Summary of Product Characteristics
last updated on the eMC:
02/01/2007
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SPC
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Erdotin 300mg capsules
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This medicine is monitored intensively by the CHM and MHRA
Go to top of the page | Erdotin 300 mg capsules | |
Go to top of the page | Each capsule contains 300 mg of erdosteineFor full list of excipients, see section 6.1. | |
Go to top of the page | Capsules, hard. The product appears as a capsule with a green cap and a yellow body | |
Go to top of the pageGo to top of the page | As an expectorant. For the symptomatic treatment of acute exacerbations of chronic bronchitis in adults. | |
Go to top of the page | 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. | |
Go to top of the page | 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. | |
Go to top of the page | 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. | |
Go to top of the page | No adverse interactions have been reported. | |
Go to top of the page | 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. | |
Go to top of the page | Erdotin has minor or negligible influence on the ability to drive and use machines. | |
Go to top of the page | Less than 1 in 1,000 can expect to get gastrointestinal undesirable effects.
Nervous system disorders Very rare (<1/10,000) | Headache | Respiratory, thoracic and mediastinal disorders Very rare (<1/10,000) | Cold, dyspnoea | Gastrointestinal disorders Very rare (<1/10,000) | Taste alterations, nausea, vomiting, diarrhoea, epigastric pain | Dermatological disorders Very rare (<1/10,000) | Urticaria, erythema, eczema |
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Go to top of the page | 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. | |
Go to top of the page | ATC Code: R 05 CB 15Pharmacotherapeutic Group: Mucolytic Agent | |
Go to top of the page | 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. | |
Go to top of the page | AbsorptionErdosteine 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 age Age does not change the pharmacokinetics of erdosteine.
Binding to plasma proteins The drug binding of erdosteine to plasma proteins is 64.5% (range: 50-86%). | |
Go to top of the page | Preclinical safety data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction. | |
Go to top of the pageGo to top of the page | Capsule content: Microcrystalline cellulosePovidoneMagnesium stearateCapsule shell: GelatinTitanium dioxide (E171)Iron oxide, yellow (E172)Indigotine (E132) | |
Go to top of the pageGo to top of the pageGo to top of the page | Do not store above 25 °C. | |
Go to top of the page | 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. | |
Go to top of the pageGo to top of the page | Edmond Pharma S.r.l.Via G. B. Grassi 1520157 MilanoItaly Representative in the United Kingdom and Ireland: koGEN LimitedSeagoe Industrial EstateCraigavonBT63 5UAUK | |
Go to top of the pageGo to top of the page | UK: 31st October 2006ROI: 13th October 2006 | |
Go to top of the page | UK: 31st October 2006ROI: 13th October 2006 | |
More information about this product
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