Class 4 Drug Alert (Caution in use): Sanofi-aventis - Surmontil 10 & 25mg Tablets - EL(09)A/02

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Dear Healthcare Professional,

Sanofi-aventis have informed the MHRA that there is an error in the patient information leaflet (PIL) supplied in batches of Surmontil 10 and 25mg tablets which they plan to distribute from today.

The error concerns the tablet description in the PIL for the 10mg tablet which has an imprint stated as “25” whereas it should state “10”. Information for the 25mg tablet is correct and the imprint is correctly stated as “25” for the 25mg tablet.

To ensure continuity of supply distribution of the stock has not ceased and Sanofi-aventis have stated that stock should not be returned for credit.

Sanofi-aventis are trying to resolve this issue as rapidly as possible but we have been informed that full resolution of the problem is not expected before March 2009.

For further enquiries, please telephone Sanofi-aventis Medical Information on 01483 505515.

Recipients of this Drug Alert are requested to bring this to the attention of relevant professionals by copy of this letter. Primary Care Trusts are requested to copy this letter to relevant clinics, General Practitioners and Community Pharmacists.

Yours faithfully
Ian Holloway
MHRA DMRC Manager

MHRA Distribution (further recipients by cascade):

Regional Contacts for NHS Trusts and Provider Units
Chief Pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief Pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special Hospitals
Healthcare Commission for distribution to Independent Health Care Establishments
Primary Care Trusts (England)