Neo Borocillina Cough 10mg + 1.2mg 20 tablets

Neo Borocillina Tosse 10mg + 1.2mg 20 tablets is a product formulated for the treatment of cough and as an antiseptic for the oropharyngeal cavity . Each tablet contains dextromethorphan hydrobromide and 2,4-dichlorobenzyl alcohol , active ingredients known for their cough sedative and antiseptic properties. This medicine is indicated to relieve the symptoms of dry and irritating cough, offering effective and targeted relief. The tablet formulation allows for practical and convenient intake, ideal for those who need rapid and discreet treatment. With a precise dosage, Neo Borocillina Tosse is designed to guarantee effective action against the discomfort of cough, contributing to the well-being of the oral cavity. "

ACTIVE INGREDIENTS

Active ingredients contained in Neo Borocillina Tosse 10mg + 1.2mg 20 lozenges - What is the active ingredient in Neo Borocillina Tosse 10mg + 1.2mg 20 lozenges?

Each tablet contains: - DEXTROMETHORPHAN HYDROBROMHYDRATE 10 mg (adsorbed on magnesium trisilicate) - 2,4-DICHLOROBENZYL ALCOHOL 1.2 mg Excipients with known effect : aspartame (E 951), compressible sugar For the full list of excipients, see section 6.1

EXCIPIENTS

Composition of Neo Borocillina Tosse 10mg + 1.2mg 20 lozenges - What does Neo Borocillina Tosse 10mg + 1.2mg 20 lozenges contain?

Freshflavor flavor, ammonium glycyrrhizinate, magnesium stearate, aspartame (E 951), copovidone, compressible sugar.

DIRECTIONS

Therapeutic indications Neo Borocillina Tosse 10mg + 1.2mg 20 tablets - Why is Neo Borocillina Tosse 10mg + 1.2mg 20 tablets used? What is it for?

Cough sedative and antiseptic of the oropharyngeal cavity.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Neo Borocillina Tosse 10mg + 1.2mg 20 tablets - When should Neo Borocillina Tosse 10mg + 1.2mg 20 tablets not be used?

Hypersensitivity to the active substances or to any of the excipients. Bronchial asthma, COPD, pneumonia, difficulty breathing, respiratory depression, cardiovascular disease, hypertension, hyperthyroidism, diabetes, glaucoma, prostatic hypertrophy, gastrointestinal and urogenital stenosis, epilepsy, severe liver disease. Do not administer to children under 12 years of age. Do not use at the same time or within two weeks of treatment with MAO inhibitor antidepressant drugs. Pregnancy, especially in the first trimester, breastfeeding (see section 4.6).

DOSAGE

Quantity and method of taking Neo Borocillina Tosse 10mg + 1.2mg 20 tablets - How do you take Neo Borocillina Tosse 10mg + 1.2mg 20 tablets?

Adults and children over 12 years: slowly dissolve one lozenge in the mouth every 2-3 hours, up to a maximum of 8 lozenges per day. Do not exceed the recommended dose.

CONSERVATION

Storage Neo Borocillina Tosse 10mg + 1.2mg 20 tablets - How do you store Neo Borocillina Tosse 10mg + 1.2mg 20 tablets?

Store below 30°C.

WARNINGS

Warnings Neo Borocillina Tosse 10mg + 1.2mg 20 tablets - About Neo Borocillina Tosse 10mg + 1.2mg 20 tablets it is important to know that:

In case of irritating cough with a significant production of mucus (e.g. in patients with diseases such as bronchiectasis and cystic fibrosis) or in patients with neurological diseases associated with a marked reduction of the cough reflex (such as stroke, Parkinson's disease and dementia), treatment with Neo Borocillina Tosse pastilles as a cough suppressant should be administered with particular caution and only on medical advice after a 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 Borocillina Tosse pastilles should be administered with caution in such patients, especially in patients with severe impairment. Dextromethorphan is metabolised by the hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. Approximately 10% of the population metabolises CYP2D6 slowly. Exaggerated and/or prolonged effects of dextromethorphan may occur in poor metabolisers and patients with concomitant use of CYP2D6 inhibitors. Caution is therefore required in patients who are poor metabolisers of CYP2D6 or who use CYP2D6 inhibitors (see also section 4.5). Due to the potential release of histamine, the use of Neo Borocillina Tosse pastilles should be avoided in cases of mastocytosis. A chronic cough may be an early symptom of asthma and therefore Neo Borocillina Tosse pastilles is not indicated for the suppression of chronic cough, particularly in children. Neo Borocillina Tosse pastilles 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 may give rise to sensitization phenomena. In this case, it is necessary to stop the treatment and consult your doctor in order to establish any appropriate therapy. After 5-7 days of treatment, without appreciable results, consult your doctor. Important information about some of the excipients Contains 1.386 g of sucrose (sugar) per tablet. To be taken into consideration in case of patients 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). It is not advisable to drink alcohol during therapy. Dextromethorphan may cause a modest addiction. Following prolonged use (e.g. exceeding the recommended treatment period), patients may develop tolerance to the medicine, as well as mental and physical dependence. Cases of abuse of dextromethorphan have been reported. Special caution 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 Borocillina Tosse for short periods and under strict medical supervision.

