VICKS MEDINAIT 0.5 MG/ML + 0.25 MG/ML + 20 MG/ML SYRUP
Treatment of cold and flu symptoms.
Dosage and method of use
Dosage Adults and adolescents over 12 years:The recommended dose is 30 ml once a day. 30 ml contains 0.015 g of dextromethorphan hydrobromide, 0.0075 g of doxylamine succinate and 0.6 g of paracetamol. Do not exceed the recommended doses.Duration of treatmentAfter 3 days of continuous use, in the absence of appreciable results, re-evaluate the clinical picture.Method of administrationVicks MediNait should be taken before bedtime for a night's rest and on a full stomach. Use the measuring cup included in the package.
- Hypersensitivity to the active substances or to any of the excipients listed in paragraph 6.1. - Children and adolescents under 12 years of age. - Asthma, diabetes, glaucoma, prostatic hypertrophy, gastrointestinal and urogenital stenosis, epilepsy, severe liver disease or severe renal impairment. - Glucose-6-phosphate dehydrogenase deficiency and hemolytic anemia (due to the paracetamol content). - History of gastrointestinal haemorrhage or perforation due to previous treatment with medicinal products with anti-inflammatory, anti-pyretic and pain-relieving activity or history of recurrent haemorrhage/peptic ulcer (two or more distinct episodes of demonstrated ulceration or bleeding). - Severe heart failure. Do not administer at the same time as or in the two weeks following therapy with MAO inhibitor antidepressant drugs.
Undesirable effects are classified according to their frequency and listed in order of decreasing severity. The frequency of adverse reactions is defined using the following convention: Very common (≥1/10); common (≥1/100 to
|Classification by systems and organs
|Pathologies of the blood and lymphatic system
|thrombocytopenia, leukopenia, agranulocytosis, hemolytic anemia, neutropenia, pancytopenia, epistaxis, increased propensity for wound bleeding.
|Immune system disorders
|hypersensitivity, anaphylactic shock, anaphylaxis, angioedema, laryngeal edema, bronchospasm.
|Nervous system disorders
|drowsiness, headache, blurred vision, psychomotor impairment.
|dry mouth, constipation, gastric reflux.
|nausea, vomiting, abdominal pain, diarrhea.
|exacerbation of colitis and Crohn's disease (see section 4.4), peptic ulcer, gastrointestinal perforation or haemorrhage** (see section 4.4), gastritis, melena, haematemesis, ulcerative stomatitis, flatulence, dyspesia.
|hepatitis, increased aminotransferases, jaundice, hepatic necrosis.
|Pathologies of the skin and subcutaneous tissue
|skin rashes, urticaria, erythema, pruritus, fixed drug eruption
|erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
|Renal and urinary disorders
|acute renal failure, interstitial nephritis, haematuria, anuria, urinary retention, dysuria.
*Paradoxical stimulation of the central nervous system, especially in children **sometimes fatal, especially in elderly patientsClass side effects: AntihistaminesAsthenia, photosensitivity, convulsions (at high doses), breathing difficulties due to increased bronchial secretions, and, especially in the elderly, hypotension and rhythm disturbances (extrasystoles and tachycardia).Medicines with anti-inflammatory, anti-pyretic and pain-relieving activityEdema, hypertension and heart failure.Reporting of suspected adverse reactionsReporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system reported on the site https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Side effects can be minimized with the shortest possible treatment duration needed to control symptoms. The elderly have a greater susceptibility to the onset of side effects. A chronic or persistent cough due to smoking, emphysema, asthma requires clinical evaluation. In case of irritating cough with significant mucus production, Vicks MediNait must be used with particular caution and after a careful risk-benefit assessment. High or prolonged doses of paracetamol, present in the product, can cause high-risk liver disease and even serious alterations to the kidney and blood. Paracetamol should be used with caution in subjects with renal or hepatic insufficiency, including those with non-cirrhotic alcoholic liver disease. The damage from overdose is greater in subjects suffering from alcoholic liver disease. Vicks MediNait must not be used with other products containing paracetamol or medicines with anti-inflammatory, anti-pyretic and pain-relieving properties. In the rare cases of allergic reactions, administration should be suspended and suitable treatment instituted. The use of antihistamines with ototoxic antibiotics can mask the first signs of ototoxicity, which can be perceived late, when the damage is irreversible. Vicks MediNait should be used with caution in patients with cardiovascular disease, hypertension and hyperthyroidism. