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.
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.
