Levotuss Syrup 30 mg/5 ml Levodropropizina 200 ml

INDICATIONS

Symptomatic treatment of cough

ACTIVE INGREDIENTS

100 ml of solution contains: active ingredient: levodropropizine 600 mg Excipients with known effects: sucrose, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium. For the full list of excipients, see section 6.1.

EXCIPIENTS

Sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, citric acid monohydrate, sodium hydroxide, cherry flavor (containing propylene glycol), purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Administration of the drug should be avoided in patients with bronchorrhea and reduced mucociliary function (Kartagener syndrome, ciliary dyskinesia). Pregnancy and breastfeeding (see 4.6). Do not administer to children under 2 years of age.

DOSAGE

Dosage 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. However, if after 2 weeks of therapy the cough is still present, it is advisable to stop treatment and ask your doctor for advice. In fact, cough is a symptom and the causal pathology should be studied and treated. Pediatric population Do not administer to children under 2 years of age (see section 4.3). Method of administration The package includes a measuring cup with notches corresponding to 3, 5 and 10 ml. To open the package you need to firmly press the cap and rotate it counterclockwise at the same time.

CONSERVATION

This medicinal product does not require any special storage conditions.

WARNINGS

The observation that the pharmacokinetic profiles of levodropropizine are not markedly altered in the elderly suggests that dose corrections or modifications of 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. It is advisable to use caution in patients with severe renal insufficiency (creatinine clearance below 35 ml/min). It is also advisable to use caution in case of simultaneous intake of sedative drugs in particularly sensitive individuals (see 4.5). This medicine contains 4 g of sucrose per dose (10 ml). To be taken into consideration in people suffering from diabetes mellitus. Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). This medicinal product contains 22.5 mg of propylene glycol per dose (10 ml), equivalent to 2.25 mg/ml. This medicinal product contains less than 1 mmol (23 mg) sodium per single 10 ml dose, i.e. essentially sodium-free. This medicinal product contains 41 mg sodium per 20 ml daily dose (10 ml twice a day in the adult dosage), equivalent to 2% of the WHO recommended maximum daily intake of 2 g sodium for an adult. This medicinal product contains 62 mg sodium per maximum daily dose of 30 ml (10 ml 3 times during the day in the adult dosage), equivalent to 3% of the maximum daily intake recommended by WHO which corresponds to 2 g sodium for an adult. Antitussive drugs are symptomatic and should only be used while awaiting diagnosis of the underlying cause and/or the effect of therapy on the underlying pathology. In the absence of information on the effect of food intake on the absorption of the drug, it is advisable to take the drug between meals.

INTERACTIONS

Animal pharmacology studies have shown that levodropropizine does not enhance 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 association with benzodiazepine does not modify the EEG picture. However, it is necessary to use caution in case of simultaneous intake of sedative drugs in particularly sensitive individuals (see 4.4). Clinical studies show no interaction with drugs used in the treatment of bronchopulmonary diseases such as β₂-agonists, methylxanthines and derivatives, corticosteroids, antibiotics, mucoregulators and antihistamines.

SIDE EFFECTS

During treatment with levodropropizine palpitations, tachycardia, nausea, vomiting, diarrhea, erythema may occur. Reactions reported as serious are urticaria and anaphylactic reaction. Most of the reactions that occur following the intake of levodropropizine are not serious and the symptoms resolve with the suspension of therapy and, in some cases, with specific pharmacological treatment. The adverse reactions encountered (incidence unknown) are as follows: Eye pathologies: Mydriasis, bilateral blindness. Immune system disorders: Allergic and anaphylactoid reactions, eyelid edema, angioneurotic edema, urticaria. Psychiatric disorders: Nervousness, drowsiness, personality change or personality disorder. Nervous system disorders: Syncope, dizziness, vertigo, tremors, paraesthesia, tonic-clonic convulsion and petit mal attack, hypoglycaemic coma. Cardiac diseases: Palpitations, tachycardia, atrial bigeminy. Vascular pathologies: Hypotension. Respiratory, thoracic and mediastinal disorders: Dyspnea, cough, respiratory tract edema. Gastrointestinal disorders: Gastric pain, abdominal pain, nausea, vomiting, diarrhoea. Hepatobiliary disorders: Cholestatic hepatitis. Pathologies of the skin and subcutaneous tissue: Urticaria, erythema, exanthema, pruritus, angioedema, skin reactions, glossitis and aphthous stomatitis. Epidermolysis. Musculoskeletal system and connective tissue disorders: Weakness of the lower limbs. Systemic pathologies and conditions relating to the administration site: General malaise, generalized edema, asthenia. Pediatric population A case of drowsiness, hypotonia and vomiting in a newborn infant after taking levodropropizine by the nursing mother has been reported. The symptoms appeared after feeding and resolved spontaneously by suspending breastfeeding for a few feedings. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioniavverse.

OVERDOSE

No significant side effects have been reported after administration of the drug up to 240 mg in single administration and up to 120 mg t.i.d. for 8 consecutive days. There are known cases of overdose in children aged between 2 and 4 years. These are cases of accidental overdose, all resolved without consequences. In most cases, patients experienced abdominal pain and vomiting and in one case, after taking 600 mg of levodropropizine, the patient experienced excessive sleep and decreased oxygen saturation. In case of overdose with evident clinical manifestations, immediately institute symptomatic therapy and apply the usual emergency measures (gastric lavage, activated charcoal meal, parenteral administration of liquid, etc.), if appropriate.

PREGNANCY AND BREASTFEEDING

Teratogenicity, reproduction and fertility studies as well as peri- and post-natal studies did not reveal specific toxic effects. However, since in toxicological studies in animals at a dose of 24 mg/kg a slight delay in body weight gain and growth was observed and since levodropropizine is able to cross the placental barrier in rats, the use of the drug is contraindicated in women who intend to become or are already pregnant as its safety of use is not documented (see 4.3). Studies in rats indicate that the drug is found in breast milk for up to 8 hours after administration. Therefore, the use of the drug during breastfeeding is contraindicated.

EFFECTS ON DRIVING ABILITY

No studies on the effects on the ability to drive and/or use machines have been performed. However, since the product may, although rarely, cause drowsiness (see section 4.8), use with caution in patients who intend to drive vehicles or operate machinery, informing them of this possibility.