Dextromethorphan Bromidate Zeta 15mg Oral Drops 20 ml bottle

Therapeutic indications

Dextromethorphan hydrobromide is indicated for the symptomatic treatment of dry cough.

Dosage

Adults and adolescents (12 to 18 years) The generally recommended dose range is 10 mg (approximately 27 drops) to 20 mg (approximately 53 drops) every 6 hours. The maximum dose that can be reached in 24 hours is 80 mg (approximately 213 drops). Pediatric population Children up to 12 years Dextromethorphan hydrobromide should not be used.

Overdose

Symptoms Nausea, vomiting, visual disturbances and central nervous system disorders such as ataxia, dizziness, excitement, increased muscle tone, mental confusion, hypotension and tachycardia. In extreme cases, urinary retention and respiratory depression can occur. Therapy If necessary, resort to 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, particularly respiratory depression. If necessary, gastric lavage is recommended. Do not administer centrally acting emetics.

Contraindications

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; - bronchial asthma, COPD (chronic obstructive pulmonary disease), pneumonia, breathing difficulties, respiratory depression; - cardiovascular diseases, hypertension; - hyperthyroidism; - diabetes; - glaucoma; - prostatic hypertrophy; - stenosis of the gastrointestinal and urogenital systems; - epilepsy; - severe liver disease; - children under the age of 12; - do not use at the same time or in the two weeks following MAO inhibiting antidepressant drugs; - first trimester of pregnancy, lactation (see section 4.6).

Side effects

The following are the undesirable effects of dextromethorphan hydrobromide organized according to the MedDRA system organ class. Insufficient data are available to establish the frequency of all single effects listed. Nervous system disorders Somnolence, fatigue, nystagmus, dystonia, dizziness, mental light-headedness and bad language. Serotonin syndrome, characterized by: nausea, hypotension, neuromuscular hyperactivity (tremor, clonic spasm, myoclonus, increased reflex response and stiffness of pyramidal origin), hyperactivity of the autonomic nervous system (diaphoresis, fever, tachycardia, tachypnea, mydriasis) and mental status altered (agitation, excitement, confusion), leading to cardiac arrest and death. Psychiatric disorders Psychosis, hallucinations. Psychic dependence; dextromethorphan has a low risk of abuse and dependence. However, there have been reports of psychic (non-physical) dependence and cases of abuse due to the euphoric effect caused by the substance. Immune system disorders Anaphylactic and anaphylactoid reactions. General disorders and administration site conditions Hyperpyrexia and hyperthermia. Metabolism and nutrition disorders Diabetes mellitus. Gastrointestinal disorders Nausea, vomiting, gastrointestinal disturbances and decreased appetite. Skin and subcutaneous tissue disorders Allergic skin reactions and rashes. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at : www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

The results of epidemiological studies on a limited sample of the population did not indicate an increase in the frequency of malformations in children who were exposed to dextromethorphan hydrobromide during the prenatal period. However, these studies do not adequately document the period and duration of treatment with dextromethorphan hydrobromide. Reproductive toxicity studies in animals do not indicate a potential risk to humans for dextromethorphan hydrobromide (see section 5.3). Dextromethorphan hydrobromide should not be used during the first three months of pregnancy; moreover, since the administration of high doses of dextromethorphan hydrobromide, even for short periods, can cause respiratory depression in newborns in the following months, the drug should be administered only in case of real need and after a careful evaluation of the benefits and risks. Since excretion of the drug in breast milk is not known and a respiratory depressive effect on the newborn cannot be excluded, dextromethorphan hydrobromide is contraindicated during breastfeeding.

Special warnings

Treatment with dextromethorphan hydrobromide should not be continued beyond 5 - 7 days. If there is no therapeutic response within a few days, the physician should reassess the situation. Dextromethorphan hydrobromide can be addictive. Following prolonged use, patients may develop tolerance to the medicinal product, as well as mental and physical dependence (see section 4.8). Patients with a tendency to abuse or dependence should take dextromethorphan hydrobromide drops for short periods and under close medical supervision. 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. A chronic cough may be an early symptom of asthma and therefore dextromethorphan hydrobromide is not indicated for the suppression of chronic or persistent cough (e.g. due to smoking, emphysema, asthma, etc.). Dextromethorphan hydrobromide should be administered with particular caution and only on medical advice if the cough is accompanied by other symptoms such as: fever, rash, headache, nausea and vomiting. The medicine should not be taken in case of cough accompanied by profuse secretion. In case of an irritating cough with considerable mucus production, treatment with dextromethorphan hydrobromide should be administered with particular caution and only on medical advice after a careful risk-benefit assessment. The use of alcohol is not recommended during therapy with dextromethorphan hydrobromide (see section 4.5). Administer with caution and only after a careful risk-benefit assessment dextromethorphan hydrobromide in patients with cardiovascular disease, hypertension, hyperthyroidism, diabetes, glaucoma, prostatic hypertrophy, stenosis of the gastrointestinal and urogenital tract, epilepsy, impaired liver function, in subjects who are taking antidepressant medications, such as MAO inhibitor drugs. Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the population metabolise 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 CYP2D6 metabolisers or who use CYP2D6 inhibitors (see also section 4.5). Important information about some of the ingredients: This medicine contains small amounts of ethanol (ethyl alcohol), less than 100 mg per dose (27 - 53 drops). Contains parahydroxybenzoates: they can cause allergic reactions (even delayed). Contains sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine.

Expiry and Retention

Store in the original package to protect from light.

Active principles

1 ml of solution contains: active ingredient: dextromethorphan hydrobromide 15 mg (1 ml corresponds to 40 drops). Excipients with known effects: sorbitol, ethanol and parahydroxybenzoates. For the full list of excipients see section 6.1.

Excipients

Liquid sorbitol, glycerol, citric acid monohydrate, sodium benzoate, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol, sodium hydroxide, vanillin, ethanol, sodium saccharin, purified water.