{"product_id":"vicks-tosse-sedativo-1-33-mg-ml-180-ml-sciroppo","title":"Vicks Cough Sedative 1.33 mg\/ml 180 ml syrup","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eCough suppressant.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eHypersensitivity to the active substance, to structurally similar compounds, or to any of the excipients listed in paragraph 6.1. Do not use simultaneously and in the two weeks following therapy with MAO inhibitor antidepressant drugs (see section 4.5). Bronchial asthma, COPD (chronic obstructive pulmonary disease), pneumonia, breathing difficulties, respiratory depression, cardiovascular diseases, hypertension, hyperthyroidism, diabetes, glaucoma, prostatic hypertrophy, stenosis of the gastrointestinal and urogenital system, epilepsy, serious liver diseases. Do not administer to children under 12 years of age. Pregnancy, particularly in the first trimester, breastfeeding (see section 4.6).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS AND PRECAUTIONS FOR USE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eTreatment with dextromethorphan should not be continued beyond 5-7 days. If there is no therapeutic response within a few days, the doctor must reevaluate the situation. Dextromethorphan can be habit-forming. Following prolonged use, patients may develop tolerance to the medicinal product, as well as mental and physical dependence (see section 4.8). Cases of abuse and dependence on dextromethorphan have been reported. Caution is particularly recommended for adolescents and young adults, as well as with patients with a history of drug or psychoactive substance abuse. \u003ci\u003eRisks deriving from the concomitant use of sedative medicines such as benzodiazepines or related drugs\u003c\/i\u003e Concomitant use of Vicks Cough Sedative and sedative medicines such as benzodiazepines, or related drugs, may cause sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with sedative medicinal products should be reserved for patients for whom alternative treatment options are not available. If Vicks Cough is prescribed concomitantly with sedative medicinal products, the lowest effective dose should be used 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. In this regard, it is strongly recommended to inform patients and anyone caring for them to make them aware of these symptoms (see section 4.5). Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. Approximately 10% of the population slowly metabolizes CYP2D6. Exaggerated and\/or prolonged effects of dextromethorphan may occur in poor metabolizers and patients with concomitant use of CYP2D6 inhibitors. Caution is therefore necessary in patients who are poor metabolisers of CYP2D6 or who use CYP2D6 inhibitors (see also section 4.5). \u003cb\u003e \u003cu\u003eSerotonin syndrome\u003c\/u\u003e \u003c\/b\u003e Serotonergic effects, including the development of 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 serotonin metabolism (including monoamine oxidase inhibitors [MAOIs]), and CYP2D6 inhibitors. Serotonin syndrome may include mental status changes, autonomic instability, neuromuscular abnormalities, and\/or gastrointestinal symptoms. If serotonin syndrome is suspected, treatment with Vicks Cough Sedative should be discontinued. A chronic cough can be an early symptom of asthma and therefore dextromethorphan is not indicated for the suppression of chronic or persistent cough (e.g. due to smoking, emphysema, asthma, etc.). Dextromethorphan must be administered with particular caution and only on medical advice if the cough is accompanied by other symptoms such as: fever, rash, headache, nausea and vomiting. In case of irritating cough with significant mucus production, treatment with dextromethorphan should be administered with particular caution and only on medical advice after a careful risk-benefit assessment. Administer with caution in subjects with impaired hepatic or renal function, especially in patients with severe impairment. Information on excipients with known effect: - \u003cb\u003eSucrose and invert sugar (honey):\u003c\/b\u003e Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. This medicine contains approximately 5.55 g of sucrose (sugar) and 0.570 g of invert sugar (honey) per 15 ml dose of syrup (equal to 3 teaspoons). To be taken into consideration in people suffering from diabetes mellitus or who are following low-calorie diets. - \u003cb\u003eethanol (alcohol)\u003c\/b\u003e: This medicine contains 5 vol% ethanol (alcohol), e.g. up to approximately 592 mg per dose of 15 ml of syrup (equal to 3 teaspoons), equivalent to less than 15 ml of beer, 6 ml of wine per dose of 15 ml of syrup. It can be harmful to alcoholics. To be taken into consideration in pregnant or breastfeeding women, children and high-risk groups such as people with liver disease or epilepsy. - \u003cb\u003esodium\u003c\/b\u003e: this medicine contains 28.2 mg of sodium per 15 ml of syrup (equal to 3 teaspoons of coffee), equivalent to 1.40% of the maximum daily intake recommended by the WHO, which corresponds to 2 g of sodium for an adult. - \u003cb\u003epropylene glycol:\u003c\/b\u003e This medicine contains 850.50 mg of propylene glycol per 15 ml of syrup (equal to 3 teaspoons). 