NEOBOROCILLIN COUGH 20 TABLETS
Sedative of cough and antiseptic of the oropharyngeal cavity.
Dosage and method of use
Adults and children over 12 years: slowly dissolve one tablet in the mouth every 2-3 hours, up to a maximum of 8 tablets per day. Do not exceed the recommended dose.
Hypersensitivity to the active substances or to any of the excipients. Bronchial asthma, COPD, pneumonia, breathing difficulties, respiratory depression, cardiovascular diseases, hypertension, hyperthyroidism, diabetes, glaucoma, prostatic hypertrophy, stenosis of the gastrointestinal and urogenital tract, epilepsy, severe liver disease. Do not administer to children under 12 years of age. Do not use at the same time or in the two weeks following treatment with MAO inhibitor antidepressant drugs. Pregnancy, particularly in the first trimester, lactation (see section 4.6).
Insufficient data are available to establish the frequency of the listed effects. Disorders of the immune system Hypersensitivity reactions (including anaphylactic reaction, angioedema, urticaria, pruritus, rash and erythema) Metabolism and nutrition disorders Decreased appetite Psychiatric disorders Hallucinations Dextromethorphan abuse and dependence Nervous system disorders Drowsiness Ear and labyrinth disorders Dizziness Respiratory, thoracic and mediastinal disorders Respiratory depression Gastrointestinal disorders Nausea, vomiting, gastrointestinal disturbances General disorders and administration site conditions Fatigue Reporting of suspected adverse reactions. Reporting 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: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
In the case of an irritating cough with significant mucus production (e.g. in patients with diseases such as bronchiectasis and cystic fibrosis) or in patients with neurological diseases associated with a marked reduction in the cough reflex (such as stroke, Parkinson's disease and dementia), treatment with Neo Borocillin Cough lozenges as a cough suppressant should be administered with particular caution and only on medical advice after careful risk-benefit assessment (see section 4.5). There is limited information on the use of dextromethorphan in patients with impaired hepatic or renal function. Therefore, Neo Borocillin Cough lozenges should be administered with caution in such patients, especially in patients with severe impairment. Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the population metabolizes 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). Due to the potential for histamine release, the use of Neo Borocillin Cough lozenges should be avoided in case of mastocytosis. A chronic cough can be an early symptom of asthma and therefore Neo Borocillin Cough Pads are not indicated for chronic cough suppression, particularly in children. Neo Borocillin Cough lozenges should be used with caution in patients taking serotonergic drugs (other than MAO inhibitor drugs), such as selective serotonin reuptake inhibitors (SSRIs) (e.g. fluoxetine, paroxetine) or tricyclic antidepressant drugs (see section 4.5 ). The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and consult the doctor in order to establish any suitable therapy. After 5-7 days of treatment, without noticeable results, consult your doctor. Important information about some of the ingredients Contains 1.386 g of sucrose (sugar) per tablet. 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. The product contains aspartame, a source of phenylalanine (see section 4.3). Alcohol intake is not recommended during therapy. Dextromethorphan can be mildly addictive. Following prolonged use (e.g. exceeding the recommended treatment period), patients may develop tolerance to the drug, as well as mental and physical dependence. Cases of dextromethorphan abuse have been reported. Special care is recommended with adolescents and young adults, as well as with patients with a history of drug or psychoactive substance abuse. Patients with a tendency to abuse or dependence should take Neo Borocillin Cough for short periods and under close medical supervision.
Pregnancy and breastfeeding
Neo Borocillin Cough lozenges should not be used during the first three months of pregnancy; in the following months the drug must be administered only in case of real need and under the direct supervision of the doctor. Since excretion of the drug in breast milk is not known and a respiratory depressive effect on the newborn cannot be excluded, Neo Borocillin Cough lozenges are contraindicated during breastfeeding.
Expiry and retention
Store at a temperature below 30 ° C.
Interactions with other drugs
Dextromethorphan has weak serotonergic properties. Dextromethorphan may therefore lead to an increased risk of serotonergic toxicity (serotonin syndrome), especially when taken together with other serotonergic agents, such as MAO inhibitors or SSRIs or tricyclic antidepressants. Especially pre-treatment or concomitant treatment with drugs that impair serotonin metabolism, such as antidepressant drugs of the MAO inhibitor type, may induce the development of a serotonin syndrome with the following characteristic symptoms: neuromuscular hyperactivity (e.g. tremor, spasm clonic, myoclonus, increased reflex response and stiffness of pyramidal origin), hyperactivity of the autonomic nervous system (e.g. diaphoresis, fever, tachycardia, tachypnea, mydriasis) and altered mental status (e.g. agitation, excitement, confusion) (see section 4.3 (MAO inhibitor drugs) and 4.4). The concomitant administration of drugs with an inhibitory effect on the central nervous system such as hypnotics, sedatives or anxiolytics, or the intake of alcohol, may lead to additive effects. If dextromethorphan is used in combination with mucolytics in patients with pre-existing diseases of the respiratory tract, such as cystic fibrosis and bronchiectasis, suffering from mucus hypersecretion, the reduced cough reflex can lead to a (severe) accumulation of mucus. CYP2D6 inhibitors 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, terbinafine, cimetidine, ritonavir, berberine. 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.
Symptoms In case of overdose, known side effects may occur with greater frequency or severity: nausea, vomiting, visual disturbances and central nervous system disorders such as ataxia, dizziness, excitement, increased muscle tone, mental confusion, drowsiness, hypotension and tachycardia. In extreme cases, urinary retention and respiratory depression can occur. Treatment If necessary, seek intensive medical care (in particular intubation, ventilation). Precautions may be necessary to safeguard heat loss and replenish fluids. Intravenous administration of naloxone may antagonize the effects of dextromethorphan on the central nervous system. If necessary, carry out gastric lavage with stable circulation. Do not administer centrally acting emetics.
Every tablet contains: - DESTROMETORPHAN BROMIDRATE 10 mg (adsorbed on magnesium trisilicate) - 2,4-DICHLOROBENZIL ALCOOL 1.2 mg Excipients with known effects: aspartame (E 951), compressible sugar For a full list of excipients, see section 6.1
Aroma freshflavor, ammonium glycyrrhizinate, magnesium stearate, aspartame (E 951), copovidone, compressible sugar.