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Getting the same medication every time
Making sure you are prescribed the same version of your anti-epileptic drugs (AEDs) every time is vital in ensuring optimum seizure control.This letter, from our medical director Professor Ley Sander, supports your right to be prescribed the same drugs without switching from branded to generic or between generic drugs.
Phenytoin sodium capsules
A new version of phenytoin sodium capsules are now available from the pharmaceutical company NRIM Limited.
The capsules are available as 100mg capsules only.
As with any anti-epileptic drug, if you are taking phenytoin sodium capsules you may wish to check that you receive the same version (from the same company) with every prescription. This is because different versions of drugs can very in the combination of ingredients which can affect how the active ingredient of the drug is used in the body (called its ‘bioavailability’). Getting the same medication each time is referred to as 'consistency of supply'.
Epilepsy drug link to skin and eye problems
The US Food and Drug Administration (FDA) has issued a drug safety alert around the anti-epileptic drug retigabine (Trobalt) following concerns that the drug may cause blue discoloration in the skin and changes to the retina in the eye after prolonged treatment.
EU regulators have also advised that the drug should only be prescribed when all other anti-epileptic medications have proved inadequate or have not been tolerated .
The European Medicines Agency recommend a comprehensive eye examination should be performed at the start of treatment and at least every six months during treatment. Among 55 patients receiving Trobalt in long-term studies examined so far, 15 had retinal pigmentation, the agency added.
Abnormal colouring of the retina can result in impaired vision.
The drug’s manufacturer, GlaxoSmithKline, is working with regulatory authorities to update this information on the drug’s label. If you are taking this medication and are concerned, it is recommended that you do not suddenly stop taking it, and that you speak to your prescribing doctor about it.
Tegretol Prolonged Release
Some people are currently experiencing problems with their supply of the anti-epileptic drug (AED) Tegretol Prolonged Release .
Novartis Pharmaceuticals UK has advised any pharmacists who are having difficulties with obtaining the AEDs to contact Novartis Customer Care on 0845 419 442 who will arrange for the product to be delivered to the pharmacy on the next working day.
If patients, or carers, have any questions, then they should call Novartis Medical Information on 01276 698370.
Novartis Pharmaceuticals have issued the following statement:
'There is a supply constraint on Tegretol 200mg and 400mg Prolonged Release tablets. We are working closely with the manufacturing plant to improve immediate supply and we expect stock levels to improve considerably over the next two to three weeks. By managing our existing stock tightly, we are able to ensure that we can supply all urgent requests for these products via Novartis Customer Care during this time.'
Pharmaceutical company Eisai, have launched a new anti-epileptic drug. Fycompa® (perampanel) is now available in the UK as an add-on (adjunctive) treatment of focal-onset (partial-onset) seizures, with or without secondarily generalisation, in people with epilepsy aged 12 years and older. Fycompa® is available as once-daily tablets in 2mg, 4mg, 6mg, 8mg, 10mg and 12mg tablets.
Changes to Epanutin (phenytoin) capsules
The following information relates to Epanutin capsules only. It does not apply to Epanutin infatabs or oral suspension – these will not change.
From 24 September phenytoin (current brand name Epanutin) is being transferred from one pharmaceutical company (Pfizer) to another (Flynn Pharma ltd).
The capsules will be called ‘Phenytoin Sodium Flynn’ or (‘Phenytoin Sodium Flynn Hard Capsules’ to give it its full name).
This change means that Epanutin capsules will no longer be produced by Pfizer. However, the pharmaceutical company Flynn Pharma Ltd will be producing phenytoin (also called phenytoin sodium) capsules (although they will not be called Epanutin any more).
What this means
If you take Epanutin (phenytoin) capsules you will still be able to get this medication on prescription. The change just means that the capsules will be available from Flynn pharma under a different name: ‘Phenytoin Sodium Flynn Hard Capsules’.
Will the capsules be the same as Epanutin?
Yes. The new capsules will be exactly the same as Epanutin. The only thing that is changing is the name.
The capsules will not differ in any way: they will contain the same ingredients and be prepared and packaged in the same way. They will also be made in the same manufacturing warehouse. To reassure you that the capsules are the same as Epanutin, they will look the same – the same size and colour, even down to the word ‘Epanutin’ on the capsule itself.
The capsules will be available in all the same sizes as Epanutin: 25mg, 50mg, 100mg and 300mg.
So what is changing?
The bottles and packages that Epanutin comes in will look slightly different once the capsules are produced as ‘Phenytoin Sodium Flynn’. As Pfizer will no longer be selling them, the packaging will not say ‘Epanutin’ on it. So, rather than saying ‘Epanutin capsules Phenytoin sodium’, they will say ‘Phenytoin Sodium Flynn Hard Capsules’
The main changes to the packaging are:
The name of the drug on the bottle or box; and
The name of the drug company (which will say ‘Flynn Pharma Ltd’ instead of ‘Pfizer’).
The packaging will continue to have the recognisable dark and light blue bands on a white background.
To start with, the 25mg, 50mg and 100mg capsules will be available in plastic bottles (the same size and shape as Epanutin). In the future, the plastic bottles will come within a cardboard box. The 300mg capsules will continue to be available in blister packs within a cardboard box.
Epanutin infatabs and oral suspension will continue to be made by Pfizer.
If you currently take Epanutin and you have any questions, you can contact Flynn Pharma’s freephone helpline on 0800 077 8566 (open during office hours, with an answerphone outside of these hours).
18 September 2012
Epistatus - changes to syringes
Emergency medication Epistatus (buccal midazolam), is going through further changes to the syringe. This applies to the version which you draw up from a bottle (it does not apply to the pre-filled syringes).
From September 2012, the 1ml syringes will have a tip with a straight edge (a ‘non-luer’ tip).
