LISOMUCIL COUGH SED * SCIR 100ML

LISOMUCIL COUGH SED * SCIR 100ML

Therapeutic indications

Symptomatic treatment of dry cough.

Dosage and method of use

Dosage. Adults and adolescents over 12 years: The recommended dose is 30 mg (corresponding to 10 ml) up to 4 times a day, if needed, with an interval of at least 6 hours. The maximum daily dose is 120 mg. Do not exceed the maximum daily dose. Children from 6 to 12 years: The recommended dose is 15 mg (corresponding to 5 ml) up to 4 times a day, if needed, with an interval of at least 6 hours. The maximum daily dose is 60 mg. Do not exceed the maximum daily dose. Lisomucil Cough Sedative is contraindicated in children under 6 years of age (see section 4.3). Dosage should be halved in elderly patients or in patients with renal and / or hepatic insufficiency, especially in patients with severe impairment. The dose may possibly be increased according to tolerability and needs or the interval between doses may be increased. Duration of treatment: The treatment should not exceed 5 days. Method of administration: The dose should be taken preferably after meals. Do not dilute. A measuring spoon is attached to the package. Instructions for opening the bottle : The bottle is equipped with a cap with a “child-proof” safety closure. To open the bottle it is necessary to press the cap against the cap and unscrew. To close the bottle screw the cap back on.

Contraindications

- hypersensitivity to the active substance or to any of the excipients listed in section 6.1, - children less than 6 years of age, - pregnancy and breastfeeding (see section 4.6), - bronchial asthma, COPD, lung infection or respiratory depression, - respiratory failure, - in case of concomitant treatment or in the two weeks following therapy with antidepressant medicines such as MAO inhibitors (MAOIs),

Side effects

The table below lists the adverse reactions that may occur. Frequency classes are defined as follows: very common (≥ 1/10); common (≥ 1/100,

Reporting 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

Before starting a cough treatment, the causes should be studied, which require specific etiological treatment. Do not use for prolonged treatments beyond 5 days: if after this period of treatment no appreciable results have been obtained, re-evaluate the situation. Dextromethorphan is not recommended for the suppression of chronic cough. Productive cough, being an essential bronchopulmonary defense factor, should not be suppressed. Consequently, the concomitant use of an expectorant or mucolytic medicinal product for the treatment of cough is not rational. Administer with caution in subjects with impaired hepatic and / or renal function. Dextromethorphan can be addictive. Following prolonged use, patients may develop tolerance to the drug, as well as mental and physical dependence. Cases of dextromethorphan abuse and dependence have been reported. Special care is recommended with adolescents, young adults and children, as well as with patients with a history of alcoholism, drug abuse or psychoactive substance. Patients with a tendency to abuse or dependence should take Lisomucil Cough Sedative for short periods and be closely monitored. Alcohol intake during treatment is not recommended. Indeed, dextromethorphan potentiates the inhibitory effect of alcohol on the central nervous system (see section 4.5).Risk from concomitant use of sedative medicines such as benzodiazepines or related medicines:Concomitant use of Lisomucil Cough Sedative and sedative medicines such as benzodiazepines or related medicines can cause sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicinal products should be limited to patients for whom alternative treatment options are not possible. If a decision is made to prescribe Lisomucil Cough Sedative together with sedative medicinal products, the lowest effective dose should be used and the duration of treatment should be as short as possible (see also general dose recommendations in section 4.2). Patients should be monitored closely for signs and symptoms of respiratory depression and sedation. In this regard, it is strongly recommended to inform patients and their carers (where applicable) so that they are aware of these symptoms (see section 4.5). Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the population is a poor metaboliser for CYP2D6. 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 section 4.5). Concomitant use of dextromethorphan and CYP2D6 inhibitors may enhance and prolong the effects of dextromethorphan (see section 4.5). Dextromethorphan should be used with caution in patients taking serotonergic drugs such as selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants (see section 4.5). Due to the potential for histamine release, the use of sedative Lisomucil cough in mastocytosis is not recommended. Serotonin Syndrome: Serotonergic 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), altering drugs the metabolism of serotonin (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 Lisomucil Cough Sedative should be discontinued. Pediatric population: In children, serious adverse events, including neurological disorders, may occur in case of overdose. People caring for patients should be advised not to exceed the recommended dose. In the case of a productive cough, with significant mucus production (for example in patients with bronchiectasis or cystic fibrosis) or in patients with neurological conditions associated with a marked reduction in the cough reflex (such as stroke, Parkinson's disease or dementia), treatment antitussive with dextromethorphan should be administered only after a careful evaluation of the risk / benefit ratio and with particular caution. Important information about some of the ingredients: Lisomucil Cough Sedative contains 24 g of sucrose per maximum daily dose. To be taken into consideration in people with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. Lisomucil Cough Sedative contains 364 mg of sorbitol per maximum daily dose equivalent to 5.2 mg / kg. Sorbitol is a source of fructose. Patients with hereditary fructose intolerance should not be given this medicine. The medicine contains methyl and propyl para-hydroxybenzoates which can cause allergic reactions, even if delayed.

