Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, UK
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.
There is no experience for the use of erdosteine in pregnant women.
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.
Uncommon (≥1/1,000 to <1/100): Headache
Uncommon (≥1/1,000 to <1/100): Cold, dyspnoea
Uncommon (≥1/1,000 to <1/100): Taste alterations, nausea, vomiting, diarrhoea
Common (≥1/100 to <1/10): Epigastric pain
Uncommon (≥1/1,000 to <1/100): Angioedema and cutaneous hypersensitivity reactions, such as urticaria, erythema, oedema and eczema
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 Scheme, Website: www.mhra.gov.uk/yellowcard.
Not applicable.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
