Fluimucil

ACETYLCYSTEINE

100 mg Granules for Solution
200 mg Granules for Solution
100 mg/5 mL Syrup

MUCOLYTIC

Category:

Description

FORMULATION

Each 5 mL of syrup contains acetylcysteine 100 mg.

PHARMACOLOGY

Acetylcysteine, active ingredient of FLUIMUCIL, exerts an intensive mucolytic-fluidifying 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 other secretions.

Furthermore, acetylcysteine exerts a direct antioxidant action, having a free thiol (-SH) nucleophilic group which is able to interact directly with the electrophilic group of the oxidant radicals. Of particular interest is the recent finding that acetylcysteine protects α1-antitrypsin enzyme inhibiting elastase from the inactivation by hypochlorous acid (HOCl), a powerful oxidant agent produced by the myeloperoxidase enzyme of activated phagocytes.

These features make ACETYLCYSTEINE (FLUIMUCIL) particularly suitable for the treatment of acute and chronic affections of the respiratory system, characterized by thick, viscous mucous and mucopurulent secretions.

In addition, due to its molecular structure, acetylcysteine can easily cross the cellular membranes. Inside the cell, acetylcysteine is deacetylated to L-cysteine, an amino acid indispensable for the glutathione synthesis (GSH).

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

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

Due to this mechanism of action, acetylcysteine is also indicated as a specific antidote in paracetamol poisoning and in the course of treatment of cyclophosphamaide-induced hemorrhagic cystitis, in the latter case, it provides the –SH groups necessary to inactivate acrolein, a toxic metabolite that affects the urinary mucosae, whist not interfering with chemotherapy.

INDICATIONS

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

CONTRAINDICATIONS

Hypersensitivity to the ingredients of the product and to other chemically related substances.

Children below 2 years of age.

DOSAGE AND ADMINISTRATION

Adults:

10 mL of FLUIMUCIL Syrup equivalent to 200 mg acetylcysteine, 2 to 3 times daily

Children:

5 mL (1 teaspoonful) of FLUIMUCIL Syrup equivalent to 100 mg acetylcysteine, 2 to 4 times daily, according to age. The duration of treatment should be 5 to 10 days in the acute phase. It may be continued in the chronic state for several months according to the advice of the physician.

Chronic Diseases

Children, 6 to 14 years: 5 mL (1 teaspoonful) 3 times daily

Adults: 10 mL (2 teaspoonful) two times daily

Mucoviscidosis

Children, 2 to 6 years: 5 mL (1 teaspoonful) 4 times daily

Children over 6 years: 10 mL (2 teaspoonful) 3 times daily

Acute Diseases

Children, 2 to 6 years: 5 mL (1 teaspoonful) 3 times daily

Children, 6 to 14 years: 10 mL (2 teaspoonful) 2 times daily

Adults: 10 mL (2 teaspoonful) 3 times daily

Or as prescribed by the physician.

FLUIMUCIL is contraindicated in children below 2 years of age.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

It is not advised to mix other drugs with Acetylcysteine (FLUIMUCIL) Syrup.

Patients suffering from bronchial asthma must be strictly monitored during the therapy. Should bronchospasm occur, the treatment must be suspended immediately. It should be used with caution in asthmatic patients and patients with a history of peptic ulceration.

Mucolytic agents can induce respiratory obstruction in children under 2 years of age. Due to the physiological characteristics of the airways in this age group, the ability to expectorate may be limited. Therefore, mucolytic agents should not be used in children under 2 years of age,

Acetylcysteine (FLUIMUCIL) Syrup contains sodium benzoate that may induce slight contact irritation to the skin, eyes and mucosae. It may also increase the risk of neonatal jaundice. The possible presence of sulfurous smell is not indicative of product alterations but is a characteristic of the active ingredient contained in this preparation.

Acetylcysteine (FLUIMUCIL) Syrup contains parahydroxybenzoate which may cause allergic reactions (possibly delayed). The preparation likewise contains 0.7 mmol (or 16.6 mg) sodium per dose. This must be taken into consideration by patients on a controlled sodium diet.

