Intended for UK patients and members of the public
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintProduct Documentation
Last updated on this site: 05 Feb 2026
IB C.I.3.a: To update sections 4.2, 4.4, 4.8, 4.9 of the SmPC in line with MHRA recommendation. Consequently, the PIL and labels are updated.
IB C.I.3.z: To update SmPC sections 4.4 and 4.8 in line with PRAC recommendation (PSUSA/00001499/202502) - for causal relationship between gabapentin and withdrawal reactions following dose reduction, and exacerbation of myasthenia gravis. Consequently, the PIL is updated.
In addition, to make formatting updates to sections 4.2, 4.8 and 4.9 of the SmPC and to make editorial and QRD updates to the PIL.
Date of approval: 16/01/2026
SmPC sections updated: 4.2, 4.4, 4.8, 4.9 and 10
Last updated on this site: 05 Feb 2026
IB C.I.3.a: To update sections 4.2, 4.4, 4.8, 4.9 of the SmPC in line with MHRA recommendation. Consequently, the PIL and labels are updated.
IB C.I.3.z: To update SmPC sections 4.4 and 4.8 in line with PRAC recommendation (PSUSA/00001499/202502) - for causal relationship between gabapentin and withdrawal reactions following dose reduction, and exacerbation of myasthenia gravis. Consequently, the PIL is updated.
In addition, to make formatting updates to sections 4.2, 4.8 and 4.9 of the SmPC and to make editorial and QRD updates to the PIL.
Date of approval: 16/01/2026
PIL sections updated: Headline, 1, 2, 3, 4, 5 and 6
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintFor any further assistance, please get in touch.