on the effect of food intake on drug absorption, it is advisable to take the drug between meals.
SEDATUSS 60 mg / ml oral drops, solution it does not affect low-calorie or controlled diets and can also be administered to diabetic patients.
SEDATUSS 60 mg / ml oral drops, solution does not contain gluten; therefore it can be administered to patients with celiac disease.
04.5 Interactions with other medicinal products and other forms of interaction
Animal pharmacology studies have shown that levodropropizine does not potentiate the pharmacological effect of active substances on the central nervous system (eg benzodiazepines, alcohol, phenytoin, imipramine). In animals, the product does not modify the activity of oral anticoagulants, such as warfarin nor does it interfere with the hypoglycemic action of insulin. In human pharmacology studies, the combination with benzodiazepine does not modify the EEG picture. However, caution should be exercised in case of concomitant use of sedative drugs in particularly sensitive individuals (see section "Special warnings and precautions for" use ").
Clinical studies show no interaction with drugs used in the treatment of bronchopulmonary diseases such as β2-agonists, methylxanthines and derivatives, corticosteroids, antibiotics, mucoregulators and antihistamines.
04.6 Pregnancy and lactation
Studies of teratogenesis, reproduction and fertility as well as peri and postnatal studies did not reveal specific toxic effects.
However, since a slight delay in weight gain and growth was observed in animal toxicology studies at the dose of 24 mg / kg and since levodropropizin is able to overcome the placental barrier in the rat, the use of the drug it is contraindicated in women who intend to become or are already pregnant since its safety of use is not documented (see section "Contraindications"). Studies in rats indicate that the drug is found in breast milk for up to 8 hours after administration. Therefore, the use of the drug during lactation is contraindicated.
04.7 Effects on ability to drive and use machines
No studies on the ability to drive and / or use machines have been performed. However, since the product may, although rarely, cause drowsiness (see section "Undesirable effects"), use with caution in patients intending to drive vehicles. or operate machinery, informing them of this possibility.
04.8 Undesirable effects
The experience derived from the marketing of products containing levodropropizin in more than 30 countries around the world shows that the occurrence of undesirable effects is a very rare event. Based on the estimate of patients exposed to levodropropizin, derived from the number of packs sold, and considering the number of spontaneous reports, fewer than one in every 500,000 patients experienced adverse reactions Most of these reactions are not serious and symptoms have resolved with discontinuation of therapy and, in some cases, with specific drug treatment.
The adverse reactions found, all very rare (incidence
Skin and appendages: urticaria, erythema, rash, pruritus, angioedema, skin reactions. A single case of epidermolysis with fatal outcome has been reported.
Digestive system: gastric and abdominal pain, nausea, vomiting, diarrhea. Two single cases of glossitis and aphthous stomatitis have been reported, respectively. One case of cholestatic hepatitis and one case of hypoglycemic coma have been reported in an elderly patient treated concomitantly with oral hypoglycemic agents.
General conditions: allergic and anaphylactoid reactions, general malaise. Single cases of generalized edema, syncope and asthenia have been reported, respectively.
Nervous system: dizziness, vertigo, tremors, paraesthesia. A single case of tonic-clonic seizure and one case of a petit mal attack have been reported.
Cardiovascular system: palpitations, tachycardia, hypotension. One case of cardiac arrhythmia (atrial bigeminy) has been reported.
Psychiatric disorders: nervousness, drowsiness, sense of depersonalization.
Respiratory system: dyspnoea, cough, edema of the respiratory tract.
Musculoskeletal system: asthenia and weakness of the lower limbs.
Few cases of eyelid edema have been reported, most of which refer to angioneurotic edema, considering the concomitant presence of urticaria.
A single case of mydriasis and a case of bilateral vision loss have been reported. In both cases the reaction resolved after discontinuation of the drug.
A single case of somnolence, hypotonia and vomiting has been reported in a neonate following the nursing mother's intake of levodropropizin. Symptoms appeared after the feed and resolved spontaneously by suspending breastfeeding for a few feedings.
Only occasionally some adverse reactions were of a serious nature. These include some cases of skin reactions (urticaria, pruritus), the case of cardiac arrhythmia, already mentioned above, the case of hypoglycemic coma, as well as some cases of allergic / anaphylactoid reactions involving edema, dyspnoea, vomiting, diarrhea. As already mentioned, a single case of epidermolysis, which occurred abroad in a polytreated elderly patient, had a fatal outcome.
The medicine contains methyl para-hydroxybenzoate, which is known to cause hives. In general, para-hydroxybenzoates can cause delayed reactions, such as contact dermatitis and rarely immediate reactions with manifestation of urticaria and bronchospasm.
04.9 Overdose
No significant side effects have been reported after drug administration up to 240 mg single administration and up to 120 mg t.i.d. for 8 consecutive days. Only one case of overdose is known in a 3-year-old child treated with a daily dose of 360 mg levodropropizin. The patient experienced non-severe abdominal pain and vomiting which resolved without sequelae. In case of overdose with evident clinical manifestations, immediately institute symptomatic therapy and apply the usual emergency measures (gastric lavage, activated charcoal meal, parenteral administration of liquid, etc.), if necessary.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: preparations for cough and colds - cough suppressants.
ATC: R05DB27.
Levodropropizin is a molecule obtained by stereospecific synthesis and chemically corresponds to S (-) 3- (4-phenyl-piperazin-1-yl) -propan-1,2-diol.
It is a drug with antitussive activity, mainly of the peripheral type at the tracheobronchial level, associated with antiallergic and antibronchospastic activity; moreover it exerts, in the animal, a local anesthetic action.
