Access to Product Information for Anticonvulsant Medicines Authorised in Ireland

*The active substance is the main ingredient contained in every medicine. For example, the active substance in Epilim is sodium valproate. The active substance in every medicine is listed on the outer packaging and in the package leaflet (PL), usually under the brand name.

Active Substance*Brands available in Ireland include:Product Information** available from HPRA or EMA website
Carbamazepine Tegretol – Carbamazepine EssentialHPRA
Clobazam           Clobazam – Frisium
Thame – Epaclob – Perizam  
Clonazepam        -Clonazepam Rosemont -RivotrilHPRA
Ethosuximide      -ZarontinHPRA
Gabapentin         Gabapentin -Gabapentin Rosemont -Gabin -Neurontin -NeurotilHPRA
Lacosamide         Lacosamide Accord -Lacosamide Krka -Lacosamide UCB -Vimpat  EMA
Lamotrigine        -Lamictal -Lamoro -Larig  HPRA
Levetiracetam          Keppra -Levetiracetam Accord -Levetiracetam Actavis -Levetiracetam Bluefish -Levetiracetam Brillpharm -Levetiracetam Clonmel -Levetiracetam Ratiopharm -Levetiracetam Sun -Levetiracetam Teva -Levetiracetam Thame -Levetiracetam Wockhardt -Matever  EMA (Keppra, Levetiracetam Accord, Levetiracetam Actavis, Levetiracetam Ratiopharm, Sun, Teva, Matever)   HPRA (Levetiracetam Bluefish, Levetiracetam Brillpharm, Levetiracetam Clonmel, Levetiracetam Wockhardt)  
Oxcarbazepine    TrileptalHPRA
Phenytoin           EpanutinHPRA
Phenobarbital                       PhenobarbitalHPRA
Pregabalin              Brieka -Lyrica -Mypreg -Pregablin -Pregablin Accord – Pregablin Clonmel – Pregablin Krka – Pregablin Mylan – Pregablin Pfizer – Pregablin Sandoz – Pregablin Sandoz GmbH – Pregablin Teva – Pregablin Wockhardt – Pregablin Zentiva  HPRA Brieka, Mypreg, Pregablin, Pregablin Clonmel, Pregablin Krka, Pregablin Teva, Pregablin Wockhardt       EMA Lyrica, Pregablin Accord, Pregablin Mylan, Pregablin Pfizer, Pregablin Sandoz, Pregablin Sandoz GmbH, Pregablin Zentiva    
Primidone           MysolineHPRA
Rufinamide         InovelonEMA
Sodium ValproateEpilimHPRA
Tiagabine            GabitrilHPRA
Topiramate         TopamaxHPRA
Vigabatrin           Kigabeq -SabrilEMA (Kigabeq) HPRA (Sabril)
Zonisamide  Zonegran -Zonisamide MylanEMA

**Product information for a medicine is made up of the Summary of Product Characteristics (SmPC) and Package Leaflet (PL). These documents are issued when a medicine is first licensed for use and are reviewed and updated as necessary throughout the lifetime of a medicine, to reflect the current knowledge about a medicine and risks associated with its use. The Summary Product Information (SmPC) is mainly intended for use by healthcare professionals and the Patient Information Leaflet (PIL) has more comprehensive information presented in an abbreviated and easy to read format for patients.

Educational Materials are one of the measures used to describe safety concerns about a medicines to healthcare professionals and patients. The materials focus on one or more specific safety concern related to use of the medicine. They provide information on specific risks and actions required to minimise/prevent such risks. Examples of educational materials for healthcare professionals include dosing and administration guides, prescriber checklists etc. Examples of such materials for patients include patient alert cards, patient guides and patient reminder cards.

Educational materials for valproate are accessible via the link below. At present, there are no educational materials in place for any of the other currently authorised anticonvulsant medicines.

Searching for product information/educational materials on the HPRA website

SmPCs, PLs and educational materials (if available) for medicines currently authorised in Ireland are accessible via the HPRA website. Please follow the following instructions:

  • Go to the HPRA website
  • Use the ‘Find a medicine’ search function on the homepage (See Figure 1 below)
  • Type in the medicine name (brand name or active substance) where it says ‘Enter a Trade Name, Active Substance or Licence Number’ and press enter
  • All the results will be listed and the product information (and educational materials if relevant) are listed on the right hand side under ‘Documents’. Click on ‘SPC’ or ‘PIL’ and the documents will open as a PDF document.
  • Please see figure below.

Figure 1 – Search function on HPRA website

Searching for product information on the EMA website

Product information for medicines authorised via the centralised application procedure, co-ordinated by the European Medicines Agency (EMA) is available on the EMA website. If you search for a medicine on the HPRA website as per above, when you click on SPC or PIL under ‘Documents’, you will automatically be transferred to the EMA website for such products.

  • Once on the EMA website (, search for the medicine using the search box available (See figure 2 below)
  • Click on the Human medicine European public assessment report (EPAR) for the medicine you wish to access product information for
  • Click on product information under the ‘Table of Contents’
  • Click on ‘EPAR – Product Information’ to open a PDF document of the SmPC and PIL.

Figure 2 – Search function on EMA website

It is very important that you do NOT STOP taking you medication without speaking to your Health Care Professional.