Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Raxone 150 mg film-coated tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Idebenone may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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).
- This eye problem is inherited – this means it runs in families.
- It is caused by a problem with your genes (called a "genetic mutation") that affects the ability of cells in the eye to produce the energy they need to work normally, so they become inactive.
- LHON can lead to loss of eyesight due to the inactivity of cells responsible for vision. 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 it
e Raxone Do not take Raxone
- if you are allergic to idebenone or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before taking Raxone if:
- you have any blood, liver or kidney problems. 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.
- Tell your doctor if your urine changes colour.
- He or she may do a urine check to make sure the change in colour is not hiding other problems. 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:
- antihistamines to treat allergies (astemizole, terfenadine)
- to treat heartburn (cisapride)
- to treat muscle and speech tics associated with Tourette syndrome (pimozide)
- to treat heart rhythm disorders (quinidine)
- to treat migraine (dihydroergotamine, ergotamine)
- to put you to sleep called "anaesthetics" (alfentanil)
- to treat inflammation in rheumatoid arthritis and psoriasis (cyclosporine)
- to prevent the rejection of an organ transplant (sirolimus, tacrolimus)
- to treat strong pain called "opioids" (fentanyl) 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.
- Your doctor will prescribe Raxone to you only if the benefits of the treatment are greater than the risks to the unborn child.
- Raxone may pass into the mother's milk. If you are breastfeeding your doctor will discuss with you whether to stop breast-feeding or to stop taking the medicine. This will take into account the benefit of breast-feeding to the child and the benefit of the medicine for you. Driving and using machines Raxone is not expected to affect your ability to drive or use machines. Raxone contains lactose and sunset yellow (E110)
- If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
- Raxone contains a colourant called "sunset yellow" (also called E110). This may cause allergic reactions.
3. H ow 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
- Take the tablets with food – this helps to get more of the medicine from your stomach into your blood.
- Swallow the tablets whole with a glass of liquid.
- Do not crush or chew the tablets.
- Take the tablets at the same time of day each day. For example in the morning at breakfast, with lunch at mid-day and with dinner in the evening. 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):
- nasopharyngitis (cold)
- cough Common (may affect up to 1 in 10 people):
- diarrhoea (mild to moderate that usually does not require discontinuation of treatment)
- back pain Unknown frequency (frequency cannot be estimated from the available data):
- bronchitis
- changes in blood test results: low level of white blood cells, or low level of red blood cells, or low level of platelets
- increased cholesterol or fat in the blood -shown in tests
- fits, feeling confused, seeing or hearing things that are not real (hallucinations), feeling excited, movements that you cannot control, a tendency to wander away, feeling dizzy, headache, feeling restless, dazed and unable to act or think normally
- nausea, vomiting, loss of appetite, indigestion
- high levels of some liver enzymes in the body which mean you have liver problems – shown in tests, high levels of "bilirubin" – this can make your skin and the whites of your eyes look yellow, hepatitis
- rash, itching
- pain in extremity
- high levels of nitrogen in the blood – shown in tests change in urine colour
- generally feeling unwell 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store By reporting side effects you can help provide more information on the safety of this medicine.
5. H ow 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
- The active substance is idebenone. Each film-coated tablet contains 150 mg of idebenone.
- The other ingredients are: Tablet core: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, povidone K25, magnesium stearate and silica colloidal anhydrous. Tablet film-coating: macrogol, poly(vinyl alcohol), talc, titanium dioxide, sunset yellow (E110). What Raxone looks like and contents of the pack
- Raxone film-coated tablets are orange, round tablets of 10 mm diameter, engraved with '150' on one side.
- Raxone is supplied in white plastic bottles. Each bottle contains 180 tablets.
Marketing Authorisation Holder Chiesi Limited 333 Styal Road Manchester M22 5LG United Kingdom Manufacturer Excella GmbH & Co. KG Nürnberger Strasse 12 90537 Feucht Germany Is this leaflet hard to see or read? Phone 0161 488 5555 for help. This leaflet was last revised in 03/2024 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.
CP0078-2
Frequently asked questions about Raxone 150 mg film-coated tablets
How do I take Raxone 150 mg film-coated tablets?
Raxone 150 mg film-coated tablets comes as tablet containing 150mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Raxone 150 mg film-coated tablets?
The active substance in Raxone 150 mg film-coated tablets is idebenone.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Raxone 150 mg film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Raxone 150 mg film-coated tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: idebenone
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber's Hereditary Optic Neuropathy (LHON) (see section 5.1).
4.2. Posology and method of administration
Posology
The recommended dose is 900 mg/day idebenone (300 mg, 3 times a day).
Data regarding continuous treatment with idebenone for up to 24 months are available as part of a Natural History controlled open label clinical trial (see section 5.1).
Special populations
Elderly
No specific dose adjustment is required for the treatment of LHON in elderly patients.
Hepatic or renal impairment
Patients with hepatic or renal impairment have been investigated. However, no specific posology recommendations can be made. Caution is advised in treatment of patients with hepatic or renal impairment, since adverse events have resulted in temporary interruption or discontinuation of treatment (see section 4.4).
