Cough sedative medicine
Indications
Recotuss sedative is a medicine used in the symptomatic treatment of cough.
Composition
Active ingredients
Each chewable tablet contains 6.5 mg of dextromethorphan hydrobromide (equivalent to 5.007 mg of dextromethorphan)
Excipients with known effects: Sucrose
Excipients
Sucrose Precipitated silica Sodium stearate Gum arabic Balsamic flavouring
Directions for use and Dosage
- Adults: dissolve two tablets in the mouth, three–four times a day;
- Children over two years of age: Dissolve one tablet in the mouth, three–four times a day.
Warnings
After 5–7 days of treatment without appreciable results, consult your doctor. Dextromethorphan should be used with caution in debilitated patients. The product is not recommended for asthmatic patients.
Cases of dextromethorphan abuse have been reported. Particular caution is recommended with adolescents and young adults, as well as with patients with a history of drug or psychoactive substance abuse.
Paediatric population: In children under two years of age, the preparation should be administered only if strictly necessary and under the direct supervision of a doctor. Dextromethorphan is metabolized by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. Approximately 10% of the population is a poor metabolizer of CYP2D6.
Exaggerated and/or prolonged effects of dextromethorphan may occur in poor metabolizers and patients using concomitant CYP2D6 inhibitors. Caution is therefore required in patients who are poor metabolizers of CYP2D6 or who use CYP2D6 inhibitors (see also section 4.5). Recotuss Sedative contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.
Contraindications
Hypersensitivity to the active substance or to other chemically related substances, or to any of the excipients listed in section 6.1. Do not administer during or within two weeks of treatment with antidepressants.
Undesirable effects
During therapy, drowsiness, gastrointestinal disturbances (nausea, vomiting), and dizziness may occur. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product.
Overdose
Symptoms of overdose may include mental confusion and strong excitement. High doses may induce respiratory depression.
Pregnancy and breastfeeding
In pregnant women, the preparation should be administered only if strictly necessary and under the direct supervision of a doctor.
Format
30 chewable tablets
Product Code:FRCM172143
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