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 consequence, the administration of propylene glycol to pregnant or breastfeeding patients should be considered on a case-by-case basis. Additionally, clinical monitoring is required for patients with hepatic or renal insufficiency due to various adverse events attributed to propylene glycol such as renal dysfunction (acute tubular necrosis), acute kidney injury, and hepatic dysfunction. - \u003cb\u003esodium benzoate:\u003c\/b\u003e This medicine contains 15 mg of sodium benzoate per 15 ml dose of syrup (equal to 3 teaspoons). - Honey is a source of phenylalanine. It can be harmful to those suffering from Phenylketonuria. It is inadvisable to consume alcohol during therapy.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eMAO inhibitor drugs\u003c\/b\u003e Concomitant administration of dextromethorphan with MAO inhibitor drugs is contraindicated. Furthermore, dextromethorphan should not be administered during or in the two weeks following the administration of monoamine oxidase inhibitor drugs. The association of these drugs can, in fact, induce the development of a serotonin syndrome characterized by the following symptoms: nausea, hypotension, neuromuscular hyperactivity (tremor, clonic spasm, myoclonus, increased reflex response and rigidity of pyramidal origin), hyperactivity of the autonomic nervous system (diaphoresis, fever, tachycardia, tachypnea, mydriasis) and altered mental state (agitation, excitation, confusion), leading to cardiac arrest and death. \u003cb\u003eLinezolid and sibutramine\u003c\/b\u003e Cases of serotonin syndrome have also been reported following concomitant administration of dextromethorphan with linezolid or sibutramine. \u003cb\u003eCYP2D6 inhibitors\u003c\/b\u003e Dextromethorphan is metabolized by CYP2D6 and has extensive first-pass metabolism. Concomitant use of strong inhibitors of the CYP2D6 enzyme can increase dextromethorphan concentrations in the body to levels many times higher than the normal value. This increases the patient's risk for toxic effects of dextromethorphan (agitation, confusion, tremor, insomnia, diarrhea, and respiratory depression) and for the development of 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 central nervous system effects 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 necessary, the patient should be monitored and the dose of dextromethorphan may need to be reduced. \u003cb\u003eCentral nervous system inhibitor drugs\u003c\/b\u003e Concomitant administration of dextromethorphan with drugs with an inhibitory effect on the central nervous system such as hypnotics, sedatives or anxiolytics, or with alcohol, may lead to additive effects on the central nervous system. Concomitant use of opioids and sedative medicines such as benzodiazepines, or related drugs, increases the risk of sedation, respiratory depression, coma and death due to additive CNS depressant effect. The dosage and duration of concomitant treatment should be limited (see section 4.4). \u003cb\u003eSecretolytic drugs\u003c\/b\u003e If dextromethorphan is used in combination with secretolytic drugs, the reduction of the cough reflex can lead to severe mucus accumulation. \u003cb\u003eGrapefruit juice\u003c\/b\u003e Grapefruit juice may increase the absorption, bioavailability and elimination of dextromethorphan, resulting in an increase in its toxicity and a decrease in its effect.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eAdverse reactions are listed below by system organ class and frequency, according to the following categories: very common ≥ 1\/10; common ≥ 1\/100, \u003c1\/10; uncommon ≥ 1\/1,000, \u003c1\/100; rare ≥ 1\/10,000, \u003c1\/1,000; very rare \u003c1\/10,000; not known the frequency cannot be estimated from the available data. \u003ci\u003eImmune system disorders:\u003c\/i\u003e Not known: hypersensitivity reactions including anaphylactic reaction, angioedema, urticaria, pruritus, rash and erythema. \u003ci\u003eMetabolism and nutrition disorders:\u003c\/i\u003e Not known: diabetes mellitus. \u003ci\u003ePsychiatric disorders:\u003c\/i\u003e Very rare: hallucinations; Not known: psychosis. \u003ci\u003eNervous system disorders:\u003c\/i\u003e Common: dizziness; Rare: drowsiness. \u003ci\u003eGastrointestinal disorders:\u003c\/i\u003e Common: nausea, vomiting, gastrointestinal disorders and decreased appetite. \u003ci\u003eSkin and subcutaneous tissue disorders:\u003c\/i\u003e Rare: skin rashes. \u003ci\u003eSystemic disorders and conditions relating to the administration site:\u003c\/i\u003e Common: fatigue; Not known: hyperpyrexia. Cases of dependence and abuse have been reported with dextromethorphan. \u003cb\u003eReporting of suspected adverse reactions\u003c\/b\u003e Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioni-avverse.\u003c\/p\u003e","brand":"Procter \u0026 Gamble","offers":[{"title":"Default Title","offer_id":51730214093127,"sku":"028688024","price":12.05,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/procter-gamble-srl-vicks-tosse-sedativo-1-33-mg-ml-180-ml-sciroppo-farmacia-dottor-tili-1213791345.jpg?v=1767156407","url":"https:\/\/www.dottortili.com\/en-eu\/products\/vicks-sedative-cough-1-33-mg-ml-180-ml-syrup","provider":"Farmacia Dottor Tili","version":"1.0","type":"link"}