Active ingredient
- idebenone
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/15/1020/001 .
Raxone 150 mg film-coated tablets
Package leaflet: Information for the user
Raxone 150 mg film-coated tablets
idebenone
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Raxone is and what it is used for
2. What you need to know before you take Raxone
3. How to take Raxone
4. Possible side effects
5. How to store Raxone
6. Contents of the pack and other information
1. What Raxone is and what it is used for
Raxone contains a substance called idebenone.
Idebenone is used to treat vision impairment in adults and adolescents with an eye disease called Leber’s Hereditary Optic Neuropathy (LHON).
Treatment with Raxone can restore the ability of cells to produce energy and so allow inactive eye cells to work again. This can lead to some improvement in lost eyesight.
2. What you need to know before you take Raxone
Do not take Raxone
Warnings and precautions
Talk to your doctor or pharmacist before taking Raxone if:
Change in urine colour
Raxone may make your urine become reddish brown. This change in colour is harmless – it does not mean your treatment needs to change. However, the change in colour could mean that you have problems with your kidneys or bladder.
Tests
Your doctor will check your eye-sight before you start taking this medicine and then at regular visits while you are taking it.
Children and adolescents
This medicine should not be used in children This is because it is not known if Raxone is safe or works in patients under 12 years of age.
Other medicines and Raxone
Some medicines may interact with Raxone. Tell your doctor if you are taking, have recently taken or might take any other medicines, especially any of the following:
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines
Raxone is not expected to affect your ability to drive or use machines.
Raxone contains lactose and sunset yellow (E110)
3. How to take Raxone
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
The recommended dose is 2 tablets three times a day - this is a total of 6 tablets per day.
Taking this medicine
If you take more Raxone than you should
If you take more Raxone than you should, talk to your doctor straight away.
If you forget to take Raxone
If you forget a dose, skip the missed dose. Take the next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Raxone
Talk to your doctor before you stop taking this medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effect may happen with this medicine:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Unknown frequency (frequency cannot be estimated from the available data):
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
United Kingdom:
or search for MHRA Yellow Card in the Google Play or Apple App Store.
Ireland:
By reporting side effecs you can help provide more information on the safety of this medicine.
5. How to store Raxone
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the bottle after ‘EXP’. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Raxone contains
What Raxone looks like and contents of the pack
Marketing Authorisation Holder and Manufacturer
This leaflet was last revised in : August 2020
This medicinal product has been authorised under ‘exceptional circumstances’.
This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product.
The European Medicines Agency will review any new information which may become available every year and this leaflet will be updated as necessary.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.
CP0068-3
Chiesi Limited, 333 Styal Road, Manchester, M22 5LG
0800 009 2329
+44 (0)1748 827 271
+44 (0) 161 488 5555