20.07.2020

Trimogal - trimethoprim - Ennogen Pharma Limited

Threat

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.

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Source of the alert

MHRA

The risk concerns products
Recommendations for consumers
Section 3 (How To Take Trimogal Tablets)

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

Riverside Way

Dartford

Kent

DA1 5BS

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.


Alert details

Country of origin

-

Country for notification

United Kingdom

Category

Pharmaceuticals

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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