EXOMUC 200 mg Glé s buv en sachet 24Sach

N - Acetylcysteine................................................................................................................................... 200,0 mg

Per sachet.

Excipients with known effect: aspartame, sorbitol.

Treatment of disorders of bronchial secretion, particularly during acute bronchial conditions: acute bronchitis and acute episode of chronic bronchopneumopathies.

Dosage

Adults and children over 7 years : 600 mg per day, in 3 doses, i.e. 1 sachet 3 times per day.

Children from 2 to 7 years : 400 mg per day, in 2 doses, i.e. 1 sachet 2 times per day.

The duration of treatment should not exceed 8 to 10 days without medical advice.

Method of administration

Oral use.

Dissolve the granules in half a glass of water.

• Hypersensitivity to the active substance or to any of the excipients listed in section Composition.

• Infants (less than 2 years) (see section Warnings and precautions).

• Due to the presence of aspartame, this medicine is contraindicated in cases of phenylketonuria.

Special warnings

Productive coughs, which are a fundamental element of bronchopulmonary defence, should be preserved.

The combination of bronchial mucomodifiers with antitussives and/or substances that dry bronchial secretions (antimuscarinics) is irrational.

Treatment with EXOMUC should be reassessed in case of persistence or worsening of symptoms or of the condition.

At the start of treatment with acetylcysteine, bronchial secretions may become more fluid and increase in volume, which may lead to bronchial congestion. This medicine should be used with caution in subjects having difficulty or inability to expectorate.

Mucolytics may induce bronchial overload in infants. Indeed, their capacity to drain bronchial mucus is limited, due to the physiological particularities of their respiratory tree. They should therefore not be used in infants (see sections Contraindications and Adverse effects).

Acetylcysteine has a dose-dependent effect on histamine release by mast cells. Due to the bronchial hyperreactivity of asthmatic patients, there is a risk of bronchospasm occurring in these patients treated with EXOMUC. Caution is required in asthmatic subjects or those with a history of bronchospasm. If bronchospasm occurs, treatment must be stopped immediately.

Serious skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome have been reported very rarely during administration of acetylcysteine. However, the role of acetylcysteine in the occurrence of these reactions could not be clearly established. In most cases, the concomitant administration of at least one other suspect medicine, more likely responsible for the occurrence of the mucocutaneous syndrome, could be identified. As a precaution, if skin or mucosal lesions appear, treatment must be stopped immediately and a doctor must be consulted.

Studies in vitro Literature data have shown that acetylcysteine causes a decrease in platelet aggregation. The clinical significance of these observations is not known. Caution is recommended in patients at high risk of bleeding.

This medicine contains 25 mg of aspartame per sachet. Aspartame contains a source of phenylalanine. It may be harmful for people with phenylketonuria (PKU), a rare genetic disease characterised by the accumulation of phenylalanine that cannot be properly eliminated.

This medicine contains 662,7 mg of sorbitol per sachet. Sorbitol is a source of fructose. Patients with hereditary fructose intolerance (HFI) must not take/receive this medicine.

Precautions for use

Caution is recommended in subjects with gastroduodenal ulcer.

The data available to date do not suggest a risk of clinically significant interactions. However, the combination of bronchial mucomodifiers with an antitussive and/or a substance that dries up bronchial secretions (anticholinergics) is illogical and irrational.

Pregnancy

Results of studies carried out in animals have not shown any teratogenic effect. Data available in pregnant women are limited. As a precaution, it is preferable to avoid administering this medicine during pregnancy.

Breast-feeding

In the absence of available data on passage into breast milk, it is preferable to avoid administration to breastfeeding women.

Fertility

There are no data on the effect of acetylcysteine on human fertility. Animal studies have not shown harmful effects on human fertility at the recommended doses (see section Preclinical safety).

No effect on the ability to drive vehicles or use machines has been observed.

The assessment of adverse effects is generally based on the following definition of frequencies of occurrence:

Very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000), frequency not known (cannot be estimated from the available data).

• Immune system disorders

Frequency not known: hypersensitivity, anaphylactic shock, anaphylactic and anaphylactoid reactions.

• Respiratory, thoracic and mediastinal disorders 

Frequency not known: bronchial obstruction (particularly in infants and in certain patients unable to expectorate effectively, see sections Contraindications and Warnings and precautions), bronchospasm particularly in asthmatic patients (see section Warnings and precautions).

• Gastrointestinal disorders:

Frequency not known: upper abdominal pain, nausea, vomiting, diarrhoea

It is then advised to reduce the dose.

• Skin and subcutaneous tissue disorders:

Frequency not known: allergic dermatitis, pruritus, erythematous rash, urticaria, angioedema, Stevens-Johnson and Lyell syndromes (see section Warnings and precautions)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr/

In case of overdose, risk of symptoms such as epigastric pain, nausea, vomiting.

Pharmacotherapeutic class: MUCOLYTIC (R: Respiratory system) – ATC code: R05CB01.

Acetylcysteine is a mucomodifier of the mucolytic type. It acts on the gel phase of mucus by breaking the disulfide bridges of glycoproteins.

Acetylcysteine is rapidly absorbed; the peak plasma concentration is reached within one hour, after oral administration of 200 to 600 mg.

Bioavailability is in the range of 4 to 10% of the administered dose, with intraluminal metabolism and a significant hepatic first-pass effect.

It is metabolised into several oxidised derivatives.

Its half-life is 2 hours. Renal clearance accounts for approximately 30 % of total clearance.

Elimination of acetylcysteine and its metabolites occurs mainly via the kidney.

Non-clinical data from conventional studies of repeated-dose toxicity, genotoxicity, and reproductive and developmental function did not reveal any particular risk for humans.

3 years.

No special precautions for storage.

No special requirements.