Bronchenolo Sedative Fluidifying Cough Syrup 150 ml

WARNINGS
In the following cases it should only be used after consulting your doctor: chronic or persistent cough, such as that which occurs in the case of asthma or emphysema. Severe hepatic insufficiency. Severe renal insufficiency. Concomitant use of selective serotonin re-uptake inhibitor antidepressants or tricyclic antidepressants. Consult your doctor if the cough persists, or if it is accompanied by a 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 noticeable results, consult your doctor. The concomitant use of other cough and cold medicines should be avoided. Concomitant use of alcohol should be avoided during drug therapy. The product contains sucrose, which 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 drug. The syrup contains ethyl alcohol. This could be a risk factor in patients with liver failure, alcoholism or epilepsy, pregnant and lactating women and children. The syrup contains para-hydroxybenzoates, which can cause allergic reactions (more likely delayed).
PHARMACOTHERAPEUTIC CATEGORY
Cough suppressants and expectorants in combination.
STORAGE
No special storage precautions.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active ingredients or to any of the excipients. Children under the age of 6. Patients who are taking or have taken monoamine oxidase inhibitor antidepressants (MAOIs) within 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 (e.g. patients with chronic obstructive airway disease or pneumonia, patients with ongoing asthma attack or with exacerbation of asthma).
NAME
SEDATIVE AND FLUIDIFYING BRONCHENOL
EXCIPIENTS
100 ml of syrup contain: mountain pine essential oil; citric acid monohydrate; alcohol; glycerol; sucrose; sweet orange essence; propyl para-hydroxybenzoate; methyl para-hydroxybenzoate; sodium saccharin; purified water. A 2.3 g mint flavored tablet contains: pinomugo essential oil; magnesium trisilicate; aspartame; magnesium stearate; sucrose; mint flavor.
SIDE EFFECTS
Data from clinical studies: the adverse events reported below have been observed in clinical studies and are to be considered as uncommon adverse reactions (i.e. occurring in a percentage between> = 1/1000 and <1/100 patients). Nervous system disorders: drowsiness; dizziness. Gastrointestinal disorders: gastrointestinal disorders; nausea; He retched; abdominal discomfort. Post marketing data. Nervous system disorders: serotonin syndrome. Serotonin syndrome (with altered mental status, agitation, myoclonus, hyperreflexia, diaphoresis, chills, 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. In pregnant and lactating women, the preparation must be administered only in case of real need and under the direct supervision of the doctor.
INDICATIONS
Symptomatic treatment of cough.
INTERACTIONS
The product should not be used at the same time or within 2 weeks after 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 combination with the following drugs: Concomitant use of dextromethorphan with selective serotonin reuptake inhibitor antidepressants or tricyclic antidepressants can 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; the concomitant use of dextromethorphan and alcohol can 'increase the depressive effects on the central nervous system of both substances. The association with phenylpropanolamine should be used with caution in subjects with hypertension, heart disease, diabetes, peripheral vasculopathy, prostatic hypertrophy and glaucoma. Treatment with guaifenesin can cause false positives for the urinary vanillylmandelic acid dosage.
DOSAGE
Syrup. Adults (including the elderly) and children over 12 years: 2 teaspoons (10 ml) 2/4 times a day, up to a maximum of 8 teaspoons (40 ml) per day. Children from 6 to 12 years: 1 teaspoon (5 ml) 3/4 times a day, up to a maximum of 4 teaspoons (20 ml) per day. Administer the product every 4-6 hours as needed. Pads. Adults (including the elderly) and children over 12 years: 3/6 tablets per 'to be dissolved in the mouth, up to a maximum of 6 tablets per day. Children from 6 to 12 years: 2/3 tablets per day to be dissolved in the mouth, up to a maximum of 3 tablets per day. Administer the product every 4-6 hours as needed. To be administered orally only. Do not exceed the recommended dose.
ACTIVE PRINCIPLES
100 ml of syrup contain: dextromethorphan hydrobromide 0.15 g, guaifenesin 1.00 g. One tablet contains: dextromethorphan hydrobromide 7.5 mg, guaifenesin 55 mg.