VICKS MEDINAITI SCIR 90ML

VICKS MEDINAIT 0.5 MG/ML + 0.25 MG/ML + 20 MG/ML

active ingredients

100 ml of syrup contain: Active ingredients Destrometorphan bromitted 0.05 g; Succinate doxylamine 0.025 g; Paracetamol 2 g. Excipients with known effects: sucrose, sodium, benzoate sodium, propylene glycol. For the full list of excipients, see paragraph 6.1

Excellent

Propylene glycol, citrate sodium, monohydrate citric acid, sorbate potassium, benzoate sodium, macrogol, sucrose, glycerol, anetol, chinoline yellow (E 104), FCF brilliant blue (E 133) and purified water.

Therapeutic indications

Treatment of symptoms of cold and flu.

Contraindications

- Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. - Children and teenagers under 12 years of age. - Asthma, diabetes, glaucoma, prostate hypertrophy, gastroenteric and urogenital stenosis, epilepsy, severe liver disease or severe kidney impairment. - Deficit of glucose-6-phosphate dehydrogenases and hemolytic anemia (for paracetamol content). - History of gastrointestinal hemorrhage or perforation due to previous treatments with medicines to anti-inflammatory, anti-pyretic and painkilling or history of hemorrhage/recurring peptic ulcer (two or more separate episodes of proven ulceration or bleeding). - Severe heart failure. Do not administer at the same time or in the next two weeks to therapy with antidepressant inhibition drugs of MAO.

Population

Population Adults and teenagers over 12 years: The recommended dose is 30 ml once a day. 30 ml contain 0.015 g of bromished dextromethtorphan, 0.0075 g of succinate doxylamine and 0.6 g of paracetamol Do not exceed the recommended doses. Duration of treatment After 3 days of continuous use, in the absence of appreciable results, reevaluate the clinical picture. Method of administration Vicks MediNait must be taken before bed for night rest and full stomach. Serve with the dispenser glass included in the package.

Conservation

Keep the bottle in the outside packaging to protect the medicine from light. Any variation of the coloring of the syrup does not alter the quality of the product.