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease should only be treated with Vicks MediNait after careful consideration given the risk of fluid retention and edema. Alcohol intake during treatment is to be avoided.Risks arising from concomitant use of sedative medicines such as benzodiazepines or related medicinesConcomitant use of Vicks MediNait and sedative medicines such as benzodiazepines, or related drugs, may cause sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicinal products should be limited to patients for whom alternative treatments are not possible. If the decision is made to prescribe Vicks MediNait together with sedative medicines, the duration of treatment should be as short as possible. Patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this regard, it is strongly recommended to inform patients and anyone caring for them (where applicable) so that they are aware of these symptoms (see section 4.5). Dextromethorphan can be habit-forming. Following prolonged use, patients may develop tolerance to the medicine, as well as mental and physical dependence. Patients with a tendency towards abuse or dependence should take Vicks MediNait for short periods and be carefully monitored. Cases of abuse and dependence on dextromethorphan have been reported. Caution is particularly recommended for adolescents and young adults, as well as in patients with a history of drug or psychoactive substance abuse. 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 the serotonin metabolism (including monoamine oxidase inhibitors[monoamine oxidase inhibitors, MAOI]) 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 Medinait should be discontinued. Concomitant use of medicinal products with anti-inflammatory, anti-pyretic and pain-relieving activity, including selective COX-2 inhibitors, should be avoided. Dextromethorphan is metabolised by hepatic cytochrome P450 2D6 (see section 5.2). 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 required in patients who are poor metabolisers of CYP2D6 or who use CYP2D6 inhibitors (see section 4.5).Elderly people:Elderly people have an increased frequency of adverse reactions to medicinal products with anti-inflammatory, anti-pyretic and pain-relieving activity, especially gastrointestinal bleeding and perforation, which can be fatal.Gastrointestinal bleeding, ulceration and perforation:During treatment with all anti-inflammatory, anti-pyretic and pain-relieving medicinal products, gastrointestinal haemorrhage, ulceration and perforation, which may be fatal. In patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of medicinal products with anti-inflammatory, anti-pyretic and pain-relieving activity. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5) . Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any gastrointestinal symptoms (especially gastrointestinal bleeding) even at the start of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or haemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Vicks MediNait, treatment should be discontinued. Medicines with anti-inflammatory, anti-pyretic and pain-relieving activity should be administered with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of medicinal products with anti-inflammatory, anti-pyretic and pain-relieving activity (see section 4.8 ). At the beginning of treatment patients appear to be at higher risk. Vicks MediNait should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Invite the patient to contact the doctor before combining any other medication. Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to the increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. e.g. chronic alcoholism), as well as in those who use the maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.Important information about some excipientsVicks MediNait contains 8.25 g ofsucroseper dose (equal to 30 ml). To be taken into consideration in people suffering from diabetes mellitus. 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 75 mg ofsodiumper dose (equal to 30 ml) equivalent to approximately 3.8% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult. Vicks MediNait contains 30 mg ofsodium benzoateper dose (equal to 30 ml). This medicine contains 3 g ofpropylene glycolper dose (equal to 30 ml). 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. 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. Interference with serological tests The administration of paracetamol can interfere with the determination of uric acid (by the phosphotungstic acid method) and glycaemia (by the glucose-oxidase-peroxidase method).
Pregnancy and breastfeeding
Data on the safety of use of Vicks MediNait during pregnancy and during breastfeeding are limited. Vicks MediNait during pregnancy and breastfeeding is not recommended. The use of should be considered only if the expected benefit to the mother outweighs the risk to the fetus or child.PregnancyThe numerous data relating to the use of paracetamol during pregnancy do not indicate either malformative or fetal/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used for as short a time as possible and as frequently as possible. Literature data do not show a proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus induced by dextromethorphan. Use during late pregnancy may expose the newborn to respiratory depression. Epidemiological studies do not indicate doxylamine-induced malformation toxicity. Given the anticholinergic and sedative activity of doxylamine, monitoring of the newborn is strongly recommended in case of use of Vicks MediNait close to birth.Feeding timeAlthough it is excreted in breast milk, the use of paracetamol is compatible with breastfeeding. Dextromethorphan and doxylamine are not known to be excreted in breast milk.
