Solmucol Dry Cough Dextromethorphan Hydrobromide 15mg/ml Oral Drops 20ml

NAME
SOLMUCOL DRY COUGH 15 MG / ML ORAL DROPS, SOLUTION

PHARMACOTHERAPEUTIC CATEGORY
Antitussives, excluding associations with expectorants.

ACTIVE PRINCIPLES
Dextromethorphan hydrobromide 15 mg.

EXCIPIENTS
Glycerol, levomentol, methyl parahydroxybenzoate, purified water.

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

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the excipients; 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 inhibitor antidepressant drugs; first trimester of pregnancy, breastfeeding.

DOSAGE
Adults and adolescents (12 to 18 years): The generally recommended dose range is 10 mg (approximately 14 drops) to 20 mg (approximately 28 drops) every 6 hours. The maximum dose that can be reached in 24 hours is 80 mg (about 110 drops). Children up to 12 years: the medicine should not be used.

STORAGE
Store in the original package to protect from light.

WARNINGS
Treatment with dextromethorphan hydrobromide should not be continued beyond 5-7 days. In the absence of a therapeutic response within a few days, the situation needs to be reassessed. Dextromethorphan hydrobromide can be addictive. Following prolonged use, patients may develop tolerance to the drug, as well as addictional and physical. Patients with a tendency to abuse or dependence should take the dextromethorphan hydrobromide drops for short periods. 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 the event 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. During therapy with dextromethorphan hydrobromide the use of alcohol is not recommended. Administer with caution and only after a careful risk-benefit assessment of 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 with or who are taking antidepressant medications, such as MAO inhibitor medications. The product contains methyl para-hydroxy-benzoate, which can cause allergic reactions (sometimes delayed) in some subjects.

INTERACTIONS
MAO inhibitor drugs: concomitant administration of dextromethorphan hydrobromide with MAO inhibitor drugs is contraindicated. In addition, dextromethorphan hydrobromide drops should not be taken for 2 weeks following therapy with MAO inhibitor drugs. The association of these drugs can, in fact, induce the development of a serotonin syndrome characterized by the following symptoms: nausea, hypotension, neuromuscular hyperactivity (tremor, clonic spasm, myoclonus, increased reflex response and rigidity of pyramidal origin) , hyperactivity of the autonomic nervous system (diaphoresis, fever, tachycardia, tachypnea, mydriasis) and altered mental status (agitation, excitement, confusion), up to cardiac arrest and death. Linezolid and sibutramine: Cases of serotonin syndrome have also been reported following concomitant administration of dextromethorphan hydrobromide with linezolid or with sibutramine. Central nervous system inhibitory drugs: concomitant administration of dextromethorphan hydrobromide with drugs with an inhibitory effect on the central nervous system such as hypnotics, sedatives and anxiolytics, or with the intake of alcohol, can lead to additive effects on the central nervous system. Cytochrome P450-2D6 inhibitor drugs: concomitant administration of dextromethorphan hydrobromide with drugs that inhibit the enzymatic activity of cytochrome P450-2D6 in the liver, and therefore, the metabolism of dextromethorphan, can lead to an increase in the plasma concentration of dextromethorphan resulting in an increase in its toxicity. It should be borne in mind that this effect may occur even if the cytochrome P450-2D6 inhibitor drug has been taken recently and not necessarily simultaneously with the didxtromethorphan hydrobromide drops. The main drugs that inhibit cytochrome P450-2D6 are: amiodarone, quinidine, fluoxetine, haloperidol, paroxetine, propafenone, thioridazine, cimetidine and ritonavir. Secretolytic drugs: if dextromethorphan hydrobromide is used in combination with secretolytic drugs, the reduction of cough reflex can 'lead to a severe accumulation of mucus. Grapefruit juice: grapefruit juice can increase the absorption, bioavailability and elimination of dextromethorphan hydrobromide, with a consequent increase in its toxicity and decrease in its effect.

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 dizziness 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, tachypnoea, mydriasis) and altered mental state (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.

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 on animals do not indicate a potential risk to humans for dextromethorphan hydrobromide. Dextromethorphan hydrobromide should not be used during the first three months of pregnancy; furthermore, 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 must be administered only in case of real need and after a careful evaluation of the benefits and risks. . Since excretion of the drug into breast milk is not known and a respiratory depressing effect on the newborn cannot be excluded, dextromethorphan hydrobromide is contraindicated during breastfeeding.