VICKS MEDINAIT * SCIR 90ML

VICKS MEDINAIT * SCIR 90ML

Therapeutic indications

Treatment of cold and flu symptoms.

Dosage and method of use

Dosage Adults and adolescents over 12 years:The recommended dose is 30ml 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, reassess the clinical picture.Method of administrationVicks MediNait should be taken before bed for a night's rest and on a full stomach. Use the measuring cup included in the package.

Contraindications

- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. - Children and adolescents under 12 years of age. - Asthma, diabetes, glaucoma, prostatic hypertrophy, stenosis of the gastrointestinal and urogenital tract, epilepsy, severe liver disease or severe renal impairment. - Deficit of glucose-6-phosphate dehydrogenase and haemolytic anemia (due to the paracetamol content). - History of gastrointestinal bleeding or perforation due to previous treatment with anti-inflammatory, anti-pyretic and pain relieving medicinal products or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding). - Severe heart failure. Do not administer at the same time or in the two weeks following therapy with MAO inhibitor antidepressant drugs.

Side effects

Undesirable effects are classified according to their frequency and listed in descending order of severity. The frequency of adverse reactions is defined using the following convention: Very common (≥1 / 10); common (≥1 / 100 to

* Paradoxical stimulation of the central nervous system, especially in children ** sometimes fatal, particularly 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 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 listed at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Undesirable 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 an irritating cough with a considerable production of mucus Vicks MediNait should 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 changes in the kidney and blood. Paracetamol should be used with caution in subjects with renal or hepatic insufficiency, including those with non-alcoholic cirrhotic liver disease. The damage from overdose is greater in people with alcoholic liver disease. Vicks MediNait should not be used with other products containing paracetamol or medicines with anti-inflammatory, anti-pyretic and pain relieving activity. In the rare cases of occurrence of allergic reactions, administration should be suspended and appropriate 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 the concomitant use of sedative medicines such as benzodiazepines or related medicinesConcomitant use of Vicks MediNait and sedative medicines such as benzodiazepines, or related drugs, can 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 who cares for them (where applicable) so that they are aware of these symptoms (see section 4.5). Dextromethorphan can be addictive. Following prolonged use, patients may develop tolerance to the drug, as well as mental and physical dependence. Patients with a tendency to abuse or dependence should take Vicks MediNait for short periods and be closely monitored. Cases of dextromethorphan abuse and dependence 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 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 the metabolism of serotonin (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 Medinait should be discontinued. The 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. 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. Caution should be exercised in patients who are poor metabolisers of CYP2D6 or who use CYP2D6 inhibitors (see section 4.5).Elderly people:The elderly have an increased frequency of adverse reactions to anti-inflammatory, anti-pyretic and pain relieving medicinal products, especially gastrointestinal bleeding and perforation, which can be fatal.Gastrointestinal bleeding, ulceration and perforation:Gastrointestinal bleeding, ulceration and perforation, which may be fatal. In patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of anti-inflammatory, anti-pyretic and pain relieving medicinal products. 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 bleeding, 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 the treatment should be discontinued. Medicinal products with anti-inflammatory, anti-pyretic and pain relieving activity should be administered with caution to 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 anti-inflammatory, anti-pyretic and pain relieving medicinal products (see section 4.8 ). Patients appear to be at higher risk at the start of treatment. Vicks MediNait should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Instruct the patient to contact the physician before associating any other medication. Caution is advised if paracetamol is co-administered 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. eg chronic alcoholism), as well as in those using the maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.Important information about some of the ingredientsVicks MediNait contains 8.25 g ofsucroseper dose (equal to 30 ml). To be taken into consideration in people with diabetes mellitus. Patients with 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 renal 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 was 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. Interference with serological tests The administration of paracetamol can interfere with the determination of uric acid (by the phosphotungstic acid method) and blood glucose (by the glucose-oxidase-peroxidase method).

Pregnancy and breastfeeding

There are limited data on the safe use of Vicks MediNait during pregnancy and breastfeeding. Vicks MediNait during pregnancy and breastfeeding is not recommended. The use of should only be considered if the expected benefit to the mother outweighs the risk to the fetus or baby.PregnancyThe numerous data relating to the use of paracetamol during pregnancy indicate neither malformative nor fetal / neonatal toxicity. Epidemiological studies of neurodevelopmental in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy, however it should be used for the shortest possible time and as infrequently 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 can expose the newborn to respiratory depression. Epidemiological studies do not indicate doxylamine-induced malformative toxicity. Given the anticholinergic and sedative activity of doxylamine, monitoring of the newborn is strongly recommended if Vicks MediNait is used close to delivery.Feeding timeDespite being excreted in breast milk, the use of paracetamol is compatible with breastfeeding. The excretion of dextromethorphan and doxylamine into breast milk is not known.

Expiration and retention

Keep the bottle in the outer carton to protect the medicine 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 determine 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 acetaminophen hepatotoxicity. The absorption rate of paracetamol can be increased by metoclopramide or domperidone and the absorption can be reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarin drugs can be enhanced by prolonged and regular use of paracetamol, increasing the risk of bleeding. Inducers of liver enzymes (eg 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 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. During concomitant use with quinidine, plasma concentrations of dextromethorphan 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.Diuretics, ACE inhibitors and Angiotensin II antagonists:Medicinal products with anti-inflammatory, anti-pyretic and pain relieving activity may reduce the effect of diuretics and other antihypertensive drugs. In subjects with impaired renal function (e.g. dehydrated or elderly patients) co-administration with an ACE inhibitor or an angiotensin II antagonist may lead to further deterioration of renal function. Hydration is recommended before initiating concomitant therapy and close monitoring of renal function after initiation of treatment.Corticosteroids:co-administration may increase the risk of gastrointestinal ulceration or bleeding (see section 4.4).Anticoagulants:Medicinal products 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 result in an increased risk of gastrointestinal haemorrhage (see section 4.4).Sedative medicines such as benzodiazepines or related medicinesConcomitant use of opioids and sedative medicinal products such as benzodiazepines, or related medicinal products, increases the risk of sedation, respiratory depression, coma and death due to the additive depressant effect on the CNS. 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 intake has been associated with high anion gap metabolic acidosis, especially in patients with risk factors (see section 4.4).

Overdose

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 can occur 12 to 48 hours after ingestion. Abnormalities in glucose metabolism and metabolic acidosis may occur. In 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 arousal, confusion, convulsions and respiratory depression may occur following an overdose with doxylamine. 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:Immediate treatment is essential for the management of acetaminophen overdose. Despite the lack of significant early symptoms, patients must urgently go to the hospital for immediate medical attention and any patient who has ingested approximately 7.5 g or more paracetamol in the previous 4 hours must undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine may be required, which may have a beneficial effect for up to at least 48 hours after overdose. General supportive measures should be available. 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.

Active principles

100 ml of syrup contain: 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

Excipients

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.