Bronchenolo sedative and mucolytic - syrup for the symptomatic treatment of cough - 150 ml bottle

Product Description

Drug useful for the symptomatic treatment of cough.

Therapeutic indications

Bronchenolo sedative and fluidifying is a syrup that can be used to calm coughs and thin phlegm, thus promoting its elimination.

Composition

100 ml of Bronchenolo Sedative and Fluidifying contain:

Active Ingredients

• Dextromethorphan hydrobromide 0.15 g (which acts to sedate coughs);
• Guaifenesin 1.00 g (which acts to thin phlegm).

Excipients

Mountain pine essential oil; citric acid monohydrate; alcohol; glycerol; sucrose; sweet orange essence; propyl parahydroxybenzoate; methyl parahydroxybenzoate; sodium saccharin; purified water.

Dosage

Bronchenolo cough syrup can be used for: be administered to adults and children over 12 years according to the following dosage:
2 teaspoons (10 ml) 2/4 times a day, up to a maximum of 8 teaspoons (40 ml) a day.

For children from 6 to 12 years the dosage is as follows:
1 teaspoon (5 ml) 3/4 times a day, up to a maximum of 4 teaspoons (20 ml) a day.

Administer the product every 4–6 hours as needed.

Contraindications

Hypersensitivity to the active substances or to any of the excipients.
Children under 6 years of age.
Patients who are taking or have taken in the last two weeks monoamine oxidase inhibitor (MAOI) antidepressants.
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).

Warnings

Use Bronchenolo syrup only after consulting your doctor in case of:

• Chronic or persistent cough (for example, in case of asthma or emphysema).
• Severe liver failure.
• Severe renal 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 Bronchenolo Sedative and Fluidifying Syrup.

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 Bronchenolo Sedative and Fluidifying Syrup.

Bronchenolo Sedative and Fluidifying Syrup contains ethyl alcohol. This could represent a risk factor in patients with liver failure, alcoholism or epilepsy, in pregnant and breastfeeding women and in children.

Bronchenolo Sedative and Fluidifying contains para-hydroxybenzoates, which can cause allergic reactions (more likely delayed).

Keep the medicine out of the reach and sight of children.

Use of Bronchenolo Syrup in Pregnancy

No data are available regarding pregnancy and breastfeeding. In pregnant and breastfeeding women, the preparation should be administered only if really necessary and under the direct supervision of a doctor.

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).

Adverse reactions are listed according to the MedDRA classification.

Nervous system disorders: somnolence; dizziness.
Gastrointestinal disorders: gastrointestinal disorders; nausea; vomiting; abdominal discomfort.

Post-marketing data

The adverse reactions identified during post-marketing use are listed below. Since These reactions are reported voluntarily from a population of uncertain size; their frequency is unknown, but is probably very rare (seen in <1/10,000 patients).

Nervous system disorders: serotonin syndrome. Serotonin syndrome (with mental status changes, agitation, myoclonus, hyperreflexia, diaphoresis, chills, tremors, and hypertension) has been reported in 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).

Interactions

The product should not be used concomitantly with, or within 2 weeks of, treatment with antidepressants that are monoamine oxidase inhibitors (MAOIs), since they may increase the risk of developing dextromethorphan. 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 increase the risk of serious adverse reactions. cause serotonin syndrome with mental status changes, hypertension, agitation, myoclonus, hyperreflexia, diaphoresis, chills 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 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 depressant effects on the Central Nervous System of both substances.
• The combination with phenylpropanolamine should be used with caution in subjects with hypertension, heart disease, diabetes, peripheral vascular disease, prostatic hypertrophy and glaucoma.

Treatment with guaifenesin may cause false positives in urinary vanillylmandelic acid measurements.

Format

150 ml bottle