COMPOSITION: Each 5 ml of syrup contains: Levodropropizine 30 mg/5 ml.

Therapeutic Indications

Symptomatic treatment of cough.

Posology and method of administration

Syrup: A measuring dispenser is attached to the pack.
Adults: 10 ml of syrup up to 3 times daily at intervals of at least 6 hours unless otherwise prescribed by the physician.
Children: 10-20 kg: 3 ml of syrup 3 times a day
Children: 20-30 kg: 5 ml of syrup 3 times a day.
Pediatric population: Do not administer to children under 2 years of age.

Contraindications

Hypersensitivity to the active ingredient or to any of the excipients.
Administration of the drug should be avoided in patients with bronchial hyper-secretion and with reduced mucosal function (Kartagener syndrome, ciliary dyskinesia).
Do not administer to children under 2 years of age.

Special warnings and precautions for use

The observation that the pharmacokinetic profiles of Levodropropizine are not significantly altered in the elderly suggests that dosage adjustments or dosage Interval changes may not be required in the elderly. In any Case, in the light of the evidence that in the elderly, sensitivity to various drugs is altered, special caution should be used when Levodropropizine is administered to elderly patients.
Caution should be taken in patients with severe renal impairment (creatinine clearance below 35 ml / min).
Antitussive drugs are symptomatic and should be used only depending on the diagnosis of the triggering cause and / or the effect of the underlying pathology therapy.
In the absence of information on the effect of food on the absorption of the drug, it is advisable to take the drug apart from meals.
Rapitus syrup does not affect low-calorie and controlled diets, and also can be administered to diabetic patients.

Fertility, pregnancy and lactation

Teratogenesis, reproduction and fertility studies as well as peri-and post-natal studies have revealed no specific toxic effects. The use of the drug should be avoided in women who intend to become pregnant or are already pregnant as its safe use is not documented. Therefore, the use of the drug during lactation is contraindicated.

Effects on ability to drive and use machinery

No studies on the ability to drive and / or use machinery have been performed. However, as the product may, although rarely, cause drowsiness, use with caution in those patients who intend to drive or operate machinery, informing them of this possibility.

Side effects

Palpitations, tachycardia, nausea, vomiting, diarrhea, erythema may occur during treatment with levodropropizine. The reactions reported as serious are hives and anaphylactic reaction. Most adverse reactions occurring after levodropropizine intake are not severe and the symptoms have resolved by discontinuation of therapy and, in some cases, with specific pharmacological treatment… The adverse reactions found (unknown) are as follows:

Eye disorders: Mydriasis, bilateral blindness.
Immune system disorders: Allergic reactions and anaphylactoid, eyelid edema, angioneurotic edema, urticaria.
Psychiatric disorders: Nervousness, drowsiness, personality alteration, or personality disorder.
Nervous system disorders: Syncope, dizziness, vertigo, tremors, paresthesia, tonic-conic seizure and petit mal attack, hypoglycemic coma.
Cardiac disorders: Palpitations, tachycardia, atrial bigeminy.
Vascular disorders: Hypotension.
Respiratory, thoracic and mediastinal disorders: Discomfort, cough, respiratory tract edema.
Gastrointestinal disorders: Gastric pain, abdominal pain, nausea, vomiting, diarrhea, glossitis and aphthous stomatitis.
Hepatobililary disorders: Cholestatic hepatitis.
Skin and subcutaneous tissue disorders: Hives, erythema, exanthema, itching, angioedema, skin reactions Epidermotysis.
Musculoskeletal and connective tissue disorders: Weakness of the lower limbs.
Systemic pathologies and conditions at the site of administration: General malaise, generalized edema, asthenia.

Pharmacodynamic properties

Levodropropizine is a medication with antitussive activity, predominantly peripheral type tracheobronchial, associated with anti-allergic and anti-bronchospasm activity; In addition, it shows a local anesthetic action.
Levodropropizine does not cause depression of respiratory function nor appreciable cardiovascular effects, also does not induce constipating effects in animals.
Levodropropizine acts on the bronchopulmonary system by inhibiting hapten-induced bronchospasm, serotonin and bradykinin.The drug does not inhibit acetylcholine-induced bronchospasm, thus demonstrating the absence of anticholinergic effects.
At therapeutic doses, Levodropropizine does not alter the EEG tracing and psychomotor capacity in humans.

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