150 mg film-coated tablets
idebenone
What Raxone is and what it is used for
Raxone contains a substance called idebenone.
Idebenone is used to treat impaired vision in adults and adolescents with an eye disease called Leber’s hereditary optic neuropathy (LHON).
- This eye problem is hereditary – meaning that several people in the same family or relatives may have the same problem.
- It is caused by a problem with your genes (a so-called “genetic mutation”) that affects the ability of the cells in the eye to produce the energy they need to function normally, which makes them inactive.
- LHON can lead to loss of vision due to the inactivity of the cells responsible for vision.
Treatment with Raxone can restore the cells’ ability to produce energy and thus make inactive eye cells function again. This can lead to some improvement in lost vision.
What you need to know before you take 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 cautions
Talk to your doctor or pharmacist before taking Raxone
- Do you have any blood, liver, or kidney problems?
Change in urine color
Raxone may cause the color of the urine to turn reddish-brown. This color change is harmless – it does not mean that your treatment needs to be changed. However, the color change can mean that you have problems with your kidneys or your bladder.
- Tell your doctor if your urine changes color.
- He or she may need to take a urine sample to ensure that the color change does not obscure other problems.
Sampling
Your doctor will check your vision before you start taking this medicine and then at regular visits while you are taking it.
Children and young people
This medicine should not be given to children. It is not known whether Raxone is safe or effective in patients under 12 years of age.
Other medicines and Raxone
Some medicines may affect or be affected by Raxone. Tell your doctor if you are taking, have recently taken, or might take any other medicines, especially any of the following:
- antihistamines for the treatment of allergies (astemizole, terfenadine)
- drugs for the treatment of heartburn (cisapride)
- drugs for the treatment of muscle and voice tics associated with Tourette’s syndrome (pimozide)
- drugs for the treatment of cardiac arrhythmias ( quinidine )
- drugs for the treatment of migraine (dihydroergotamine, ergotamine )
- drugs that make you fall asleep, so-called “anesthetics” (alfentanil)
- drugs for the treatment of inflammation in rheumatoid arthritis and psoriasis (cyclosporine)
- drugs that prevent the rejection of transplanted organs (sirolimus, tacrolimus)
- drugs for the treatment of severe pain, so-called “opioids” ( fentanyl )
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
- Your doctor will only prescribe Raxone to you if the benefits of the treatment outweigh the risks to the unborn baby.
- Raxone can pass into breast milk. If you are breastfeeding, your doctor will discuss with you whether you should stop breastfeeding or stop taking the medicine. This discussion will consider the benefit of breastfeeding for the baby and the benefit of the medicine for you.
Driving and using machines
Raxone is not expected to affect the ability to drive or use machines.
Raxone contains lactose and para-orange (E110)
- Raxone contains lactose (a sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
- Raxone contains a dye called “para-orange” (also called E110). It can cause allergic reactions.
How to take Raxone
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Recommended dose
The recommended dose is two tablets three times a day – a total of six tablets per day.
Taking this medicine
- Take the tablets with food. In this way, more drugs are taken up in the stomach and end up in your blood.
- Swallow the tablets whole along with a glass of liquid.
- Do not divide or chew the tablets.
- Take the tablets at the same time each day. For example, in the morning for breakfast, at lunchtime in the middle of the day, and with the food in the evening.
If you take more Raxone than you should
If you take more Raxone than you should, contact a doctor immediately.
If you forget to take Raxone
If you have missed a dose, do not take 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
Contact a doctor before stopping the medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur 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):
- diarrhea (mild to moderate which usually does not require discontinuation of treatment)
- back pain.
No known frequency (can not be calculated from the available data):
- bronchitis
- changes in blood test results: low levels of white blood cells, or low levels of red blood cells, or low levels of platelets
- elevated cholesterol or fat content in the blood – shown in blood tests
- seizures, feeling confused, seeing or hearing things that are not real (hallucinations), feeling aroused, movements that can not be controlled, a tendency to walk away, dizziness, headache, restlessness, confusion, and not being able to act and think normally
- nausea, vomiting, loss of appetite, indigestion
- high levels of certain liver enzymes in the body which means you have liver problems – shown in blood tests, high levels of “bilirubin” – this can make your skin and whites of the eyes look yellow, hepatitis
- rash, itching
- pain in arms or legs
- high levels of nitrogen in the blood – shown in blood tests, change in the color of the urine
- general malaise.
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 vial after “EXP”. or “EXP”. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is idebenone. Each film-coated tablet contains 150 mg of idebenone.
- Other ingredients: Tablet core: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, povidone K25, magnesium stearate, and silica colloidal anhydrous.Film coating of the tablet: macrogol, poly (vinyl alcohol), talc, titanium dioxide, para-orange (E110).
What the medicine looks like and the contents of the pack
- Raxone film-coated tablets are orange, round tablets, 10 mm in diameter and marked with the Santhera logo on one side and “150” on the other side.
- Raxone is supplied in white plastic bottles. Each bottle contains 180 tablets.
Marketing Authorization Holder and Manufacturer
Santhera Pharmaceuticals (Deutschland) GmbH
Marie-Curie Strasse 8
79539 Lörrach
Germany
tel. +49 (0) 7621 1690 200
fax +49 (0) 7621 1690 201
email: office@santhera.com