Class 4 Medicines Defect Information: Ennogen Pharma Limited, Trimogal 100mg and 200mg Tablets, EL (20)A/31
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.
MDR Number
MDR 134-07/20
Company Name
Ennogen Pharma Limited
Product description
Trimogal 100mg Tablets (POM)
| 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)
| 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 |
Active pharmaceutical ingredient: trimethoprim
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.
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.
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
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.
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