SKYCLARYS 50 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Skyclarys 50mg Hard Capsules

omaveloxolona

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. 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.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor.
• 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. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Skyclarys and what is it used for

What is Skyclarys

Skyclarys contains the active substance omaveloxolona, which activates a specific protein, Nrf2, in your body.

What Skyclarys is used for

Skyclarys is used to treat adults and adolescents from 16 years of age who suffer from Friedreich's ataxia, a neurodegenerative movement disorder. Friedreich's ataxia is a rare inherited disease that causes progressive damage to the nervous system and movement problems.

How Skyclarys works

The Nrf2 protein in your body plays a key role in controlling oxidative stress (a disorder that can damage your body's cells) and has a protective function against neurodegenerative diseases. In patients with Friedreich's ataxia, Nrf2 activity is reduced. Skyclarys activates Nrf2 so that it can control oxidative stress.

In a clinical trial, patients treated with Skyclarys had better results in neurological function tests than patients treated with an inactive substance.

2. What you need to know before you take Skyclarys

Do not take Skyclarysif you are allergic to omaveloxolona or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor before starting Skyclarys:

• if you have liver problems, your doctor may decide to change the dose or not start treatment with Skyclarys;
• tell your doctor about all the medicines you are taking before starting Skyclarys.

Your doctor will check how your liver is working and your cholesterol level before you start taking Skyclarys. Your doctor will also check your BNP (brain natriuretic peptide, a blood test to detect heart problems) level before you start taking Skyclarys.

Consult your doctor while taking Skyclarys

Contact your doctor immediately if you have a sudden weight gain, swelling of your legs, ankles or feet, or difficulty breathing, which may be signs or symptoms of heart problems while taking Skyclarys. Your doctor will decide on the treatment and whether you should continue taking Skyclarys.

Consult your doctor if you experience any hypersensitivity reaction (an allergic or allergy-like reaction that can include itching and skin rash).

Your doctor will perform blood tests while you are taking Skyclarys. This will include blood tests to see how your liver is working while taking Skyclarys. Your doctor will decide whether to stop treatment with Skyclarys if liver problems appear. Other blood tests that your doctor will perform will check your cholesterol and BNP levels after you start taking Skyclarys.

Tell your doctor if you experience weight loss with Skyclarys.

Children and adolescents

Do not give Skyclarys to children and adolescents under 16 years of age because it has not been studied in this group of patients.

Other medicines and Skyclarys

Tell your doctor if you are taking, have recently taken or might take any other medicines. This is because some medicines may affect how Skyclarys works. Also, Skyclarys may affect how some other medicines work.

Certain medicines may increase the risk of side effects of Skyclarys by increasing Skyclarys levels in the blood. Some of these medicines include:

• itraconazole, fluconazole or ketoconazole (antifungal medicines used to treat various fungal infections);
• ciclosporin (a medicine used after organ transplantation);
• ciprofloxacin or clarithromycin (antibiotics used to treat bacterial infections);
• fluvoxamine (an antidepressant known as a selective serotonin reuptake inhibitor [SSRI]).

If your doctor prescribes one of these medicines, they may reduce your dose of Skyclarys to avoid side effects when taking both medicines at the same time.

Certain medicines may reduce the effectiveness of Skyclarys by decreasing the amount of Skyclarys in the blood. Some of these medicines include:

• St. John's Wort (a herbal remedy used for mild depression);
• rifampicin (used to treat tuberculosis);
• carbamazepine, phenobarbital, phenytoin, primidone (used to treat epilepsy);
• efavirenz (a medicine used for HIV).

Skyclarys may reduce the effectiveness of other medicines by decreasing the amount of these medicines in the blood. Some of these medicines include:

• midazolam (used as a sedative and to treat severe agitation);
• repaglinide (a medicine to control type 2 diabetes);
• rosuvastatin (a statin used to reduce harmful lipids);
• hormonal contraceptives (a type of contraceptive that uses hormones to prevent pregnancy, such as the pill, patch or ring).

Consult your doctorif you are taking any medicine, in particular those mentioned above, as they may affect how Skyclarys or other medicines work.

Using Skyclarys with food and drinks

Avoid eating grapefruit or drinking grapefruit juice while taking Skyclarys.

Pregnancy

Do not take Skyclarys if you are pregnant, think you may be pregnant or are planning to have a baby. Tell your doctor immediately if you become pregnant while taking Skyclarys.

