BRONCHENOLO COUGH AND COLD

BRONCHENOLO TOSSE 1.54 MG/ML SCIROP

active ingredients

100 ml of syrup contain: • active ingredient: dextrometorphan bromidated 154 mg Excipients with known effects: sucrose (114,63 g), methyl para-hydroxybenzoate (0,128 g), ethanol (3,84 g). For the full list of excipients, see paragraph 6.1.

Excellent

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

Therapeutic indications

Syntomatic treatment of cough.

Contraindications

Hypersensitivity to the active ingredient, other substances strictly related to the chemical or any of the excipients listed in the paragraph 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 respiratory disease or pneumonia, patients with asthma attack or asthma exacerbation). Patients who are taking or hired in the last two weeks antidepressant inhibitors of monoamino-oxidase (IMAO).

Population

Population Adults: 3-4 tablespoons (from 15 ml) per day. A spoon every 4-6 hours. Maximum daily dose: 60 ml. Pediatric population Children over 12 years: 3-4 tablespoons (from 15 ml) per day. A spoon every 4-6 hours. Maximum daily dose: 60 ml. Children from 6 to 12 years: 3-4 half spoons (from 7.5 ml) per day. Half a spoon every 4-6 hours. Maximum daily dose: 30 ml. After 5-7 days of treatment without appreciable results, the patient should be advised to consult the doctor. DOESN'T EVERYTHING Method of administration Oral use.

Conservation

Special precautions for conservation are not necessary.

Warnings

In the following cases BRONCHENOLO TOSSE must be used only after careful medical evaluation: - chronic or persistent cough, such as that manifested in case of asthma or emphysema, or when cough is accompanied by excessive secretion; - severe liver failure; - severe kidney failure; - concomitant use of selective antidepressants of serotonin reuptake or antidepressants (see paragraph 4.5 “Interactions with other medicines and other forms of interaction”). The patient should be informed to consult the doctor if the cough persists, or if it is accompanied by high fever, skin rash or persistent headache. It must be avoided the contemporary use of other products for cough and cold. Cases of detachment and detachment were reported. It is recommended to pay special attention to teenagers and young adults as well as patients with a history of drug abuse or psychoactive substances. The rightmetorphan is metabolized by the liver cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the population slowly metabolizes CYP2D6. In slow metabolizers and patients with concomitant use of CYP2D6 inhibitors, exaggerated and/or prolonged effects of dextromethtorphan may occur. It is therefore necessary to pay attention to CYP2D6 slow metabolizer patients or to use CYP2D6 inhibitors (see also paragraph 4.5). Risks resulting from the concomitant use of sedative medicines such as benzodiazepines or related drugs. Concurrent use of BRONCHENOLO TOSSE and sedative medicines such as benzodiazepines, or related drugs, can cause sedation, respiratory depression, as and death. Due to these risks, the concomitant prescription with sedative medicines must be reserved to patients for whom alternative treatment options are not available. Where BRONCHENOLO TOSSE was prescribed in conjunction with sedative medicines, the lowest effective dose must be used and the duration of treatment must be as short as possible. Patients should be carefully monitored for signs and symptoms of respiratory depression and sedation. In this regard, it is strongly recommended to inform patients and anyone who takes care of them in order to make them aware of these symptoms (see paragraph 4.5). Seratonin syndrome Serotonininergic effects, including the development of a potentially lethal serotonin syndrome, have been reported for dextromethtorphan with concomitant administration of serotonininergic agents, such as selective serotonin reuptake inhibitors (SSRIs), drugs that alter serotonin metabolism (including monotonin inhibitors) [monoamine oxidase inhibitors, MAOI]) and CYP2D6 inhibitors. Serotonin syndrome may include changes in mental state, autonomic instability, neuromuscular abnormalities and/or gastrointestinal symptoms. If a serotonin syndrome is suspected, treatment with BRONCHENOLO TOSSE must be interrupted. Pediatric population Severe adverse events can occur in children in case of overdose, including neurological disorders. People taking care of patients should be advised not to exceed the recommended dose. Information about excipients with known effects This medicine contains: • sucrose. Contains 17,2 g sucrose (sugar) for a dose of 15 ml. This should be considered in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure should not take this medicine; • ethiopian alcohol. This medicine contains 576 mg of alcohol (ethanol) in each dose of 15 ml. The amount in 15 ml of this medicine is equivalent to less than 14 ml of beer or 6 ml of wine. It can be harmful to alcoholics. To be taken into account in pregnant or breastfeeding women, children and high-risk groups such as people with liver or epilepsy disorders. A dose of 15 ml of this medicine given to a child aged 12 years and weight less or equal to 38kg would result in an exposure of 15, 16 mg which can cause an increase in the concentration of alcohol in the blood (BAC) of about 2.5 mg. Co-administration with medicines containing propylene glycol or ethanol can lead to the accumulation of ethanol and induce adverse effects, especially in small children with low metabolic activity or immature. • para-hydroxybenzoate methyl, can cause allergic reactions (also delayed); • sodium. This medicine contains less than 1 mmole of sodium (23 mg), that is to be considered essentially “without sodium”. Concurrent use of alcohol should be avoided during therapy with BRONCHENOLO TOSSE. Do not exceed the maximum recommended dose or frequency of administration.

