Bronchenolo Sedative and fluidifying for cough and phlegm (Symptomatic treatment of cough).
Contraindications and Side Effects
Hypersensitivity to the active ingredients or to any of the excipients. Children under 6 years of age. Patients who are taking or have taken monoamine oxidase inhibitor (MAOI) antidepressants in the last two weeks. Due to the presence of aspartame, the product is contraindicated in cases of phenylketonuria. Patients with respiratory failure or at risk of developing respiratory failure (for example, patients with chronic obstructive airway disease or pneumonia, patients with an ongoing asthma attack or asthma exacerbation).
Dosage and method of use
Syrup. Adults (including the elderly) and children over 12 years: 2 teaspoons (10 ml) 2-4 times daily, up to a maximum of 8 teaspoons (40 ml) per day. Children 6 to 12 years: 1 teaspoon (5 ml) 3-4 times daily, up to a maximum of 4 teaspoons (20 ml) per day. Administer the product every 4-6 hours as needed. Lozenges. Adults (including the elderly) and children over 12 years: 3-6 lozenges per day to dissolve in the mouth, up to a maximum of 6 lozenges per day. Children 6 to 12 years: 2-3 lozenges per day to dissolve in the mouth, up to a maximum of 3 lozenges per day. Administer the product every 4-6 hours as needed. For oral administration only. Do not exceed the recommended dose.
Storage
No special storage precautions.
Warnings
In the following cases, it should be used only after consulting your doctor: chronic or persistent cough, such as that which occurs in asthma or emphysema. Severe liver failure. Severe kidney failure. Concomitant use of selective serotonin reuptake inhibitor antidepressants or tricyclic antidepressants. Consult your doctor if the cough persists, or if it is accompanied by high fever, skin rash, or persistent headache. Do not exceed the maximum recommended dose or frequency of administration. After 5-7 days of treatment without appreciable results, consult your doctor. The simultaneous use of other cough and cold medicines should be avoided. The concomitant use of alcohol should be avoided during therapy with the drug. The product contains sucrose; this should be taken into account in case of diabetes or low-calorie diets. Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency should not take the medicine. The syrup contains ethyl alcohol. This could represent a risk factor in patients with liver failure, alcoholism, or epilepsy, in pregnant or breastfeeding women, and in children. The syrup contains parahydroxybenzoates, which can cause allergic reactions (more likely delayed).
Interactions
The product should not be used concomitantly with, or within 2 weeks of, treatment with monoamine oxidase inhibitor (MAOI) antidepressants, as serious adverse reactions, including serotonin syndrome, have been reported. Patients should consult their doctor before taking dextromethorphan in combination with the following drugs: Concomitant use of dextromethorphan with selective serotonin reuptake inhibitor antidepressants or tricyclic antidepressants may cause serotonin syndrome with mental status changes, hypertension, agitation, myoclonus, hyperreflexia, diaphoresis, chills, and tremors. Serum dextromethorphan levels may be increased by concomitant use of cytochrome P450 2D6 inhibitors, such as the antiarrhythmics quinidine and amiodarone, antidepressants such as fluoxetine and paroxetine, or other drugs that inhibit cytochrome P450 2D6 such as haloperidol and thioridazine. Concomitant use of dextromethorphan and alcohol may increase the CNS depressant effects of both substances. The combination with phenylpropanolamine should be used with caution in patients with hypertension, heart disease, diabetes, peripheral vascular disease, prostatic hypertrophy, and glaucoma. Treatment with guaifenesin may cause false-positive urinary vanillylmandelic acid tests.
Undesirable effects
Data from clinical studies: the adverse events reported below have been observed in clinical studies and are considered uncommon adverse reactions (i.e., occurring in between >=1/1000 and <1/100 patients). Nervous system disorders: drowsiness; dizziness. Gastrointestinal disorders: gastrointestinal disorders; nausea; vomiting; abdominal discomfort. Post-marketing data. Nervous system disorders: serotonin syndrome. Serotonin syndrome (with mental status changes, agitation, myoclonus, hyperreflexia, diaphoresis, chills, tremors, and hypertension) has been reported with 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 are available regarding pregnancy and breastfeeding. In pregnant and breastfeeding women, the preparation should be administered only if clearly needed and under the direct supervision of a doctor.
Active ingredients
100 ml of syrup contains: dextromethorphan hydrobromide 0.15 g, guaifenesin 1.00 g. One lozenge contains: dextromethorphan hydrobromide 7.5 mg, guaifenesin 55 mg.
Excipients
100 ml of syrup contains: mountain pine essential oil; citric acid monohydrate; alcohol; glycerol; sucrose; sweet orange essence; propyl parahydroxybenzoate; methyl parahydroxybenzoate; sodium saccharin; purified water. One 2.3 g mint-flavored lozenge contains: mountain pine essential oil; magnesium trisilicate; aspartame; magnesium stearate; sucrose; mint flavor.
Format
Pack with 20 lozenges to dissolve.
Product Code:FRCM046178
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