MHRA issues defect information notice for Trimogal tablets

The Medicines and Health products Regulatory Agency (MHRA) has issued a class four medicines defect information notice for Trimogal 100mg and 200mg tablets of Ennogen Pharma Limited.

Ennogen has noted that the patient information leaflets (PILs) within the packs of the affected batches contain an error in section three which describes how to take Trimogal tablets with regard to the dosage instructions for children under the age of six.

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How to take Trimogal tablets (Section Three)

Incorrect information in the PILs of the affected batches	Correct information that should be in the PILs
Children aged six 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.	Children under six years: This tablet form of Trimogal is not recommended for use in children under 6 years.

Product Details

MDR Number of the product is MDR 134-07/20 and trimethoprim is the active pharmaceutical ingredient.

Trimogal 100mg Tablets

Batch Number	Expiry Date	Pack Size	First Distributed
1402264	09/2021	28	03/02/2020
1402265	09/2021	28	03/02/2020
1402266	09/2021	28	09/03/2020

Trimogal 200mg Tablets  

Batch Number	Expiry Date	Pack Size	First Distributed
1402171	07/2021	14	02/03/2020
1402262	08/2021	14	02/03/2020
1402263	08/2021	14	12/03/2020

The pharmacists have been adviced to ensure that the correct PIL is issued. The correct PILs are available from the electronic medicines compendium (EMC) website and MHRA portal.