Sandoz Ltd. have informed the MHRA that the Patient Information Leaflet included in specified batches of Apixaban does not contain up‑to‑date information.
DMRC Number: DMRC-38614094
Company name:Sandoz Limited
Product description: Apixaban 5mg Tablets
PL: 04416/1608
Active Ingredient: apixaban
SNOMED code: 40640311000001107
Details of the affected batch:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| PS2891 | 30/06/2028 | 56 | 19/01/2026 |
| PT0565 | 30/06/2028 | 56 | 16/01/2026 |
| PT1417 | 31/07/2028 | 56 | 19/01/2026 |
| PU0476 | 31/07/2028 | 56 | 15/01/2026 |
| PU0481 | 31/08/2028 | 56 | 15/01/2026 |
| PV5375 | 31/07/2028 | 28 | Not yet distributed |
| PW1623 | 31/07/2028 | 28 | Not yet distributed |
| PW1624 | 30/04/2028 | 28 | Not yet distributed |
Product description: Apixaban 2.5mg Tablets
PL: 04416/1607
Active Ingredient: apixaban
SNOMED code: 40655511000001108
Details of the affected batch:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| PU1963 | 31/07/2028 | 60 | 15/01/2026 |
| PU3287 | 31/01/2028 | 20 | 15/01/2026 |
| PT4596 | 31/07/2028 | 60 | 15/01/2026 |
| PT2868 | 31/07/2028 | 60 | Not yet distributed |
| PU2604 | 31/07/2028 | 60 | Not yet distributed |
| PU2605 | 31/07/2028 | 60 | Not yet distributed |
| PU2606 | 31/07/2028 | 60 | Not yet distributed |
| PT1722 | 30/11/2027 | 10 | Not yet distributed |
Background information:
Sandoz Ltd. have informed the MHRA that the Patient Information Leaflet (PIL) included in the affected batches of Apixaban does not contain up‑to‑date information relating to:
- The newly authorised paediatric indication (children aged 28 days to <18 years), and
- Updated guidance regarding use following spinal/epidural catheter removal.
The updated PIL wording is shown in Table 1 and will be included in all future manufactured batches.
The batches listed as ‘not yet distributed’ have also been manufactured and packed with the previous PIL version. The MHRA, in discussion with the Department of Health and Social Care, considers these products critical for patients, therefore these batches will not be repackaged and continue to be distributed. They are therefore included in this notification.
All subsequently manufactured batches will include the updated PIL.
Table 1- Summary of the updated safety information missing from the packed PIL:
| PIL Section | New PIL Wording (Actual Text) |
|---|---|
| Section 1 - What is Apixaban used for | “Apixaban is used in children aged 28 days to less than 18 years to treat blood clots and to prevent re-occurrence of blood clots in the veins or in the blood vessels of the lungs. For body weight appropriate recommended dose, see section 3.” |
| Section 2 - What you need to know before you take Apixaban (Warnings and precautions) | “Talk to your doctor, pharmacist or nurse before you take this medicine if you have any of the following: Had a tube (catheter) or an injection into your spinal column (for anaesthesia or pain reduction), your doctor will tell you to take this medicine 5 hours or more after catheter removal.” |
| Section 3 - How to Take Apixaban (Paediatric Dosing) | “Use in children and adolescents… The dose depends on the body weight, and will be calculated by the doctor. Paediatric posology: Two tablets of Apixaban 5 mg twice a day for 7 days, then one tablet twice daily thereafter. Caregivers should observe dosing; scheduled doctor visits may be required to adjust weight-based dose.” |
Advice to Healthcare Professionals:
Be aware of the updated information regarding the use of Apixaban in children aged 28 days to less than 18 years, and administration at least 5 hours after spinal/epidural catheter removal. Inform patients and carers of the approved dosing advice for children or patients with a catheter fitted.
Upon request, Sandoz Limited will provide hard copies of the updated PIL to wholesalers and pharmacies so that any remaining stock can be supplemented with the correct PIL information. To request hard copies of the PIL, please contact sales.sandoz-gb@sandoz.com with your details, i.e. address, product with batch details, required number of leaflets.
The updated PILs for each strength are available via the Electronic Medicines Compendium (eMC).
Apixaban Sandoz 2.5 mg film-coated tablets - Patient Information Leaflet (PIL) 13807
Apixaban Sandoz 5 mg film-coated tablets - Patient Information Leaflet (PIL) 13806
Advice to Patients:
Patients should continue to take Apixaban as prescribed by their healthcare professional. The quality of the tablets is not impacted by the missing information. If patients have questions about these updates, they should speak to their pharmacist, nurse, or doctor.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Company contacts for further information:
For all medical information enquiries and information on this product, please email mi.uk@sandoz.com, or telephone +44 1276 698101.
For stock control enquiries please email sales.sandoz-gb@sandoz.com, or telephone +44 1276 698020.
To access the full recall/alert:
Class 4 Medicines Defect Notification: Sandoz Limited, Apixaban 2.5mg and 5mg Tablets, EL(26)A/17