Interactions

The medicinal product should not be used at the same time or in the 2 weeks following treatment with antidepressants inhibitors of monoamino oxidase (IMAO), since severe adverse reactions have been reported, including serotoninergic syndrome (see paragraph 4.3 “Controindications). Patients should be informed to consult the doctor before taking the dextromethtorphan in the following situations: - the concomitant use of dextromethtorphan with selective antidepressants of serotonin reuptake or antidepressants can cause serotonin syndrome with changes in mental state, hypertension, agitation, myclonus, hyperreflection, diaphoresis, fremites and tremors (see paragraph 4.4 “Special warnings and precautions of use”); - Concurrent use of dextromethtorphan and alcohol can increase depressive effects on the Central Nervous System of both substances. CYP2D6 inhibitors The dextromethtorphan is metabolized by the CYP2D6 and has a wide metabolism of the first step. Concurrent use of powerful CYP2D6 enzyme inhibitors can increase the concentrations of dextromethtorphan in the body at many times higher than normal value. This increases the risk for the patient of toxic effects of dextromethtorphan (acting, confusion, tremor, insomnia, diarrhea and respiratory depression) and of development of serotonin syndrome. Powerful inhibitors of CYP2D6 are fluoxetine, paroxetine, chinidine and terbinaphine. In use in conjunction with chinidine, plasma concentrations of dextromethtorphan have increased up to 20 times, resulting in increased adverse effects on the central nervous system of the agent. Also amiodarone, flecainide and propafenone, sertralin, bupropion, methadone, cinacalcet, aloperidol, perfenazine and thiodazine have similar effects on the metabolism of the dextromethtorphan. If the concomitant use of CYP2D6 inhibitors and dextromethtorphans is necessary, the patient must be monitored and it may be necessary to reduce the dose of dextromethtorphan. Sedative medicines such as benzodiazepines or related medicines Concurrent 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 depressive effect on SNC. The dosage and duration of the concurrent treatment must be limited (see paragraph 4.4).

Effects

Data from clinical studies The following adverse events have been observed in clinical studies with the dextromethtorphan and are considered to be uncommon adverse reactions (i.e. found in a percentage between ≥1/1000 and Nervous System pathologies: • drowsiness. Ear and labyrinth pathologies: • vertigo. Gastrointestinal diseases: • gastrointestinal disorder; • nausea; • vomiting; • abdominal disorder. Post marketing data Below are the adverse reactions identified during the post-marketing use of dextromethtorphan products. Since these reactions are voluntarily reported by a population of not certain dimensions, their frequency is not known but is probably very rare (responded in Nervous Diseases: • Serotonin Syndrome. Serotoninergic syndrome (with alterations of the mental state, agitation, myoclonus, hyperreflection, diaphoresis, fremites, tremors and hypertension) was reported in case of concomitant use of the dextromethtorphan with antidepressants (inhibitions of monoamino oxidases or serotonin reuptake inhibitors) (see paragraphs 4.3 “Interindications” and 4.5”). Pathologies of skin and subcutaneous tissue: • hypersensitivity (e.g. rash, hives, angioedema). Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Signs and symptoms Overdose from dextromethtorphan can be associated with nausea, vomiting, dystonia, agitation, confusion, drowsiness, astonishment, nistagm, cardiotoxicity (tachycardia, abnormal ECG including extension of the QTc range), ataxia, toxic psychosis with visual hallucinations, hypereccitability. In case of mass overdose, the following symptoms can be observed, respiratory depression, and seizures. Management Active carbon can be administered to asymptomatic patients who ingested overdose of dextromethtorphan in the previous hour. Emergency interventions include the emptying of the stomach and the support of vital functions. For patients who have ingested dextromethtorphan and are sedated or comatose, naloxone can be considered, in the usual doses for the treatment of opioid overdose. Benzodiazepines can be used for convulsions and benzodiazepines and external cooling measures for hyperthermia from serotonin syndrome.

Pregnancy and nursing data are not available. During pregnancy and breastfeeding, the medicinal product must be used only in case of actual need and under direct medical control.

Source: Farmadati