BISOLVON TOSSE SED SCIR 2MG/ML

BISOLVON SEDATIVE TOSSE 2 MG/ML

active ingredients

Bisolvon sedative cough 2 mg/ml syrup - 200 ml bottle 100 ml of syrup contain: dextromethtorphan bromirate 200 mg. Excipients with known effects: liquid maltitol, methyl-parahydroxybenzoate, glycol propylene (E 1520) 991,22 mg in 15 ml or 330,41 mg in 5 ml syrup (see paragraph 4.4). For the full list of excipients see paragraph 6.1.

Excellent

Saccarina, liquid maltitol, glycol propylene (E 1520), vanilla aroma, apricot aroma, methyl-parahydroxybenzoate, purified water.

Therapeutic indications

Syntomatic treatment of dry cough.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. Bronchial asthma, BPCO (chronic obstructivebroncopneumopathy), pneumonia, pulmonary infection respiratory difficulty, respiratory failure, respiratory depression, cardiovascular disease, hypertension, hyperthyroidism, glaucoma, prostate hypertrophy, gastroenteric and urogenital stenosis, epilepsy, severe liver disease. First trimester of pregnancy and nursing with breast milk (see paragraph 4.6). Children under 6 years of age. Do not use at the same time or in the next two weeks at MAO inhibitive antidepressants (see paragraph 4.5).

Population

Adults and adolescents over 12 years The recommended dose is 30 mg (corresponding to 15 ml, equal to 3 scoops of 5 ml each) 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 5- 10 mg (corresponding to 2.5 - 5 ml of the dosing scoop) up to 6 times a day, if necessary, with a range of at least 4 hours. The maximum daily dose is 60 mg. Do not exceed the maximum daily dose. Bisolvon sedative cough is contraindicated in children under the age of 6 (see paragraph 4.3). The maximum duration of treatment is 5 days.

Conservation

This medicine does not require any special condition of conservation.

Warnings

The right-metorphan can give a moderate addiction. As a result of prolonged use, patients can develop tolerance to the drug, as well as mental and physical dependence. Patients with a tendency to abuse or dependence should take Bisolvon sedative cough for short periods and be carefully monitored. Cases of abuse and detachment were 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. Sedative cough bisolvon should be used with caution in patients taking serotoninergic drugs (other than inhibition drugs of MAO), such as selective serotonin reuptake inhibitors (SSRIs) (e.g. fluoxetine, paroxetine) or tricyclic antidepressant drugs (see paragraph 4.5). Risk resulting from the concomitant use of sedative medicines such as benzodiazepines or related medicines: Concurrent use of Bisolvon 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 Bisolvon sedative cough together with sedative medicines, the lowest effective minimum dose should be used and the duration of treatment should 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). There is limited information on the use of dextromethtorphan in patients with impairment of liver or kidney function. Therefore, Bisolvon sedative cough should be given with caution in such patients, especially in patients with severe renal impairment. Due to the potential release of histamine, the use of Bisolvon sedative cough in case of mastocytosis is not recommended. Chronic cough may be an early symptom of asthma and therefore Bisolvon sedative cough is not indicated for the suppression of chronic cough, especially in children. In case of productive cough, with a remarkable production of mucus (e.g. in patients suffering from pathologies such as bronchiettasia and cystic fibrosis) or in patients suffering from neurological diseases associated with a marked reduction of cough reflex (such as stroke, Parkinson's disease and dementia), the treatment of Bisolvon sedative cough as sedative cough should be given with particular caution after a careful evaluation 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 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). 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 serotonin reuptake inhibitors (selective serotonin reuptake inhibitors, SSRI), drugs that alter serotonin metabolism (selective serotonin [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, the treatment with Bisolvon 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. Important information about some excipients Bisolvon sedative cough contains methyl-parahydroxybenzoate. It can cause allergic reactions (also delayed). The recommended maximum daily dose of Bisolvon sedative cough contains 52,08 g of liquid maltyt. It can have a slight laxative effect. The caloric value of maltitol is 2.3 kcal/g. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Bisolvon Tosse Sedativo contains less than 1 mmol (23 mg) of sodium per dose, both for adults and for children, i.e. it is essentially “without sodium”. This medicine contains 991.22 mg of glycol propylene per dose (15 ml) in adults and adolescents over 12 years and 330.41 mg per dose (5 ml) in children aged 6 to 12 years, equivalent respectively to 56.64 mg/kg per day in adults, to 99.12 mg/kg per day in adolescents aged 12 years and to 96.68 mg/kg/day in children aged 6 years. Although glycol propylene has not shown toxic effects on reproduction and development in animals or humans, it can reach fetus and has been found in breast milk. As a result, the administration of glycol propylene to pregnant or breastfeeding patients should be considered randomly. Clinical monitoring is required for patients with liver or kidney failure due to various adverse events attributed to glycol propylene such as kidney dysfunction (acute tubular necrosis), acute kidney damage and liver dysfunction. Alcohol intake during treatment is not recommended. Dextromethtorphan enhances the inhibitory effect of alcohol on the central nervous system (see paragraph 4.5).

