Raxone

Package leaflet: Information for the user

Raxone 150 mg film-coated tablets

idebenone
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Raxone is and what it is used for
2. What you need to know before taking 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 loss in adults and adolescents with a disease called
Leber's hereditary optic neuropathy (LHON).

• This eye disease is hereditary, meaning it runs in families.
• It is caused by a genetic problem (called a “genetic mutation”) that affects the eye cells’ ability to produce the energy needed for normal function; as a result, these cells become inactive.
• LHON can lead to vision loss due to the inactivity of the cells responsible for sight.

Treatment with Raxone may restore the cells’ ability to produce energy, allowing the inactive eye cells to resume functioning. This may lead to some improvement in lost vision.

2. What you should know before taking Raxone

Do not take Raxone

• if you are allergic to idebenone or to 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 kind of blood, liver, or kidney disease.

Change in urine colour
Raxone may turn your urine brownish-red. This change in colour is not harmful and does not mean that you need to change your treatment. However, the colour change could indicate problems with the kidneys or bladder.

• Inform your doctor if your urine changes colour.
• Your doctor may request a urine test to make sure the colour change is not hiding other problems.

Tests
Your doctor will perform vision checks before starting treatment with this medicine and during regular follow-up visits throughout treatment.

Children and adolescents
This medicine must not be used in children, as the safety and efficacy of Raxone have not been established in patients under 12 years of age.

Other medicines and Raxone
Some medicines may interact with Raxone. Inform 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)
• medicines for heartburn (cisapride)
• medicines for the treatment of motor and vocal tics associated with Tourette’s syndrome (pimozide)
• medicines for the treatment of heart rhythm disorders (quinidine)
• medicines for migraine (dihydroergotamine, ergotamine)
• anaesthetics (alfentanil)
• medicines for treating inflammation in rheumatoid arthritis and psoriasis (cyclosporine)
• medicines to prevent rejection of a transplanted organ (sirolimus, tacrolimus)
• painkillers, called “opioids” (fentanyl)

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

• Your doctor will prescribe Raxone only if the benefits of treatment outweigh the risks to the unborn child.
• Raxone may pass into breast milk. If you are breastfeeding, your doctor will discuss with you whether to discontinue breastfeeding or to stop taking the medicine. The decision will take into account the benefit of breastfeeding for 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 operate machinery.

Raxone contains lactose and sunset yellow (E110).

• Raxone contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
• Raxone contains a colouring agent called “sunset yellow” (also known as E110), which may cause allergic reactions.

3. How to take Raxone

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose is 2 tablets three times a day, for a total of 6 tablets per day.
How to take the medicine

• Take the tablets with food: this helps deliver a greater amount of medicine from the stomach into the bloodstream.
• Swallow the tablets whole with a glass of liquid.
• Do not break 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, consult your doctor immediately.
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 the missed dose.
If you stop taking Raxone
Consult your doctor before stopping treatment with this medicine.
If you have any questions about the use of this medicine, consult 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 occur 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):

• diarrhoea (mild to moderate, which usually does not require discontinuation of treatment)
• back pain

Not known (frequency cannot be estimated from the available data):

• bronchitis
• changes in blood test results: low levels of white blood cells in the blood, low levels of red blood cells in the blood, or low levels of platelets
• increased cholesterol or fats in the blood, detected in laboratory tests
• seizures, feeling confused, seeing or hearing things that are not real (hallucinations), feeling excited, uncontrollable movements, tendency to wander aimlessly (wandering), feeling dizzy, headache, feeling restless, feeling drowsy, and inability to act or think normally
• nausea, vomiting, loss of appetite, indigestion
• increased levels of certain liver enzymes in the blood, indicating liver problems, detected in laboratory tests; increased levels of "bilirubin" (this may cause yellowing of the skin and whites of the eyes); hepatitis
• skin rash, itching sensation
• pain in a limb
• increased levels of nitrogen in the blood, detected in laboratory tests; change in urine colour
• general feeling of being unwell

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, 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 on the vial after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Raxone contains

• The active substance is idebenone. Each film-coated tablet contains 150 mg of idebenone.
• The other components are:
  Tablet core: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, povidone K25, magnesium stearate, and anhydrous colloidal silica.
  Tablet film coating: macrogol, polyvinyl alcohol, talc, titanium dioxide, sunset yellow FCF (E110).

