LEVODROPROPIZINE EG SCIR 200ML

LEVODROPROPIZINA EG 30 MG/5 ML SCIROP

active ingredients

100 ml of solution contain Active ingredient: levodropropizin 600 mg Excipients with known effects: sucrose, methyl-para-hydroxybenzoate, propyl-para-hydroxybenzoate and sodium. For the full list of excipients, see paragraph 6.1.

Excellent

Saccarosio, methyl para-hydroxybenzoate, propil para-hydroxybenzoate, citric acid monohydrate, sodium hydroxide, cherry aroma, purified water.

Therapeutic indications

Syntomatic cough therapy

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. The administration of the drug must be avoided in patients with bronchorrea and with reduced mucocyliar function (Cartagener syndrome, ciliar dyskinesia). Pregnancy and nursing (see paragraph 4.6). Do not administer children under 2 years of age.

Population

In the package is attached a dosing glass with heels corresponding to 3, 5 and 10 ml. To open the package it is necessary to press the cap with force and rotate simultaneously in anticlockwise direction. Adults: 10 ml 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 still needs to be present, it is advisable to stop the treatment and ask your doctor for advice. In fact cough is a symptom and should be studied and treated causal pathology. Pediatric population Do not administer children under 2 years of age (see paragraph 4.3).

Conservation

The medicinal product must be kept at a temperature not exceeding 25°C.

Warnings

The observation that drug profiles of levodropropizin are not markedly altered in the elderly suggests that dose corrections or modifications of intervals between administrations may not be required in the third age. In any case, in the light of the evidence that in the elderly the sensitivity to various drugs is altered, special caution should be used when levodropropizin is administered to elderly patients. It is recommended to use caution in patients with severe renal failure (clearance of creatinine below 35 ml/min). It is recommended to use caution even in case of simultaneous intake of sedative drugs in particularly sensitive individuals (see paragraph 4.5). Important information about some excipients This medicine contains sucrose: patients with rare hereditary problems of fructose intolerance, glucose and galactose mal absorption, or insufficiency of isomaltase sucrasis, should not take this medicine. This medicine contains para-hydroxybenzoates that can cause allergic reactions (also delayed). This medicine contains less than 1 mmol (23 mg) of sodium per dose (10 ml), i.e. essentially without sodium. Antitox drugs are symptomatic and should only be used pending the diagnosis of the trigger cause and/or the effect of underlying pathology therapy. In the absence of information on the effect of taking food on the absorption of the drug, it is advisable to take the drug away from meals. LEVODROPROPIZINA EG syrup does not contain gluten; therefore it can be administered to patients suffering from celiac disease.

Interactions

Animal pharmacology studies have shown that levodropropizin does not enhance the pharmacological effect of active substances on the central nervous system (e.g. benzodiazepines, alcohol, phenytoin, imipramine). In the animal, the product does not change the activity of oral anticoagulants, such as warfarine, nor does it interfere with the hypoglycemic action of insulin. In human pharmacology studies the association with benzodiazepine does not change the EEG framework. However, it is necessary to use caution in case of simultaneous intake of sedative drugs in particularly sensitive individuals (see paragraph 4.4). Clinical studies show no interaction with drugs used in the treatment of bronchopolmonary diseases such as β2-agonists, methylxanthine and derivatives, corticosteroids, antibiotics, mucoregulators and antihistamines.

Effects

During treatment with levodropropizin palpitations, tachycardia, nausea, vomiting, diarrhea, erythema may occur. The reactions reported as a series are hives and anaphylactic reaction. Most of the reactions that occur as a result of taking levodropropizin are not serious and the symptoms have been resolved with the suspension of therapy and, in some cases, with specific pharmacological treatment. The adverse reactions (unknown incidence) are as follows: Pathologies of the eye Midriasis, bilateral blindness. Immune system disorders Allergic reactions and anaphylactoids, eyelid edema, angiourotic edema, hives. Psychiatric disorders Nervosism, drowsiness, personality alteration or personality disorder. Diseases of the nervous system Syncope, capogiro, vertigo, tremors, paresthesia, tonic-clonic convulsion and attack of small evil, hypoglycemic coma. Heart disease Palpitations, tachycardia, atrial bigeminism. Vascular diseases Hypotension. Respiratory, chest and mediastinic pathologies Dispnea, cough, respiratory edema. Gastrointestinal diseases Gastric pain, abdominal pain, nausea, vomiting, diarrhea. Hepatobiliary diseases Hepatitis cholestatic. Pathologies of skin and subcutaneous tissue Hives, erythema, esantema, itching, angioedema, skin reactions, glossitis and aftous stomatitis. Epidermolysis. Diseases of musculoskeletal system and connective tissue Lower limb weakness. Systemic pathologies and conditions for administration General malaise, general edema, astenia. Pediatric population A case of drowsiness, hypotonia and vomiting in a newborn after taking levodropropizin by the mother nourishes. Symptoms appeared after the aft and resolved spontaneously suspending for some breastfeeding. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazioneavversa.

Overdosing

No significant side effects were 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. Overdose cases are known in children aged 2 to 4 years. These are cases of accidental overdose all solved without consequences. In most cases, patients manifested abdominal pain and vomiting and in one case, after taking 600 mg of levodropropizin, the patient manifested excessive sleep and reduced oxygen saturation. In case of overdose with obvious clinical manifestations immediately establish symptomatic therapy and apply usual emergency measures (gastric sink, activated carbon meal, parental administration of liquid, etc.), if appropriate.

The studies of teratogenesis, reproduction and fertility as well as the peri and post natal ones have not revealed specific toxic effects. However, since in toxicological studies in the animal at the dose of 24 mg/kg a slight delay in body weight gain and growth has been observed and since levodropropizin is able to overcome the placental barrier in the rat, the use of the drug is contraindicated in women who intend to become or are already pregnant since its safety of use is not documented (see paragraph 4.3). Rat studies indicate that the drug is found in breast milk up to 8 hours after administration. Therefore the use of the drug during breastfeeding is contraindicated.

Source: Farmadati