Fluifort Mucolytic Syrup 200 ml 90 mg / ml

Fluifort Mucolytic Syrup is an over-the-counter mucolytic and expectorant drug based on carbocysteine ​​lysine salt source. Fluifort Mucolytic Syrup is indicated in the treatment of productive cough and as a fluidifier to expectorate phlegm in acute and chronic respiratory tract conditions.

Thanks to its composition, Fluifort Mucolytic Syrup helps dissolve mucus, alleviating the symptoms of flu, colds and chesty coughs .

ACTIVE INGREDIENTS

Active ingredients contained in Fluifort Mucolytic Syrup 200 ml 90 mg / ml to be taken separately - What is the active ingredient of Fluifort Mucolytic Syrup 200 ml 90 mg / ml to be taken separately?

100 ml of syrup contain; active ingredient: carbocisteine ​​lysine salt monohydrate equal to 9 g of carbocisteine ​​lysine salt. Excipients with known effect: sucrose, methyl parahydroxybenzoate, ethanol (contained in cherry flavouring). For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Fluifort Mucolytic Syrup 200 ml 90 mg / ml to be taken separately - What does Fluifort Mucolytic Syrup 200 ml 90 mg / ml to be taken separately contain?

Sucrose, natural cherry flavour (containing ethanol), methyl parahydroxybenzoate, caramel, purified water.

DIRECTIONS

Therapeutic indications Fluifort Mucolytic Syrup 200 ml 90 mg / ml to be made separately - Why is Fluifort Mucolytic Syrup 200 ml 90 mg / ml to be made separately used? What is it used for?

Mucolytic, fluidifying in acute and chronic respiratory tract conditions.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Fluifort Mucolytic Syrup 200 ml 90 mg / ml to be taken separately - When should Fluifort Mucolytic Syrup 200 ml 90 mg / ml not be used?

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Gastroduodenal ulcer. Pregnancy and breastfeeding. The drug is contraindicated in children under 2 years of age.

DOSAGE

Quantity and method of taking Fluifort Mucolytic Syrup 200 ml 90 mg / ml to be taken separately - How do you take Fluifort Mucolytic Syrup 200 ml 90 mg / ml to be taken separately?

A graduated measuring cup is included in the package. To open the package, press the cap firmly and simultaneously turn it counterclockwise. Adults: 15 ml 2-3 times a day or as directed by a doctor. The maximum duration of therapy is up to 14 days. However, carbocisteine ​​lysine monohydrate salt can also be used for prolonged periods, according to the doctor's judgment. Children; over 5 years: 5 ml 2-3 times a day or as directed by a doctor. From 2 to 5 years: 2.5 ml 2-3 times a day or as directed by a doctor. The maximum duration of therapy is up to 7 days. However, carbocisteine ​​lysine monohydrate salt can also be used for prolonged periods, according to the doctor's judgment. In consideration of the pharmacokinetic characteristics, the recommended dosage can also be maintained in patients with renal and hepatic insufficiency.

CONSERVATION

Storage Fluifort Mucolytic Syrup 200 ml 90 mg / ml to be taken separately - How do you store Fluifort Mucolytic Syrup 200 ml 90 mg / ml to be taken separately?

Store at a temperature not exceeding 25 degrees C.

WARNINGS

Warnings Fluifort Mucolytic Syrup 200 ml 90 mg / ml to be taken separately - About Fluifort Mucolytic Syrup 200 ml 90 mg / ml to be taken separately it is important to know that:

Mucolytics may induce bronchial obstruction in children under 2 years of age. In fact, the capacity for bronchial mucus drainage is limited in this age group, due to the physiological characteristics of the airways. They should therefore not be used in children under 2 years of age (see section 4.3). Gastrointestinal bleeding Cases of gastrointestinal bleeding have been reported with the use of carbocisteine. Caution is recommended in the elderly, in patients with a history of gastroduodenal ulcers or in patients taking concomitant medications known to increase the risk of gastrointestinal bleeding. In case of gastrointestinal bleeding, the patient should discontinue treatment with carbocisteine. Asthmatic and debilitated patients: Specific precautions are recommended in patients with severe respiratory insufficiency, in patients with asthma and with a history of bronchospasm, as well as in debilitated patients. The use of carbocisteine ​​causes a decrease in mucus viscosity and an increase in mucus removal, both through the ciliary activity of the epithelium and through the cough reflex. Therefore, an increase in cough and sputum is expected. The use of antitussive drugs inhibits the cough reflex and increases the risk of airway obstruction, due to an increase in mucus accumulation in the airways. The concomitant use of this medicinal product with cough sedative drugs and/or drugs that inhibit bronchial secretion (e.g. anti-muscarinic drugs) is not recommended. No phenomena of habituation or dependence are known. Fluifort 90 mg/ml syrup contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Fluifort 90 mg/ml syrup contains ethanol This medicine contains 14.4 mg of alcohol (ethanol) in each dose (15 ml). The amount in 15 ml of this medicine is equivalent to less than 3 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce any relevant effects. Fluifort 90 mg/ml syrup contains methyl parahydroxybenzoate. This medicine contains methyl parahydroxybenzoate, which is known to cause urticaria. In general, parahydroxybenzoates may cause delayed reactions such as contact dermatitis and rarely immediate reactions with urticaria and bronchospasm. Fluifort 90 mg/ml syrup does not contain gluten; therefore it can be administered to patients with coeliac disease. Fluifort 90 mg/ml syrup does not contain aspartame; therefore it can be administered to patients with phenylketonuria.

INTERACTIONS

Interactions Fluifort Mucolytic Syrup 200 ml 90 mg / ml to be taken separately - Which medicines or foods can modify the effect of Fluifort Mucolytic Syrup 200 ml 90 mg / ml to be taken separately?

In controlled clinical studies, no interactions were highlighted with the most common drugs used in the treatment of upper and lower airway conditions, nor with foods or laboratory tests.

SIDE EFFECTS

Like all medicines, Fluifort Mucolytic Syrup 200 ml 90 mg / ml to be taken separately can cause side effects - What are the side effects of Fluifort Mucolytic Syrup 200 ml 90 mg / ml to be taken separately?

Undesirable effects are described according to MedDRA system organ class and frequency estimated from post-marketing experience. Frequencies are defined as follows: very common (>=1/10); common (>=1/100, <1/10); uncommon: (>=1/1,000, <1/100); rare (>=1/10,000, <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data). Skin and subcutaneous tissue disorders: Not known: rash, urticaria, erythema, exanthema, bullous exanthema/erythema, pruritus, angioedema, dermatitis, Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme, toxic skin eruption. Gastrointestinal disorders: Not known: abdominal pain, nausea, vomiting, diarrhoea, gastrointestinal bleeding. Nervous system disorders. Not known: vertigo. Respiratory, thoracic and mediastinal disorders. Not known: dyspnoea. Vascular disorders. Not known: flushing. With oral and rectal mucolytics, bronchial obstruction may also occur with unknown frequency. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Fluifort Mucolytic Syrup 200 ml 90 mg / ml to be taken separately.

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