CORYFIN SEDATIVE FLUIDIF SCIR

CORYFIN SEDATIVE FLUIDIFICATION 20 MG/G + 1 MG/G

active ingredients

1 ml of syrup contains 22.6 mg of sulphonate potassium and 1.1 mg of bromirate dextromethtorphan. Excipients with known effects: sucrose, ethanol, methyl parahydroxybenzoate sodium, propile parahydroxybenzoate sodium and sodium. For the full list of excipients, see paragraph 6.1.

Excellent

Saccarosium, ethanol, chloride sodium, sodium parahydroxybenzoate methyl, monoammonic glyrrizinate, mint aroma, propile parahydroxybenzoate sodium, purified water.

Therapeutic indications

Syntomatic treatment of cough.

Contraindications

Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. Do not use at the same time or in the 2 weeks following treatment with antidepressant MAO inhibitors (see paragraph 4.5). Bronchial asthma, BPCO, pneumonia, respiratory difficulty, respiratory depression, cardiovascular disease, hypertension, hyperthyroidism, glaucoma, prostate hypertrophy, gastroenteric and urogenital stenosis, epilepsy, severe liver disease. Children under 2 years of age. Pregnancy, particularly in the first quarter, breastfeeding (see paragraph 4.6).

Population

Population Adults and teenagers over 12 years old The recommended dose is 20 ml (corresponding to 2 scoops of 10 ml), 1 - 3 times a day. Do not exceed the maximum daily dose (corresponding to 60 ml). Children from 6 to 12 years The recommended dose is 10 ml (corresponding to 1 scoop of 10 ml) 1 - 3 times a day. Do not exceed the maximum daily dose (corresponding to 30 ml). Children from 2 to 6 years The recommended dose is 5 ml (corresponding to a measurin of 10 ml) 1 - 3 times a day. Do not exceed the maximum daily dose (corresponding to 15 ml). Children under 2 years Coryfin Fluidifier Sedative is contraindicated in children under 2 years of age (see paragraph 4.3). 1 ml syrup contains: 22.6 mg of sulphonate potassium and 1.1 mg of bromirate dextromethtorphan. Duration of treatment Treatment should not exceed 7 days. Method of administration The dose should be taken away from meals. The package contains a measuring measuring measuring measuring measuring measuring measuring cups corresponding to the capacity of 1.25 ml, 2.5 ml, 5 ml and 10 ml.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Cases of detachment 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. 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 CORYFIN SEDATIVE FLUIDIFICATION must be interrupted. The dextromethtorphan is metabolized by the hepatic cytochrome P450 2D6 (CYP2D6). 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). Do not exceed the recommended doses. If after 7 days of treatment you do not get the expected therapeutic results you need to reevaluate the patient. Chronic cough may be an early symptom of asthma and therefore dextromethtorphan is not indicated for the suppression of chronic or persistent cough (e.g. smoke, emphysema, asthma). The dextromethtorphan should be given with particular caution and if necessary in case the cough is accompanied by other symptoms such as: fever, rash, headache, nausea and vomiting. In case of irritating cough with a remarkable production of mucus, the treatment with dextromethtorphan must be administered with particular caution and only on medical advice after careful assessment of the risk-benefit. Carefully administer in subjects with altered liver or kidney function, especially in patients with severe impairment. Risk resulting from the concomitant use of sedative medicines such as benzodiazepines or related medicines Concurrent use of CORYFIN SEDATIVO FLUIDIFICANTE and medicines with sedative action such as benzodiazepines or related medicines can cause sedation, respiratory depression, coma and death. Due to these risks, the concomitant prescription of these sedative medications must be limited to patients for whom alternative therapeutic options are not possible. If the decision is made to prescribe CORYFIN SEDATIVE FLUIDIFICATION in conjunction 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 dose 4.2). Patients should be carefully followed to recognize signs and symptoms of respiratory depression and sedation. In this regard, it is strongly recommended to inform patients and those who take care of them (where applicable) so that they are aware of these symptoms (see paragraph 4.5). Alcohol intake during treatment is not recommended. 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. CORYFIN SEDATIVO FLUIDIFICANTE contains: • sucrose: patients suffering from rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. This medicine contains 6.78 g sucrose per dose (2 scoops = 20 ml, corresponding to the recommended dose for teenagers over 12 years). To consider in people with diabetes mellitus. • ethanol: - A dose of 5 ml of this medicine (administrated to a child of 2 years of age who weighs 13.5 kg) would result in an exposure to 20.92 mg/kg of ethanol which can cause an increase in the concentration of alcohol in the blood (BAC) of about 3.5 mg/100 ml. - A dose of 10 ml of this medicine (administrated to a child of 6 years of age who weighs 22 kg) would result in an exposure to 25,68 mg/kg of ethanol which can cause an increase in the concentration of alcohol in the blood (BAC) of about 4.3 mg/100 ml. - A dose of 20 ml of this medicine (administrated to a 12-year-old child weighing 46 kg) would result in exposure to 24,56 mg/kg of ethanol which can cause an increase in blood alcohol concentration (BAC) of about 34.1 mg/100 ml. • sodium parahydroxybenzoate, propile parahydroxybenzoate sodium: can cause allergic reactions (also delayed). • sodium: this medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘without sodium’.

