Prescribing information
Summary of product characteristics
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Patient information leaflet
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Abbreviated prescribing information
Erdotin® 300mg Capsules▼
Please refer to the Summary of Product Characteristics (SPC) before prescribing Erdotin® 300mg Capsules.
Presentation: Green and yellow capsules each containing 300mg of erdosteine.
Indications: For the symptomatic treatment of acute exacerbations of chronic bronchitis in adults. As an expectorant.
Dosage and administration: Elderly and adults over 18 years:
300mg twice daily for a maximum of ten days. Capsules should be swallowed whole with a glass of water.
Contra-indications: Hypersensitivity to erdosteine or any other component of the product; severe liver failure; renal impairment (creatinine clearance <25ml/min). Patients with active peptic ulcer.
Warnings and precautions: Patients with mild liver failure should not exceed a dose of 300mg per day.
Interactions: No adverse interactions have been reported.
Pregnancy and lactation: Not recommended.
Effects on ability to drive and use machines: Erdotin® has minor or negligible influence on the ability to drive and use machines.
Undesirable effects: <1/1,000 can expect to suffer from gastrointestinal undesirable effects. Very rare (<1/10,000): headache, cold, dyspnoea, taste alterations, nausea, vomiting, diarrhoea, epigastric pain, urticaria, erythema, eczema.
Overdose: Refer to SPC.
Legal category: POM, subject to medical prescription.
Basic NHS cost: £5.00 per 20 capsules blister pack.
MA Number: PL 14682/0012.
Product Authorisation Number: PA 1325/1/1.
Price (ROI): €8.80.
MA Holder: Edmond Pharma S.r.l., Via G.B. Grassi 15, 20157 Milano, Italy.
Full prescribing information available from:
UK – Galen Limited, Seagoe Industrial Estate, Craigavon, Northern
Ireland, BT63 5UA;
ROI – Galen Limited, c/o Allphar Services, Belgard Road, Tallaght, Dublin 24, Ireland.
Date of preparation: December 2006
UK – Medical information enquiries and adverse event reports should be directed to Galen Limited on 028 38334974 or info@galen.co.uk. Information about adverse event reporting can also be found at www.yellowcard.gov.uk
Republic of Ireland – Medical information enquiries and adverse event reports should be directed to Galen Limited on 048 38334974 or info@galen.co.uk. Information about adverse event reporting can be found at www.imb.ie (pharmacovigilance).
