VICKS COUGH SEDATIVE SYRUP - IrisFarma

VICKS SEDATIVE COUGH * 180ML MIE

Therapeutic indications

Cough suppressant.

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.

Contraindications

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 give to children under 12 years of age. Pregnancy, particularly in the first trimester, lactation (see section 4.6).

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, 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: 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 reactionsReporting 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

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 and dependence have been reported. Caution is especially recommended for adolescents and young adults, as well as for patients with a history of drug or psychoactive substance abuse.Risks arising from the concomitant use of sedative medicines such as benzodiazepines or related drugsConcomitant 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 metabolize 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). Serotonin syndrome Serotonergic effects, including the development of a 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[monoamine oxidase inhibitors, MAOI]) and CYP2D6 inhibitors. Serotonin syndrome can include changes in mental status, autonomic instability, neuromuscular abnormalities, and / or gastrointestinal symptoms. If serotonin syndrome is suspected, treatment with Vicks Cough Sedative should be discontinued.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 in case the cough is accompanied by other symptoms such as: fever, rash, headache, nausea and vomiting. In case 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 and invert sugar (honey):Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. This medicine contains approximately 5.55 g of sucrose (sugar) and 0.570 g of invert sugar (honey) 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% ethanol (alcohol), eg. 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 lactating 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 WHO recommended maximum daily intake, which corresponds to 2 g of sodium for one 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 lactating patients should be considered on a case-by-case basis. In addition, 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). - Honey is a source of phenylalanine. It can be harmful for those suffering from Phenylketonuria. Alcohol intake is not recommended during therapy.

Pregnancy and breastfeeding

PregnancyThe 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 timeSince 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.

Expiry and retention

Store at a temperature not exceeding 25 ° C.

Interactions with other drugs

MAO inhibitor drugsConcomitant administration of dextromethorphan with MAO inhibitor drugs is contraindicated. In addition, 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 sibutramineCases of serotonin syndrome have also been reported following concomitant administration of dextromethorphan with linezolid or with sibutramine.CYP2D6 inhibitorsDextromethorphan 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 many 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 drugsThe 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. Dosage and duration of concomitant treatment should be limited (see section 4.4).Secretolytic drugsIf dextromethorphan is used in combination with secretolytic drugs, the reduced cough reflex can lead to severe mucus accumulation.Grapefruit juiceGrapefruit juice can increase the absorption, bioavailability and elimination of dextromethorphan, resulting in an increase in its toxicity and a decrease in its effect.

Overdose

Symptoms and signs Overdose of dextromethorphan may be associated with nausea, vomiting, dystonia, agitation, confusion, somnolence, stupor, nystagmus, cardiotoxicity (tachycardia, abnormal ECG including QTc interval prolongation), ataxia, toxic psychosis with visual hallucinations, hyperexcitability. In case of massive overdose, the following symptoms can be observed: coma, respiratory depression, convulsions. Management: Activated charcoal can be given to asymptomatic patients who have ingested overdoses of dextromethorphan within the previous hour. For patients who have ingested dextromethorphan and are sedated or comatose, naloxone in the usual doses for the treatment of opioid overdose may be considered. Benzodiazepines for seizures and benzodiazepines and external cooling measures for serotonin syndrome hyperthermia may be used. In extreme cases, urinary retention and respiratory depression can occur. If necessary, seek intensive medical care (in particular intubation, ventilation). It may be necessary to take precautions to safeguard heat loss and replenish fluids. Treatment of overdose may require gastric lavage and treatment of specific symptoms. Do not administer centrally acting emetics.

Active principles

100 ml of syrup contain:Active principle: dextromethorphan hydrobromide 0.133% w / V (0.133 g). Excipients with known effects: • Sucrose: 5.55g / 15ml • Sodium: 28.2mg / 15ml • Ethanol 96%: 0.592g / 15ml • Inverted sugar (honey): 0.570g / 15ml • Propylene glycol: 0.850 g / 15 ml • Sodium Benzoate 15 mg / 15 ml • Phenylalanine (honey) For a full list of excipients, see section 6.1.

Excipients

Sucrose; sodium saccharin; propylene glycol; 96 percent ethanol; carmellose sodium; sodium citrate; anhydrous citric acid; honey flavoring (containing honey); verbena flavoring; sodium benzoate; polyethylene oxide; menthoxypropanediol; polyoxystearate 40; purified water.