Description of the appearance of Raxone and package contents

• Raxone film-coated tablets are round, orange-coloured, 10 mm in diameter, with '150' engraved on one side.
• Raxone is supplied in white plastic bottles. Each bottle contains 180 tablets.

Marketing Authorization Holder
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma
Italy

Manufacturer
Excella GmbH & Co. KG
Nürnberger Strasse 12
90537 Feucht
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Chiesi sa/nv Chiesi Pharmaceuticals GmbH
Tél/Tel: + 32 (0)2 788 42 00 Tel: + 43 1 4073919

България Luxembourg/Luxemburg
ExCEEd Orphan Distribution d.o.o. Chiesi sa/nv
Dužice 1, Zagreb Tél/Tel: + 32 (0)2 788 42 00
10 000, Croatia
[email protected]
Teл.: +359 87 663 1858

Česká republika Magyarország
Chiesi CZ s.r.o. ExCEEd Orphan Distribution d.o.o.
Tel: + 420 261221745 Dužice 1, Zagreb
10 000, Croatia
[email protected]
Tel.: +36 70 612 7768

Danmark Malta
Chiesi Pharma AB Chiesi Farmaceutici S.p.A.
Tlf.: + 46 8 753 35 20 Tel: + 39 0521 2791

Deutschland Nederland
Chiesi GmbH Chiesi Pharmaceuticals B.V.
Tel: + 49 40 89724-0 Tel: + 31 88 501 64 00

Eesti Norge
Chiesi Pharmaceuticals GmbH Chiesi Pharma AB
Tel: + 43 1 4073919 Tlf: + 46 8 753 35 20

Ελλάδα Österreich
Chiesi Hellas AEBE Chiesi Pharmaceuticals GmbH
Τηλ: + 30 210 6179763 Tel: + 43 1 4073919

España Polska
Chiesi España, S.A.U. ExCEEd Orphan Distribution d.o.o.
Tel: + 34 93 494 8000 Dužice 1, Zagreb
10 000, Croatia
[email protected]
Tel: +48 799 090 131

France Portugal
Chiesi S.A.S. Chiesi Farmaceutici S.p.A.
Tél: + 33 1 47688899 Tel: + 39 0521 2791

Hrvatska România
Chiesi Pharmaceuticals GmbH Chiesi Romania S.R.L.
Tel: + 43 1 4073919 Tel: + 40 212023642

Ireland Slovenija
Chiesi Farmaceutici S.p.A. CHIESI SLOVENIJA d.o.o.
Tel: + 39 0521 2791 Tel: + 386-1-43 00 901

Ísland Slovenská republika
Chiesi Pharma AB Chiesi Slovakia s.r.o.
Sími: +46 8 753 35 20 Tel: + 421 259300060

Italia Suomi/Finland
Chiesi Italia S.p.A. Chiesi Pharma AB
Tel: + 39 0521 2791 Puh/Tel: +46 8 753 35 20

Κύπρος Sverige
Chiesi Farmaceutici S.p.A. Chiesi Pharma AB
Τηλ: + 39 0521 2791 Tel: +46 8 753 35 20

Latvija
Chiesi Pharmaceuticals GmbH
Tel: + 43 1 4073919

This medicinal product has been authorised under "exceptional circumstances".
This means that, because the disease is rare, it has not been possible to obtain complete information about this medicinal product.
The European Medicines Agency will review any new information on this medicinal product annually, and this package leaflet will be updated as necessary.
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu. In addition, links to other websites on rare diseases and their treatments are provided.