LISOMUCIL COUGH SED SCIR 100 ML

LISOMUCIL SEDATIVE TOSSE 15 MG / 5 ML SCIROP

active ingredients

100 ml contain: Active ingredient: bromitted dextromethtorphan 0,3 g. Excipients with known effects: sucrose, sorbitol, para-hydroxybenzoate methyl and para-hydroxybenzoate propile. For the full list of excipients, see paragraph 6.1.

Excellent

Saccarosio, 70% sorbitol, methyl para-hydroxybenzoate, propile para-hydroxybenzoate, orange aroma, purified water.

Therapeutic indications

Syntomatic treatment of dry cough.

Contraindications

- hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1, - children under the age of 6, - pregnancy and breastfeeding (see paragraph 4.6), - bronchial asthma, BPCO, pulmonary infection or respiratory depression, - respiratory failure, - in the case of contemporary treatment or in the two weeks following therapy with antidepressive drugs type MAO inhibition,

Dosage

Posology. Adults and teenagers over 12 years: The recommended dose is 30 mg (corresponding to 10 ml) up to 4 times a day, if necessary, with a range 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 necessary, with a range of at least 6 hours. The maximum daily dose is 60 mg. Do not exceed the maximum daily dose. Lisomucil Sedative cough is contraindicated in children under the age of 6 (see section 4.3). The dosage must be halved in elderly patients or patients with kidney and/or liver failure, especially in patients with severe impairment. The dose may possibly be increased according to tolerance and need or the interval between doses may be increased. Duration of treatment: Treatment should not exceed 5 days. Method of administration: The dose should be taken preferably after meals. Don't dilute. A spoon is attached to the package. Instructions for opening the bottle : The bottle is equipped with a “child-proof” safety cap. To open the bottle it is necessary to press the cap against the capsule and unscrew. To close the bottle reboot the cap.

Conservation

Store at a temperature below 25°C. Keep the container well closed and sheltered from light.

Warnings

Before starting a cough treatment, you should study the causes that require specific etiological treatment. Do not use for extended treatments over 5 days: if after this period of treatment no appreciable results have been obtained to reevaluate the situation. Dextromethtorphan is not recommended for suppressing chronic cough. The productive cough, being an essential factor of bronchopulmonary defense, should not be suppressed. Consequently, the concomitant use of an expectant or mucolitic drug for the treatment of cough is not rational. Carefully administer in subjects with altered liver and/or kidney function. The dextrometorphan can give addiction. As a result of prolonged use, patients can develop tolerance to the drug, as well as mental and physical dependence. Cases of detachment and detachment were reported. It is recommended to pay special attention to teenagers, young adults and children, as well as patients with a history of alcoholism, drug abuse or psychoactive substances. Patients with a tendency to abuse or dependence must take Lisomucil Sedative Tosse for short periods and be carefully monitored. Alcohol intake during treatment is not recommended. The dextromethtorphan, in fact, enhances the inhibitory effect of alcohol on the central nervous system (see paragraph 4.5). Risk resulting from the concomitant use of sedative medicines such as benzodiazepines or related medicines: Concurrent use of Lisomucil Sedative cough and sedative medicines such as benzodiazepines or related medicines can cause sedation, respiratory depression, coma and death. Due to these risks, the concomitant prescription with these sedative medicines must be limited to patients for whom alternative treatment options are not possible. If you decide to prescribe Lisomucil Tosse Sedativo together with sedative medicines, the minimum effective dose must be used and the duration of treatment must be as short as possible (see also the general recommendations on the dose in paragraph 4.2). Patients should be carefully followed for signs and symptoms of respiratory depression and sedation. In this regard, it is strongly recommended to inform patients and people who take care of them (where applicable) so that they are aware of these symptoms (see paragraph 4.5). The rightmetorphan is metabolized by the liver cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the population is a slow metabolizer for 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 paragraph 4.5). Concurrent use of dextromethtorphan and CYP2D6 inhibitors can increase and prolong the effects of dextromethtorphan (see paragraph 4.5). Dextromethtorphan should be used with caution in patients taking serotoninergic drugs such as selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants (see paragraph 4.5). Due to the potential release of istamine, the use of Lisomucil sedative cough in case of mastocytosis is not recommended. Serotonin 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 Lisomucil Sedative Tosse should be stopped. 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. In case of productive cough, with considerable production of mucus (e.g. in patients with bronchiectasia or cystic fibrosis) or in patients with neurological pathologies associated with a marked reduction of cough reflex (such as stroke, Parkinson's disease or dementia), the antitussive treatment with dexterphan should be administered only after careful evaluation of the risk/benefit ratio and with particular caution. Important information about some excipients: Lisomucil Sedative cough contains 24 g sucrose per daily maximum dose. To consider in people with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or sucrasis-isomaltase failure should not take this medicine. Lisomucil Sedative cough contains 364 mg of sorbitol per daily maximum 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 drug contains methyl and propile para-hydroxybenzoates that can cause allergic reactions even delayed.

