VICKS TOSSE SEDATIVE 180ML MIE

VICKS SEDATIVE TOSSE 1,33 MG/ML SCIROP

active ingredients

100 ml of syrup contain: Active ingredient: bromitted dextromethtorphan 0.133% p/V (0,133 g). Excipients with known effects: • Sucrose: 5.55g/15 ml • Sodium: 28.2 mg/15 ml • Ethanol 96%: 0.592g/15 ml • Reverse sugar (myel): 0.570 g/15 ml • Propylene glycol: 0.850 g/15 ml • Sodium Benzoate 15 mg/15 ml • Fenilalanin (myel) For the full list of excipients, see paragraph 6.1.

Excellent

Saccarosine; sodium saccarin; propylene glycol; ethanol 96 percent; carmellosa sodica; sodium citrate; citric acid anidro; honey aroma (containing honey); verbena aroma; sodium benzoate; polyethylene oxide; menthoxpropandol; polyoxstearate 40; purified water.

Therapeutic indications

Cough sedative.

Contraindications

Hypersensitivity to the active ingredient, structurally similar compounds, or any of the excipients listed in the paragraph 6.1. Do not use at the same time and in the next two weeks to therapy with antidepressant MAO inhibitors (see par.4.5). Bronchial asthma, BPCO (broncopneumopathy chronic obstructive), pneumonia, respiratory difficulty, respiratory depression, cardiovascular disease, hypertension, hyperthyroidism, diabetes, glaucoma, prostatic hypertrophy, stenosis of the gastroenteric and urogenital apparatus, epilepsy, severe liver disease. Do not administer children under 12 years of age. Pregnancy, especially in the first quarter, nursing (see paragraph 4.6).

Population

Adults and teenagers over 12 years: 15 ml (equivalent to 3 teaspoons of coffee). These doses can be repeated every 6 hours, up to 4 times a day. Do not exceed the recommended doses. Children up to 12 years: the dextrometorphan should not be used.

Conservation

Store at a temperature not exceeding 25°C.

Warnings

Treatment with dextromethtorphan should not be protracted over 5-7 days. In the absence of a therapeutic response within a few days, the doctor must reevaluate the situation. The dextrometorphan can give addiction. As a result of prolonged use, patients may develop tolerance to the medicinal product, as well as mental and physical dependence (see paragraph 4.8). Cases of detachment and detachment were reported. It is recommended caution especially for teenagers and young adults, as well as patients with an amnesi of drug abuse or psychoactive substances. Risks arising from the concomitant use of sedative medicines such as benzodiazepines or related drugs Concurrent use of Vicks Tosse Sedative and sedative medicines such as benzodiazepines, or related drugs, can cause sedation, respiratory depression, coma and death. Due to these risks, the concomitant prescription with sedative medicines must be reserved to patients for whom alternative treatment options are not available. If Vicks Tosse is prescribed in conjunction with sedative medicines, the lowest effective dose must be used 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. In this regard, it is strongly recommended to inform patients and anyone who takes care of them in order to make them aware of these symptoms (see paragraph 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 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 Vicks Tosse Sedativo should be interrupted A chronic cough may be an early symptom of asthma and therefore the dextromethtorphan is not indicated for the suppression of chronic or persistent cough (e.g. smoking, emphysema, asthma, etc.), The dextromethtorphan should be given with particular caution and only on medical advice in case the cough is accompanied by other stintomas 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. Information about excipients with known effect: - Sucrose and invert sugar (myel): patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose mal absorption or saccarase-isomaltase failure should not take this medicine. This medicine contains about 5.55 g sucrose (sugar) and 0.570 g inverted sugar (myel) per dose of 15 ml syrup (equal to 3 teaspoons of coffee). To be considered in people with diabetes mellitus or who are following hypocaloric diets. - ethanol (alcohol): this medicine contains 5 vol% of ethanol (alcohol), e.g. up to about 592 mg per dose of 15 ml syrup (equal to 3 teaspoons of coffee), equivalent to less than 15 ml of beer, 6 ml of wine per dose of 15 ml syrup. It can be harmful to alcoholics. To be taken into account in pregnant or nursing women, children and high-risk groups such as people with liver or epilepsy disorders. - sodium: This medicine contains 28.2 mg sodium for 15 ml syrup (equal to 3 teaspoons of coffee), equivalent to 1.40% of the maximum daily consumption recommended by the WHO, which corresponds to 2 g sodium for an adult. - propylene glycol: this medicine contains 850.50 mg of propylene glycol for 15 ml syrup (equal to 3 teaspoons of coffee). Although propylene glycol has not shown toxic effects on reproduction and development in animals or humans, it can reach the fetus and has been found in breast milk. As a result, the administration of propylene glycol to pregnant or breastfeeding patients should be considered randomly. In addition, 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. - sodium benzoato: this medicine contains 15 mg of benzoate sodium per dose of 15 ml syrup (equal to 3 teaspoons of coffee). - Honey is a source of phenylalanine. It can be harmful to those who love Fenilchetonuria. Alcohol intake is not recommended during therapy.

Interactions

MAO inhibitor drugs Concurrent administration of dextromethtorphan with MAO inhibitors is contraindicated. In addition, you should not administer dextromethtorphan during or in the two weeks following the administration of monoamino-oxidase inhibitors. 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 dextromethtorphan with linezolid or sybutramine. 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. 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. Concurrent use of opioids and 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 dosage and duration of the concurrent treatment must be limited (see paragraph 4.4). Secretolithic drugs If the dextromethtorphan is used in combination with secretolytic drugs, the reduction of cough reflex may lead to severe mucus accumulation. Grapefruit juice Grapefruit juice can increase absorption, bioavailability and elimination of dextromethtorphan, resulting in increased toxicity and decreased effect.

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 system disorders: Not known: hypersensitivity reactions including anaphylactic reaction, angioedema, hives, itching, rash and erythema. Disorders of metabolism and nutrition: Not known: diabetes mellitus. Psychiatric disorders: Very rare: hallucinations; Don't notice: psychosis. Diseases of the nervous system: Municipality: vertigo; Rare: drowsiness. Gastrointestinal diseases: Common: nausea, vomiting, gastrointestinal disorders and appetite reduction. Pathologies of skin and subcutaneous tissue: Rare: rashes. Systemic pathologies and conditions for administration: Common: fatigue; Not known: hyperpyressia. Cases of addiction and abuse were reported with detachment. 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 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. In extreme cases, urinary retention and respiratory depression may occur. In case of need to use intensive medical care (in particular intubation, ventilation). Precautions may be required to safeguard heat loss and replenish liquids. Treatment of hyperdose may require gastric lavender and treatment of specific symptoms. Do not administer hemetics at central action.

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) for dextrometor. Destrometorphan should not be used during the first three months of pregnancy; 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 newborn, dextromethtorphan is contraindicated during breastfeeding.

Source: Farmadati