In the animal, the antitussive activity of levodropropizin after oral administration was equal to or superior to dropropizine and cloperastine on cough induced by peripheral stimuli such as chemicals, mechanical stimulation of the trachea and electrical stimulation of the vagal afferent. Its activity on cough induced by central stimulus such as the electrical stimulation of the trachea in the guinea pig is about 10 times lower than that of codeine while the power ratio between the two drugs is between 0.5 and 2 in peripheral stimulation tests such as those for citric acid, ammonium hydrate and sulfuric acid.
Levodropropizin is not active when administered intracerebroventricularly in the animal. This fact suggests that the antitussive activity of the compound is due to a peripheral mechanism and not to action on the central nervous system. The comparison between the efficacy of levodropropizine and that of codeine, administered orally and aerosol, in preventing experimentally induced cough in the guinea pig, further confirms the peripheral site of action of levodropropizin; in fact, levodropropizine is equivocal or more potent than codeine for aerosol administration while, when administered orally, it is 2 times less potent than codeine.
Regarding the mechanism of action, levodropropizine performs its antitussive effect through an inhibitory action at the level of the C fibers. anesthetized cat, markedly reduces the activation of C fibers and abolishes associated reflexes.
Levodropropizine is significantly less active than dropropizine on oxotremorin-induced tremors and pentamethylenetetrazole-induced seizures and in modifying spontaneous motility in mice.
Levodropropizine does not displace naloxone from the opioid receptors in the rat brain; it does not modify the morphine withdrawal syndrome and the interruption of its administration is not followed by the appearance of addictive behaviors.
Levodropropizina does not cause in the animal neither depression of the respiratory function nor appreciable cardiovascular effects, moreover it does not induce constipating effects.
Levodropropizin acts on the bronchopulmonary system by inhibiting the bronchospasm induced by histamine, serotonin and bradykinin. The drug does not inhibit acetylcholine-induced bronchospasm thus demonstrating the absence of anticholinergic effects. In the animal the ED50 of the anti-bronchospastic activity is comparable to that of the antitussive activity.
In healthy volunteers, a dose of 60 mg of the drug reduces cough induced by citric acid aerosols for at least 6 hours.
Numerous experimental evidences demonstrate the clinical efficacy of levodropropizin in reducing cough of various etiologies including cough associated with bronchopulmonary carcinoma, cough associated with upper and lower respiratory tract infections and whooping cough. The antitussive action is generally comparable to that one. of centrally acting drugs with respect to which levodropropizin demonstrates a better tolerability profile, especially as regards the central sedative effects.
At therapeutic doses, levodropropizine did not modify the EEG trace and psychomotor capacity in humans. There were no changes in cardiovascular parameters in healthy volunteers treated up to a dose of 240 mg of levodropropizine.
This drug does not depress neither respiratory function nor mucociliary clearance in humans. In particular, a recent study has shown that levodropropizin is devoid of depressive effects on the central breathing regulation systems in patients with chronic respiratory insufficiency, both in conditions of spontaneous breathing and during hypercapnic ventilation.
05.2 Pharmacokinetic properties
Pharmacokinetic studies were conducted in rats, dogs and humans. Absorption, distribution, metabolism and excretion were very similar in the three species considered, with an oral bioavailability greater than 75%. radioactivity after oral administration of the product was 93%.
Binding to human plasma proteins is negligible (11-14%) and comparable to that observed in dogs and rats.
Levodropropizin is rapidly absorbed in humans after oral administration and is rapidly distributed throughout the body. The half-life is approximately 1-2 hours. The product is mainly excreted in the urine as unaltered product and its metabolites (conjugated levodropropizin and free and conjugated p-hydroxy levodropropizin). In 48 hours the urinary excretion of the product and the aforementioned metabolites is equal to about 35% of the administered dose. Repeated administration tests show that an 8-day treatment (tid) does not alter the absorption and elimination profile of the drug. thus allowing to exclude accumulation and metabolic self-induction phenomena.
There are no significant changes in the pharmacokinetic profile in children, the elderly and patients with mild or moderate renal impairment.
05.3 Preclinical safety data
The acute oral toxicity is 886.5 mg / kg, 1287 mg / kg and 2492 mg / kg in rats, mice and guinea pigs, respectively. The therapeutic index in the guinea pig, calculated as the ratio DL 50 / DE 50 after oral administration is between 16 and 53 depending on the experimental model of cough induction. The toxicity tests for repeated oral administration (4-26 weeks) have shown that the dose without toxic effects is 24 mg / kg / day.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Propylene glycol, xylitol, sodium saccharinate, methyl para-hydroxybenzoate, forest fruit flavor, anise flavor, anhydrous citric acid, purified water.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
18 months.
The shelf life after first opening the bottle is 21 weeks.
06.4 Special precautions for storage
The medicine should be stored at a temperature not exceeding 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
White polyethylene bottle, 35 ml capacity, containing 30 ml of solution, equipped with a dropper that delivers 20 drops / ml and a plastic cap with child resistant closure.
06.6 Instructions for use and handling
To open the package it is necessary to press the cap firmly and turn counterclockwise at the same time.
07.0 MARKETING AUTHORIZATION HOLDER
EPIFARMA Srl - Via S. Rocco, 6 - 85033 Episcopia (PZ)
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 039657010
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 28/04/2011
10.0 DATE OF REVISION OF THE TEXT
28/04/2014
-nelle-carni-di-maiale.jpg)
