KOFITUSS MUCOLITICAL SCIR 200ML

KOFITUSS MUCOLITICAL 90 MG/ML

active ingredients

100 ml of syrup contain: Active Ingredient: carbocysteine salt of monohydrate lysine equal to 9 g of carbocysteine salt of lysine excipients: ethyl alcohol, sucrose, methyl para-hydroxybenzoate. For the full list of excipients, see paragraph 6.1.

Excellent

Para-hydroxybenzoate, sucrose, bitter aroma, ethyl alcohol, purified water.

Therapeutic indications

Mucolitic, fluidizing in the affections of the acute and chronic respiratory system.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. Gastroduodeal ulcer. Pregnancy and nursing. The drug is contraindicated in children under 2 years of age.

Population

A graduated dosing glass is attached to the package. Any adjustments of the dosage may concern the frequency of administrations or fractionation of the dose but must be included within the maximum daily dosage indicated. Adults: 15 ml 2–3 times a day Children: over 5 years: 5 ml 2–3 times a day from 2 to 5 years: 2.5 ml 2–3 times a day In view of pharmacokinetic characteristics and high tolerance, recommended dosage can also be maintained in patients with kidney and liver failure. Duration of treatment: Carbocysteine monohydrate lysine salt can also be used for prolonged periods, in this case it is appropriate to follow the doctor's advice.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Mucolitics may induce bronchial obstruction in children under 2 years of age. In fact, the drainage capacity of the bronchial mucus is limited in this age range, due to the physiological characteristics of the respiratory tract. They must not be used in children under 2 years of age (see paragraph 4.3). No known phenomena of addiction or addiction. Notices related to excipients Sucrose Because of the sucrose present in the formulation, individuals suffering from rare hereditary forms of fructose intolerance, glucose/galactose mal absorption, or from saccarase deficiency– isomaltasi, should not take this medicine. If used chronically (i.e. for two weeks or more) KOFITUSS MUCOLITICO can be harmful to the teeth (it makes the formation of dental caries). Alcohol This medicinal product contains 0.65 vol. % of ethanol (ethyl alcohol); each dose of 15 ml contains a quantity of 100 mg which is equivalent to 2 ml of beer or 1 ml of wine. It can be harmful to subjects who have alcohol problems. The alcoholic content of this medicinal product must be considered before using it in children (see contraindications) and in high risk categories such as persons suffering from liver disease or epilepsy. Para–hydroxybenzoate It can cause allergic reactions (possibly delayed).

Interactions

In controlled clinical studies, interactions with the most common use drugs were not highlighted in the treatment of upper and lower airway diseases or with food and laboratory tests.

Effects

The side effects that may occur with MUCOLITIC KOFITUSS, classified by systems and organs (SOC), are as follows: Pathologies of skin and subcutaneous tissue: skin rash, urticaria, erythema, esantema, esantema/eritema bolloso, itching, angioedema, dermatitis. Gastrointestinal diseases: abdominal pain, nausea, vomiting, diarrhea. Diseases of the nervous system: vertigo. Vascular diseases: red. Respiratory pathologies: dispatch. Bronchial obstruction (unknown frequency). The drug contains para-hydroxybenzoate methyl, 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. 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: www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Symptoms reported in overdose cases are headaches, nausea, vomiting, diarrhea, gastralgia, skin reactions, alterations of sensory systems. There is no specific antidote; it is recommended to cause vomiting and possibly perform gastric lavender followed by specific support therapy.

Although the active ingredient is neither teratogenic nor mutagenic and has not shown any adverse effects on the reproductive function in the animal, KOFITUSS MUCOLITICO must not be given in pregnancy (see "Controindications"). Since there is no data on the passage of carboxysteine salt of lisina monohydrate in breast milk, use during breastfeeding is contraindicated (see paragraph "Controindications").

Source: Farmadati