Bronchenolo Dextromethorphan Hydrobromide Cough Syrup 150 ml

WARNINGS
In the following cases, the drug should be used only after consulting your doctor: chronic or persistent cough, such as that which occurs in the case of asthma or emphysema, or when the cough is accompanied by excessive secretion; severe liver failure; severe kidney failure; concomitant use of selective serotonin reuptake inhibitor antidepressants or tricyclic antidepressants. Simultaneous use of other cough and cold products should be avoided. The syrup contains sucrose, which should be taken into account in the case of diabetes or low-calorie diets. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine. Concomitant use of alcohol should be avoided during therapy. Do not exceed the maximum recommended dose or frequency of administration.
PHARMACOTHERAPEUTIC CATEGORY
Cough suppressants (opium alkaloids and its derivatives).
STORAGE
Keep the product in the original packaging.
CONTRAINDICATIONS / SECONDARY EFFECT
In case of hypersensitivity to the components or other strictly correlated substances from a chemical point of view. Children under the age of 6. Patients with respiratory failure or at risk of developing respiratory failure (e.g. patients with chronic obstructive airway disease or pneumonia, patients with ongoing asthma attack or exacerbation of asthma). Patients who are taking or have taken monoamine oxidase inhibitor antidepressants (MAOIs) within the last two weeks.
NAME
COUGH BRONCHENOL
EXCIPIENTS
Ethyl alcohol, sodium citrate, citric acid monohydrate, methyl p-hydroxybenzoate, lemon flavor, mint flavor, sucrose, purified water.
SIDE EFFECTS
Data from clinical studies. The adverse events reported below were observed in clinical studies with dextromethorphan and are considered uncommon adverse reactions (ie 'occurring in a percentage between> = 1/1000 and <1/100 patients). Adverse reactions are listed according to the MedDRA classification. Nervous system disorders: drowsiness; dizziness. Gastrointestinal disorders: gastrointestinal disorders; nausea; He retched; abdominal discomfort. Post marketing data. Adverse reactions identified during post-marketing use of dextromethorphan products are listed below. Since these reactions are reported voluntarily from a population of uncertain size, their frequency is not known but is probably very rare (found in <1/10000 patients). Nervous system disorders: serotonin syndrome. Serotonin syndrome (with altered mental status, agitation, myoclonus, hyperreflexia, diaphoresis, tremors, tremors and hypertension) has been reported in the case of concomitant use of dextromethorphan with antidepressants (monoamine oxidase inhibitors or serotonin reuptake inhibitors). Skin and subcutaneous tissue disorders: allergic reactions (e.g. rash, urticaria, angioedema).
PREGNANCY AND BREASTFEEDING
No data on pregnancy and lactation are available. During pregnancy and lactation the product must be used only in case of real need and under direct medical supervision.
INDICATIONS
Symptomatic treatment of cough.
INTERACTIONS
The product should not be used at the same time or in the 2 weeks following treatment with monoamine oxidase inhibitor antidepressants (MAOIs), as serious adverse reactions, including serotonin syndrome, have been reported. Patients should consult their physician before taking dextromethorphan in the following situations: Concomitant use of dextromethorphan with selective serotonin reuptake inhibitor antidepressants or tricyclic antidepressants can cause serotonin syndrome with changes in mental status, hypertension, agitation, myoclonus , hyperreflexia, diaphoresis, tremors and tremors; serum levels of dextromethorphan may be increased by concomitant use of cytochrome P450 2D6 inhibitors, such as the antiarrhythmics quinidine and amiodarone, antidepressants such as fluohexitine and paroxetine, or other drugs that inhibit cytochrome P450 2D6 such as haloperidol and thioridazine; the concomitant use of dextromethorphan and alcohol can 'increase the depressive effects on the central nervous system of both substances.
DOSAGE
Adults and children (over 12 years): 3-4 tablespoons (15 ml) per day. One tablespoon every 4-6 hours. Maximum daily dosage: 60 ml. Children from 6 to 12 years: 3-4 half tablespoons (7.5 ml) per day. Half a spoon every 4-6 hours. Maximum daily dosage: 30 ml. After 5-7 days of treatment with no appreciable results, the patient should be advised to consult the doctor.
ACTIVE PRINCIPLES
Dextromethorphan hydrobromide 154 mg.