• On sale!
search

BRONCHENOL SED FLUID * 20PASTL

  • Perrigo Italia S.r.l.
  • 026564094
Bronchenolo Sedative and Fluidifying is a drug based on the active ingredient dextromethorphan + guaifenesin, belonging to the category of opioid antitussives + expectorants and specifically Opium derivatives and expectorants. Bronchenolo Sedative and Fluidifying can be prescribed with OTC Recipe - self-medication. Symptomatic treatment of cough.
info_outline View product sheet
Final Price €9.90
Quantity
check_circle Available
Shipped within 24 h
  Convenient and safe payments

Even with a credit card

  Shipping in 24h all over the world

Fast and safe international shipping worldwide

  Fast returns

14 days to reconsider

  Pharmaceutical experience

Always at your service. Experts in international shipping

Other products Others products at unbeatable price

Perrigo Italia S.r.l.

Discover all products

BRONCHENOL SED FLUID * 20PASTL

Therapeutic indications

Symptomatic treatment of cough.

Dosage and method of use

Dosage Syrup Adults(including the elderly): 2 teaspoons (10ml) 2-4 times per day, up to a maximum of 8 teaspoons (40ml) per day.Pediatric population Children over the age of 12: 2 teaspoons (10 ml) 2-4 times per day, up to a maximum of 8 teaspoons (40 ml) per day.Children from 6 to 12 years: 1 teaspoon (5 ml) 3-4 times a day, up to a maximum of 4 teaspoons (20 ml) per day. Administer the medicine every 4-6 hours as needed.Pads Adults(including the elderly): 3-6 tablets per day to be dissolved in the mouth, up to a maximum of 6 tablets per day.Pediatric population Children over the age of 12: 3-6 tablets per day to be dissolved in the mouth, up to a maximum of 6 tablets per day.Children from 6 to 12 years: 2-3 tablets per day to be dissolved in the mouth, up to a maximum of 3 tablets per day. Administer the medicine every 4-6 hours as needed.Method of administrationTo be administered orally only. Do not exceed the recommended dose.

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Children under the age of 6. Patients who are taking or have taken monoamine oxidase inhibitor antidepressants (MAOIs) within the last two weeks (see section 4.5). Patients with respiratory failure or at risk of developing respiratory failure (e.g. patients with chronic obstructive airway disease or pneumonia, patients with ongoing asthma attack or exacerbation of asthma).

Side effects

Data from clinical studiesThe adverse events reported below were observed in clinical trials and are considered uncommon adverse reactions (ie occurring in a percentage ranging from ≥1 / 1000 to Nervous system disorders • somnolence.Ear and labyrinth disorders• vertigo.Gastrointestinal disorders• gastrointestinal disturbance; • nausea; • He retched; • abdominal discomfort.Post marketing dataAdverse reactions identified during post-marketing use are listed below. As these reactions are reported voluntarily from a population of uncertain size, their frequency is not known but is probably very rare (found in Nervous system disorders • serotonin syndrome. Serotonin syndrome (with altered mental status, agitation, myoclonus, hyperreflexia, diaphoresis, chills, tremors and hypertension) have been reported in the case of concomitant use of dextromethorphan with antidepressants (monoamine oxidase inhibitors or serotonin reuptake inhibitors) (see sections 4.3 and 4.5).Disorders of the immune system• hypersensitivity (eg rash, hives, angioedema).Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

