Bronchenolo Sedative and Fluidifying 1.5mg/ml + 10mg/ml syrup 150ml

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Symptomatic treatment of cough.

CONTRAINDICATIONS

Hypersensitivity to the active substances or to any of the excipients listed in paragraph 6.1. Children under 6 years of age. Patients who are taking or have taken in the last two weeks monoamine oxidase inhibitor (MAOI) antidepressants (see section 4.5). Patients with respiratory failure or at risk of developing respiratory failure (for example patients with chronic obstructive airway disease or pneumonia, patients with a current asthma attack or an exacerbation of asthma).

WARNINGS AND PRECAUTIONS FOR USE

In the following cases BRONCHENOL SEDATIVE AND FLUIDIFYER must be used only after careful medical evaluation: - chronic or persistent cough, such as that which occurs in cases of asthma or emphysema; - severe liver failure; - severe renal failure; - concomitant use of selective serotonin re-uptake inhibitor antidepressants or tricyclic antidepressants (see section 4.5). The patient should be advised to consult a 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 necessary. The simultaneous use of other cough and cold medicines should be avoided. The concomitant use of alcohol during therapy with SEDATIVE AND FLUIDIFYING BRONCHENOL must be avoided. Cases of abuse and dependence of dextromethorphan have been reported. Particular caution 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. Approximately 10% of the population slowly metabolizes CYP2D6. Exaggerated and/or prolonged effects of dextromethorphan may occur in poor metabolizers and patients with concomitant use of CYP2D6 inhibitors. Caution is therefore necessary in patients who are poor metabolisers of CYP2D6 or who use CYP2D6 inhibitors (see also section 4.5). Risks deriving from the concomitant use of sedative medicines such as benzodiazepines or related drugs. The concomitant use of BRONCHENOL SEDATIVE AND FLUIDIFYER and sedative medicines such as benzodiazepines, or related drugs, may 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 SEDATIVE AND FLUIDICANT 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 carefully monitored for signs and symptoms of respiratory depression and sedation. In this regard, it is strongly recommended to inform patients and anyone caring for them to make them aware of these symptoms (see section 4.5). Seratonin syndrome Serotonergic effects, including the development of 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 [MAOIs]), and CYP2D6 inhibitors. Serotonin syndrome may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. If serotonin syndrome is suspected, treatment with SEDATIVE AND FLUIDIFYING BRONCHENOL must be discontinued. Pediatric population Serious adverse events, including neurological disorders, may occur in children in case of overdose. Persons caring for patients should be advised not to exceed the recommended dose. Information on excipients with known effects BRONCHENOL SEDATIVE AND FLUIDIFIER syrup contains: • sucrose. Contains 7.35 g of sucrose (sugar) per 10 ml dose. This should be taken into consideration in patients with diabetes mellitus. Patients suffering from 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 breastfeeding women, children and high-risk groups such as people with liver disease or epilepsy. A 10ml dose of this medicine administered to a child aged 12 years and weighing less than or equal to 32kg would result in an exposure of 15 mg which may cause an increase in blood alcohol concentration (BAC) of approximately 2.5 mg/100ml. Co-administration with medicines containing e.g. propylene glycol or ethanol may lead to ethanol accumulation 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. BRONCHENOL SEDATIVE AND FLUIDIFIER mint flavor tablets contains: • sucrose. contains 2.08 g of sucrose per dose. Patients suffering from 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 may be harmful to you if you suffer from phenylketonuria, a rare genetic disease that causes the accumulation of phenylalanine because the body is unable to dispose of it correctly.

INTERACTIONS

The medicine must not be used simultaneously with or within 2 weeks of treatment with monoamine oxidase inhibitor (MAOI) antidepressants, as serious adverse reactions, including serotonin syndrome, have been reported (see section 4.3). Patients should be informed to consult their doctor 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 changes in mental status, hypertension, agitation, myoclonus, hyperreflexia, diaphoresis, chills and tremors (see section 4.4); - the concomitant use of dextromethorphan and alcohol can increase the depressant 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 strong inhibitors of the CYP2D6 enzyme can increase dextromethorphan concentrations in the body to levels many times higher than the normal value. This increases the patient's risk for toxic effects of dextromethorphan (agitation, confusion, tremor, insomnia, diarrhea, and respiratory depression) and for the development of 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 central nervous system effects 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 necessary, the patient should be monitored and the dose of dextromethorphan may need to be reduced. The association with phenylpropanolamine should be used with caution in subjects with hypertension, heart disease, diabetes, peripheral vascular disease, prostatic hypertrophy and glaucoma. Treatment with guaifenesin can cause false positive results in the measurement of urinary vanillylmandelic acid. 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 additive CNS depressant effect. The dosage and duration of concomitant treatment should be limited (see section 4.4).

SIDE EFFECTS

Data from clinical studies The adverse events reported below were observed in clinical studies and are considered uncommon adverse reactions (i.e. found in a percentage between ≥1/1000 and <1/100 patients). Adverse reactions are listed according to MedDRA classification. Nervous system disorders • drowsiness. Ear and labyrinth disorders • dizziness. Gastrointestinal disorders • gastrointestinal disorder; • nausea; • vomit; • abdominal discomfort. Post marketing data Adverse reactions identified during post-marketing use are listed below. Since these reactions are reported voluntarily from a population of uncertain size, their frequency is not known, but is probably very rare (occurring in <1/10,000 patients). Nervous system disorders • serotonin syndrome. Serotonin syndrome (with mental status changes, agitation, myoclonus, hyperreflexia, diaphoresis, chills, tremors and hypertension) has been reported in case of concomitant use of dextromethorphan with antidepressants (monoamine oxidase inhibitors or serotonin reuptake inhibitors) (see sections 4.3 and 4.5). Immune system disorders • hypersensitivity (e.g. rash, urticaria, angioedema). Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance 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.