KOFITUSS SED TOSSE SCIR 200ML

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active ingredients

100 ml of solution contain Active ingredient: levodropropizin 600 mg For excipients, see paragraph "List of excipients".

Excellent

Saccarosium, methyl–para–hydroxybenzoate, propil–para–hydroxybenzoate, monohydrate citric acid, hydroxide sodium, cherry aroma, purified water.

Therapeutic indications

Syntomatic cough therapy

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. The administration of the drug must be avoided in patients with bronchorrea and with reduced mucocyliar function (Cartagener syndrome, ciliar dyskinesia). Pregnancy and lactation (see paragraph "Gravidance and lactation").

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 daily; 20–30 kg 5 ml 3 times a day. Treatment should be continued until the cough disappears or according to the doctor's prescription. 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.

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. The effect of administering the product to children under 24 months has not been fully studied and in any case the drug must be used with caution in patients of this age. 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 "Interactions"). This medicine contains 4 g sucrose per dose (10 ml): patients with rare hereditary problems of fructose intolerance, glucosegalactose mal absorption, or isomaltase sucrasis failure, should not take this medicine. To be considered for administration to subjects suffering from diabetes mellitus. The drug contains methyl para-hydroxybenzoate and propil para-hydroxybenzoate, known for the possibility of causing hives. In general, para-hydroxybenzoates can cause delayed reactions, such as contact dermatitis and rarely immediate reactions with manifestation of hives and bronchospasm. 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. KOFITUS SEDATIVE FOR COUGH syrup does not contain gluten; therefore it can be administered to patients with 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 "Special warnings and precautions for use"). 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

The experience derived from the marketing of products containing levodropropizin in more than 30 countries worldwide shows that the appearance of unwanted effects is a very rare event. Based on the estimate of patients exposed to levodropropylene, derived from the number of packages sold, and considering the number of spontaneous reports, less than one patient every 500,000 manifested adverse reactions. Most of these reactions are not severe and the symptoms have resolved with the suspension of therapy and, in some cases, with specific pharmacological treatment. The adverse reactions found, all very rare ( Cute incidence and outbuildings: hives, erythema, esantema, itching, angioedema, skin reactions. A single case of epidermolysis was reported with fatal outcome. Digestive system: gastric and abdominal pain, nausea, vomiting, diarrhea. Two individual cases were reported respectively of glossitis and aftous stomatitis. A case of cholestatic hepatitis and a case of hypoglycemic coma in an elderly patient treated concomitantly with oral hypoglycemics. General conditions: allergic reactions and anaphylatoids, general malaise. Individual cases of generalized edema, syncops and astenia were reported respectively. Nervous system: dizziness, dizziness, tremors, paresthesia. A single case of tonic–clonic convulsion was reported and a case of small evil attack. Cardiovascular system: palpitations, tachycardia, hypotension. A case of cardiac arrhythmia has been reported (atrial bigeminism). Psychiatric disorders: nervousness, drowsiness, sense of personalization. Respiratory system: dispnea, cough, edema of the respiratory tract. Musculoskeletal system: astenia and weakness of the lower limbs. A few cases of palpebral edema have been reported, most of which refer to angiourotic edema, considering the concomitant presence of hives. A single case of midriasis was reported and a case of loss of bilateral visual capacity. In both cases the reaction was resolved after the suspension of the drug. A single case of drowsiness, hypotonia and vomiting in a newborn after taking levodropropizin by the mother nourishes was reported. Symptoms appeared after the aft and resolved spontaneously suspending for some breastfeeding. Only occasionally some adverse reactions had seriousness. These include some cases of skin reactions (orticaria, itching), the case of cardiac arrhythmia, already mentioned above, the case of hypoglycemic coma, as well as some cases of allergic/anaphylatoids reactions that involved edema, dispnea, vomiting, diarrhea. As already mentioned, a single case of epidermolysis, manifested abroad in an elderly patient polytreated, has been fatal. The drug contains methyl para-hydroxybenzoate and propil para-hydroxybenzoate, known for the possibility of causing hives. In general, para-hydroxybenzoates can cause delayed reactions, such as contact dermatitis and rarely immediate reactions with manifestation of hives and bronchospasm.

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. It is known only one case of overdose in a 3-year-old treated child with a daily dose of levodropropizin of 360 mg. The patient manifested abdominal pain and non-gravious vomiting that resolved without sequel. 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 there has been a slight delay in body weight gain and growth 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 "Controindications"). 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