In the following cases, BRONCHENOL SEDATIVE AND FLUIDIFYING must be used only after careful medical evaluation: - chronic or persistent cough, such as that which occurs in the case of asthma or emphysema; - severe hepatic insufficiency; - severe renal insufficiency; - concomitant use of selective serotonin re-uptake inhibitor antidepressants or tricyclic antidepressants (see section 4.5). The patient should be advised to consult the physician if the cough persists, or if it is accompanied by a high fever, skin rash or persistent headache. Do not exceed the maximum recommended dose or frequency of administration. After 5-7 days of treatment with no appreciable results, a clinical evaluation is required. The concomitant use of other cough and cold medicines should be avoided. The concomitant use of alcohol should be avoided during therapy with SEDATIVE AND FLUIDIFYING BRONCHENOL. Cases of dextromethorphan abuse and dependence have been reported. Special care is recommended with adolescents and young adults, as well as with patients with a history of drug or psychoactive substance abuse. Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the population metabolize CYP2D6 slowly. Exaggerated and / or prolonged effects of dextromethorphan may occur in poor metabolisers and patients with concomitant use of CYP2D6 inhibitors. Therefore, caution should be exercised in patients who are poor metabolisers of CYP2D6 or who use CYP2D6 inhibitors (see also section 4.5).Risks arising from the concomitant use of sedative medicines such as benzodiazepines or related drugs.Concomitant use of SEDATIVE AND FLUIDIFYING BRONCHENOL and sedative medicines such as benzodiazepines, or related drugs, can cause sedation, respiratory depression, such as and death. Because of these risks, concomitant prescribing with sedative medicinal products should be reserved for patients for whom no alternative treatment options are available. the duration of treatment should be as short as possible. Patients should be closely monitored for signs and symptoms of respiratory depression and sedation. In this regard, it is strongly recommended that patients and anyone caring for them be informed in order to make them aware of these symptoms (see section 4.5).Seratonin syndromeSerotonergic effects, including the development of a life-threatening serotonin syndrome, have been reported for dextromethorphan with concomitant administration of serotonergic agents, such as selective serotonin reuptake inhibitors (SSRIs), drugs that alter serotonin metabolism (including monoamine oxidase inhibitors[monoamine oxidase inhibitors, MAOI]) and CYP2D6 inhibitors. Serotonin syndrome can include changes in mental status, autonomic instability, neuromuscular abnormalities, and / or gastrointestinal symptoms. If serotonin syndrome is suspected, treatment with SEDATIVE AND FLUIDIFYING BRONCHENOL should be discontinued.Pediatric populationSerious adverse events, including neurological disorders, may occur in children in case of overdose. People caring for patients should be advised not to exceed the recommended dose.Information on excipients with known effects BRONCHENOL SEDATIVE AND FLUIDIFYING syrup contains:• sucrose. Contains 7.35 g of sucrose (sugar) per 10 ml serving. This should be taken into consideration in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine; • ethyl alcohol. This medicine contains 480 mg of alcohol (ethanol) in each 10 ml dose. The quantity in 10 ml of this medicine is equivalent to 12 ml of beer and 5 ml of wine. It can be harmful to alcoholics. To be taken into consideration in pregnant or lactating women, children and high-risk groups such as people with liver disease or epilepsy. A 10ml dose of this medicine given to a child aged 12 years and weighing 32kg or less would result in 15mg exposure which may cause an increase in blood alcohol concentration (BAC) of approximately 2.5 mg / 100ml. Co-administration with medicinal products containing e.g. Propylene glycol or ethanol can lead to the accumulation of ethanol and induce adverse effects, particularly in young children with low or immature metabolic activity. • propyl and methyl para-hydroxybenzoates, which can cause allergic reactions (even delayed); • Sodium. This medicinal product contains less than 1 mmol sodium (23 mg), i.e. essentially sodium-free.SEDATIVE AND FLUIDIFYING BRONCHENOL mint flavor tablets contain:• sucrose. contains 2.08 g of sucrose per serving. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine; • aspartame. This medicine contains 23 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It can be harmful to you if you have phenylketonuria, a rare genetic disease that causes phenylalanine to build up because the body cannot dispose of it properly.

Pregnancy and breastfeeding

No data on pregnancy and lactation are available. In pregnant and lactating women, the medicine should only be administered if clearly needed and under the direct supervision of the doctor.

