FLUIFORT 10BUST GRAT 2,7G

FLUIFORT 2,7 G FREE FOR ORAL DEPARTMENT

active ingredients

1 bag of 5 g contains: active ingredient: carbocysteine monohydrate lysine salt of 2.7 g carbocysteine salt of lysine Eccipienti with known effect: aspartame For the full list of excipients, see paragraph 6.1.

Excellent

Citric acid, mannitol, povidone, natural aroma of cedar, natural aroma of orange, orange juice, aspartame, maltodextrin.

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 listed in paragraph 6.1. Gastroduodeal ulcer. Pregnancy and nursing. Patients of pediatric age (under 11 years).

Population

1 bag per day. In view of pharmacokinetic characteristics, recommended posology can also be maintained in patients with kidney and liver failure. The maximum duration of therapy is up to 14 days. However carbocysteine salt of monohydrate lysine can also be used for prolonged periods, according to doctor's judgment. Instructions for use of the bag: dissolve the contents of the sachet in about half a glass of water mixing well.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Gastrointestinal bleeding Cases of gastrointestinal bleeding were reported with the use of carbocysteine. It is recommended caution in the elderly, in patients with a history of gastroduodenal ulcers or in patients taking concomitant drugs known to increase the risk of gastrointestinal bleeding. In case of gastrointestinal bleeding, the patient must stop treatment with carboxysteine. Asthmatic and debilitated patients: It is recommended to take specific precautions in patients with severe respiratory failure, in patients with asthma and with a history of bronchospasm, as well as in debilitated patients. The use of carboxysteine causes a decrease in the viscosity of the mucus and an increase in the removal of the mucus, both through the ciliar activity of the epithelium, and through the reflex of the cough. Therefore, an increase in cough and inspectorate is expected. The use of antitussive medicines inhibits cough reflex and increases the risk of airway obstruction, due to an increase in mucus accumulation in the respiratory tract. Concurrent use of this medicine with sedative medications of cough and/or medicines that inhibit bronchial secretion (e.g. anti-muscarinic medicines) is not recommended. No known phenomena of addiction or addiction. Fluifort 2,7 g granulate per oral solution does not affect hypocaloric or controlled diets and can also be administered to diabetic patients. Fluifort 2,7 g granulated for oral solution does not contain gluten; therefore it can be administered to patients suffering from celiac disease. Fluifort 2,7 g granulate per oral solution contains a source of phenylalanine which can be harmful to patients suffering from phenylchetonuria. Dissolve the contents of the sachet in about half a glass of water mixing well.

Interactions

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

Effects

The side effects are described according to the classification for systems and organs according to MedDRA and based on the frequency estimated by post-marketing experience. The frequencies are defined as follows: very common (≥1/10); common (≥1/100, Classification for systems and organs Frequency Action against Pathologies of skin, subcutaneous tissue Notable Skin Rash, urticaria, erythema, esantema, esantema/eritema bolloso, itching, angioedema, dermatitis. Stevens-Johnson syndrome, bollous dermatitis, multiform erythema, toxic rash. Gastrointestinal diseases Notable Abdominal pain, nausea, vomiting, diarrhea. Gastrointestinal bleeding Diseases of the nervous system Notable Vertigo Respiratory, chest and mediastinic pathologies Notable Dispense Vascular diseases Notable Red 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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

The symptoms reported in case of overdose are headaches, nausea, vomiting, diarrhea, gastralgia, skin reactions, alteration 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, Fluifort should not be given in pregnancy (see 4.3). Since there is no data on the passage of carboxysteine salt of lisina monohydrate in breast milk, use during breastfeeding is contraindicated (see 4.3).

Source: Farmadati