INTERACTIONS

Interactions Neo Borocillina Tosse 10mg + 1.2mg 20 lozenges - Which medicines or foods can modify the effect of Neo Borocillina Tosse 10mg + 1.2mg 20 lozenges?

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 lead to the development of a serotonin syndrome with the following characteristic symptoms: neuromuscular hyperactivity (e.g. tremor, clonic spasm, myoclonus, increased reflex response and pyramidal rigidity), autonomic hyperactivity (e.g. diaphoresis, fever, tachycardia, tachypnoea, mydriasis) and altered mental status (e.g. agitation, excitation, confusion) (see sections 4.3 (MAO inhibitors) and 4.4). Concomitant administration of drugs with an inhibitory effect on the central nervous system such as hypnotics, sedatives or anxiolytics, or alcohol intake, may lead to additive effects. If dextromethorphan is used in combination with mucolytics in patients with pre-existing respiratory tract diseases such as cystic fibrosis and bronchiectasis, with hypersecretion of mucus, the reduction of the cough reflex may lead to (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 may increase dextromethorphan concentrations in the body to levels several times higher than normal. This increases the patient's risk of toxic effects of dextromethorphan (agitation, confusion, tremor, insomnia, diarrhoea and respiratory depression) and the development of serotonin syndrome. Potent inhibitors of CYP2D6 are fluoxetine, paroxetine, quinidine, terbinafine, cimetidine, ritonavir, berberine. When used concomitantly 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 necessary, the patient should be monitored and the dose of dextromethorphan may need to be reduced.

SIDE EFFECTS

Like all medicines, Neo Borocillina Tosse 10mg + 1.2mg 20 pastilles can cause side effects - What are the side effects of Neo Borocillina Tosse 10mg + 1.2mg 20 pastilles?

There are insufficient data to establish the frequency of the listed effects . Immune system disorders 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 Somnolence Ear and labyrinth disorders Vertigo Respiratory, thoracic and mediastinal disorders Respiratory depression Gastrointestinal disorders Nausea, vomiting, gastrointestinal disorders General disorders and administration site conditions Fatigue Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. 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

OVERDOSE

Overdose Neo Borocillina Tosse 10mg + 1.2mg 20 tablets - What are the risks of Neo Borocillina Tosse 10mg + 1.2mg 20 tablets in case of overdose?

Symptoms In case of overdose, the following known side effects may occur more frequently or severely: 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 may occur. Treatment If necessary, resort to intensive medical care (in particular intubation, ventilation). Precautions may be necessary to safeguard against heat loss and fluid replacement. Intravenous administration of naloxone may antagonise the effects of dextromethorphan on the central nervous system. If necessary, perform gastric lavage with stable circulation . Do not administer centrally acting emetics.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Neo Borocillina Tosse 10mg + 1.2mg 20 tablets.

Neo Borocillina Tosse pastilles should not be used during the first three months of pregnancy; in the following months the drug should be administered only in case of real need and under the direct supervision of a doctor. Since the excretion of the drug in breast milk is not known and a respiratory depression effect on the newborn cannot be excluded, Neo Borocillina Tosse pastilles is contraindicated during breastfeeding.

DRIVING AND USE OF MACHINERY

Taking Neo Borocillina Tosse 10mg + 1.2mg 20 lozenges before driving or using machinery - Does Neo Borocillina Tosse 10mg + 1.2mg 20 lozenges affect driving or using machinery?

Since the product may cause drowsiness and/or dizziness (especially in conjunction with the intake of alcohol or other medicines that may reduce reaction times), this must be taken into account by those who may drive motor vehicles or carry out operations requiring a high level of alertness.