BRONCHENOLO SED FLUID SCIR 150ML

BRONCHENOLO SEDATIVE AND FLUIDIFICATION

active ingredients

100 ml of syrup contain: • active ingredients: dextromethtorphan bromitted 0.15 g and sheathfenesine 1,00 g. Excipients with known effects: sucrose 73,50 g, propile para-hydroxybenzoate 0.025 g, methyl para-hydroxybenzoate 0.075g, 5,00 g ethyl alcohol • active ingredients: dextromethtorphan bromirate 7.5 mg and sheathfenesin 55 mg. Excipients with known effects: sucrose 2080.92 mg, aspartame (E951) 23 mg. For the full list of excipients, see paragraph 6.1.

Excellent

BRONCHENOLO SEDATIVE AND FLUIDIFICANT syrup 100 ml of syrup contain: pine mugo essential oil; citric acid monohydrate; alcohol; glycerol; sucrose; sweet orange essence; propile para-hydroxybenzoate; methyl para-hydroxybenzoate; sodium saccharin; purified water. BRONCHENOLO SEDATIVE AND FLUIDIFICATION tablets taste minta A 2,3 g pastel BRONCHENOLO SEDATIVE AND FLUIDIFICANT mint taste contains: pine mugo essential oil; magnesium trisilicate; aspartame; magnesium stearate; sucrose; mint aroma.

Therapeutic indications

Syntomatic treatment of cough.

Contraindications

Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. Children under the age of 6. Patients who are taking or hired in the last two weeks antidepressant inhibitors of monoamino-oxidase (IMAO) (see paragraph 4.5). 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).

Population

Population Syrup Adults (including the elderly): 2 teaspoons (10 ml) 2-4 times a day, up to a maximum of 8 teaspoons (40 ml) per day. Pediatric population Children over 12 years: 2 teaspoons (10 ml) 2-4 times a day, up to a maximum of 8 teaspoons (40 ml) per day. Children from 6 to 12 years old: 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. Meals Adults (including the elderly): 3-6 tablets per day to melt in the mouth, up to a maximum of 6 tablets per day. Pediatric population Children over 12 years: 3-6 tablets per day to melt in the mouth, up to a maximum of 6 tablets per day. Children from 6 to 12 years old: 2-3 pills per day to melt in the mouth, up to a maximum of 3 tablets per day. Administer the medicine every 4-6 hours as needed. Method of administration To administer only by mouth. Do not exceed the recommended doses.

Conservation

None

Warnings

In the following cases BRONCHENOLO SEDATIVE AND FLUIDIFICATION should be used only after careful medical evaluation: - chronic or persistent cough, such as the one manifested in case of asthma or emphysema; - severe liver failure; - severe kidney failure; - concomitant use of selective antidepressants of serotonin re-uptake or antidepressants (see paragraph 4.5). 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. Do not exceed the maximum recommended dose or frequency of administration. After 5-7 days of treatment without appreciable results, a clinical evaluation is required. It must be avoided the contemporary use of other medicines for cough and cold. Concurrent use of alcohol should be avoided during therapy with BRONCHENOLO SEDATIVE AND FLUIDIFICATION. Cases of detachment and detachment have been 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 SEDATIVE AND FLUIDIFICANT 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 treatment options are not available alternative.Qualora BRONCHENOLO SEDATIVE AND FLUIDIFICATION 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 Serotoninergic effects, including the development of a potentially lethal serotonin syndrome, have been reported for dextromethtorphan with concomitant administration of serotonininergic agents, such as selective inhibitors of serotonin reuptake (selective serotonin reuptake inhibitors, SSRIs), drugs that alter serotonin metabolism (including monoamine 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 SEDATIVE AND FLUIDIFICATION 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 BRONCHENOLO SEDATIVE AND FLUIDIFICANT syrup contains: • sucrose. Contains 7.35 g sucrose (sugar) for a dose of 10 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 480 mg of alcohol (ethanol) in every dose of 10 ml. 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 account in pregnant or nursing women, children and high-risk groups such as people with liver or epilepsy disorders. A dose of 10ml of this drug administered to a child aged 12 years and weight less or equal to 32kg would result in a 15 mg exposure which can cause an increase in blood alcohol concentration (BAC) of about 2.5 mg/100ml. 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. • propylene and para-hydroxybenzoate methyl, which can cause allergic reactions (also delayed); • Sodium. This medicine contains less than 1 mmole of sodium (23 mg), i.e. essentially without sodium. BRONCHENOLO SEDATIVE AND FLUIDIFICATION Mental taste pads contains: • sucrose. contains 2,08 g sucrose per dose. Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, 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 if it is suffering from phenylchetonuria, a rare genetic disease that causes the accumulation of phenylalanin because the body fails to dispose of it properly.

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). Patients should be informed to consult the doctor before taking the dextromethtorphan in association with the drugs listed below: - concomitant use of dextrometorphan with selective antidepressants of serotonin re-uptake or antidepressants can cause serotoninergic syndrome with changes in mental state, hypertension, agitation, myclonus, hyperreflection, diaphoresis, shivers and tremors (see paragraph 4.4); - 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. The association with phenylpropanolamin should be used with caution in subjects carrying hypertension, cardiopathy, diabetes, peripheral vasculopathy, prostatic hypertrophy and glaucoma. Treatment with sheathfenesin can determine false positives to the dosage of urinary vanilmandelic acid. 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 adverse events listed below were observed in clinical studies and are considered to be uncommon adverse reactions (i.e. found in a percentage between ≥1/1000 and Nervous Diseases). Ear and labyrinth pathologies • vertigo. Gastrointestinal diseases • gastrointestinal disturbance;• nausea;• vomiting;• abdominal discomfort. Post marketing data Below are the adverse reactions identified during post-marketing use. Since these reactions are voluntarily reported by a population of not certain dimensions, their frequency is not known, but it is probably very rare (responded in Nervous Diseases • Serotonin Syndrome. Serotonin reuptake inhibitors (see paragraphs 4.3 and 4.5). Immune system disorders • hypersensitivity (e.g. rash, hives, angioedema). Reporting of suspicious adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued 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 at - www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Signs and symptoms Overdose of dextromethtorphan can be associated with nausea,vomite, 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: coma, respiratory depression and seizures. If assumed in excessive quantities, sheathfenesin may cause kidney computation. 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, especially in order to control respiratory depression and other disturbances to the Central Nervous System. For patients who have ingested the rightmetorphan and are sedated or comatose, naloxone can be considered, in the usual doses for the treatment of opioid overdose may be used benzodiazepines for convulsions and benzodiazepines and external cooling measures for hyperthermia from serotonin syndrome.

Pregnancy and nursing data are not available. In pregnant women and during breastfeeding, the medicinal product should only be administered in case of actual need and under the direct control of the doctor.

Source: Farmadati