Vicks Cough Sedative 1.33 mg/ml 180 ml syrup

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Cough suppressant.

CONTRAINDICATIONS

Hypersensitivity 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).

WARNINGS AND PRECAUTIONS FOR USE

Treatment 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. Risks deriving from the concomitant use of sedative medicines such as benzodiazepines or related drugs 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). Serotonin syndrome 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: - Sucrose and invert sugar (honey): 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. - ethanol (alcohol): 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. - sodium: 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. - propylene glycol: 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. - sodium benzoate: 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.

INTERACTIONS

MAO inhibitor drugs 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. Linezolid and sibutramine Cases of serotonin syndrome have also been reported following concomitant administration of dextromethorphan with linezolid or sibutramine. CYP2D6 inhibitors 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. Central nervous system inhibitor drugs 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). Secretolytic drugs If dextromethorphan is used in combination with secretolytic drugs, the reduction of the cough reflex can lead to severe mucus accumulation. Grapefruit juice Grapefruit juice may increase the absorption, bioavailability and elimination of dextromethorphan, resulting in an increase in its toxicity and a decrease in its effect.

SIDE EFFECTS

Adverse reactions are listed below by system organ class and frequency, according to the following categories: very common ≥ 1/10; common ≥ 1/100, <1/10; uncommon ≥ 1/1,000, <1/100; rare ≥ 1/10,000, <1/1,000; very rare <1/10,000; not known the frequency cannot be estimated from the available data. Immune system disorders: Not known: hypersensitivity reactions including anaphylactic reaction, angioedema, urticaria, pruritus, rash and erythema. Metabolism and nutrition disorders: Not known: diabetes mellitus. Psychiatric disorders: Very rare: hallucinations; Not known: psychosis. Nervous system disorders: Common: dizziness; Rare: drowsiness. Gastrointestinal disorders: Common: nausea, vomiting, gastrointestinal disorders and decreased appetite. Skin and subcutaneous tissue disorders: Rare: skin rashes. Systemic disorders and conditions relating to the administration site: Common: fatigue; Not known: hyperpyrexia. Cases of dependence and abuse have been reported with dextromethorphan. Reporting of suspected adverse reactions 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.