NIROLEX TOSSE SECTOR 150ML

NIROLEX DRY COUGH 30 MG/10 ML SYRUP

active ingredients

10 ml of syrup contain: Active Ingredient: 30 mg bromidrate dextromethtorphan sucrose and benzoate sodium (E 211). For the full list of excipients, see paragraph 6.1.

Excellent

Saccarosium, glycerol, benzoate sodium (E 211), citric acid, citrate sodium, purified water.

Therapeutic indications

Bromidated dextromethtorphan is indicated for the symptomatic treatment of dry cough.

Contraindications

- Hypersensitivity to the active ingredient or any of the excipients; - bronchial asthma, BPCO (chronic obstructivebroncopneumopathy), pneumonia, difficulty breathing, respiratory depression; - cardiovascular disease, hypertension; - hyperthyroidism; - diabetes; - glaucoma; - prostate hypertrophy; - stenosis of gastroenteric and urogenital apparatus; - epilepsy; - severe liver disease; - children under 12 years of age; - do not use at the same time or in the two weeks following antidepressant inhibition drugs of MAO; - first trimester of pregnancy, nursing (see paragraph 4.6).

Population

Adults and teenagers (from 12 to 18 years): The generally recommended dose range varies from 10 mg (a coffee spoon corresponding to about 3 ml) to 20 mg (2 teaspoons of coffee corresponding altogether to about 6 ml) every 6 hours. The maximum dose reached in 24 hours is 80 mg. Children up to 12 years: Destrometorphan bromirate should not be used.

Conservation

Store the bottle well closed, sheltered from heat sources. Store in the original packaging to protect the medicine from light.

Warnings

Treatment with bromitted dextromethtorphan should not be protracted over 5-7 days. In the absence of a therapeutic response within a few days, the doctor must reevaluate the situation. The bromitted dextrometorphan can give assuefation. As a result of prolonged use, patients may develop tolerance to the medicinal product, as well as mental and physical dependence (see paragraph 4.8). 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. Patients with a tendency to abuse or dependence must take bromirate dextromethtorphan syrup for short periods and under strict control of the doctor. Chronic cough may be an early symptom of asthma and then bromirate dextromethtorphan is not indicated for the suppression of chronic or persistent cough (e.g. smoke, emphysema, asthma, etc.). Bromidated dextromethtorphan should be given with particular caution and only on medical advice in case the cough is accompanied by other stintomi such as: fever, rash, headache, nausea and vomiting. The medicine should not be taken in case of cough when the cough is accompanied by abundant secretion. In case of irritating cough with a remarkable production of mucus, the treatment with bromirate dextromethtorphan should be administered with particular caution and only on medical advice after careful assessment of the risk-benefit. During therapy with bromirate dextromethtorphan it is not advisable to use alcohol (see paragraph 4.5). Administer right-metorphan bromirate with caution and only after careful risk-benefit assessment in patients with cardiovascular disease, hypertension, hyperthyroidism, diabetes, glaucoma, prostate hypertrophy, gastroenteric and urogenital stenosis, epilepsy, altered liver function, and in subjects that are taking antidepressant drugs, such as epilepsy. The rightmetorphan is metabolized by the liver cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the population slowly metabolizes CYP2D6. In slow metabolizers and patients with concomitant use of CYP2D6 inhibitors, exaggerated and/or prolonged effects of dextromethtorphan may occur. It is therefore necessary to pay attention to CYP2D6 slow metabolizer patients or to use CYP2D6 inhibitors (see also paragraph 4.5). Risk from the concomitant use of sedative medicines such as benzodiazepines or medicines related to them: Concurrent use of Nirolex Tosse Secca and sedative medicines such as benzodiazepines or medicines related to them can cause sedation, respiratory depression, coma and death. Due to these risks, the concomitant prescription with these sedative medicines must be reserved to patients for whom alternative treatment options are not possible. If you decide to prescribe Nirolex Tosse Secca in conjunction with sedative medicines, you must use the lowest effective dose possible and the duration of treatment must be as short as possible. Patients should be carefully evaluated for signs and symptoms of respiratory depression and sedation. In this regard, it is strongly recommended to inform patients and people who take care of them (where applicable) to pay attention to these symptoms (see paragraph 4.5). 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 inhibitors of serotonin reuptake (selective serotonin reuptake inhibitors, SSRIs), drugs that alter serotonin metabolism (including monoamine inhibitors) [monoamine oxidase inhibitors, MAOI]) and CYP2D6 inhibitors. Serotonin syndrome may include changes in mental state, autonomic instability, neuromuscular abnormalities and/or gastrointestinal symptoms. If a serotonin syndrome is suspected, the treatment with Nirolex Tosse Secca should be stopped. Important information about some excipients: This medicine contains 5.5 g sucrose for 10 ml: to be taken into account 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 4.5 mg of benzoate sodium per minimum dose of 10 mg (equivalent to 3 ml) and 36 mg per maximum daily dose of 80 mg (equivalent to 24 ml). This medicine contains less than 1 mmol (23 mg) of sodium per daily maximum dose of 80 mg (equivalent to 24 ml), i.e. essentially ‘without sodium’.

