RECOTUSS SEDATIVE SCIR 100ML

RECOTUSS SEDATIVE

active ingredients

Chewable tablets Each chewable tablet contains 6.5 mg of bromidrate dextromethtorphan (equal to 5,007 mg of dextromethtorphan). Excipients with known effects: Sucrose. Syrup 1 ml of syrup contains 2.0 mg of bromirate dextromethtorphan (equal to 1,541 mg of dextromethtorphan). Excipients with known effects: Sucrose, ethanol and p-hydroxybenzoate methyl. For the full list of excipients, see paragraph 6.1.

Excellent

Chewable tablets Saccarosio Silice precipitated Sodium stearato Gomma arabica Aroma balsaamico Syrup Ethanol Sorbitol solution Saccarosio Glicerolo Metile para-hydroxybenzoato Aroma Lemon Aroma Menta Purified water

Therapeutic indications

Syntomatic treatment of cough.

Contraindications

Hypersensitivity to the active ingredient or other chemicals related substances, or to any of the excipients listed in the paragraph 6.1. Do not administer during or in the two weeks following antidepressant therapy.

Population

Chewable tablets Adults: dissolve in the mouth two tablets, three-four times a day. Syrup Adults: a scoop (tack “5 ml” of the dosing spoon included in the package) three-four times a day. Do not exceed the recommended doses. Pediatric population Chewable tablets Children over two years: dissolve in the mouth a tablet, three-four times a day. Syrup Children over two years: half a scoop (table “2.5 ml” of the dosing spoon included in the package) three-four times a day.

Conservation

Syrup: do not store at temperature above 30°C.

Warnings

After 5-7 days of treatment without appreciable results consult your doctor. Dextromethtorphan should be used with caution in debilitated patients. The product is not recommended in asthmatic patients. Cases of 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. Risk resulting from the concomitant use of sedative medicines such as benzodiazepines or related drugs: concurrent use of Sedative Recotuss and sedative drugs such as benzodiazepines or related drugs can cause sedation, respiratory depression, coma and death. Due to these risks, the concomitant prescription with these sedative medicines must be reserved to patients for whom alternative treatment options are not possible. If the decision is taken to prescribe Recotuss Sedative in conjunction with sedative medicines, the lowest effective dose must be used and the duration of treatment must be as short as possible. Patients must be carefully monitored for signs and symptoms of respiratory depression and sedation. In this regard, it is strongly recommended to inform patients and those who assist them to control these symptoms (see paragraph 4.5). Pediatric population In children under two years the preparation should only be administered in case of actual need and under the direct control of the doctor. 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). Recotuss Sedativo contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine.

Interactions

Alcohol use is not recommended during therapy. 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 destrometorfano.Interazione with other sedative medicines such as benzodiazepines or related medicines Concurrent use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death due to the additive depressive effect on SNC. The dose and duration of concomitant use must be limited (see paragraph 4.4).

Effects

During therapy may occur drowsiness, gastrointestinal disorders (nausea, vomiting) dizziness. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring 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.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

As a symptom of overdose can manifest mental confusion and strong excitement. High dosages can induce respiratory depression.

In pregnant women, the preparation must be administered only in case of actual need and under the direct control of the doctor.

Source: Farmadati