Interactions

The dextromethtorphan possesses weak serotoninrgical properties. Dextromethtorphan can therefore lead to an increase in the risk of serotoninnergic toxicity (serotoninnergic syndrome), especially if taken together with other serotoninergic agents, such as MAO inhibitors or SSRIs or tricyclic antidepressants. Especially pre-treatment or concomitant treatment with drugs that compromise serotonin metabolism, such as antidepressant drugs of the type MAO inhibitors can induce the development of a serotoninergic syndrome with the following characteristic symptoms such as neuromuscular hyperactivity (e.g. tremor, clonic spasm, myoclonus, increased reflex response and stiffness of pyramidal origin), hyperactivity of the autonomic nervous system (e.g. diaphoresis, fever, tachycardia, tachypnea, midriasis) and altered mental state (e.g. agitation, excitement, confusion) (see paragraph 4.3 (fake MAO inhibitors) and 4.4). Concurrent administration of drugs with an inhibitory effect on the central nervous system such as hypnotic, sedative or anxiolytic, or alcohol intake, can lead to additive effects. Other sedative medicines such as benzodiazepines or related medicines: 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). 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,tioridazine, cimetidine, ritonavir and berberin 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. Although they are no longer taken, these effects may occur if these medicines have recently been taken. If 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 severe accumulation of mucus, therefore in case of irritating cough with a remarkable production of mucus, the treatment with dextrophine should be given with particular caution and after a careful risk.

Effects

Adverse reactions are listed below by classification for systems and organs and by frequency, according to the following categories: Very common ≥ 1/10 Common ≥ 1/100, Immune disorders. Not known: hypersensitivity reactions including anaphylactic reaction, angioedema, hives, fixed eruption from drugs, bronchospasm. Psychiatric disorders. Municipalities: confusion; Very rare: hallucinations, abuse and addiction. Nervous system pathologies. Very common: drowsiness, dizziness; Municipality: vertigo; Notable: disartria, nistagmo, distonia especially in children. Gastrointestinal pathologies. Common: nausea, vomiting, gastrointestinal disorders, constipation and appetite reduction. Pathologies of skin and subcutaneous tissue. Note: erythema, rash, itching. Systemic pathologies and conditions for administration. Common: 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. Dextromethtorphan can lead to an increase in the risk of serotoninnergic syndrome, a risk that is increased in case of overdose, especially in case of concomitant intake of other serotoninergic agents. Cases of fatal outcomes were reported with overdose combined with dextromethtorphan and other drugs (combination poisoning Management Active carbon can be administered to asymptomatic patients who ingested overdose of dextromethtorphan in the previous hour. For patients who have ingested dextromethtorphan and are sedated or comatose, naloxone can be considered, in the usual doses for the treatment of opioid overdose. Benzodiazepines can be used for convulsions and benzodiazepines and external cooling measures for hyperthermia from serotonin syndrome.

Pregnancy

The results of epidemiological studies on a limited sample of population did not indicate an increase in the frequency of malformations in children who were exposed to dextrogen during the prenatal period. However, these studies do not adequately document the period and duration of treatment with dextromethtorphan. Non-clinical studies on reproductive toxicity do not indicate a potential risk for man (see paragraph 5.3) for the rightmetorphan. Bisolvon sedative cough should not be used during the first three months of pregnancy (see paragraph 4.3); moreover, since the administration of high doses of dextromethtorphan, even for short periods, may cause respiratory depression in infants, in the following months the drug must be administered only in case of actual need and after careful evaluation of benefits and risks.

Food

Since it is not known the excretion of the drug in breast milk and cannot be excluded an effect of respiratory depression on the infant, Bisolvon sedative cough is contraindicated during breast milk lactation (see paragraph 4.3).

Fertility

On the basis of the non-clinical experience available, there were no effects on fertility as a result of the use of dextromethtorphan (see paragraph 5.3).

Source: Farmadati