Warnings

Undesirable effects can be minimized with the shortest possible duration of treatment needed to control symptoms. The elderly have a greater susceptibility to the occurrence of unwanted effects. Chronic or persistent cough due to smoking, emphysema, asthma requires clinical evaluation. In case of irritating cough with a remarkable production of mucus Vicks MediNait must be used with particular caution and after careful assessment of the risk-benefit. High or prolonged doses of paracetamol, present in the product, can cause high-risk hepatopathy and alterations to the kidney and blood even severe. Paracetamol should be used with caution in subjects with kidney or hepatic insufficiency, including those with non cirrhotic alcohol hepatopathy. Overdose damage is greater in subjects with alcoholic hepatopathy. Vicks MediNait should not be used with other products containing paracetamol or medicines with anti-inflammatory, anti-pyretic and painkiller activities. In rare cases of the appearance of allergic reactions the administration should be suspended and appropriate treatment should be established. 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 cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with Vicks MediNait only after careful evaluation, considered the risk of water retention and edema. Intake of alcohol during treatment is to be avoided. Risks resulting from the concomitant use of sedative medicines such as benzodiazepines or related medicines Concurrent use of Vicks MediNait and sedative medicines such as benzodiazepines, or related drugs, can cause sedation, respiratory depression, coma and death. Due to these risks, the concomitant prescription of sedative medicines must be limited to patients for whom no alternative treatments are possible. If the decision is taken to prescribe Vicks MediNait together with sedative medicines, the duration of treatment must be as short as possible. Patients should be carefully followed to recognize signs and symptoms of respiratory depression and sedation. In this regard it is strongly recommended to inform patients and anyone who takes care of them (where applicable) so that they are aware of these symptoms (see paragraph 4.5). The dextrometorphan can give addiction. As a result of prolonged use, patients can develop tolerance to the drug, as well as mental and physical dependence. Patients with a tendency to abuse or addiction must take Vicks MediNait for short periods and be carefully monitored. Cases of abuse and detachment were reported. Precaution is recommended for teenagers and young adults, as well as patients with drug abuse or psychoactive substances. Serotonin syndrome Serotoninergic effects, including the development of a potentially lethal serotonin syndrome, have been reported for dextromethtorphan with concomitant administration of serotonininergic agents, such as selective serotonin reuptake inhibitors (selective serotonin reuptake inhibitors, SSRI), drugs that alter serotonin metabolism (selective serotonin [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, antipyretic and analgesic activity, including selective COX-2 inhibitors, should be avoided.Dextromethorphan is metabolised by the hepatic cytochrome P450 2D6 (see section 5.2).The activity of this enzyme is genetically determined.Approximately 10% of the population is a slow metaboliser of CYP2D6.Exaggerated and/or prolonged effects of dextromethorphan may occur in poor metabolisers and patients with concomitant use of CYP2D6 inhibitors.Caution is advised in patients who are poor metabolisers of CYP2D6 or who use CYP2D6 inhibitors (see section 4.5). Elderly people: Elderly patients have an increased frequency of adverse reactions to drugs with anti-inflammatory, antipyretic and analgesic activity, especially gastrointestinal bleeding and perforation, which may be fatal. Gastrointestinal bleeding, ulceration and perforation: gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported with all anti-inflammatory, antipyretic and analgesic medicinal products at any time during treatment, with or without warning symptoms or a previous history of serious GI events.In patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of anti-inflammatory, antipyretic and analgesic medicinal products.These patients should start treatment on the lowest dose available.Concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients requiring concomitant low dose acetylsalicylic acid or other medicinal products likely to increase gastrointestinal risk (see below and section 4.5).Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any gastrointestinal symptoms (especially gastrointestinal bleeding) early in the treatment.Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid (see section 4.5).If gastrointestinal bleeding or ulceration occurs in patients receiving Vicks MediNait, the treatment should be withdrawn.Medicinal products with anti-inflammatory, antipyretic and analgesic 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 medicinal products with anti-inflammatory, antipyretic and analgesic activity (see section 4.8).Patients appear to be at highest risk at the beginning of treatment.Vicks MediNait should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.The patient should be advised to contact their doctor before combining any other medicinal product.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. chronic alcoholism), as well as in those using maximum daily doses of paracetamol.Careful monitoring, including measurement of urinary 5-oxoproline, is recommended. Important information about some excipients Vicks MediNait contains 8.25 g sucrose per dose (equal to 30 ml). To consider in people with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. This medicine contains about 75 mg of sodium per dose (equal to 30 ml) equivalent to approximately 3.8% of the maximum daily intake recommended by the WHO that corresponds to 2 g sodium for an adult. Vicks MediNait contains 30 mg of sodium benzoate per dose (equal to 30 ml). This medicine contains 3 g of propylene glycol per dose (equal to 30 ml). Clinical monitoring is required for patients with liver or kidney failure due to various adverse events attributed to glycol propylene such as kidney dysfunction (acute tubular necrosis), acute kidney damage and liver 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 result, the administration of propylene glycol to pregnant or breastfeeding patients should be considered randomly. Reference with serological tests Paracetaminol administration may interfere with the determination of uricemia (by the method of phosphotungstic acid) and glycemia (by the method of glucose-oxidase-peroxidase).

