Class 4 Medicines defect information: Trimogal 100mg and 200mg tablets (Ennogen Pharma Limited)

Class 4 Medicines defect information: Trimogal 100mg and 200mg tablets (Ennogen Pharma Limited)

July 20, 2020

Class 4 Medicines Defect Information: Trimogal 100mg and 200mg tablets (Ennogen Pharma Limited)

Drug alert number: EL (20)A/31

Date issued: 20 July 2020

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Class 4 Medicines Defect Information: Trimogal 100mg and 200mg tablets (Ennogen Pharma Limited)

Ennogen Pharma Limited has informed us that the Patient Information Leaflets (PILs) within the packs for the above batches contain an error in Section 3 (How To Take Trimogal Tablets) with
regard to the dosage instructions for children under 6 years.

Section 3 (How To Take Trimogal Tablets)

Incorrect information in the PILs of the affected batches Correct information that should be in the PILs
Children aged 6 months to 6 years*
500mg twice a day (see * below)
*For children a lower strength tablet or a syrup may be more suitable, especially for smaller
children.
Children under 6 years
This tablet form of Trimogal is not
recommended for use in children under 6 years

Trimogal 100mg Tablets (POM) PL 40147/0082

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 (POM) PL 40147/0083

Batch Number Expiry Date Pack Size  First Distributed
1402171 07/2021 148 02/03/2020
1402262 08/2021 148 02/03/2020
1402263 08/2021 148 12/03/2020

Advice for healthcare professionals

When dispensing this medicine from the affected batches listed above, please ensure that the correct PIL is issued.

The correct PILs are available from the electronic medicines compendium (EMC) website by clicking on the links below:

PIL for Trimogal 100mg Tablets

PIL for Trimogal 200mg Tablets

Alternatively the correct PILs are also available from the MHRA website by clicking here.

View full alert here

Further Information

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: Info@Ennogen.com

Tel: 01322 629 220



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