USE DURING PREGNANCY AND LACTATION

Pregnancy

There is limited clinical data relating to women exposed to acetylcysteine during pregnancy. Animal studies do not suggest any direct or indirect harmful effects on the pregnancy, embryo/fetal development, birth or postnatal development.

Lactation

There is no available information on the excretion in breast milk. The product should only be used during pregnancy and lactation after the benefit/risks have been weighed up carefully.

DRUG INTERACTIONS

Drug interaction studies have been performed only in adults. Antitussive drugs and acetylcysteine should not be concurrently administered because the reduction in cough reflex could lead to accumulation of bronchial secretions.

Concurrent administration of nitroglycerin and acetylcysteine has been shown to cause significant hypotension and enhance temporal artery dilation. If concurrent nitroglycerin and acetylcysteine therapy is necessary, patients should be monitored for hypotension, which can be severe, and warned of the possibility of headaches.

Acetylcysteine may interfere with colorimetric assay method for salicylate measurement.

Acetylcysteine may interfere with urine ketone test.

Activated charcoal may reduce the effect of acetylcysteine.

ADVERSE EVENTS

In some patients, the following events were rarely observed after acetylcysteine intake: pyrosis, nausea, vomiting and diarrhea. In rare cases, hypersensitivity reactions such as urticarial and bronchospasm may occur.

Adverse reactions reported after use of N-acetylcysteine oral formulations are shown below.

System Organ Class Adverse Reactions
Uncommon (>1/1,000 to <1/100) Rare (>1/10,000 to <1/1,000) Very Rare

(<1/10,000)

Unknown
Immune System Disorders Hypersensitivity Anaphylactic shock, anaphylactic/anaphylactoid reaction
Nervous System disorders Headache
Ear and labyrinth Disorders Tinnitus
Cardiac Disorders Tachycardia
Vascular disorders Haemoorhage
Respiratory, thoracic and Mediastinal Disorders Bronchospasm

Dyspnea

Gastrointestinal Disorders Vomiting, diarrhea, stomatitis, abdominal pain, nausea Dyspepsia
Skin and subcutaneous tissue disorders Urticarial, rash, angioedema, pruritus
General Disorders and Administration Site conditions Pyrexia Face oedema
Investigations Blood pressure decreased

In very rare cases, the occurrence of severe skin reactions such as Stevens-Johnson syndrome and Lyell’s syndrome has been reported in temporal connection with the administration of acetylcysteine.

In most cases, at least one co-suspect drug more probably involved in triggering the reported mucocutaneous syndrome could be identified. Seek immediate medical advice if any new changes to the skin or mucous membrane occur. Acetylcysteine must be stopped immediately.

A decrease in platelet aggregation in the presence of acetylcysteine has been confirmed by various investigations. The clinical significance has not been established.

OVERDOSAGE

For oral pharmaceutical forms of acetylcysteine, no case of overdose has been reported to date. Healthy volunteers received 11.6 g of acetylcysteine daily for three months without any serious undesirable effects. Oral doses of up to 500 mg NAC/kg bodyweight were tolerated without any symptoms of poisoning.

Symptoms

Overdose may lead to gastrointestinal symptoms such as nausea, vomiting and diarrhea.

Treatment

There are no specific antidote for acetylcysteine and treatment is symptomatic.

EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES

Acetylcysteine has no known influence on the ability to drive and use machines.

STORAGE

Store at temperatures not exceeding 25°C. The bottle, once opened, can be used for 15 days.

FORMULATION AND AVAILABILITY

FLUIMUCIL Syrup, each amber glass bottle of 100 mL Syrup contains 2 g of acetylcysteine (2%) or 100 mg of acetylcysteine per 5 mL of FLUIMUCIL Syrup.

Each 100 mL bottle of syrup is packed in individual boxes provided with a measuring cup.

KEEP OUT OF REACH OF CHILDREN.

DO NOT USE BEYOND EXPIRY DATE.

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