Interactions

MAO inhibitor drugs: Concurrent administration of bromirate dextromethtorphan with MAO inhibitor drugs is contraindicated. In addition, you should not take the bromirate dextromethtorphan syrup in the 2 weeks following the treatment with MAO inhibitor drugs. The association of these drugs can, in fact, induce the development of a serotoninergic syndrome characterized by the following symptoms: nausea, hypotension, neuromuscular hyperactivity (tremity, clonic spasm, myoclonus, increased reflex response and stiffness of pyramidal origin), hyperactivity of the autonomic nervous system (diaphoresis, fever, tachycardia, tachypnea, midriasis) and altered mental state (acting, excitement, confusion), until arriving at cardiac arrest and death. Linezolid and sibutramine: Serotoninergic syndrome cases have been reported also following the concomitant administration of the bromidrate dextromethtorphan with linezolid or sybutramine. Central nervous system inhibitors: Concurrent administration of bromirate dextromethtorphan with drugs with an inhibitory effect on the central nervous system such as hypnotics, sedatives or anxiolytics, or with alcohol intake, can lead to additive effects on the central nervous system. Sedative medicines such as benzodiazepines or medicines related to them: Concurrent use of opioids with sedative medicines such as benzodiazepines or related to them increases the risk of sedation, respiratory depression, coma and death due to the additional depressive effect on SNC. The dose and duration of combined treatment must be limited (see paragraph 4.4). Cytochrome inhibitors CYP2D6: 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 dextromethtorphan (acting, confusion, tremor, insomnia, diarrhea and respiratory depression) and of development of serotonin syndrome. It should be taken into account that this effect can occur even if the inhibition drug of the cytochrome P450-2D6 has recently taken place and not necessarily in a contemporary way to the rightmetorphan syrup bromidrato.Potenti cYP2D6 inhibitors are fluoxetine, paroxetine, chinidine and terbinaphine. In use in conjunction 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. Secretolithic drugs: If the bromidrate dextromethtorphan is used in combination with secretolithic drugs, the reduction of cough reflex can lead to a severe accumulation of mucus. Grapefruit juice: Grapefruit juice can increase absorption, bioavailability and elimination of bromirate dextromethtorphan, resulting in increased toxicity and decrease in its effect.

Effects

Below are the undesirable effects of the bromidrate dextromethtorphan organized according to the organic system classification MedDRA. No sufficient data is available to determine the frequency of all the individual effects listed. Diseases of the nervous system: Sleeplessness, fatigue, nistagm, dystonia, dizziness, mental stunnel and dark language. Serotoninergic syndrome, characterized by: nausea, hypotension, neuromuscular hyperactivity (tremity, chlonic spasm, myoclonus, increased reflex response and stiffness of pyramidal origin), hyperactivity of the autonomic nervous system (diaphoresis, fever, tachycardia, tachypnea, midriasis) and altered mental state (agitation, excitement, confusion), to the death of cardiac arrest and. Psychiatric disorders: Psychosis, hallucinations. Psychic addiction; the dextromethtorphan has a low risk of abuse and dependence. However, cases of psychic dependence (non-physical) and cases of abuse were reported due to the euphoric effect caused by the substance. Immune system disorders: Anaphylactic and anaphylactic reactions. Systemic pathologies and conditions for administration: Hyperpyressia and hyperthermia. Disorders of metabolism and nutrition: Diabetes mellitus. Gastrointestinal diseases: Nausea, vomiting, gastrointestinal disorders and appetite reduction. Pathologies of skin and subcutaneous tissue: Skin allergic reactions and rashes. Reporting of suspected 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 via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdose

Symptoms and signs Overdose of dextromethtorphan can be associated with nausea, vomiting, dystonia, agitation, confusion, drowsiness, astonishment, nistagm, cardiotoxicity (tachycardia, abnormal ECG including extension of the QTc range), ataxia, toxic psychosis with visual hallucinations, hypereccitability, excitement, muscle tone and hypotension. In case of mass overdose, the following symptoms can be observed: coma, urinary retention, respiratory depression, seizures. Management -Active carbon can be administered to asymptomatic patients who ingested overdose of dextromethtorphan in the previous hour. -For patients who have ingested the rightmetorphan and are sedated or comatose, naloxone can be considered, in the usual doses for the treatment of overdose from opioids. Benzodiazepines can be used for convulsions and benzodiazepines and external cooling measures for hyperthermia from serotonin syndrome. In case of need to use intensive medical care (in particular intubation, ventilation). Precautions may be required to safeguard heat loss and replenish liquids. If necessary, it is recommended to carry out the gastric lavender. Do not administer hemetics at central action.

The results of epidemiological studies on a limited sample of population did not indicate an increase in the frequency of malformations in children who were exposed to bromirate dextrometorphan during the prenatal period. However, these studies do not adequately document the period and duration of treatment with bromidrate dextromethtorphan. Reproductive toxicity studies on animals do not indicate a potential risk for man for the bromidal dextromethtorphan (see paragraph 5.3).

Pregnancy

: Destrometorphan bromidrate should not be used during the first three months of pregnancy; moreover, since the administration of high doses of bromirate dextromethtorphan, even for short periods, may cause respiratory depression in infants, in the following months the drug must be administered only in case of actual need and after careful assessment of benefits and risks.

Breastfeeding

: Since it is not known the excretion of the drug in breast milk and cannot be excluded an effect of respiratory depression on the newborn, dextrometorphan bromirate is contraindicated during breastfeeding.

Source: Farmadati