FLUIFORT SYRUP SACHETS 6 SACHETS
TECHNICAL DATA SHEET RCP DRUGS FROM DATA BANK
[su_spoiler title="MEDICINAL NAME" style="fancy" icon="chevron-circle"]Fluifort 2.7 g/10 ml syrup.[/su_spoiler]
[su_spoiler title="QUALITATIVE AND QUANTITATIVE COMPOSITION" style="fancy" icon="chevron-circle"]A 10 ml sachet of 27% syrup contains:
active ingredient: carbocisteine lysine salt monohydrate equal to 2.7 g of carbocisteine lysine salt.
Excipients: methyl parahydroxybenzoate, propyl parahydroxybenzoate, sorbitol.
For the full list of excipients, see section 6.1.[/su_spoiler]
[su_spoiler title="PHARMACEUTICAL FORM" style="fancy" icon="chevron-circle"]Syrup.[/su_spoiler]
[su_spoiler title="THERAPEUTIC INDICATIONS" style="fancy" icon="chevron-circle"]Mucolytic, fluidifying in acute and chronic respiratory tract conditions.[/su_spoiler]
[su_spoiler title="DOSAGE AND METHOD OF ADMINISTRATION" style="fancy" icon="chevron-circle"]1 sachet per day.
Fluifort 2.7 g/10 ml syrup, thanks to its innovative packaging, ensures precision in dosage, hygiene, practicality and ease of administration and is particularly indicated in acute phase conditions for which short-term treatment is foreseen.
Considering the pharmacokinetic characteristics, the recommended dosage can also be maintained in patients with renal and hepatic insufficiency.
Duration of treatment: carbocisteine lysine salt monohydrate can also be used for prolonged periods, in this case it is advisable to follow the doctor's advice.[/su_spoiler]
[su_spoiler title="CONTRAINDICATIONS" style="fancy" icon="chevron-circle"]Hypersensitivity to the active substance or to any of the excipients. Gastroduodenal ulcer. Pregnancy and breastfeeding. The drug is contraindicated in pediatric patients under 11 years of age.[/su_spoiler]
[su_spoiler title="WARNINGS AND PRECAUTIONS FOR USE" style="fancy" icon="chevron-circle"]There are no known phenomena of habituation or dependence.
The medicinal product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which are known to cause urticaria. In general, parahydroxybenzoates may cause delayed reactions, such as contact dermatitis and rarely immediate reactions with urticaria and bronchospasm.
The medicinal product contains sorbitol, patients with rare hereditary problems of fructose intolerance should not take this medicine. 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 aspartame; therefore it can be administered to patients with phenylketonuria.
Fluifort 2.7 g/10 ml syrup does not contain gluten; therefore it can be administered to patients suffering from celiac disease.
Open the sachet following the dotted line and ingest the contents.[/su_spoiler]
[su_spoiler title="INTERACTIONS" style="fancy" icon="chevron-circle"]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.[/su_spoiler]
[su_spoiler title="FERTILITY, PREGNANCY AND BREASTFEEDING" style="fancy" icon="chevron-circle"]Although the active substance is neither teratogenic nor mutagenic and has not shown any negative effects on reproductive function in animals, Fluifort must 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.[/su_spoiler]
[su_spoiler title="EFFECTS ON THE ABILITY TO DRIVE VEHICLES" style="fancy" icon="chevron-circle"]No negative effects of the drug on the ability to drive vehicles or use machinery have been reported.[/su_spoiler]
[su_spoiler title="SIDE EFFECTS" style="fancy" icon="chevron-circle"]Undesirable effects that may occur with Fluifort, classified by system organs (SOC), are as follows:
Skin and subcutaneous tissue disorders: skin rash, urticaria, erythema, exanthema, bullous exanthema/erythema, pruritus, angioedema, dermatitis.
Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea.
Nervous system disorders: dizziness.
Respiratory, thoracic and mediastinal disorders: dyspnea.
Vascular pathologies: redness.
Bronchial obstruction may also occur with oral and rectal mucolytics with unknown frequency.[/su_spoiler]
[su_spoiler title="OVERDOSE" style="fancy" icon="chevron-circle"]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.[/su_spoiler]
[su_spoiler title="LIST OF EXCIPIENTS" style="fancy" icon="chevron-circle"]
Sorbitol (70% solution); xylitol; ammonium glycyrrhizinate; sodium carmellose; glycerol; cherry flavour; methyl parahydroxybenzoate; propyl parahydroxybenzoate; purified water.[/su_spoiler]
[su_spoiler title="CONSERVATION" style="fancy" icon="chevron-circle"]Store at a temperature below 25 °C. If stored correctly, any change in colour of the preparation does not affect the therapeutic activity of the specialty which remains valid until the expiry date indicated.[/su_spoiler]
[su_spoiler title="MARKETING AUTHORISATION HOLDER" style="fancy" icon="chevron-circle"]Dompé farmaceutici spa - Via San Martino, 12 - Milan.[/su_spoiler]
[su_spoiler title="AUTHORIZATION NUMBER - MINSAN" style="fancy" icon="chevron-circle"]6 sachets AIC n. 023834132[/su_spoiler]