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DOMPE' FARMACEUTICI SpA

Fluifort 2.7g/10ml syrup 12 sachets 10ml

Fluifort 2.7g/10ml syrup 12 sachets 10ml

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Fluifort 2.7g/10ml syrup in single-dose sachets is a mucolytic fluidifier based on carbocysteine ​​lysine salt , indicated for acute and chronic respiratory conditions with thick mucus. The practical 12-sachet pack ensures precise dosing , hygiene , and ease of administration , promoting expectoration and relief from coughs and phlegm.

NET WEIGHT OF THE PRODUCT

EAN

023834144

MINSAN

023834144

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Fluifort 2.7g/10ml syrup 12 sachets 10ml is a mucolytic and fluidifying agent indicated for the treatment of respiratory tract conditions, both acute and chronic. Each 10ml sachet contains carbocysteine ​​lysine salt monohydrate , equivalent to 2.7g of carbocysteine ​​lysine salt, which acts by reducing the viscosity of the mucus and facilitating its expulsion. This syrup is formulated to ensure precision in dosage and ease of use , making it ideal for those who need effective and targeted treatment. The 12-sachet pack is designed to offer hygiene and ease of intake , helping to improve the management of respiratory conditions.

ACTIVE INGREDIENTS

Active ingredients contained in Fluifort 2.7g/10ml syrup 12 sachets 10ml - What is the active ingredient in Fluifort 2.7g/10ml syrup 12 sachets 10ml?

A 10 ml sachet of 27% syrup contains: active ingredient: carbocisteine ​​lysine salt monohydrate equal to 2.7 g of carbocisteine ​​lysine salt. Excipients with known effect: methyl parahydroxybenzoate, propyl parahydroxybenzoate, sorbitol, carmellose sodium, ethanol (contained in cherry flavouring). For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Fluifort 2.7g/10ml syrup 12 sachets 10ml - What does Fluifort 2.7g/10ml syrup 12 sachets 10ml contain?

Sorbitol (70% solution); xylitol; ammonium glycyrrhizinate; sodium carmellose; glycerol; cherry flavouring (containing ethanol); methyl parahydroxybenzoate; propyl parahydroxybenzoate; purified water.

DIRECTIONS

Therapeutic indications Fluifort 2.7g/10ml syrup 12 sachets 10ml - Why is Fluifort 2.7g/10ml syrup 12 sachets 10ml used? What is it for?

Mucolytic, fluidifying in acute and chronic respiratory tract conditions.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Fluifort 2.7g/10ml syrup 12 sachets 10ml - When should Fluifort 2.7g/10ml syrup 12 sachets 10ml 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 pediatric patients under 11 years of age.

DOSAGE

Quantity and method of taking Fluifort 2.7g/10ml syrup 12 sachets 10ml - How do you take Fluifort 2.7g/10ml syrup 12 sachets 10ml?

1 sachet per day. Fluifort 2.7 g/10 ml syrup, due to its innovative packaging, ensures precision in dosage, hygiene, practicality and ease of intake and is particularly indicated in acute conditions for which short-term treatment is foreseen. In consideration of the pharmacokinetic characteristics, the recommended dosage can also be maintained in patients with renal and hepatic insufficiency. The maximum duration of therapy is up to 14 days. However, carbocisteine ​​lysine salt monohydrate can also be used for prolonged periods, according to the doctor's judgment.

CONSERVATION

Storage Fluifort 2.7g/10ml syrup 12 sachets 10ml - How do you store Fluifort 2.7g/10ml syrup 12 sachets 10ml?

Store below 25°C. If stored correctly, any change in color of the preparation does not affect the therapeutic activity of the specialty, which remains valid until the expiry date indicated.

WARNINGS

Warnings Fluifort 2.7g/10ml syrup 12 sachets 10ml - About Fluifort 2.7g/10ml syrup 12 sachets 10ml it is important to know that:

Gastrointestinal bleeding Cases of gastrointestinal bleeding have been reported with the use of carbocisteine. Caution is advised 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 the event 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 the accumulation of mucus in the airways. Concomitant use of this medicinal product with cough sedatives and/or medicinal products that inhibit bronchial secretion (e.g. anti-muscarinic medicinal products) is not recommended. No phenomena of habituation or dependence are known. This medicinal product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, known to possibly cause urticaria. In general, parahydroxybenzoates may cause delayed reactions such as contact dermatitis and rarely immediate reactions with manifestation of urticaria and bronchospasm. This medicinal product contains sorbitol, patients with rare hereditary problems of fructose intolerance should not take this medicinal product. Fluifort 2.7 g /10 ml syrup contains ethanol This medicinal product contains 15.2 mg of alcohol (ethanol) in each dose (10 ml). The amount in 10 ml of this medicinal product is equivalent to less than 4 ml of beer or 2 ml of wine. The small amount of alcohol in this medicinal product will not produce any relevant effects. Fluifort 2.7 g /10 ml syrup contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium-free'. Fluifort 2.7 g /10 ml syrup does not contain aspartame; therefore it can be administered to patients with phenylketonuria. Fluifort 2.7 g/10 ml syrup does not affect low-calorie or controlled diets and can also be administered to diabetic patients. Fluifort 2.7 g/10 ml syrup does not contain gluten; therefore it can be administered to patients with coeliac disease. Open the sachet following the dotted line and swallow the contents.

INTERACTIONS

Interactions Fluifort 2.7g/10ml syrup 12 sachets 10ml - Which medicines or foods can modify the effect of Fluifort 2.7g/10ml syrup 12 sachets 10ml?

In controlled clinical studies, no interactions have been 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 2.7g/10ml syrup 12 sachets 10ml can cause side effects - What are the side effects of Fluifort 2.7g/10ml syrup 12 sachets 10ml?

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 (cannot be estimated from the available data).

Classification by systems and organs Frequency Adverse reaction
Skin and subcutaneous tissue disorders Not known Skin 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, diarrhea Gastrointestinal bleeding
Nervous system disorders Not known Vertigo
Respiratory, thoracic and mediastinal pathologies Not known Dyspnea
Vascular pathologies Not known Redness

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued 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.

OVERDOSE

Overdose Fluifort 2.7g/10ml syrup 12 sachets 10ml - What are the risks of Fluifort 2.7g/10ml syrup 12 sachets 10ml in case of 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 recommended to induce vomiting and possibly perform gastric lavage followed by specific supportive therapy.

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 2.7g/10ml syrup 12 sachets 10ml

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).

DRIVING AND USE OF MACHINERY

Taking Fluifort 2.7g/10ml syrup 12 sachets 10ml before driving or using machines - Does Fluifort 2.7g/10ml syrup 12 sachets 10ml affect driving or using machines?

No negative effects of the drug on the ability to drive vehicles or use machinery have been reported.

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