This will fit into the hole (the bottle adaptor) in the top of the bottle as before.
The packs containing this new syringe and bottle adaptor will have yellow and black writing on the packaging stating “This pack contains 1ml syringes without luer tip.”
You can continue to use the Epistatus syringe with a narrow end if you currently have that, but they will no longer be produced, to avoid confusion. Always use the syringe with the bottle it comes with.
Whatever type or dose of Epistatus syringe you are using, take care to only draw up the dose the person needs (which is written in their protocol or care plan). For example, if the dose they need is 1ml, draw up the plunger fully to the 1ml mark, rather than rely on the plunger stop.
If you have any queries you can seek advice from your pharmacist.
Zonegran - change in licence
Pharmaceutical company Eisai have announced that their anti-epileptic drug Zonegran (zonisamide) has been given a licence for use as monotherapy. This means that Zonegran can now be used on its own in the treatment of epilepsy.
Zonegran is used for the treatment of focal seizures with or without secondary generalisation.
Tegretol Prolonged Release (used to be called Tegretol Retard)
Novartis is changing the packaging of Tegretol Prolonged Release 200mg and 400mg tablets.
There will be two changes:
the blister strips that the tablets come in are currently rectangular and will become squarer
the outside box is currently rectangular and will become squarer to match the new blister strips. The text that is written on the box will be the same, but it’s position on the box will move.
The packaging is changing but the tablets themselves are not changing and will remain the same.
If you take Tegretol Prolonged Release and you have any queries about this, you can contact the Novartis Medical Information line on 01276 698 370 or firstname.lastname@example.org
Sanofi-Aventis, who produce Epilim, have advised us of a change to the name of Epilim 200mg and 500mg tablets. The current name of 'Epilim enteric coated tablets' is changing to 'Epilim gastro-resistant tablets'. The tablets will still be enteric coated (having a protective coating that protects the tablets until they reach the intestines): it is only the name that is changing (and no change to the tablets themselves).
Changes to Epanutin (phenytoin)
27 March 2012
The bottles that capsules of the drug Epanutin come in will be changing over the next few weeks. The bottles, which are currently rounded will become square bottles with rounded corners.
The new bottles will be coming into circulation in the next few weeks. This only affects Epanutin capsules (of all sizes) – it does not affect Epanutin infatabs or oral suspension.
It is only the packaging that is changing – everything else about the drug is staying the same.
22 December 2011
Epilepsy Society has received a query regarding the packaging of the anti-epileptic drug Topamax (a brand version of topiramate) which is produced by the pharmaceutical company Janssen-Cilag.
We have been in contact with the company who confirm that their drug Topamax should have the words ‘Janssen-Cilag’ on the packaging. This drug comes in a bottle.
If the packaging does not have the word Janssen-Cilag on it, or has any other manufacturer or company name on it, it may be that this drug is a parallel import (where it has been sold in another country and brought into the UK). This is also the case if the drugs are in a blister pack rather than in a bottle. Although parallel imports should be identical to drugs sold within the UK, if you are concerned about this, you can ask the pharmacist to give you a supply from within the UK. For this reason, it is worth checking the packaging before you leave the pharmacists or chemists.
If you are given Topamax that is in a different packaging than usual, or you have any concerns about what you have been prescribed or dispensed, you may like to talk to your prescribing doctor or the pharmacist about it.
Please note that this information only relates to the brand version of topiramate called Topamax. There are also generic versions of the drug topiramate available.
Keppra / levetiracetam update
30 September 2011
The anti-epileptic drug Keppra (levetiracetam) made by pharmaceutical company UCB,
has recently come off patent and generic versions of levetiracetam are starting to become available. Although UCB continue to manufacture all strengths and formulations of Keppra, other companies are also able to manufacture and supply levetiracetam to pharmacies as a generic version.
Generic versions of drugs can often become available at a cheaper cost than branded versions because the manufacturer does not have to recover the costs of developing the drug. However, once the generic version becomes available, the manufacturer of the branded version may reduce their price so that it is similar to the generic version. This tends to be standard practice when a drug comes off patent.
Epilepsy Society understands how important it is for people with epilepsy to have the same version of their anti-epileptic medication with each prescription, and a consistent supply from the same manufacturer. This does not mean that a brand version is better than a generic version: the active ingredient is the same so one is not necessarily better than the other. Sticking to the version you usually have that suits you, whether it is a brand or a generic version, means there is less chance of you having side effects or possible seizures.
Epilepsy Society encourages people who write prescriptions for anti-epileptic drugs, especially GPs, to make sure patients receive a supply of their usual anti-epileptic medication from the same manufacturer. You may want to check with your GP that the correct version is written on your prescription for AEDs.
28 September 2011
Keppra is now off patent – this is effective from 30 September 2010. There are several patents, but the last important one ended on 30 September 2011.
Once a drug comes off patent, other manufacturing companies can submit dossiers to make generic versions. The first known generic version in the UK was given a licence for production on 27 July 2011, and available now. It is manufactured by Consilient Health.
There has been no change in Keppra’s licence and all generics will be under the same licence. If people wish to contact UCB, their medical information team number is 01753 534 655.
Buccolam given european approval
8 Sep 2011
Emergency seizure drug Buccolam which is used to treat prolonged convulsive seizures has been given European approval for the treatment of babies over three months old and children under the age of 18.
ViroPharma produces the oral midazolam treatment in a liquid form. It comes in age-specific doses and is used to treat children with epilepsy who have prolonged convulsive seizures that may progress to status epilepticus, known as status. The drug, which is placed between the cheek and gums, has been shown in four clinical studies to be either comparable or superior to the current standard treatment, the suppository diazepam.
There are other versions of buccal midazolam available, but these are not currently licensed.