Contraceptives

Using Skyclarys may reduce the effectiveness of hormonal contraceptives. You should use a different contraceptive method, such as a non-hormonal intrauterine device (IUD) or barrier contraceptives like condoms. You should use a reliable contraceptive method during treatment with Skyclarys and for 28 days after stopping treatment with Skyclarys. Consult your doctor about the most suitable contraceptive method for you.

Breast-feeding

Do not breast-feed your child while taking Skyclarys. It is not known whether this medicine is excreted in breast milk.

Driving and using machines

Some patients may feel tired after taking this medicine. If you feel tired after taking Skyclarys, avoid driving and using machines.

Skyclarys contains a negligible amount of sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

3. How to take Skyclarys

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor again.

The recommended dose is 150 mg (3 capsules) once a day.

Taking Skyclarys

• Take the capsules on an empty stomach at least 1 hour before or 2 hours after eating.
• Take the capsules at about the same time each day.
• Swallow the capsules whole with a glass of water.
• If you cannot swallow the capsules whole, open them and sprinkle all the contents into 2 tablespoons of applesauce. You must swallow all the applesauce and medicine mixture right after preparing it. Do not save the applesauce and medicine mixture for later use.

If you have liver problems, your doctor may decide to change the dose or not start treatment with Skyclarys.

Certain medicines may cause side effects if taken at the same time as Skyclarys. If your doctor prescribes one of these medicines while you are taking Skyclarys, your doctor may reduce your dose of Skyclarys to avoid side effects when taking both medicines at the same time.

If you vomit after taking your usual dose, do nottake more capsules to make up for it. Take the capsules as usual the next day.

If you take more Skyclarys than you should

If you take more Skyclarys than your doctor has prescribed, contact your doctor immediately. Bring this leaflet with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Skyclarys

If you miss a dose of Skyclarys, take the next dose as usual the next day. Do nottake a double dose to make up for forgotten doses.

If you stop taking Skyclarys

Do not stop taking this medicine unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects of Skyclarys could be or become serious

Consult your doctorimmediately if you experience any of these side effects.

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

• digestive problems. You may have symptoms such as

• nausea (feeling sick or wanting to be sick)
• diarrhoea
• vomiting
• stomach pain
• weight loss

If you experience any of these side effects, consult your doctor.

Based on your blood tests, your doctor may tell you that you have:

• high liver enzymes in the blood (very common, may affect more than 1 in 10 people)
• high BNP level (a marker of heart problems); (common, may affect up to 1 in 10 people)
• changes in cholesterol and triglycerides in the blood (common, may affect up to 1 in 10 people)

Your doctor will decide on the treatment and whether you should continue taking Skyclarys.

Other possible side effects of Skyclarys

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

• headache
• fatigue
• sore throat
• back pain
• muscle spasms
• flu
• decreased appetite
• hypersensitivity (an allergic or allergy-like reaction that can include itching and skin rash)

Common (may affect up to 1 in 10 people)

• urinary tract infection (infection of the structures that carry urine, UTI)
• menstrual cramps in women (dysmenorrhoea)

Reporting of side effects

If you experience 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 Skyclarys

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 after “EXP”. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

If the capsule is opened and mixed with applesauce, you must swallow all the applesauce and medicine mixture right after preparing it. See section 3, Taking Skyclarys.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

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

Composition of Skyclarys

• The active substance is omaveloxolona.
• Each capsule contains 50 mg of omaveloxolona.
• The other ingredients are:

Capsule content: pregelatinised maize starch, microcrystalline cellulose, sodium croscarmellose, magnesium stearate and anhydrous colloidal silica.

Capsule shell: hypromellose, titanium dioxide (E-171), brilliant blue FCF (E-133) and yellow iron oxide (E-172).

Printing ink: shellac (E-904) and titanium dioxide (E-171).

Appearance and packaging of Skyclarys

Skyclarys 50 mg hard capsules are greenish-blue capsules with “RTA 408” printed in white ink on the body and “50” printed in white ink on the cap.

Skyclarys 50 mg is available in packs of 90 hard capsules and in packs of 3 bottles of 90 hard capsules each.

Not all pack sizes may be marketed.

Marketing authorisation holder

Biogen Netherlands B.V.

Prins Mauritslaan 13

1171 LP Badhoevedorp

Netherlands

Manufacturers

Reata Ireland Limited,

77 Sir John Rogersons Quay Block C, Spaces South Docklands

Dublin 2

D02 VK60

Ireland

Biogen Netherlands B.V.

Prins Mauritslaan 13

1171 LP Badhoevedorp,

Netherlands

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu. There are also links to other web sites about rare diseases and orphan medicines.