Medicines

Rufinamide for preventing seizures

This leaflet is for parents and carers about how to use this medicine in children. Our information may differ from that provided by the manufacturers, because their information usually relates to adults. Read this leaflet carefully. Keep it somewhere safe so that you can read it again.

Do not stop giving Rufinamide suddenly, as your child may have more seizures.

Name of medicine

Rufinamide

Brand name: Inovelon

Why is it important for my child to take Rufinamide?

It is important that your child takes Rufinamide regularly so that they have fewer seizures.

What is Rufinamide available as?

  • Tablets: 100mg, 200mg, 400 mg
  • Liquid medicine: 200 mg in 5 mL

When should I give Rufinamide

The Rufinamide is usually given twice each day. Give one dose in the morning and one in the evening. Ideally these times are 10–12 hours apart. For example, this could be between 7am and 8am and between 7pm and 8pm.

Give the medicine at about the same time(s) each day so that this becomes part of your child’s daily routine, which will help you to remember.

How much should I give?

Your doctor will work out the amount of Rufinamide (the dose) that is right for your child. The dose will be shown on the medicine label.

When you first start giving Rufinamide to your child, you will probably give them a low dose, which may be increased bit by bit over a few days or weeks. This helps your child to get used to the medicine. Your doctor will explain what to do.

It is important that you follow your doctor’s instructions about how much to give.

How should I give Rufinamide?

Tablets

  • Tablets should be swallowed with a glass of water, squash, or juice. Your child should not chew the tablets. You can crush the tablet and mix it with a small amount of soft food such as yoghurt, honey, or mashed potato. Make sure your child swallows it straight away without chewing.
  • You can crush the tablet and dissolve it in water, squash, or fruit juice. Your doctor will have told you how much liquid to use, and how much of it to give your child. Give the right amount of mixture to your child straight away, using an oral syringe or medicine spoon.

Liquid medicine

  • Shake the medicine well. Measure out the right amount using an oral syringe or a medicine spoon. You can get these from your pharmacist. Do not use a kitchen teaspoon as it will not give the right amount.

When should the medicine start working?

It may take a few weeks for Rufinamide to work properly, so your child may still have their symptoms for a while. Continue to give the medicine as you have been told to by your doctor.

What if my child is sick (vomits)?

  • If your child is sick less than 30 minutes after having a dose of Rufinamide, give them the same dose again.
  • If your child is sick more than 30 minutes after having a dose of Rufinamide, do not give them another dose. Wait until the next normal dose.

If your child is sick again, seek advice from your family doctor, nurse, pharmacist, or hospital. They will decide what to do based on your child’s condition and the specific medicine involved.

What if I forget to give it?

If you usually give it twice a day: If you remember up to 4 hours after you should have given a dose, give your child the missed dose. For example, if you usually give a dose at about 7am, you can give the missed dose at any time up to 11am. If you remember after that time, do not give the missed dose. Give the next dose as usual.

Never give a double dose of Rufinamide.

What if I give too much?

If you think you may have given your child too much Rufinamide, contact your doctor or local NHS services (details at end of leaflet) or take your child to hospital. Have the medicine container or packaging with you, even if it is empty. This will be useful to the doctor.

Are there any possible side effects?

We use medicines to make our children better, but sometimes they have other effects that we don’t want (side effects).

Side effects you must do something about

If your child gets a fever (high temperature) in the first 2 or 3 weeks of starting Rufinamide, they may be reacting to the medicine. Contact your doctor straight away.

Other side-effects you need to know about

The following side-effects should get better after 2–3 weeks as your child’s body gets used to the medicine. If they don’t, contact your doctor for advice but continue to give the medicine as usual.

  • Your child may feel sick (nausea) or be sick (vomit).

  • Your child may have a headache or feel dizzy, tired (lethargic) or sleepy (drowsy).

There may sometimes be other side effects that are not listed above. If you notice anything unusual and are concerned, contact your doctor. You can report any suspected side effects to a UK safety scheme at www.mhra.gov.uk/yellowcard

Can other medicines be given at the same time as Rufinamide?

  • You can give your child medicines that contain paracetamol or ibuprofen, unless your doctor has told you not to.
  • Check with your doctor or pharmacist before giving any other medicines to your child. This includes herbal and complementary medicines.

Epilepsy and pregnancy

  • Pregnancy presents a risk to both the mother with epilepsy and her unborn baby. If your daughter has sex, it is essential that she uses adequate contraception to prevent an unplanned pregnancy.
  • If your daughter thinks that she may be pregnant, it is important that she sees her doctor as early as possible. Your daughter should keep taking her medication until she sees her doctor.

Rufinamide and pregnancy

  • Doctors don’t yet know whether rufinamide can harm an unborn baby.
  • The oral contraceptive pill can be used safely in women or girls who are taking rufinamide.

Is there anything else I need to know about this medicine?

  • Your doctor may need to reduce the dose of phenytoin if your child is taking this when they start to take rufinamide.
  • Your doctor may need to reduce the dose of rufinamide if your child starts to take sodium valproate.

General advice about medicines

Advice about medicines for seizures

  • If your doctor decides to stop a particular medicine, they will discuss this with you. They will usually reduce the dose bit by bit.
  • It is best that your child always has the same brand of each medicine, as there may be differences between brands. Keep a record of which medicines your child has.
  • Try to give medicines at about the same times each day, to help you remember.
  • Make sure that you always have enough medicine. Order a new prescription at least 2 weeks before you will run out.
  • Make sure that the medicines you have at home have not reached the ‘best before’ or ‘use by’ date on the packaging. Give old medicines to your pharmacist to dispose of.
  • If your child seems to have more seizures than usual, contact your doctor or your epilepsy nurse.
  • Only give this medicine to your child. Never give it to anyone else, even if their condition appears to be the same, as this could do harm.

Do not suddenly stop giving any medicines for seizures to your child. If you are worried, contact your doctor but carry on giving the medicine to your child as usual.

Do not change the dose of any medicine without talking to your doctor first.

If you think someone else may have taken the medicine by accident, contact your doctor straight away.

Where should I keep this medicine?

  • Keep the medicine in a cupboard, away from heat and direct sunlight.
  • It does not need to be kept in the fridge.
  • Make sure that children cannot see or reach the medicine.
  • Keep the medicine in the container it came in.

Who to contact for more information?

Your child’s doctor, pharmacist or nurse will be able to give you more information about Rufinamide and about other medicines used to treat epilepsy.

England: NHS 111

Tel 111

www.nhs.uk

Scotland: NHS 24

Northern Ireland: NI Direct

Wales: NHS Direct

Tel 111 (free) or 0845 46 47 (2p per minute)

111.wales.nhs.uk/

Epilepsy Action

0808 800 5050

www.epilepsy.org.uk

Epilepsy Society

Young Epilepsy

Copyright disclaimer

Version [2]. © NPPG, RCPCH and WellChild, all rights reserved. Review by January 2017.

The primary source for the information in this leaflet is the British National Formulary for Children. For details on any other sources used for this leaflet, please contact us through our website, www.medicinesforchildren.org.uk.

We take great care to make sure that the information in this leaflet is correct and up-to-date. However, medicines can be used in different ways for different patients. It is important that you ask the advice of your doctor or pharmacist if you are not sure about something. This leaflet is about the use of these medicines in the UK, and may not apply to other countries. The Royal College of Paediatrics and Child Health (RCPCH), the Neonatal and Paediatric Pharmacists Group (NPPG), WellChild and the contributors and editors cannot be held responsible for the accuracy of information, omissions of information, or any actions that may be taken as a consequence of reading this leaflet.