Interactions

Concurrent administration with MAO inhibitors is contraindicated (see paragraph 4.3). Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monoxygenases or in case of exposure to substances that may have such an effect (e.g. rifampin, cimetidine, anti-epileptics such as glutetimide, phenobarbital, carbamazepine and alcohol) due to an increased risk of hepatotoxicity from paracetamine. Paracetamol absorption speed can be increased by metoclopramide or domperidone and absorption can be reduced by choleramine. The anticoagulant effect of warfarin and other cumarinic drugs can be strengthened by prolonged and regular use of paracetamol, increasing the risk of bleeding. Inductors of liver enzymes (e.g. alcohol and antiepileptics) can increase hepatotoxicity of paracetamol, especially after an overdose. CYP2D6 inhibitors There is a possibility of interaction between the dextromethtorphan and medicines that inhibit the isoenzyme CYP2D6 as the SSRIs (e.g., fluoxetine, paroxetine). The dextromethtorphan is metabolized by the CYP2D6 and has a wide metabolism of the first step. Concurrent use of powerful CYP2D6 enzyme inhibitors can increase the concentrations of dextromethtorphan in the body at many times higher than normal value. This increases the risk for the patient of toxic effects of the dextromethtorphan (acting, confusion, tremor, insomnia, diarrhea and respiratory depression) and the development of serotoninergic syndrome. Powerful inhibitors of CYP2D6 are fluoxetine, paroxetine, chinidine and terbinaphine. During concurrent use with chinidine, plasma concentrations of dextromethtorphan have increased up to 20 times, resulting in increased adverse effects on the central nervous system of the agent. Also amiodarone, flecainide and propafenone, sertralin, bupropion, methadone, cinacalcet, aloperidol, perfenazine and thiodazine have similar effects on the metabolism of the dextromethtorphan. If the concomitant use of CYP2D6 inhibitors and dextromethtorphans is necessary, the patient must be monitored and it may be necessary to reduce the dose of dextromethtorphan. Diuretics, ACE inhibitors and Angiotensin II antagonists: Drugs with anti-inflammatory, anti-pyretic and painkilling activities can reduce the effect of diuretics and other antihypertensive drugs. In subjects with compromised kidney function (e.g. dehydrated or elderly patients) co-administration with an inhibitor ACE or an angiotensin II antagonist may lead to further deterioration of the kidney function. Hydration is recommended before starting concurrent therapy and tight monitoring of kidney function after treatment begins. Corticosteroids: contemporary administration may increase the risk of gastrointestinal ulceration or hemorrhage (see paragraph 4.4). Anticoagulanti: anti-inflammatory, anti-pyretic, and painkilling medicines can increase the effects of anticoagulants, such as warfarin (see paragraph 4.4). Serotonin reuptake selective agents and inhibitors (SSRIs): co-administration may lead to an increase in the risk of gastrointestinal hemorrhage (see paragraph 4.4). Sedative medicines such as benzodiazepines or related medicines Concurrent use of opioids and sedative medicines such as benzodiazepines, or related medicines, increases the risk of sedation, respiratory depression, coma and death due to the additive depressive effect on SNC. The dose and duration of concomitant use must be limited (see paragraph 4.4). You should pay attention when paracetamol is used in conjunction with flucloxacillin since concurrent intake was associated with metabolic acidosis with high anionic gap, especially in patients with risk factors (see paragraph 4.4).

