Medicines

Idebenone for Friedreich’s ataxia

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.

Name of medicine

Idebenone

This leaflet is about the use of idebenone for Friedreich’s ataxia.

Why is it important for my child to take idebenone?

Friedreich’s ataxia is an inherited disease that gradually damages parts of the nervous system. This causes problems throughout the body but particularly the heart. Taking idebenone regularly will help to prevent or slow down damage to the heart.

What is idebenone available as?

Tablets: 45 mg

When should I give idebenone

Idebenone is usually given three times a day. This should be first thing in the morning, early afternoon and at bedtime. Ideally, these times are at least 4 hours apart.

How much should I give?

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

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

How should I give idebenone?

Tablets

Tablets should be swallowed with a glass of water, milk 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 yogurt, honey or jam. Make sure your child swallows it all straight away.

Your child should have something to eat when they take the tablets.

When should the medicine start working?

The medicine will start working straight away, although you won’t be able to see the effects. Your doctor will check your child’s heart to see whether idebenone is helping.

What if my child is sick (vomits)?

  • If your child is sick less than 30 minutes after having a dose of idebenone, give them the same dose again.
  • If your child is sick more than 30 minutes after having a dose of idebenone, 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 miss a dose, wait until the next normal dose. Do not give the missed dose.

Never give a double dose of idebenone.

What if I give too much?

If you think you may have given your child too much idebenone, contact your doctor or local NHS services (details at end of leaflet). Have the medicine or packaging with you if you telephone for advice.

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 (temperature above 38°C), sore throat, rash or mouth ulcers, contact your doctor straight away. This is because idebenone may affect the white blood cells (neutropenia), which makes it harder for your child’s body to fight infection.

Other side-effects you need to know about

Your child may get some of the following side effects when they first start taking idebenone. These usually wear off after a few days as your child gets used to the medicine. If they are still a problem after a week, or you are worried, contact your doctor but continue to give idebenone.

  • Your child may get indigestion, stomach ache, feel sick or be sick (vomit). Giving each dose with some food may help.

  • Your child may get diarrhoea.

  • Your child may feel tense, nervous, distressed, restless, worried or on edge.

  • They may have difficulty sleeping (insomnia). You can try giving the medicine earlier in the evening.

  • They may get headaches.

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

More information on side-effects can be found in the following leaflet http://www.medicinesforchildren.org.uk/side-effects-childrens-medicines

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

  • 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.

General advice about medicines

  • Try to give medicines at about the same times each day, to help you remember.
  • 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.
  • If you are not sure a medicine is working, contact your doctor but continue to give the medicine as usual in the meantime. Do not give extra doses, as you may do harm.
  • 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 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 idebenone and about other medicines used to treat Friedreich’s ataxia.

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/

Ataxia UK

0800 995 6037

www.ataxia.org.uk/

Copyright disclaimer

Version [2]. © NPPG, RCPCH and WellChild, all rights reserved. Review by April 2018.

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.