Expiration and conservation
Keep the bottle in the outer carton in order to protect from light. Any variation in the color of the syrup does not alter the quality of the product.
Interactions with other drugs
Concomitant administration with MAO inhibitor drugs is contraindicated (see section 4.3). Use with extreme caution and under strict control during chronic treatment with drugs that can cause the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example, rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital, carbamazepine and alcohol) due to an increased risk of hepatotoxicity from paracetamol. The rate of absorption of paracetamol may be increased by metoclopramide or domperidone and the absorption may be reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarin drugs can be strengthened by prolonged and regular use of paracetamol, increasing the risk of bleeding. Liver enzyme inducers (e.g. alcohol and antiepileptics) may increase the hepatotoxicity of paracetamol, particularly after an overdose.CYP2D6 inhibitorsThere is a possibility of interaction between dextromethorphan and medicinal products that inhibit the CYP2D6 isoenzyme such as SSRIs (e.g., fluoxetine, paroxetine). Dextromethorphan is metabolised 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. During 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.Diuretics, ACE inhibitors and Angiotensin II antagonists:Medicines with anti-inflammatory, anti-pyretic and pain-relieving activity can reduce the effect of diuretics and other antihypertensive drugs. In subjects with compromised renal function (for example dehydrated or elderly patients) co-administration with an ACE inhibitor or an angiotensin II antagonist may lead to a further deterioration of renal function. Hydration before initiating concomitant therapy and close monitoring of renal function after initiation of treatment are recommended.Corticosteroids:co-administration may increase the risk of gastrointestinal ulceration or haemorrhage (see section 4.4).Anticoagulants:Medicines with anti-inflammatory, anti-pyretic and pain-relieving activity may increase the effects of anticoagulants, such as warfarin (see section 4.4).Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs):co-administration may lead to an increased risk of gastrointestinal bleeding (see section 4.4).Medicines with sedative action such as benzodiazepines or related medicinesConcomitant use of opioids and sedative medicines such as benzodiazepines, or related medicines, increases the risk of sedation, respiratory depression, coma and death due to additive CNS depressant effect. The dose and duration of concomitant use should be limited (see section 4.4). Caution should be exercised when paracetamol is used concomitantly with flucloxacillin as concomitant use has been associated with high anion gap metabolic acidosis, especially in patients with risk factors (see section 4.4).
In case of overdose, paracetamol can cause hepatic cytolysis, which can evolve towards massive and irreversible necrosis.Symptoms and signs Paracetamol:Symptoms of paracetamol overdose in the first 24 hours are paleness, nausea, vomiting, anorexia and abdominal pain. Liver damage may occur 12 to 48 hours after ingestion. Abnormalities in glucose metabolism and metabolic acidosis may occur. In cases of severe poisoning, liver failure can progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis can develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported. Other symptoms may include CNS depression, cardiovascular effects, and kidney damage.Dextromethorphan or Doxylamine:Symptoms such as excitation, mental confusion, convulsions and respiratory depression may occur following an overdose with doxylamine. Dextromethorphan overdose may be associated with nausea, vomiting, dystonia, agitation, confusion, drowsiness, 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 may be observed: coma, respiratory depression, convulsions.Management:Immediate treatment is essential for the management of acetaminophen overdose. Despite the lack of significant early symptoms, patients should urgently attend hospital for immediate medical attention and any patient who has ingested approximately 7.5 g or more of paracetamol in the previous 4 hours should undergo gastric lavage. The administration of oral methionine or intravenous N-acetylcysteine may be necessary, which may have a beneficial effect for up to at least 48 hours after the overdose. General supportive measures must be available. Activated charcoal may be administered 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 doses usual for the treatment of opioid overdose, may be considered. Benzodiazepines may be used for seizures and benzodiazepines and external cooling measures for serotonin syndrome hyperthermia.
100 ml of syrup contains: Active principles Dextromethorphan hydrobromide 0.05 g; Doxylamine succinate 0.025 g; Paracetamol 2 g. Excipients with known effects: sucrose, sodium, sodium benzoate, propylene glycol. For the full list of excipients, see section 6.1
Propylene glycol, sodium citrate, citric acid monohydrate, potassium sorbate, sodium benzoate, macrogol, sucrose, glycerol, anethole, quinoline yellow (E 104), brilliant blue FCF (E 133) and purified water.