Syrup
Composition:
100 ml of solution contain Active ingredient: levodropropizine 600 mg. For excipients, see section "List of excipients".
Excipients
Sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, citric acid monohydrate, sodium hydroxide, cherry flavouring, purified water.
Therapeutic indications
Symptomatic treatment of cough
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Administration of the drug should be avoided in patients with bronchorrhea and reduced mucociliary function (Kartagener's syndrome, ciliary dyskinesia). Pregnancy and breastfeeding (see section "Pregnancy and breastfeeding").
Dosage
The package includes a measuring cup with markings corresponding to 3, 5, and 10 ml. To open the package, press the cap firmly and simultaneously turn counterclockwise. Adults: 10 ml of syrup up to 3 times a day at intervals of at least 6 hours. Children: 10–20 kg: 3 ml 3 times a day; 20–30 kg: 5 ml 3 times a day. Treatment should be continued until the cough disappears or as prescribed by your doctor. However, if the cough is still present after 2 weeks of treatment, it is advisable to discontinue treatment and seek medical advice. In fact, cough is a symptom and the causative pathology should be investigated and treated.
Warnings and precautions
The observation that the pharmacokinetic profiles of levodropropizine are not markedly altered in the elderly suggests that dose adjustments or changes in the intervals between administrations may not be required in old age. In any case, in light of the evidence that sensitivity to various drugs is altered in the elderly, special caution should be used when levodropropizine is administered to elderly patients. The effect of administering the product to children under 24 months has not been fully studied and in any case the drug should be used with caution in patients of this age. Caution is advised in patients with severe renal insufficiency (creatinine clearance below 35 ml/min). Caution is also advised when taking sedative drugs concomitantly in particularly sensitive individuals (see section "Interactions"). This medicinal product contains 4 g of sucrose per dose (10 ml): patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. To be taken into consideration when administering to patients with diabetes mellitus. The medicinal product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, known to possibly cause urticaria. In general, parahydroxybenzoates can cause delayed reactions, such as contact dermatitis, and rarely immediate reactions with manifestation of urticaria and bronchospasm. Antitussive drugs are symptomatic and should be used only while awaiting diagnosis of the triggering cause and/or the effect of treatment of the underlying disease. In the absence of information on the effect of food intake on drug absorption, it is advisable to take the medicine between meals. LEVODROPROPIZINA EG syrup does not contain gluten; therefore, it can be taken with food. be administered to patients with celiac disease.
Interactions
Animal pharmacology studies have shown that levodropropizine does not potentiate the pharmacological effect of substances active on the central nervous system (e.g., benzodiazepines, alcohol, phenytoin, imipramine). In animals, the product does not modify the activity of oral anticoagulants, such as warfarin, nor does it interfere with the hypoglycemic action of insulin. In human pharmacology studies, the combination with a benzodiazepine does not alter the EEG pattern. However, caution should be exercised when taking sedative drugs concomitantly in particularly sensitive individuals (see section "Special warnings and precautions for use"). Clinical studies have not shown any interactions with drugs used in the treatment of bronchopulmonary diseases such as
Product Code:FRCM046778
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