Interactions

Dextromethtorphan can increase the risk of serotonin intoxication (serotonin syndrome), especially if taken with other serotoninergic agents, such as monoamino oxidase inhibitors (IMAO) or selective serotonin reuptake inhibitors (SSRI, such as fluoxetine, paroxetine, sertralin, fluvoxamina). In particular, pretreatment or concomitant treatment with drugs affecting serotonin metabolism, such as antidepressants of the IMAO type, can determine the development of serotoninergic syndrome, with characteristic symptoms such as psychomotor hyperactivity, autonomic hyperactivity and alterations of the mental state. - The combination of drugs containing monoaminooxidase inhibitors (IMAO) and dextromethtorphans can be lethal, with the appearance of muscle stiffness, hyperpyrexia, hypereccitability, apnea and larynxia. Alcohol: reduced supervision can be dangerous for driving vehicles or using machinery. The consumption of alcoholic beverages must be avoided during treatment, due to the risk of increased sedative effect of the right-hometorphan (see paragraph 4.4). Other sedative medicines such as benzodiazepines or related drugs: Concurrent use of opioids with sedative action 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 dose and duration of concurrent use must be limited (see paragraph 4.4). Interactions that must be taken into account: - Other substances depressing the central nervous system (opioid analgesics, some antidepressants, antihistamines anti H1, barbiturates, benzodiazepines, clonidine and related products, hypnotic drugs, neuroleptics, anxiolytics other than benzodiazepines): strengthening the depression of the central nervous system. Reduced supervision can be dangerous for driving vehicles or using machinery. - Other derivatives of morphine (analgesic or cough sedatives): respiratory depression (powering depressive effects of morphine derivatives), especially in the elderly patient. - Drugs in which metabolism intervenes the cytochrome CYP2D6. - CYP2D6 inhibitors: the dextromethtorphan is metabolized by the CYP2D6 and has a wide first-pass metabolism. 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. Amiodarone, flecainide, chinidine and propafenone, sertralin, bupropion, aloperidol, methadone, cinacalcet, aloperidol, perfenazine and thiodazine also have similar effects on the metabolism of the rightmethtorphan. 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. It has been confirmed that fluoxetine can inhibit the metabolism of the dextromethtorphan and consequently constitutes a risk of morphine-similar intoxication. The reverse reaction is also possible with the risk of occurrence of a serotoninergic syndrome (mental confusion, agitation, hyperreflection, hyperthermia, sweating, myclonies). If the dextromethtorphan is used in combination with secretolytics in patients with pre-existing respiratory diseases, such as cystic fibrosis and bronchiettasia, affected by mucus hypersecretion, the reduction of cough reflex may lead to a serious accumulation of mucus, therefore the treatment in case of irritating cough with a remarkable production of mucus, the treatment with dex must be administered with particular caution.

Effects

The following table shows the adverse reactions that may occur. Frequency classes are defined as follows: very common (≥ 1/10); common (≥ 1/100, Type MedDRA Frequency Undesirable effects Pathologies of skin and subcutaneous tissue Town itching Notable skin rash Pathologies of the eye Notable midriasis (after taking high doses) Gastrointestinal diseases Very common nausea, vomiting, constipation Diseases of the nervous system Very common drowsiness, dizziness Notable disartria, nistagmo, distonia (especially in children), agitation (after taking high doses). Ear and labyrinth pathologies Notable vertigo Immune system disorders Notable hypersensitivity reactions including anaphylactic reaction, angioedema, hives, fixed eruption from drugs, bronchospasm Psychiatric disorders Town confusion Very rare abuse and dependence Notable hallucination, psychotic disorder Systemic pathologies and conditions for administration Town fatigue 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

Symptoms and signs The overdose of dextromethtorphan can be associated with nausea, vomiting, dystonia, agitation, confusion, drowsiness, astonishment, nistagm, cardiotoxicity (tachycardia, abnormal ECG including the extension of the QTc range), ataxia, toxic psychosis with visual hallucinations, hypereccitability. In case of massive overdose, the following symptoms can be observed: coma, respiratory depression, seizures. Serotoninergic syndrome has been reported in the context of overdose by dextromethtorphan. Cases with fatal outcome were reported as a result of combination of overdose of dextromethtorphan and other drugs (association poisoning). Management -Active carbon can be administered to asymptomatic patients who ingested overdose of dextromethtorphan in the previous hour. -For patients who have ingested the rightmetorphan and are sedated or comatose, naloxone can be considered, in the usual doses for the treatment of overdose from opioids. Benzodiazepines can be used for convulsions and benzodiazepines and external cooling measures for hyperthermia from serotonin syndrome.

Pregnancy

: The rightmetorphan is not teratogenic: perspective studies in a limited number of women have not shown a teratogenic risk. At the end of pregnancy the administration of dextromethtorphan to the mother, although only for a short period, can cause respiratory depression in the newborn. Chronic administration of dextromethtorphan during the last 3 months of pregnancy can be the cause of withdrawal symptoms in the newborn. The use of the medicinal product is contraindicated in pregnant women (see paragraph 4.3).

Nursing:

Dextrometh0orphan is excreted in breast milk. Some cases of hypotonia and respiratory breaks were described in infants after the mother had taken other central-action anti-tox drugs at doses higher than therapeutic ones. Since a respiratory depressive effect on the infant cannot be excluded, this medicine is contraindicated during breast milk feeding (see paragraph 4.3).

Source: Farmadati