VICKS SEDATIVE COUGH * 180ML MIE
Dosage and method of use
Adults and adolescents over 12 years: 15 ml (equivalent to 3 teaspoons). These doses can be repeated every 6 hours, up to 4 times a day. Do not exceed the recommended dose. Children up to 12 years: dextromethorphan should not be used.
Hypersensitivity to the active substance, to structurally similar compounds, or to any of the excipients listed in section 6.1. Do not use at the same time and in the two weeks following therapy with MAO inhibiting 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, gastrointestinal and urogenital stenosis, epilepsy, severe liver disease. Do not administer to children under 12 years of age. Pregnancy, particularly in the first trimester, lactation (see section 4.6).
Adverse reactions are listed below by system organ class and frequency under 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. Metabolism and nutrition disorders: Not known: diabetes mellitus. Psychiatric disorders: Very rare: hallucinations. Not known: psychosis. Nervous system disorders: Common: dizziness. Rare: somnolence. Gastrointestinal disorders: Common: nausea, vomiting, gastrointestinal upset and decreased appetite. Skin and subcutaneous tissue disorders: Rare: skin rashes. General disorders and administration site conditions: Common: fatigue. Not known: hyperpyrexia. There have been reports of dependence and abuse with dextromethorphan. Reporting of suspected adverse reactions Reporting 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 http://www.agenziafarmaco.gov.it/content/comesegnalare-una-sospetta-reazione-avversa.
Treatment with dextromethorphan should not be continued beyond 5-7 days. If there is no therapeutic response within a few days, the physician should re-evaluate the situation. Dextromethorphan can be addictive. Following prolonged use, patients may develop tolerance to the medicinal product, as well as mental and physical dependence (see section 4.8). Cases of dextromethorphan abuse have been reported. Special care is recommended with adolescents and young adults, as well as with patients with a history of drug or psychoactive substance abuse. Risks arising 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, can cause sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with sedative medicinal products should be reserved for patients for whom no alternative treatment options are 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 closely monitored for signs and symptoms of respiratory depression and sedation. In this regard, it is strongly recommended that patients and anyone caring for them be informed in order 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. About 10% of the population metabolizes 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). A chronic cough may 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 should 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 the event of an irritating cough with considerable 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: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. This medicine contains approximately 5.5 g of sucrose (sugar) per dose of 15 ml of syrup (equal to 3 teaspoons). To be taken into consideration in people with diabetes mellitus or who are following low-calorie diets. - ethanol (alcohol): this medicine contains 5 vol% of ethanol (alcohol), e.g. up to about 592 mg per dose of 15 ml of syrup (equal to 3 coffee spoons), equivalent to 15 ml of beer, 6.3 ml of wine per dose of 15 ml of syrup. It can be harmful to alcoholics. To be taken into consideration in pregnant or lactating women, children and high-risk groups such as people with liver disease or epilepsy. - sodium: This medicine contains 30 mg of sodium per 15 ml dose (equal to 3 teaspoons), equivalent to 1.5% the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult; - propylene glycol: this medicine contains 1.5 g 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 lactating 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 renal injury and hepatic dysfunction. - sodium benzoate: this medicine contains 15 mg of sodium benzoate per dose of 15 ml of syrup (equal to 3 teaspoons). Alcohol intake is not recommended during therapy.
Pregnancy and breastfeeding
Pregnancy The results of epidemiological studies on a limited sample of the population did not indicate an increase in the frequency of malformations in children who were exposed to dextromethorphan during the prenatal period. However, these studies do not adequately document the period and duration of treatment with dextromethorphan. Reproductive toxicity studies in animals do not indicate a potential risk to humans for dextromethorphan (see section 5.3). Dextromethorphan should not be used during the first three months of pregnancy; moreover, since the administration of high doses of dextromethorphan, even for short periods, can cause respiratory depression in newborns, in the following months the drug should be administered only in case of real need and after a careful evaluation of the benefits and risks. Feeding time Since excretion of the drug in breast milk is not known and a respiratory depressive effect on the newborn cannot be excluded, dextromethorphan is contraindicated during breastfeeding.
Expiration and retention
Store at a temperature not exceeding 25 ° C.
Interactions with other drugs
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 administration of monoamine oxidase inhibitor drugs. The combination 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 stiffness of pyramidal origin), hyperactivity of the autonomic nervous system (diaphoresis, fever, tachycardia, tachypnea, mydriasis) and altered mental status (agitation, excitement, confusion), up 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 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 several 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. Central nervous system inhibitory drugs Concomitant administration of dextromethorphan with drugs with an inhibitory effect on the central nervous system such as hypnotics, sedatives or anxiolytics, or with the intake of alcohol, can lead to additive effects on the central nervous system. Concomitant use of opioids and sedative drugs such as benzodiazepines, or related drugs, increases the risk of sedation, respiratory depression, coma and death due to the additive depressant effect on the CNS. 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 reduced cough reflex can lead to severe mucus accumulation. Grapefruit juice Grapefruit juice can increase the absorption, bioavailability and elimination of dextromethorphan, resulting in an increase in its toxicity and a decrease in its effect.
Symptoms Gastrointestinal disorders (e.g. nausea, vomiting), visual disturbances and central nervous system disorders such as ataxia, dizziness, excitement, increased muscle tone, mental confusion, hypotension and tachycardia. In extreme cases, urinary retention and respiratory depression can occur. Treatment If necessary, seek intensive medical care (especially intubation, ventilation). Precautions may be necessary to safeguard heat loss and replenish fluids. Treatment of overdose may require gastric lavage and treatment of specific symptoms. Intravenous administration of naloxone may antagonize the effects of dextromethorphan on the central nervous system, particularly respiratory depression. Do not administer centrally acting emetics.
100 ml of syrup contain: active principle: dextromethorphan hydrobromide 0.133% w / V (0.133 g). Excipients with known effects: sucrose, ethanol, propylene glycol, sodium benzoate and sodium. For the full list of excipients, see section 6.1.
Sucrose, sodium saccharin, propylene glycol, 96 percent ethanol, carmellose sodium, sodium citrate, citric acid anhydrous, honey flavoring (containing honey), verbena flavoring, sodium benzoate, polyethylene oxide, menthoxy propanediol, polyoxystearate 40, purified water.