Pregnancy and breastfeeding

Pregnancy: Dextromethorphan is not teratogenic: Prospective studies in a limited number of women have not shown a teratogenic risk. At the end of pregnancy, the administration of dextromethorphan to the mother, even if only for a short time, can cause respiratory depression in the newborn. Chronic administration of dextromethorphan during the last 3 months of pregnancy may be the cause of withdrawal symptoms in the newborn. The use of the medicinal product is contraindicated in pregnant women (see section 4.3).Feeding time:Dextromethorphan is excreted in breast milk. Some cases of hypotonia and respiratory pauses have been described in infants after the mother had taken other centrally acting anti-cough drugs at higher than therapeutic doses. Since a respiratory depressive effect on the infant cannot be excluded, this medicinal product is contraindicated during breastfeeding (see section 4.3).

Expiry and retention

Store below 25 ° C. Keep the container tightly closed and protected from light.

Interactions with other drugs

Dextromethorphan may increase the risk of serotonin intoxication (serotonin syndrome), especially when taken with other serotonergic agents, such as monoamine oxidase inhibitors (MAOIs) or selective serotonin reuptake inhibitors (SSRIs, such as fluoxetine, paroxetine, sertraline, fluvoxamine). In particular, pre-treatment or concomitant treatment with drugs that affect the metabolism of serotonin, such as MAOI antidepressants, can lead to the development of serotonin syndrome, with characteristic symptoms such as psychomotor hyperactivity, autonomic hyperactivity and alterations in mental status. - The combination of drugs containing monoamine oxidase inhibitors (MAOIs) and dextromethorphan can be lethal, with the appearance of muscle stiffness, hyperpyrexia, hyperexcitability, apnea and laryngospasm. Alcohol: Reduced alertness can be dangerous for driving vehicles or using machines. The consumption of alcoholic beverages should be avoided during treatment due to the risk of increased sedative effect of dextromethorphan (see section 4.4). Other sedative medicines such as benzodiazepines or related drugs: Concomitant use of opioids with 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 the CNS . The dose and duration of concomitant use should be limited (see section 4.4). Interactions to be considered: - Other substances that depress the central nervous system (opioid analgesics, some antidepressants, anti-H1 antihistamines, barbiturates, benzodiazepines, clonidine and related products, hypnotic drugs, neuroleptics, anxiolytics other than benzodiazepines): enhancement of central nervous system depression. Reduced alertness can be dangerous for driving vehicles or using machines. - Other morphine derivatives (analgesics or cough suppressants): respiratory depression (potentiation of the depressive effects of morphine derivatives), especially in the elderly patient. - Drugs in which cytochrome CYP2D6 is involved in their metabolism. - 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, quinidine and propafenone, sertraline, bupropion, haloperidol, 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. It has been confirmed that fluoxetine can inhibit the metabolism of dextromethorphan and consequently poses a risk of morphine-like intoxication. The reverse reaction is also possible with the risk of developing a serotonin syndrome (mental confusion, agitation, hyperreflexia, hyperthermia, sweating, myoclonus). If dextromethorphan is used in combination with secretolytics in patients with pre-existing diseases of the respiratory tract, such as cystic fibrosis and bronchiectasis, suffering from mucus hypersecretion, the reduction of the cough reflex can lead to a severe accumulation of mucus, therefore treatment in case of irritating cough with considerable mucus production, treatment with dextromethorphan should be administered with particular caution and after a careful risk-benefit assessment.

Overdose

Symptoms and signsOverdose of dextromethorphan 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 can be observed: coma, respiratory depression, convulsions. Serotonin syndrome has been reported in the context of dextromethorphan overdose. Cases with fatal outcome have been reported following a combination of overdose of dextromethorphan and other drugs (combination poisoning).ManagementActivated charcoal can be given to asymptomatic patients who have ingested overdoses of dextromethorphan within the previous hour. 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 contain:Active principle: dextromethorphan hydrobromide 0.3 g.Excipients with known effects:sucrose, sorbitol, methyl para-hydroxybenzoate and propyl para-hydroxybenzoate. For the full list of excipients, see section 6.1.

Excipients

Sucrose, 70% sorbitol, methyl para-hydroxybenzoate, propyl para-hydroxybenzoate, orange flavor, purified water.