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BECHILAR * SCIR FL 100ML 3MG / ML

  • MONTEFARMACO OTC SpA
  • 018130029
Bechilar is a drug based on the active ingredient dextromethorphan hydrobromide (FU) - belonging to the category of Opioid Antitussives and specifically Opium Alkaloids and its derivatives. Bechilar can be prescribed with OTC Recipe - self-medication. Cough suppressant.
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BECHILAR * SCIR FL 100ML 3MG / ML

Therapeutic indications

Cough suppressant with central action. Cough suppressant.

Dosage and method of use

Adults: 1 teaspoon to 3 times a day. Teens and children over 2 years old: half to a coffee spoon 1 to 3 times a day, depending on age. Do not exceed the recommended dose. Do not use in children under the age of two unless otherwise indicated by a doctor.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Patients with chronic respiratory problems. Patients who are taking or have taken monoamine oxidase inhibitor antidepressants (MAOIs) within the last two weeks.

Side effects

Nervous system disorders : sleepiness; dizziness. Gastrointestinal disorders : gastrointestinal disorders; nausea; He retched; abdominal discomfort.Reporting of suspected adverse reactionsReporting 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 www.aifa.gov.it/content/segnalazioni-sospette-reazioni-avverse.

Special warnings

In the absence of a therapeutic response within a few days, consult your doctor; the treatment must not be continued beyond 5-7 days. The product is not recommended in asthmatic patients. Administer with caution in subjects with impaired liver function. Cases of dextromethorphan abuse and dependence have been reported. Special care is recommended with adolescents and young adult children, as well as with patients with a history of alcoholism and / or drug or psychoactive substance abuse. Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the population metabolize CYP2D6 slowly. 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 also section 4.5). Concomitant use of Bechilar and sedative drugs such as benzodiazepines or related substances can cause sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing / counseling of these sedative medications should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe or recommend Bechilar at the same time as sedative medications, the lowest possible dose of Bechilar should be administered and the duration of treatment should 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 their carers to pay attention to these symptoms (see section 4.5). 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), drugs that alter 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 Bechilar should be stopped. This medicine contains fructose as an excipients therefore patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicine contains Methyl p-hydroxybenzoate and Propyl p-hydroxybenzoate among the excipients therefore it can cause allergic reactions (even delayed). Serious adverse events, including neurological disorders, may occur in children in case of overdose. People caring for patients should be advised not to exceed the recommended dose.

Pregnancy and breastfeeding

Do not use during pregnancy and lactation, except in case of real need and under direct medical supervision.

Expiry and retention

This medicinal product does not require any special storage conditions

Interactions with other drugs

Administration of dextromethorphan in patients who have received MAO inhibitors can cause serious adverse reactions, including serotonin syndrome. Patients should consult their physician before taking dextromethorphan in case of concomitant therapy with selective serotonin reuptake inhibitor antidepressants or tricyclic antidepressants as serotonin syndrome may occur. Do not use at the same time and in the weeks following antidepressant therapy. It is not advisable to use alcohol during therapy because it can accentuate the undesirable effects of the drug.CYP2D6 inhibitorsDextromethorphan 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 and propafenone, sertraline, bupropion, 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.Sedative drugs such as benzodiazepines or related substancesConcomitant 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 depressant effect on the central nervous system. The dose of Bechilar and the duration of concomitant use should be limited (see section 4.4).

Overdose

Overdose 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. Management: Activated 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. If undesirable effects other than those described above occur, the patient must notify their doctor.

Active principles

100 mL of syrup (1 bottle) contains: Active ingredient: Dextromethorphan hydrobromide 300 mg Excipients: Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Fructose, For a full list of excipients, see section 6.1

Excipients

One bottle of syrup contains:Fructose, Glycerol, Citric acid monohydrate, Sodium hydroxide, Black cherry flavor, Potassium acesulfame, Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Purified water.

018130029
12 Items

Data sheet

Packaging
3 mg / ml syrup 100 ml bottle
Product Type
HUMAN DRUG
ATC code
R05DA09
ATC description
Dextromethorphan
Therapeutic Group
Opioid antitussives
Active principle
dextromethorphan hydrobromide (FU)
Class
C.
Pharmaceutical form
syrup
Type of Administration
oral
Container
bottle
Quantity
1 vial / vial / vial
Capacity
100 milliliters
Quantity of the Active Ingredient
3MG
Recipe required
OTC - self-medication medicine