Erdotin

Erdotin 300 mg capsules

Each capsule contains 300 mg of erdosteine. For full list of excipients, see section 6.1.

Capsules, hardThe product appears as a capsule with a green cap and a yellow body

As an expectorant.For the symptomatic treatment of acute exacerbations of chronic bronchitis in adults.

Elderly and adults above 18 years:300 mg twice daily for maximum 10 days.The capsules must be swallowed whole with a glass of water.

Hypersensitivity to the active substance or to any of the other excipients.Since there are no data in patients with creatinine clearance <25ml/min, or with severe liver failure, the use of erdosteine is not recommended in these patients.Patients with active peptic ulcer.

No increase in adverse events has been observed with erdosteine in patients with mild liver failure; however these patients should not exceed a dose of 300 mg per day.

No adverse interactions have been reported.

Pregnancy:There is no experience for the use of erdosteine in pregnant women.Lactation:Experience is missing.Therefore, the use of erdosteine in pregnant or breast-feeding women is not recommended.

Erdotin has minor or negligible influence on the ability to drive and use machines.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card SchemeWebsite: www.mhra.gov.uk/yellowcard.

No experience of acute overdosage is available.Symptomatic treatment and general supportive measures should be followed in all cases of overdosage.Gastric lavage may be beneficial, followed by observation.

ATC Code: R 05 CB 15Pharmacotherapeutic group: Mucolytic agent.Mucolytic agent reducing the viscosity of mucus and purulent sputum. Erdosteine is a prodrug, becoming active after metabolism whereby free thiol groups are formed.This effect is due to the opening of the disulfide bonds of the bronchial mucoproteins.It has also been demonstrated that erdosteine inhibits bacterial adhesion to epithelial cells.Due to the presence of a free thiol group in its active metabolite, erdosteine has a significant antioxidant action, demonstrated by both 'in vitro' and 'in vivo' studies.

Absorption

Erdosteine is quickly absorbed after oral administration and rapidly transformed through a first-pass metabolism to its biologically active metabolite – N- thiodiglycolyl-homocysteine (M1).After administration of 300 mg, the peak plasma concentration of erdosteine (Cmax) - 1.26 ± 0.23 µg/ml - was reached 1.18 ± 0.26 hour after administration (Tmax), while M1 showed a Cmax of 3.46 µg/ml and a Tmax of 1.48 h. The plasma concentrations of erdosteine increase in a dose-dependent manner. Plasma concentrations of M1 increased also with the dose, but not as proportionally as in the case of unchanged erdosteine.The absorption is independent from food intake.

Distribution

In animal models, erdosteine was distributed mainly to kidneys, bone, spinal cord and liver.Pharmacologically active concentrations of both erdosteine and M1 were found in Broncho Alveolar Lavage.

Elimination

The elimination T½ is 1.46 ± 0.60 h and 1.62 ±0.59 h, respectively, for erdosteine and M1. In urine, only M1 and sulphates were found, faecal elimination is negligible.No accumulation or change in the metabolism of erdosteine and M1 has been observed after oral administration of 600 to 900 mg daily for 8 days.Influence of ageAge does not change the pharmacokinetics of erdosteine.Binding to plasma proteinsThe drug binding of erdosteine to plasma proteins is 64.5% (range: 50-86%).

Preclinical safety data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.

Capsule content:

Microcrystalline

cellulosePovidoneMagnesium stearate

Capsule shell:

GelatinTitanium dioxide (E171) Iron oxide, yellow (E172) Indigotine (E132)

Not applicable.

3 years

Do not store above 25 °C.

Each PVC/PVdC/Aluminium blister pack contains 10 capsules. Pack-sizes of 20 or 60 capsules per carton.Not all pack sizes may be marketed.

No special requirements

Galen Limited

Seagoe Industrial Estate

Craigavon

BT63 5UA

UK

PL 27827/0039

27/09/2011

23 May 2019