In the absence of sufficient clinical data, caution should be exercised in patients with renal impairment.
Paediatric population
The safety and efficacy of Raxone in LHON patients under 12 years of age have not yet been established. Currently available data are described in sections 5.1 and 5.2, but no recommendation on posology can be made.
Method of administration
Raxone film-coated tablets should be swallowed whole with water. The tablets should not be broken or chewed. Raxone should be administered with food because food increases the bioavailability of idebenone.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Monitoring
Patients should be regularly monitored according to local clinical practice.
Hepatic or renal impairment
Caution should be exercised when prescribing Raxone to patients with hepatic or renal impairment. Adverse events have been reported in patients with hepatic impairment, which have resulted in temporary interruption or discontinuation of treatment.
Chromaturia
The metabolites of idebenone are coloured and may cause chromaturia, i.e. a reddish-brown discoloration of the urine. This effect is harmless, not associated with haematuria, and does not require any adaptation of dose or discontinuation of treatment.
Caution should be exercised to ensure that the chromaturia does not mask changes of colour due to other reasons (e.g. renal or blood disorders).
Lactose
Raxone contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take Raxone.
Sunset yellow
Raxone contains sunset yellow (E110) which may cause allergic reactions.
4.5. Interaction with other medicinal products and other forms of interaction
Data from in vitro studies have demonstrated that idebenone and its metabolite QS10 do not exert systemic inhibition of cytochrome P450 isoforms CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4 at clinically relevant concentrations of idebenone or QS10. In addition, no induction of CYP1A2, CYP2B6 or CYP3A4 was observed.
In vivo idebenone is a mild inhibitor of CYP3A4. Data from a drug-drug interaction study in 32 healthy volunteers indicate that on the first day of oral administration of 300 mg idebenone t.i.d., the metabolism of midazolam, a CYP3A4 substrate, was not modified when both medicinal products were administered together. After repeated administration Cmax and AUC of midazolam were increased by 28% and 34%, respectively, when midazolam was administered in combination with 300 mg idebenone t.i.d. Therefore, CYP3A4 substrates known to have a narrow therapeutic index such as alfentanil, astemizole, terfenadine, cisapride, cyclosporine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, or ergot alkaloids (ergotamine, dihydroergotamine) should be administered with caution in patients receiving idebenone.
Idebenone may inhibit P-glycoprotein (P-gp) with possible exposure increases of, e.g., dabigatran etexilate, digoxin or aliskiren. These medicines should be administered with caution in patients receiving idebenone. Idebenone is not a substrate for P-gp in vitro.
4.6. Fertility, pregnancy and lactation
Pregnancy
The safety of idebenone in pregnant women has not been established. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Idebenone should only be administered to pregnant women or women of child-bearing potential likely to become pregnant if it is considered that the benefit of the therapeutic effect outweighs any potential risk.
Breast-feeding
Available pharmacodynamic/toxicological data in animals have shown excretion of idebenone in milk (for details see 5.3). A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Raxone therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility
There are no data concerning the effect of exposure to idebenone on human fertility.
4.7. Effects on ability to drive and use machines
Raxone has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The most commonly reported adverse reactions to idebenone are mild to moderate diarrhoea (usually not requiring the discontinuation of the treatment), nasopharyngitis, cough and back pain.
Tabulated list of adverse reactions
The following adverse reactions emerging from clinical trials in LHON patients or reported post-marketing in other indications are tabulated below. Frequency groupings are defined to the following convention: very common (≥1/10), common (≥1/100 to <1/10), not known (cannot be estimated from the available data).
System Organ Class
Preferred Term
Frequency
Infections and Infestations
Nasopharyngitis
Very common
Bronchitis
Not known
Blood and lymphatic system disorders
Agranulocytosis, anaemia, leukocytopenia, thrombocytopenia, neutropenia
Not known
Metabolism and nutrition disorders
Blood cholesterol increased, blood triglycerides increased
Not known
Nervous system disorders
Seizure, delirium, hallucinations, agitation, dyskinesia, hyperkinesia, poriomania, dizziness, headache, restlessness, stupor
Not known
Respiratory, thoracic and mediastinal disorders
Cough
Very common
Gastrointestinal disorders
Diarrhoea
Common
Nausea, vomiting, anorexia, dyspepsia
Not known
Hepatobiliary disorders
Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, blood bilirubin increased, hepatitis
Not known
Skin and subcutaneous tissue disorders
Rash, pruritus
Not known
Musculoskeletal and connective tissue disorders
Back pain
Common
Pain in extremity
Not known
Renal and urinary disorders
Azotaemia, chromaturia
Not known
General disorders and administration site conditions
Malaise
Not known
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
No report of overdose has been received from the RHODOS, the LEROS and the PAROS studies. Doses up to 2,250 mg/day have been administered in clinical studies showing a safety profile consistent with that reported in section 4.8.
There is no specific antidote for idebenone. When needed, supportive symptomatic treatment should be given.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- RAXONE 150 mg prescriptionIDEBENONUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- RaxoneIdebenonum · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Raxone 150 mg film-coated tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.