Recotuss Sedative 2 mg / ml

Syrup

Active principles

Chewable tablets Each chewable tablet contains 6.5 mg dextromethorphan hydrobromide (corresponding to 5.007 mg dextromethorphan) Excipients with known effects: Sucrose Syrup 1 ml syrup contains 2.0 mg dextromethorphan hydrobromide (equivalent to 1.541 mg dextromethorphan) Excipients with known effects: Sucrose, ethanol and methyl p – hydroxybenzoate For a full list of excipients, see section 6.1.

Excipients

Chewable tablets Sucrose Precipitated silica Sodium stearate Gum arabic Balsamic flavor Syrup Ethanol Sorbitol solution Sucrose Glycerol Methyl para-hydroxybenzoate Lemon flavor Mint flavor Purified water

Therapeutic indications

Symptomatic treatment of cough.

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 in the two weeks following antidepressant therapy.

Dosage

Chewable tablets Adults: dissolve two tablets in the mouth, three to four times a day. Syrup Adults: one measuring cup ("5 ml" mark on the measuring spoon included in the package) three to four times a day. Do not exceed the recommended dose. Pediatric population Chewable tablets Children over two years of age: dissolve one tablet in the mouth three to four times a day. Syrup Children over two years of age: half a scoop ("2.5 ml" mark on the measuring spoon included in the package) three to four times a day.

Warnings and Precautions

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 in asthmatic patients. Pediatric population In children under two years of age, the preparation must be administered only in case of real need and under the direct supervision of the physician Recotuss Sedativo contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose malabsorption - galactose, or sucrase isomaltase insufficiency, should not take this medicine.

Interactions

The use of alcohol during therapy is not recommended.

Side effects

Drowsiness, gastrointestinal disturbances (nausea, vomiting), dizziness may occur during therapy. 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 ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

In pregnant women, the preparation must be administered only in case of real need and under the direct supervision of the doctor.