Interactions

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 concurrent use 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. MAO inhibitor drugs Concurrent administration of dextromethtorphan with MAO inhibitors is contraindicated. In addition, you should not hire CORYFIN SEDATIVE FLUIDIFICATION in the two weeks following the treatment with MAO inhibitor drugs (see paragraph 4.3). The association of these drugs can, in fact, induce the development of a serotoninergic syndrome characterized by the following symptoms: nausea, hypotension, neuromuscular hyperactivity (tremity, clonic spasm, myoclonus, increased reflex response and stiffness of pyramidal origin), hyperactivity of the autonomic nervous system (diaphoresis, fever, tachycardia, tachypnea, midriasis) and altered mental state (acting, excitement, confusion), until arriving at cardiac arrest and death. Linezolid and sibutramine Serotoninergic syndrome cases have been reported also following the concomitant administration of the bromidrate dextromethtorphan with linezolid or sybutramine. Central nervous system inhibitors Concurrent administration of dextromethtorphan with drugs with an inhibitory effect on the central nervous system such as hypnotics, sedatives or anxiolytics, or with alcohol intake can lead to additive effects on the central nervous system. 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 of SNC. The dose and duration of concurrent use must be limited (see paragraph 4.4).

Effects

The data in the table below describe the adverse reactions that can occur during therapy. Such reactions are not known (frequency cannot be defined on the basis of available data):

Classification for systems and organs according to MedDRA	Undesirable effects
Immune system disorders	hypersensitivity reactions, including anaphylactic reaction, angioedema, hives, itching, rash and erythema.
Psychiatric disorders	hallucinations
Diseases of the nervous system	dizziness, drowsiness
Gastrointestinal diseases	nausea, vomiting, gastrointestinal disorders and appetite reduction
Pathologies of skin and subcutaneous tissue	skin rashes
Systemic pathologies and conditions for administration	fatigue, hyperpyressia

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 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, nigstagmo, 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 may occur: coma, respiratory depression, seizures. Management In case of need to use intensive medical care (in particular intubation, ventilation). Precautions may be required to safeguard heat loss and replenish liquids. - 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. Animal reproductive toxicity studies do not indicate a potential risk for humans (see paragraph 5.3) Destrometorphan bromirate should not be used during the first three months of pregnancy; moreover, since the administration of high doses of bromirate 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 assessment of benefits and risks (see paragraph 4.3). Food Since it is not known the excretion of the dextromethtorphan in breast milk and cannot be excluded an effect of respiratory depression on the newborn, CORYFIN SEDATIVO FLUIDIFICANTE is contraindicated during breastfeeding (see paragraph 4.3).

Source: Farmadati