Effects

Undesirable effects are classified according to their frequency and listed in descending order of gravity. The frequency of adverse reactions is defined by the following convention: Very common (≥1/10); common (from ≥1/100 to Classification for systems and organs Frequency Side effects Emolinfopoietic system pathologies Very rare thrombocytopenia, leucopenia, agranulocytosis, hemolytic anemia, neutropenia, pancitopenia, epistaxis, increased propensity to bleeding of wounds. Immune system pathologies Rare hypersensitivity, anaphylactic shock, anaphylaxis, angioedema, edema of larynx, bronchospasm. Diseases of the nervous system Town drowsiness, headache, blurred vision, psychomotor impairment. Rare dizziness, insomnia. Notable psychomotor hyperactivity* Gastrointestinal disease Town dry mouth, stypsis, gastric reflux. Rare nausea, vomiting, abdominal pain, diarrhea. Notable exacerbation of colitis and Crohn's disease (see section 4.4), peptic ulcer, gastrointestinal perforation or haemorrhage** (see section 4.4), gastritis, melaena, haematemesis, ulcerative stomatitis, flatulence, dyspepsia. Hepatobiliary pathologies Notable hepatitis, increased aminotransferase, jaundice, liver necrosis. Pathologies of skin and subcutaneous tissue Rare rashes, hives, erythema, itching, eruption fixed by drugs Very rare multiform erythema, Stevens-Johnson syndrome, epidermal toxic necrolysis Kidney and urinary pathologies Notable acute kidney failure, interstitial nephritis, hematuria, watermelon, urinary retention, dysuria. * Paradoxical stimulation of the central nervous system, especially in children **sometimes fatal, especially in elderly patients Undesirable class effects: Antihistamines Asthenia, photosensitivity, seizures (at high doses), breathing difficulties due to increased bronchial secretions, and, especially in the elderly, hypotension and rhythm disorders (extrasystoles and tachycardia). Anti-inflammatory, anti-pyretic and pain-relieving medicines Edema, hypertension and heart failure. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction through the national reporting system reported on the site https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

In case of hyperdosage the paracetamol can cause liver cytolysis, which can evolve towards massive and irreversible necrosis. Symptoms and signs Paracetamol: The symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage can occur from 12 to 48 hours after ingestion. There may be abnormalities in glucose metabolism and metabolic acidosis. In case of severe poisoning, liver failure can progress in encephalopathy, coma and death. Acute kidney failure with acute tubular necrosis can also develop in the absence of severe liver damage. Heart arrhythmias have been reported. Other symptoms may include SNC depression, cardiovascular effects and kidney damage. Destrometorphan or Dossilamina: After overdose with doxylamine, symptoms such as excitement, mental confusion, seizures and respiratory depression can occur. Overdose of dextromethtorphan can be associated with nausea, vomiting, dystonia, agitation, confusion, drowsiness, astonishment, nistagm, cardiotoxicity (tachycardia, abnormal ECG including the extension of the QTc range), ataxia, toxic psychosis with visual hallucinations, hypereccitability. In case of massive overdose, the following symptoms can be observed: coma, respiratory depression, seizures. Management: Immediate treatment is essential for the management of paracetamol overdose. Despite the lack of significant early symptoms, patients must urgently go to the hospital for immediate medical care and any patient who has ingested about 7.5 g or more paracetamol in the previous 4 hours must undergo gastric lavender. It may be necessary to administer methionine by mouth or N-acetylcysteine intravenously, which may have a beneficial effect up to at least 48 hours after overdosing. General support measures must be available. Active carbon can be administered to asymptomatic patients who ingested overdose of dextromethtorphan in the previous hour. For patients who have ingested dextromethtorphan and are sedated or comatose, naloxone can be considered, in the usual doses for the treatment of opioid overdose. Benzodiazepines can be used for convulsions and benzodiazepines and external cooling measures for hyperthermia from serotonin syndrome.

The data on the safety of use of Vicks MediNait during pregnancy and during breast milk lactation are limited. Vicks MediNait during pregnancy and nursing with breast milk is not recommended. The use of must be taken into account only if the expected benefit for the mother exceeds the risk for the fetus or child. Pregnancy The numerous data relating to the use of paracetamol lasts pregnancy do not indicate neither malformation toxicity, nor fetal/neonatal. Epidemiological studies on neurological development in children exposed to paracetamol in uterus show non-conclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used for as short as possible and with as little frequency 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 dextromethtorphan. The use during the advanced phase of pregnancy can expose the newborn to respiratory depression. Epidemiological studies do not indicate malformation toxicity induced by doxylamine. Considered the anti-linergical and sedative activity of doxylamine, the monitoring of the newborn is strongly recommended in case of use of Vicks MediNait near the birth. Food Although excreted in breast milk, the use of paracetamol is compatible with breastfeeding. It is not known the excretion in the breast milk of dextromethtorphan and doxylamine.

Source: Farmadati