BECHILAR SCIR FL 100ML 3MG/ML

BECHILAR 3 MG/ML

active ingredients

100 mL syrup (1 bottle) contain: Active ingredient: Destrometorfano bromidrato 300 mg Eccipienti: P-hydroxybenzoate, P-hydroxybenzoate, Fruttosio, For the complete list of excipients, see paragraph 6.1

Excellent

A syrup bottle contains: Fruttosio, Glicerol, Citric acid monohydrate, Sodium hydroxide, Aroma bitter, Potassium acesulfame, P-hydroxybenzoate methyl, Propile p-hydroxybenzoato, Water purified.

Therapeutic indications

Cough sedative with central action. Cough sedative.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. Patients with chronic respiratory disorders. Patients who are taking or hired in the last two weeks antidepressant inhibitors of monoamino-oxidase (IMAO).

Population

Adults: a tea spoon from 1 to 3 times a day. Boys and children over 2 years: half-a tablespoon of coffee 1 to 3 times a day, depending on age. Do not exceed the recommended doses. Do not use in children under two years unless otherwise indicated.

Conservation

This medicine does not require any special condition for conservation

Warnings

In the absence of a therapeutic response within a few days, consult your doctor; treatment should not be protracted over 5-7 days. The product is not recommended in asthmatic patients. Carefully administer in subjects with altered liver function. Cases of detachment and detachment have been reported. It is recommended to pay special attention to teenagers and young adult children as well as patients with a history of alcoholism and/or abuse of drugs or psychoactive substances. 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). Concurrent use of Bechilar and sedative drugs such as benzodiazepines or related substances can cause sedation, respiratory depression, coma and death. Due to these risks, the concomitant prescription/conflict of these sedative drugs must be reserved to patients for whom alternative treatment options are not possible. If you decide to prescribe or advise Bechilar at the same time to sedative drugs, you should administer the lowest possible dose of Bechilar and the duration of treatment must be as short as possible. Patients should be carefully monitored for signs and symptoms of respiratory depression and sedation. Therefore it is strongly recommended to inform patients and people who take care of these symptoms (see section 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 Bechilar must be stopped. This medicine contains fructose among the excipients therefore patients suffering from rare hereditary problems of fructose intolerance, should not take this medicine. This medicine contains p-hydroxybenzoate and p-hydroxybenzoate propile among the excipients therefore can cause allergic reactions (also delayed). 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.

Interactions

Dextromethtorphan in patients who received inhibitors of M.A.O. can cause severe adverse reactions, including serotoninergic syndrome. Patients should consult the doctor before taking the dextromethtorphan in case of concomitant therapy with selective antidepressants of serotonin reuptake or antidepressants as serotoninergic syndrome may occur. Do not use at the same time and in the weeks following antidepressant therapy. Alcohol use is not recommended during therapy because it can accentuate the unwanted effects of the drug. 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 and thiodazine 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. Sedative drugs such as benzodiazepines or related substancesConcurrent use of opioids with sedative drugs such as benzodiazepines or related substances increases the risk of sedation, respiratory depression, coma and death due to the additive depressive effect on the central nervous system. The dose of Bechilar and the duration of concurrent use must be limited (see section 4.4).

Effects

Diseases of the nervous system : drowsiness; dizziness. Gastrointestinal diseases : gastrointestinal disorders; nausea; vomiting; abdominal disorders.Reports 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 www.aifa.gov.it/content/segnalazioni-sospette-reazioni-avverse.

Overdosing

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. 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 overdose from opioids. Benzodiazepines can be used for convulsions and benzodiazepines and external cooling measures for hyperthermia from serotonin syndrome. If there are any side effects other than those described above, the patient must notify his physician.

Do not use during pregnancy and nursing, if not in case of actual need and under direct medical control.

Source: Farmadati