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Fluimucil A

Acetylcysteine 100 mg

Acetylcysteine 200 mg

Acetylcysteine 600 mg

For oral use

 

Characteristics

N-acetyl-L cysteine (NAC),the active ingredient of Fluimucil A, exerts an intense mucolytic action on mucous and mucopurulent secretions, by depolymerizing the mucoproteic complexes and the nucleic acids which confer viscosity to the vitreous and purulent component of the sputum and of other secretions.

 

Furthermore, NAC, exerts a direct antioxidant action, being provided with a free thiol (-SH nucleophillic) group, which is able to interact directly with the electrophilic groups of the oxidant radicals. Of particular interest is the recent demonstration that NAC protects the a 1-antitrypsin, enzyme inhibitor of elastase, from the inactivation due to the action of hyprochlorous acid (HOCI), a powerful oxidant agent produced by the myeloperoxidase enzyme of activated phagocytes. These features make Fluimucil A particularly suitable for the treatment of acute and chronic affections of the respiratory system, characterized by thick and viscous mucous and mucopurulent secretions. Furthermore, the molecular structure permits the molecule to cross easily cellular membranes. Inside the cell, NAC is deacetylized, forming L-cysteine, an amino acid indispensable for the glutathione synthesis (GSH).

 

GSH is a highly reactive tripeptide, found ubiquitously in the various tissues of animals and is essential for the maintenance of functional capacity as well as cellular morphological integrity, as it represents the most important protective, endocellular mechanism against oxidant radicals, either of external or internal nature, as well as towards numerous cytotoxic substances.

 

NAC plays a role of primary importance in the maintenance of adequate GSH levels thus contributing to the cellular protections from harmful agents which, through progressive GSH depletion, would be able to express their cytotoxic action, as in the case of acetaminophen poisoning.

 

Due to this mechanism of action, NAC is also indicated as a specific antidote in acetaminophen poisoning, in the course of a cyclophosphamide treatment and in haemorrhagic cystitis, (in the latter case it provides SH-groups necessary to inactivate acrolein, a toxic metabolite that affects the urinary mucosae, whilst not interfering with chemotherapy).

 

Therapeutic indications

Treatment of respiratory affections characterized by thick and viscous hypersecretions: acute bronchitis, chronic bronchitis and its exacerbations, pulmonary emphysema, mucoviscidosis and bronchiectasis.

 

Contraindications

Known hypersensitivity to acetylcysteine. As Fluimucil A contains aspartame, it is contraindicated in patients suffering from phenylketonuria.

 

Posology

Adults:

- 1 sachet Fluimucil A 200 or 2 sachets Fluimucil A 100, 2-3 times a day;

- 1 effervescent tablet of FLUMUCIL A 600 mg a day (preferably in the evening).

For the prevention of an exacerbation, the use of Fluimucil A (200 mg) sachets is recommended.

 

Children:

Aged up to 2 years: 1 sachet of Fluimucil A 200mg or 2 sachets of Fluimucil A 100mg, once daily.

2 to 7 year old: 1 sachet of Fluimucil A 200mg or 2 sachet of Fluimucil A 100mg, twice daily.

 

The duration of treatment should be 5 to 10 days in the acute treatment, Where as it may be continued in the chorions states for several months, according to the advice of the physician.

 

Modality of use

Dissolve the tablets as well as the contents of the sachets in a glass containing a small quantity of water, mixing it, if necessary, with a spoon. A palatable solution is thus obtained, which can be drunk directly from the glass or in the case of infants, be given with a tea spoon or in a feeding bottle.

 

Warning and precautions

Patients suffering from bronchial asthma must be strictly controlled during the therapy; should bronchospasm occur, the treatment must immediately be suspended. Caution should be taken in patient suffering from or with a history of peptic ulcer. The possible presence of a sulphurous odour does not indicate an alteration of the product but is a characteristic of the active ingredient contained in this preparation. It is preferable not to mix other drugs with the Fluimucil A solution.

 

Side effects

The oral intake of the product, may, occasionally be followed by nausea and vomiting, and in rare cases by hypersensitivity reactions such as urticaria and bronchospasm.

 

Drug interaction

No cases of drug-drug interaction are descripted in literature for NAC by oral use.

 

Symptoms and treatment for overdosage and antidote(s)

When orally administered, no particular signs and symptoms, even in subjects treated with high doses of NAC, have been observed. In case of necessity proceed with postural drainage and bronchoaspiration.

 

Storage temperature

Fluimucil A 600 mg store below 30C, prevent from heat and humidity. Fluimucil A 100 mg and Fluimucil A 200 mg store below 25C, prevent from heat and humidity. SHELF-LIFE: 3 years

 

Product description

Fluimucil A 100 mg and Fluimucil A 200 mg yellow granules with characteristic orange and slightly sulphureous odour. Fluimucil A 600 mg white circular tablets, with a characteristic lemon, slightly sulphureous odour.

 

Packaging

- Fluimucil A 600 - 10 effervescent tablets of 600 mg acetylcysteine.

- Fluimucil A 200 - 30 sachets of 200 mg acetycysteine.

- Fluimucil A 100 - 30 sachets of 100 mg acetycysteine. 

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