Expiration and retention

None

Interactions with other drugs

The medicinal product should not be used concurrently with or within 2 weeks of treatment with monoamine oxidase inhibitor antidepressants (MAOIs), as serious adverse reactions, including serotonin syndrome, have been reported (see section 4.3). Patients should be advised to consult their physician before taking dextromethorphan in combination with the following drugs: - Concomitant use of dextromethorphan with selective serotonin reuptake inhibitor antidepressants or tricyclic antidepressants may cause serotonin syndrome with status changes mental, hypertension, agitation, myoclonus, hyperreflexia, diaphoresis, chills and tremors (see section 4.4); - the concomitant use of dextromethorphan and alcohol can increase the depressive effects on the central nervous system of both substances. CYP2D6 inhibitors Dextromethorphan is metabolised by CYP2D6 and has extensive first pass metabolism. Concomitant use of potent inhibitors of the CYP2D6 enzyme can increase the concentrations of dextromethorphan in the body to levels many times higher than normal. This increases the patient's risk of the toxic effects of dextromethorphan (agitation, confusion, tremor, insomnia, diarrhea and respiratory depression) and of developing serotonin syndrome. Potent inhibitors of CYP2D6 are fluoxetine, paroxetine, quinidine and terbinafine. In concomitant use with quinidine, plasma concentrations of dextromethorphan are increased up to 20-fold, resulting in increased adverse effects on the central nervous system of the agent. Amiodarone, flecainide and propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine and thioridazine also have similar effects on the metabolism of dextromethorphan. If concomitant use of CYP2D6 inhibitors and dextromethorphan is required, the patient should be monitored and the dextromethorphan dose may need to be reduced. The association with phenylpropanolamine should be used with caution in subjects with hypertension, heart disease, diabetes, peripheral vasculopathy, prostatic hypertrophy and glaucoma. Treatment with guaifenesin can cause false positives for the urinary vanylmandelic acid dosage. Sedative medicines such as benzodiazepines or related medicines Concomitant use of opioids and sedative medicines such as benzodiazepines, or related medicines, increases the risk of sedation, respiratory depression, coma and death due to the additive depressant effect on the CNS. Dosage and duration of concomitant treatment should be limited (see section 4.4).

Overdose

Signs and symptomsOverdose of dextromethorphan may be associated with nausea, vomiting, dystonia, agitation, confusion, somnolence, stupor, nystagmus, cardiotoxicity (tachycardia, abnormal ECG including QTc interval prolongation), ataxia, toxic psychosis with visual hallucinations, hyperexcitability. In case of taking massive overdose, the following symptoms can be observed: coma, respiratory depression and convulsions. If taken in excessive quantities, guaifenesin can cause kidney stones.Management:Activated charcoal can be given to asymptomatic patients who have ingested overdoses of dextromethorphan within the previous hour. Emergency interventions include emptying the stomach and supporting vital functions, particularly in order to control respiratory depression and other disorders affecting the central nervous system. For patients who have ingested dextromethorphan and are sedated or comatose, naloxone may be considered, in the usual doses for the treatment of opioid overdose Benzodiazepines for seizures and benzodiazepines and external cooling measures for hyperthermia syndrome may be used from serotonin.

Active principles

100 ml of syrup contain: •active principles: dextromethorphan hydrobromide 0.15 g and guaifenesin 1.00 g.Excipients with known effects: sucrose 73.50 g, propyl para-hydroxybenzoate 0.025 g, methyl para-hydroxybenzoate 0.075g, ethyl alcohol 5.00 g. One tablet contains: •active principles: dextromethorphan hydrobromide 7.5 mg and guaifenesin 55 mg.Excipients with known effects: sucrose 2080.92 mg, aspartame (E951) 23 mg. For the full list of excipients, see section 6.1.

Excipients

BRONCHENOL SEDATIVE AND FLUIDIFYING syrup100 ml of syrup contain: mountain pine essential oil; citric acid monohydrate; alcohol; glycerol; sucrose; sweet orange essence; propyl para-hydroxybenzoate; methyl para-hydroxybenzoate; sodium saccharin; purified water.BRONCHENOL SEDATIVE AND FLUIDIFYING mint flavor tabletsA 2.3 g tablet of SEDATIVE AND FLUIDIFYING BRONCHENOL in mint flavor contains: mountain pine essential oil; magnesium trisilicate; aspartame; magnesium stearate; sucrose; mint flavor.

026564094

Data sheet

Packaging
7.5 mg + 55 mg 20 mint flavored tablets
Product Type
HUMAN DRUG
ATC code
R05FA02
ATC description
Opium derivatives and expectorants
Therapeutic Group
Opioid antitussives + expectorants
Active principle
dextromethorphan + guaifenesin
Class
C.
Pharmaceutical form
candy pastille
Type of Administration
buccal / mucoadhesive
Container
candy / pads
Quantity
20 candies / tablets
Quantity of the Active Ingredient
7.5MG (dextromethorphan) + 55MG (guaifenesin)
Recipe required
OTC - self-medication medicine
chat Comments (0)