RAXONE 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Raxone 150 mg film-coated tablets

idebenone

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Raxone and what is it used for
2. What you need to know before you take Raxone
3. How to take Raxone
4. Possible side effects
5. Storage of Raxone
6. Contents of the pack and other information

1. What is Raxone and what is it used for

Raxone contains the active substance idebenone.

Idebenone is used to treat visual impairment in adults and adolescents with a rare eye disease called Leber's hereditary optic neuropathy (LHON).

• This is a hereditary condition, meaning it runs in some families.
• It is caused by a defect in the genes (a "genetic mutation") that affects the ability of eye cells to produce the energy they need to function normally, so they become inactive.
• LHON can cause loss of vision due to the inactivity of the cells responsible for vision.

Treatment with Raxone may restore the ability of cells to produce energy and allow inactive cells to function again. This may lead to some improvement in lost vision.

2. 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 precautions

Talk to your doctor or pharmacist before taking Raxone if:

• you have any blood, liver, or kidney disorder.
• Change in urine color

Raxone may cause your urine to turn brown-red. This color change is not dangerous (it does not mean that the treatment needs to be changed). However, the color change may indicate kidney or bladder problems.

• Talk to your doctor if your urine changes color.
• You may need to have urine tests to make sure the color change does not hide other problems.

Tests

Your doctor will check your vision before you start taking this medicine and later on during regular visits while you are taking it.

Children and adolescents

This medicine must not be used in children, as it is not known if Raxone works or is safe in patients under 12 years of age.

Using Raxone with other medicines

Some medicines may interact with Raxone. Tell your doctor if you are taking, have recently taken, or might take any other medicines, especially those used to:

• treat allergies (antihistamines such as astemizole, terfenadine)
• treat heartburn (cisapride)
• control muscle and speech tics associated with Gilles de la Tourette syndrome (pimozide)

• treat heart rhythm disorders (quinidine)
• treat migraine (dihydroergotamine, ergotamine)
• put the patient to sleep, called "anesthetics" (alfentanil)
• treat inflammation in rheumatoid arthritis and psoriasis (ciclosporin)
• prevent organ transplant rejection (sirolimus, tacrolimus)
• treat severe pain, 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 if the benefits of the treatment outweigh the risks to the fetus.
• Raxone may pass into breast milk. If you are breastfeeding, your doctor will discuss with you whether you should stop breastfeeding or stop taking the medicine. The benefits of breastfeeding for the baby and the benefits of the medicine for you will be taken into account.

Driving and using machines

Raxone is not expected to affect your ability to drive or use machines.

Raxone contains lactose and orange yellow S (E 110)

• Raxone contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to lactose or that you cannot tolerate or digest certain sugars, talk to your doctor before taking this medicine.

• Raxone contains the colorant orange yellow S (also known as E 110). This substance may cause allergic reactions.

3. How to take Raxone

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

How much to take

The recommended dose is 2 tablets three times a day (a total of 6 tablets per day).

How to take this medicine

• Take the tablets with food, as this will help the medicine pass from the stomach into the bloodstream.

• Swallow the tablets whole with a glass of liquid.
• Do not crush or chew the tablets.
• Take the tablets at the same time each day. For example, in the morning with breakfast, at noon with lunch, and in the evening with dinner.

If you take more Raxone than you should

If you take more Raxone than you should, talk to your doctor as soon as possible.

If you forget to take Raxone

If you forget to take 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 stopping 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 effects may happen with this medicine:

Very common(may affect more than 1 in 10 people):

• nasopharyngitis (common cold)
• cough

Common(may affect up to 1 in 10 people):

• diarrhea (mild to moderate; treatment does not usually need to be stopped)
• back pain

Frequency not known(cannot be estimated from the available data):

• bronchitis
• changes in blood test results: low white blood cell count or low red blood cell count or low platelet count
• blood test results indicating high cholesterol or high fat levels in the blood
• seizures, feeling confused, seeing or hearing things that are not there (hallucinations), feeling excited, uncontrolled movements, tendency to withdraw, feeling dizzy, headache, feeling restless, lack of energy

• nausea, vomiting, loss of appetite, stomach pain
• blood test results indicating high levels of certain liver enzymes, indicating liver problems, high bilirubin levels (which can cause the skin and whites of the eyes to turn yellow), hepatitis
• rash, itching
• limb pain
• blood test results indicating high nitrogen levels in the blood; changes in urine color

• feeling unwell

Reporting of side effects

If you get any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 label and carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

• The active substance is idebenone. Each film-coated tablet contains 150 mg of idebenone.

• The other ingredients are:

Tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, povidone K25, magnesium stearate, and colloidal silicon dioxide.

Tablet coating: macrogol, poly(vinyl) alcohol, talc, titanium dioxide, and orange yellow S (E 110).

Appearance of the product and pack contents

• Raxone film-coated tablets are orange, round, 10 mm in diameter, engraved with the Santhera logo on one side and "150" on the other.

• Raxone is supplied in white plastic bottles. Each bottle contains 180 tablets.

Marketing authorisation holder and manufacturer

Santhera Pharmaceuticals (Deutschland) GmbH

Marie-Curie Strasse 8

79539 Lörrach

Germany

Phone: +49 (0) 7621 1690 200

Fax: +49 (0) 7621 1690 201

Email: office@santhera.com

Date of last revision of this leaflet

This medicine has been authorised under "exceptional circumstances".

This means that due to the rarity of this disease, it has not been possible to obtain complete information on this medicine.

The European Medicines Agency will review any new information that 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 web sites about rare diseases and orphan medicines.