Bronchenol cough syrup 150ml

BRONCHENOL COUGH * SCIR 150ML

Therapeutic indications

Symptomatic treatment of cough.

Dosage and method of use

Dosage Adults:3-4 tablespoons (15 ml) per day. One tablespoon every 4-6 hours. Maximum daily dosage: 60 ml.Pediatric population Children over the age of 12:3-4 tablespoons (15 ml) per day. One tablespoon every 4-6 hours. Maximum daily dosage: 60 ml.Children from 6 to 12 years:3-4 half tablespoons (7.5 ml) per day. Half a spoon every 4-6 hours. Maximum daily dosage: 30 ml. After 5-7 days of treatment with no appreciable results, the patient should be advised to consult a doctor. DO NOT EXCEED THE RECOMMENDED DOSEMethod of administrationOral use.

Contraindications

Hypersensitivity to the active substance, other chemically closely related substances or to any of the excipients listed in section 6.1. Children under the age of 6. 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). Patients who are taking or have taken monoamine oxidase inhibitor antidepressants (MAOIs) within the last two weeks.

Side effects

Data from clinical studiesThe adverse events reported below were observed in clinical studies with dextromethorphan and are considered uncommon adverse reactions (ie occurring in a percentage between ≥1 / 1000 and 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 of dextromethorphan products are listed below. As these reactions are reported voluntarily by a population of uncertain size, their frequency is unknown but is probably very rare (found in Nervous system disorders: • serotonin syndrome. Serotonin syndrome (with altered mental status, agitation, myoclonus, hyperreflexia, diaphoresis, tremors, tremors and hypertension) has been reported in the case of concomitant use of dextromethorphan with antidepressants (monoamine oxidase inhibitors or serotonin reuptake inhibitors) (see sections 4.3 "Contraindications" and 4.5 "Interactions with other medicinal products and other forms of interaction ").Skin and subcutaneous tissue disorders:• 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

In the following cases, BRONCHENOL COUGH should only be used after careful medical evaluation: - chronic or persistent cough, such as that which occurs in the case of asthma or emphysema, or when the cough is accompanied by excessive secretion; - severe hepatic insufficiency; - severe renal insufficiency; - concomitant use of selective serotonin reuptake inhibitor antidepressants or tricyclic antidepressants (see section 4.5 "Interactions with other medicinal products and other forms of interaction"). 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. Simultaneous use of other cough and cold products should be avoided. 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 COUGH 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. If BRONCHENOL COUGH is prescribed concomitantly with sedative medicinal products, the lowest effective dose should be used and 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 COUGH 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 effectsThis medicine contains: • sucrose. Contains 17.2 g of sucrose (sugar) per 15 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 medicinal product contains 576 mg of alcohol (ethanol) in each 15 ml dose. The amount in 15ml of this medicine is equivalent to less than 14ml of beer or 6ml of wine. It can be harmful to alcoholics. To be taken into consideration in women who are already pregnant or breastfeeding, in children and in high-risk groups such as people with liver disease or epilepsy. A dose of 15ml of this medicine given to a child aged 12 years and weighing 38kg or less would result in an exposure of 15.16mg which can cause an increase in blood alcohol concentration (BAC) of approximately 2.5 mg. 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. • methyl para-hydroxybenzoate, can cause allergic reactions (even delayed); • sodium. This medicinal product contains less than 1 mmol sodium (23 mg), ie essentially 'sodium-free'. The concomitant use of alcohol should be avoided during therapy with COUGH BRONCHENOL. Do not exceed the maximum recommended dose or frequency of administration.

Pregnancy and breastfeeding

No data on pregnancy and lactation are available. During pregnancy and breastfeeding, the medicine should only be used if clearly needed and under direct medical supervision.

Expiry and retention

No special storage precautions are required.

Interactions with other drugs

The medicinal product should not be used at the same time 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 “Contraindications). Patients should be advised to consult their physician before taking dextromethorphan in the following situations: - the concomitant use of dextromethorphan with selective serotonin reuptake inhibitor antidepressants or tricyclic antidepressants may cause serotonin syndrome with changes in mental status, hypertension, agitation, myoclonus, hyperreflexia, diaphoresis, tremors and tremors (see section 4.4 “Special warnings and precautions for use”); - 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. 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 symptomsDextromethorphan overdose 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 massive overdose, the following symptoms may be observed coma, respiratory depression, and convulsions.ManagementActivated charcoal can be given to asymptomatic patients who have ingested overdoses of dextromethorphan within the previous hour. Emergency interventions include stomach emptying and support of vital functions. For patients who have ingested dextromethorphan and are sedated or comatose, naloxone in the usual doses for the treatment of opioid overdose may be considered. Benzodiazepines for seizures and benzodiazepines and external cooling measures for serotonin syndrome hyperthermia may be used.

Active principles

100 ml of syrup contain: •active principle: dextromethorphan hydrobromide 154 mgExcipients with known effects: sucrose (114.63 g), methyl para-hydroxybenzoate (0.128 g), ethanol (3.84 g). For the full list of excipients, see section 6.1.

Excipients

Ethyl alcohol, sodium citrate, citric acid monohydrate, methyl p-hydroxybenzoate, lemon flavor, mint flavor, sucrose, purified water.