FLUIFORT * SCIR 200ML 9%+ MEASURIN

THERAPEUTIC INDICATIONS

Mucolytic, fluidifying in acute and chronic respiratory diseases.

DOSAGE AND METHOD OF USE

A graduated measuring cup is attached to the package. To open the package it is necessary to press the cap firmly and turn it counterclockwise. Adults: 15 ml 2-3 times a day or according to medical prescription Children: over 5 years: 5 ml 2-3 times a day or according to medical prescription from 2 to 5 years: 2.5 ml 2-3 times a day or according to medical prescription. In consideration of the pharmacokinetic characteristics, the recommended posology can be maintained even in patients with renal and hepatic insufficiency. Duration of treatment: carbocysteine lysine salt monohydrate can also be used for prolonged periods, in this case it is advisable to follow the doctor's advice.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients. Gastroduodenal ulcer. Pregnancy and breastfeeding. The drug is contraindicated in children under 2 years of age.

SIDE EFFECTS

Side effects that may occur with Fluifort, classified by system organ (SOC), are as follows: Skin, subcutaneous tissue disorders: skin rash, urticaria, erythema, rash, rash / erythema bullous, pruritus, angioedema, dermatitis. Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea. Nervous system disorders: dizziness. Respiratory, thoracic and mediastinal disorders: dyspnoea. Vascular pathologies: redness. Bronchial obstruction may also occur with unknown frequency with mucolytics for oral and rectal use.

SPECIAL WARNINGS

Mucolytics can induce bronchial obstruction in children less than 2 years of age. In fact, the drainage capacity of the bronchial mucus is limited in this age group, due to the physiological characteristics of the respiratory tract. They should therefore not be used in children less than 2 years of age (see section 4.3). There are no known phenomena of addiction or dependence. Patients with rare hereditary problems of glucose intolerance, glucose-galactose malabsorption or sucrose-isomaltase enzyme insufficiency should not take this medicine. The medicine contains methyl para-hydroxybenzoate, which is known to cause urticaria. In general, para-hydroxybenzoates can cause delayed reactions, such as contact dermatitis and rarely immediate reactions with manifestation of urticaria and bronchospasm. Fluifort 90 mg / ml syrup does not contain gluten; therefore it can be administered to patients with celiac disease. Fluifort 90 mg / ml syrup does not contain aspartame; therefore it can be administered to patients with phenylketonuria.

PREGNANCY AND BREASTFEEDING

Although the active substance is neither teratogenic nor mutagenic and has not shown negative effects on reproductive function in animals, Fluifort should not be administered during pregnancy (see 4.3). As no data are available regarding the passage of carbocysteine lysine salt monohydrate into breast milk, use during lactation is contraindicated (see 4.3).

EXPIRATION AND RETENTION

Do not store above 25 ° C.

INTERACTIONS WITH OTHER DRUGS

In controlled clinical trials, no interactions were found with the most common drugs used in the treatment of upper and lower respiratory tract diseases, nor with food and with laboratory tests.

OVERDOSE

Symptoms reported in case of overdose are: headache, nausea, vomiting, diarrhea, gastralgia, skin reactions, alteration of sensory systems. There is no specific antidote; it is advisable to induce vomiting and possibly perform gastric lavage followed by specific supportive therapy.

ACTIVE PRINCIPLES

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

EXCIPIENTS

Sucrose, natural cherry flavor, methyl para-hydroxybenzoate, caramel, purified water.

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