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MHRA Guidance on the Treatment of Epilepsy

Following a review by the Commission on Human Medicines (CHM) the Medicines and Healthcare Products Agency (MHRA) has recently issued new guidance to prescribers, pharmacists and patients in relation to anti-epileptic drugs (AEDs).


CHM concluded that whilst there was no clear evidence of harm associated with switching products, an effect in some patients, for some drugs, could not be completely ruled out. The potential effects of switching may include a loss of seizure control or the occurrence of side effects, or both.


AEDs can be categorised dependent upon their therapeutic index, solubility and drug permeability. Three different categories are recognised depending on whether specific measures are advised to help prescribers and patients decide whether it is necessary to maintain continuity of supply of a specific manufacturer’s product (otherwise known as the ‘Marketing Authorisation Holder’).


For further information, you are recommended to refer to the MHRA website ( for the full detail of their guidance, advice for healthcare professionals and information for patients. If you are a patient, it is advised that if you have any concerns, that you raise these with your doctor and pharmacist.


(Category 1) includes phenytoin, carbamazepine, phenobarbital and primidone. For these drugs doctors are advised to ensure that their patient is maintained on a specific manufacturer’s (MAH holder) product.


For drugs included in Category 2, the need for continued supply of a particular manufacturer’s product should be based on clinical judgement and consultation with the patient.  For drugs included in Category 3, the MHRA advises it is usually unnecessary to ensure that patients are maintained on a specific manufacturer’s product unless there are specific concerns.


Flynn Pharma markets the Category 1 AED, phenytoin, and already includes the company name as part of the product name. For example – ‘Sodium Phenytoin Flynn Hard Capsules 100mg’ to assist with identification. All other strengths adopt the same naming style and each is differentiated through the judicious use of design and pack colours. They may also be identified by reference to the MAH or PL number which is printed on the outer carton and the bottle or blister label (300mg only). It is recommended that the full product name be used in prescriptions and/or in requests to dispensing pharmacists for supplies. The product names, strengths, pack sizes and MAH/PL numbers are provided below:


Phenytoin Sodium Flynn 25mg Hard Capsules (28s)                          PL 1362/0061

Phenytoin Sodium Flynn 50mg Hard Capsules (28s)                          PL 1362/0062

Phenytoin Sodium Flynn 100mg Hard Capsules (84s)                        PL 1362/0063

Phenytoin Sodium Flynn 300mg Hard Capsules (28s)                        PL 1362/0064


Flynn Pharma welcomes the new advice and guidance which clarifies an area of uncertainty for many patients, families and healthcare professionals.  Similarly we believe it important that the advice be incorporated into important reference sources used by healthcare professionals and others for product information, wholesaler ordering, stock control and supply, generation of prescriptions and pharmacy dispensary labelling systems.


Should you require further information, please contact Flynn Medical Information on 01438 727 822 or  If you are a patient, and seek further advice, please contact our confidential Helpline (Tel 0800 077 8566. Calls from landlines are free).



20 November 2013

Flynn Pharma

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