BRONCHENOL SEDATIVE AND FLUIDIFYING, 1.5 mg/ml + 10 mg/ml, syrup
Dextromethorphan hydrobromide, Guaifenesin
Directions
Symptomatic treatment of cough.
Active Ingredients
100 ml of syrup contain: • active ingredients : dextromethorphan hydrobromide 0.15 g and guaifenesin 1.00 g. Excipients with known effects : sucrose 73.50 g, propyl parahydroxybenzoate 0.025 g, methyl parahydroxybenzoate 0.075 g, ethyl alcohol 5 ,00 g. One tablet contains: • active ingredients : 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 paragraph 6.1.
Excipients
BRONCHENOLO SEDATIVE AND FLUIDIFYING syrup 100 ml of syrup contain: mountain pine essential oil; citric acid monohydrate; alcohol; glycerol; sucrose; sweet orange essence; propyl parahydroxybenzoate; methyl parahydroxybenzoate; sodium saccharin; purified water. BRONCHENOLO SEDATIVE AND FLUIDIFYING mint-flavored lozenges One 2.3 g lozenge of BRONCHENOLO SEDATIVE AND FLUIDIFYING mint-flavored contains: mountain pine essential oil; magnesium trisilicate; aspartame; magnesium stearate; sucrose; mint flavor.
Dosage
Dosage Syrup Adults (including the elderly): 2 teaspoons (10 ml) 2-4 times daily, up to a maximum of 8 teaspoons (40 ml) daily. Paediatric population Children over 12 years : 2 teaspoons (10 ml) 2-4 times a day, up to a maximum of 8 teaspoons (40 ml) a day. Children 6 to 12 years : 1 teaspoon (5 ml) 3-4 times a day, up to a maximum of 4 teaspoons (20 ml) a day. Administer the medicine every 4-6 hours as needed. Lozenges Adults (including the elderly): 3-6 lozenges per day to dissolve in the mouth, up to a maximum of 6 lozenges per day. Paediatric population Children over 12 years : 3-6 lozenges per day to dissolve in the mouth, up to a maximum of 6 lozenges per day. Children from 6 to 12 years : 2-3 lozenges per day to dissolve in the mouth, up to a maximum of 3 lozenges per day. Administer the medicine every 4-6 hours as needed. Method of administration To be administered orally only. Do not exceed the recommended dose.
Warnings
In the following cases BRONCHENOLO SEDATIVO E FLUIDIFICANTE should be used only after careful medical evaluation: - chronic or persistent cough, such as that which occurs in asthma or emphysema; - severe hepatic insufficiency; - severe renal insufficiency; - concomitant use of selective serotonin reuptake 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 concomitant use of other cough and cold medicines should be avoided. The concomitant use of alcohol should be avoided during therapy with BRONCHENOLO SEDATIVO E FLUIDIFICANTE. 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 is a slow metaboliser of CYP2D6. Exaggerated and/or prolonged effects of dextromethorphan may occur in poor metabolisers 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 arising from concomitant use of sedative medicines such as benzodiazepines or related drugs. Concomitant use of BRONCHENOLO SEDATIVE AND FLUIDIFICANTE and sedative medicines such as benzodiazepines, or related drugs, may cause sedation, respiratory depression, as well as death. Because of these risks, concomitant prescribing with sedative medicinal products should be reserved for patients for whom alternative treatment options are not available. If BRONCHENOLO SEDATIVE AND FLUIDIFICANTE 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 respect, it is strongly recommended to inform patients and their caregivers in order to make them aware of these symptoms (see section 4.5). Serotonin syndrome Serotonergic effects, including the development of a potentially life-threatening serotonin syndrome, have been reported for dextromethorphan with concomitant administration of serotonergic agents, such as selective serotonin reuptake inhibitors (SSRIs), drugs which impair metabolism of serotonin (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 BRONCHENOLO SEDATIVE AND FLUIDIFICANTE should be discontinued. Paediatric population Serious adverse events, including neurological disorders, may occur in children in case of overdose. Caregivers should be advised not to exceed the recommended dose. Information on excipients with known effects BRONCHENOLO SEDATIVE AND FLUIDIFYING syrup contains: • sucrose. Contains 7.35 g sucrose (sugar) per 10 ml dose. 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 alcohol (ethanol) in each 10 ml dose. The amount in 10 ml of this medicine is equivalent to 12 ml of beer and 5 ml of wine. May be harmful for alcoholics. To be taken into consideration in pregnant or breast-feeding 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 less than or equal to 32kg would result in an exposure of 15mg which may cause an increase in blood alcohol concentration (BAC) of approximately 2.5mg/100ml. Co-administration with medicinal products containing e.g. propylene glycol or ethanol may lead to accumulation of ethanol and induce adverse effects, particularly in young children with low or immature metabolic activity. • propyl and methyl parahydroxybenzoates, which may cause allergic reactions (possibly delayed); • Sodium. This medicine contains less than 1 mmol sodium (23 mg), i.e. essentially "sodium-free". BRONCHENOLO SEDATIVE AND FLUIDIFICANTE mint flavour lozenges contain: • sucrose. Contains 2.08 g sucrose per dose. 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 aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder in which the amount of phenylalanine builds up because the body cannot process it properly.
Conservation
None
Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 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 insufficiency or at risk of developing respiratory insufficiency (for example, patients with chronic obstructive airways disease or pneumonia, patients with an ongoing asthma attack or exacerbation of asthma).
Side effects
Data from clinical studies The adverse events reported below have been observed in clinical studies and are considered uncommon adverse reactions (i.e. occurring in ≥1/1000 to <1/100 patients). Adverse reactions are listed according to MedDRA classification. Nervous system disorders • somnolence. Ear and labyrinth disorders • vertigo. Gastrointestinal disorders • gastrointestinal disorder; • nausea; • vomiting; • abdominal discomfort. Post-marketing data The 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 <1/10000 patients). Nervous system disorders • serotonin syndrome. Serotonin syndrome (with mental status changes, agitation, myoclonus, hyperreflexia, diaphoresis, chills, tremors and hypertension) has been reported with 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 of 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.
Overdose
Signs and symptoms Dextromethorphan overdose may be associated with nausea, vomiting, dystonia, agitation, confusion, drowsiness, stupor, nystagmus, cardiotoxicity (tachycardia, abnormal ECG including QTc prolongation), ataxia, toxic psychosis with visual hallucinations, hyperexcitability. In case of massive overdose, the following symptoms may be observed: coma, respiratory depression and convulsions. If taken in excessive quantities, guaifenesin may cause renal calculosis. Management: Activated charcoal may be administered to asymptomatic patients who have ingested dextromethorphan overdoses within the previous hour. Emergency measures include emptying the stomach and supporting vital functions, particularly in order to control respiratory depression and other central nervous system disorders. For patients who have ingested dextromethorphan and are sedated or comatose, naloxone may be considered, in doses usual for the treatment of opioid overdose. Benzodiazepines may be used for seizures and benzodiazepines and external cooling measures for serotonin syndrome hyperthermia.
Pregnancy
There are no data available on pregnancy and breastfeeding. In pregnant and breastfeeding women, the medicine should be administered only in case of real need and under the direct supervision of a doctor.
