The instruction for medical use
of Fluimutsil® medicine
the Trade name
the International unlicensed
name Acetylcysteinum Dosage Form
of the Granule for preparation of solution for intake
of 1 grams of granules contains
active agent – Acetylcysteinum of 200 mg,
excipients: aspartame, betakaroten, fragrance orange, sorbitol.
of the Granule of white-yellow color with orange inclusions with characteristic orange, slightly sulphurous smell
Expectorant drugs. Mucolytics.
The code of automatic telephone exchange R05CB01
Pharmacokinetics Acetylcysteinum properties is well absorbed at oral administration. It is immediately deacetylated to cysteine in a liver. In blood the mobile balance of the free and connected with proteins of plasma Acetylcysteinum and its metabolites (cysteine, cystine, diacetylcysteinum) is observed. Because of high effect of the first passing through a liver the bioavailability of Acetylcysteinum is about 10%. Acetylcysteinum gets into intercellular space, is mainly distributed in a liver, kidneys, lungs, a bronchial secret.
The maximum concentration in plasma is reached in 1-3 hours after oral administration and makes 15 mmol/l, communication with proteins of plasma – 50%. T1/2 – about 1 hour, in cirrhosis increases till 8 o’clock. It is removed by kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteinum), an insignificant part is allocated in not changed look through intestines. Gets through a placental barrier.
Mucolytic means, dilutes a phlegm, increases its volume, facilitates department of a phlegm. Action is connected with ability of free sulfhydryl groups of the drug Fluimutsil® to break off inside – and intermolecular disulfide bridges of acid mucopolysaccharides of a phlegm that leads to a depolymerization of mucoproteins and reduction of viscosity of a phlegm. Keeps activity at a purulent phlegm.
Increases secretion of less viscous sialomutsin scyphoid cells, reduces adhesion of bacteria on epithelial cells of a mucous membrane of bronchial tubes. Stimulates mucous cells of bronchial tubes which secret lyses fibrin. Has similar effect on the secret which is formed in inflammatory diseases of ENT organs. Has the antioxidant effect caused by existence of the SH group capable to neutralize electrophilic oxidizing toxins. Флуимуцил® easily gets in a cell, it is deacetylated to L-cysteine from which intracellular glutathione is synthesized. Glutathione – high-reactive tripeptide, powerful antioxidant, the cytoprotector catching endogenous and exogenous free radicals and toxins. Флуимуцил® exhaustion warns and promotes increase in synthesis of the intracellular glutathione participating in oxidation-reduction processes of cells, thus, promoting a detoxication of hazardous substances. Action of Fluimutsila® as antidote in poisoning with paracetamol is explained by it.
Protects alfa1-antitrypsin (elastase inhibitor) from the inactivating influence of HOCl – the oxidizer produced by myeloperoxidase of active phagocytes. Possesses also anti-inflammatory action (due to suppression of education of the free radicals and active oxygen-containing agents responsible for development of inflammation in pulmonary fabric).
– disturbance of an otkhozhdeniye of a phlegm at: bronchitis, tracheitis, laryngotracheitis, a bronchiolitis, pneumonia, a bronchoectatic disease, a mucoviscidosis, abscess of lungs, emphysema of lungs
– interstitial diseases of lungs, a lung atelectasis (owing to obstruction of bronchial tubes a mucous stopper) – catarrhal and purulent otitis
– antritis and other sinusitis (simplification of an otkhozhdeniye of a secret)
– removal of a viscous secret from airways at posttraumatic and postoperative states
the Route of administration and doses
For preparation of solution for intake, dissolve contents of 1 package in 1/3 glasses of water.
To children from 2 to 6 years – on 200 mg 2 times a day, or on 100 mg 3 times a day.
To children 6 years and the adult are more senior – on 200 mg 2-3 times a day.
Duration of a course of treatment should be estimated individually. In acute diseases duration of treatment is from 5 to 10 days, at treatment of chronic diseases (according to the recommendation of the doctor) up to several months.
– nausea, vomiting
– heartburn, feeling of overflow of a stomach
– skin rash, an itching, a small tortoiseshell
– nasal bleedings, sonitus
At reception of Fluimutsila® are described development cases:
– a bronchospasm, collapse, stomatitis, decrease in aggregation of thrombocytes
of the Contraindication
– hypersensitivity to any component of drug
– a peptic ulcer of a stomach and duodenum in an aggravation stage
– the lactation period
– children’s age up to 2 years
the Combined use of Fluimutsil® with antibechics can increase stagnation of a phlegm because of suppression of a tussive reflex.
At simultaneous use with such antibiotics as tetracyclines (excepting doxycycline), ampicillin, Amphotericinum B, their interaction with the thiol Fluimutsila® group is possible that leads to decrease of the activity of both drugs. Therefore the interval between intake of these drugs has to make not less than 2 hours.
The concomitant use of Fluimutsila® and nitroglycerine can lead to strengthening of vasodilating and dezagregantny action of the last.
Флуимуцил® eliminates toxic effects of paracetamol.
With care to apply at patients with a peptic ulcer of a stomach and a 12-perstny gut in the anamnesis, a varicosity of a gullet, a blood spitting, pulmonary bleeding, diseases of adrenal glands, a liver and/or renal failure, arterial hypertension.
Patients with bronchial asthma and obstructive bronchitis should appoint with care under systematic control of bronchial conductivity.
Drug contains aspartame therefore its use for patients with phenylketonuria is not recommended.
Presence of a light sulfuric smell is a characteristic smell of active ingredient.
At dissolution of Fluimutsila® it is necessary to use glasswares, to avoid contact with metal and rubber surfaces.
Drug at pregnancy is appointed only if the expected advantage for mother exceeds potential risk for a fruit.
Features of influence of medicine on ability to run motor transport and potentially dangerous mechanisms
the Overdose does not influence
Symptoms of overdose are not described. Fluimutsil® active ingredient – Acetylcysteinum at reception in a dose of 500 mg/kg/day does not cause signs of overdose.
A form of release and packing
On 1.0 g of granules in a package from paper / aluminum / polyethylene.
On 20 packages together with the instruction for medical use place in a cardboard pack.
To Store storage conditions at a temperature not above 25 °C.
To store out of children’s reach!
Period of storage
Not to apply after the expiration date specified on packing
The producer Zambon Svittserland of Ltd.,
Via Industria 13,
Kadempino’s SN-6814, Switzerland