Ennogen Pharma Limited has informed us that the Patient Information Leaflets (PILs) within the packs for the affected batches below contain an error in Section 3 (How To Take Trimogal Tablets) with regard to the dosage instructions for children under 6 years.
Incorrect information in the PILs of the affected batches:
Children aged 6 months to 6 years: 500mg twice a day. For children a lower strength tablet or a syrup may be more suitable, especially for smaller children.
Correct information that should be in the PILs:
Children under 6 years: This tablet form of Trimogal is not recommended for use in children under 6 years.
For more information or medical information queries, please contact:
Ennogen Pharma Ltd Units G2-G4 Riverside Industrial Estate
Email: [email protected]
Tel: 01322 629 220
Fax: 01322 311 897
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.
NHS England and NHS Improvement Regional Offices are asked to forward this alert to community pharmacy contractors.
Country of origin
Country for notification
Source of the alert
MHRA - Medicines & Healthcare products Regulatory Agency, www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
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