Class 4 Medicines Defect Notification: Neuraxpharm UK Limited, Levetiracetam Neuraxpharm granules for oral solution in sachet, EL(26)A/40
Neuraxpharm UK Limited have informed the MHRA that a review of the approved Patient Information Leaflet (PIL) has identified discrepancies between the current Neuraxpharm product safety information and the corresponding reference product information.
DMRC reference number
DMRC- 40741691
Marketing Authorisation Holder
Neuraxpharm UK Limited
Medicine Details
Levetiracetam Neuraxpharm 250mg granules for oral solution in sachet
PL: 49718/0073
Active Ingredient: levetiracetam
SNOMED code: 42426311000001104
GTIN: 5060673110623
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 2153678 | 09/2027 | 60 | 26/03/2026 |
| 2184895 | 02/2028 | 60 | Not yet distributed. |
Levetiracetam Neuraxpharm 500mg granules for oral solution in sachet
PL: 49718/0074
Active Ingredient: levetiracetam
SNOMED code: 42426611000001109
GTIN: 5060673110630
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 2184908 | 02/2028 | 60 | 03/06/2026 |
| 2194807 | 04/2028 | 60 | Not yet distributed. |
Levetiracetam Neuraxpharm 750mg granules for oral solution in sachet
PL: 49718/0075
Active Ingredient: levetiracetam
SNOMED code: 41543411000001107
GTIN: 5060673110647
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 2185161 | 02/2028 | 60 | 29/09/2025 |
| 2194917 | 04/2028 | 60 | 25/09/2025 |
Levetiracetam Neuraxpharm 1000mg granules for oral solution in sachet
PL: 49718/0076
Active Ingredient: levetiracetam
SNOMED code: 42426811000001108
GTIN: 5060673110654
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 231350 | 01/2027 | 60 | 29/05/2024 |
| 2145725 | 05/2027 | 60 | 13/12/2024 |
| 2154064 | 10/2027 | 60 | Not yet distributed. |
| 2204270 | 04/2028 | 60 | Not yet distributed. |
Levetiracetam Neuraxpharm 1500mg granules for oral solution in sachet
PL: 49718/0077
Active Ingredient: levetiracetam
SNOMED code: 41544811000001107
GTIN: 5060673110661
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 231175 | 01/2027 | 60 | 13/12/2024 |
| 231591 | 02/2027 | 60 | 19/08/2026 |
| 2248690 | 06/2029 | 60 | Not yet distributed. |
Background
Neuraxpharm UK Limited have informed the MHRA that a review of the approved Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Levetiracetam Neuraxpharm Granules for Oral Solution in Sachet has identified discrepancies between the current Neuraxpharm product safety information and the corresponding reference product information.
Currently all available stock is impacted. Following discussions between the MHRA and the Department of Health and Social Care, these products have been considered critical for patients who are unable to take tablet formulations and rely on this dosage form. Therefore, the affected batches will continue to be supplied without repackaging and are included in this notification.
A corrected version of the Patient Information Leaflet, containing the required information, is not yet available on the MHRA Products website. Neuraxpharm Limited have confirmed that all packs of Levetiracetam Neuraxpharm Granules for Oral Solution in Sachet distributed from June 2027 will contain an updated and correct PIL.
Advice for Healthcare Professionals:
Healthcare professionals are advised that the current Patient Information Leaflet (PIL) for Levetiracetam Neuraxpharm Granules for Oral Solution in Sachet does not contain all the information included in the corresponding reference product information.
1. Healthcare professionals, including GPs, independent prescribers and specialist prescribers, involved in prescribing Levetiracetam should continue to prescribe and dispense Levetiracetam Neuraxpharm in accordance with the approved product information and manage patients according to their individual clinical circumstances.
Healthcare Professionals should be informed:
- that the approved indication includes use in infants from one month of age.
- of the information relating to very rare SCN8A mutation-associated early-onset epilepsy.
- that there is evidence suggesting a possible predisposition of the Japanese population to neuroleptic malignant syndrome (NMS).
- that obsessive-compulsive disorder (OCD) is a recognised very rare adverse reaction.
- that multiorgan hypersensitivity reactions is a recognised rare adverse reaction.
The following text has been included from other brands of levetiracetam products (reference product) that contain the correct information and indicate what sections will be updated in due course:
- SmPC section 4.4 and PIL section 2: Lack of efficacy or seizure worsening has for example been reported in patients with epilepsy associated with sodium voltage-gated channel alpha subunit 8 (SCN8A) mutations.
- SmPC section 4.8 and PIL section 4: Evidence also suggests a possible predisposition of the Japanese population to neuroleptic malignant syndrome (NMS).
- SmPC section 4.8 and PIL section 4: Very rare cases of development of obsessive-compulsive disorders (OCD) in patients with underlying history of OCD or psychiatric disorders have been observed in post-marketing surveillance.
- SmPC section 4.8: Multiorgan hypersensitivity reactions. Multiorgan hypersensitivity reactions (also known as Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) have been reported rarely in patients treated with levetiracetam. Clinical manifestations may develop 2 to 8 weeks after starting treatment. These reactions are variable in expression, but typically present with fever, rash, facial oedema, lymphadenopathies, haematologic abnormalities and can be associated with the involvement of different organ systems, mostly the liver. If multiorgan hypersensitivity reaction is suspected, levetiracetam should be discontinued.
- The reference product PIL section 1 includes the indication: partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age. By comparison, the PIL for Levetiracetam Neuraxpharm currently states only: partial onset seizures with or without generalisation in adults, adolescents and children.
2.Healthcare professionals involved in dispensing the impacted products, including pharmacy teams are advised to review the information contained within this notification and take this into account when dispensing this product.
a. Where possible, patients should be provided a copy of the supplementary letter detailing the missing information from the PIL with each subsequent dispensing activity. A copy of the supplementary letter can also be found by scanning the below QR code.
b. There is no expectation that patients should be contacted retrospectively, however if patients present with specific symptoms they should be referred to the appropriate healthcare professional.
Additionally, Neuraxpharm Limited will provide a copy of the supplementary letter with each future delivery so that this can be provided to patients directly when the product is dispensed. To request hard copies of the supplementary letter, please contact Medinfo-uk@neuraxpharm.com, or telephone +44 (0) 330 128 0919 with your details, i.e. name, address, required number of supplementary letters.
Advice for Healthcare Professionals to Provide to Patients:
Patients should continue to take medicines from these batches as prescribed by your healthcare professional. The quality of the granules for oral solution in sachets is not affected by this issue.
Patients should contact the relevant healthcare professional if:
Patients should seek medical advice if they experience any unexpected change or worsening in their condition, including an increase in the frequency or severity of seizures.
Very rarely, changes in thoughts or behaviour, including new or worsening obsessive thoughts or repetitive behaviours, may occur. Patients should speak to their healthcare professional if they experience such symptoms.
Patients should seek urgent medical attention if they develop any combination of high temperature, marked muscle stiffness, confusion, reduced consciousness, or changes in blood pressure or heart rate, as these may be signs of a serious reaction known as neuroleptic malignant syndrome.
Patients should also seek urgent medical attention if they develop any combination of fever, skin rash, swelling of the face, swollen lymph nodes, or other unexplained symptoms affecting different parts of the body, particularly within 2 to 8 weeks of starting treatment, as these may indicate a serious hypersensitivity reaction known as DRESS.
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.
Additional information:
For all medical information enquiries and information on this product, please email Medinfo-uk@neuraxpharm.com, or telephone +44 (0) 330 128 0919.
For stock control enquiries please email info-uk@neuraxpharm.com, or telephone +44 (0) 118 211 4039.
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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