Kofituss Cough Suppressant 30mg/5ml Syrup 200ml

NAME
KOFITUSS SEDATIVE COUGH 30 MG / 5ML SYRUP

ACTIVE PRINCIPLES
100 ml of solution contain Active ingredient: 600mg levodropropizin For excipients, see section List of excipients.

EXCIPIENTS
Sucrose, methyl-para-hydroxybenzoate, propyl-para-hydroxybenzoate, citric acid monohydrate, sodium hydroxide, cherry flavor, purified water.

INDICATIONS
Symptomatic cough therapy

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients. Administration of the drug should be avoided in patients with bronchorrhea and with reduced mucociliary function (Kartagener's syndrome, ciliary dyskinesia). Pregnancy and breastfeeding.

DOSAGE
The package includes a measuring cup with notches corresponding to 3, 5 and 10 ml. To open the package it is necessary to press the cap firmly and turn counterclockwise at the same time. 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 subsides or as directed by the doctor. However, if the cough is still present after 2 weeks of therapy, 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.

STORAGE
The medicine should be stored at a temperature not exceeding 25 degrees C.

WARNINGS
The observation that the pharmacokinetic profiles of levodropropizin are not markedly altered in the elderly suggests that dose adjustments or modification of the intervals between dosing may not be required in the third 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 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 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). It is advisable to use caution even in case of simultaneous intake of sedative drugs in particularly sensitive individuals. This medicine 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 for administration to subjects with diabetes mellitus. The medicine contains methyl para-hydroxybenzoate and propyl para-hydroxybenzoate, known for the possibility of causing urticaria. In general, para-hydroxybenzoates can cause delayed reactions, such as contact dermatitis and rarely immediate reactions with manifestation of urticaria and bronchospasm. Antitussive drugs are symptomatic and should only be used pending diagnosis of the underlying cause and / or therapy effect of the underlying disease. In the absence of information on the effect of food intake on drug absorption, it is advisable to take the drug between meals. The syrup does not contain gluten; therefore it can be administered to patients with celiac disease.

INTERACTIONS
Animal pharmacology studies have shown that levodropropizine does not potentiate the pharmacological effect of active substances 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 and does not even interfere with the blood sugar lowering action of insulin. In human pharmacology studies the association with benzodiazepine does not change the EEG picture. However, caution must be exercised in case of simultaneous intake of sedative drugs in particularly sensitive individuals. Clinical studies show no interaction with drugs used in the treatment of bronchopulmonary diseases such as beta2-agonists, methylxanthines and derivatives, corticosteroids, antibiotics, mucoregulators and antihistamines.

SIDE EFFECTS
Adverse reactions found, all very rare (incidence <1 / 10,000). Skin and appendages: urticaria, erythema, rash, pruritus, angioedema, skin reactions. A single case of epidermolysis with fatal outcome has been reported. Digestive system: gastric and abdominal pain, nausea, vomiting, diarrhea. Two single cases of glossitis and aphthous stomatitis have been reported, respectively. One case of cholestatic hepatitis and one case of hypoglycemic coma have been reported in an elderly patient treated concomitantly with oral hypoglycemic agents. General conditions: allergic and anaphylactoid reactions, general malaise. Single cases of generalized edema, syncope and asthenia have been reported, respectively. Nervous system: dizziness, vertigo, tremors, paraesthesia. A single case of tonic-clonic seizure and one case of a petit mal attack have been reported. Cardiovascular system: palpitations, tachycardia, hypotension. One case of cardiac arrhythmias (atrial bigeminy) has been reported. Psychiatric disorders: nervousness, drowsiness, sense of depersonalization. Respiratory system: dyspnoea, cough, edema of the respiratory tract. Musculoskeletal system: asthenia and weakness of the lower limbs. Few cases of eyelid edema have been reported, most of which refer to angioneurotic edema, considering the concomitant presence of urticaria. A single case of mydriasis and a case of bilateral visual loss have been reported. In both cases the reaction resolved after discontinuation of the drug. A single case of somnolence, hypotonia and vomiting has been reported in a newborn after the nursing mother took levodropropizin. Symptoms appeared after the feed and resolved spontaneously by suspending breastfeeding for a few feedings. Only occasionally some adverse reactions were of a serious nature. These include some cases of skin reactions (urticaria, pruritus), the case of cardiac arrhythmia, already mentioned above, the case of hypoglycemic coma, as well as some cases of allergic / anaphylactoid reactions involving edema, dyspnoea, vomiting, diarrhea. . A single case of epidermolysis, which occurred abroad in a polytreated elderly patient, had a fatal outcome. The medicine contains methyl para-hydroxybenzoate and propyl para-hydroxybenzoate, known for the possibility of causing urticaria. In general, para-hydroxybenzoates can cause delayed reactions, such as contact dermatitis and rarely immediate reactions with manifestation of urticaria and bronchospasm.

PREGNANCY AND BREASTFEEDING
Studies of teratogenesis, reproduction and fertility 'as well as that of hypers and postnatal ones did not reveal specific toxic effects. However, since in toxicological studies in animals at the dose of 24 mg / kg a slight delay in weight gain and growth was observed and because 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. 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.