Package Insert: Information for the User

Riluzol SUN50 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1.What Riluzol SUN is and for what it is used

2.What you need to know before starting to take Riluzol SUN

3.How to take Riluzol SUN

4.Possible adverse effects

5Storage of Riluzol SUN

6.Contents of the package and additional information

What is Riluzol SUN

The active ingredient ofRiluzol SUNis riluzol that acts on the nervous system.

What is Riluzol SUN used for

Riluzol SUN is used in patients with amyotrophic lateral sclerosis (ALS).

ALS is a type of motor neuron disease that affects the nerve cells responsible for sending signals to muscles and produces weakness, muscle wasting, and paralysis.

The destruction of nerve cells in motor neuron disease may be caused by excess glutamate (a chemical messenger) in the brain and spinal cord. Riluzol SUN stops the release of glutamate and this may help prevent damage to nerve cells.

For further information consult your doctor about ALS and the reason why you have been prescribed this medication.

Do not take Riluzol SUN

• if you areallergicto riluzol or to any of the other components ofthis medication (listed in section 6).
• if you have anyliver diseaseor elevated levels of certain liver enzymes (transaminases) in your blood.
• if you arepregnantor breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeRiluzol SUN:

• if you haveliver problems: yellowing of the skin or the white part of the eyes (jaundice), generalized itching, feeling of dizziness, nausea
• if yourkidneysdo not function correctly
• if you havefever: it may be due to a lower number of white blood cells, which may increase the risk of infections

If you are affected by any of the circumstances mentioned above or if you have any doubts, inform your doctor so that they can tell you what to do.

Children and adolescents

If you are under 18 years of age, the use of Riluzol SUN is not recommended, as there is no available information in this population.

Taking Riluzol SUN with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medications.

Pregnancy and breastfeeding

DO NOT takeRiluzol SUNif you are pregnant or suspect you may be pregnant, or if you are breastfeeding.

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

You may drive or operate tools or machines, unless you feel dizzy or confused after taking this medication.

Riluzol SUN containssodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet twice a day.

Tablets should be taken orally, every 12 hours, at the same time each day (for example: in the morning and at night).

If you take more Riluzol SUN than you should

If you take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20.

If you forget to take Riluzol SUN

If you forget to take a tablet, omit this dose and take the next tablet at the usual time.

Do not take a double dose to compensate for missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

IMPORTANT

Consult your doctor immediately

• if you havefever(elevated temperature) becauseRiluzol SUNmay cause a decrease in the number of white blood cells. Your doctor may instruct you to have blood tests to monitor the number of white blood cells, which are important in fighting infections.
• if you experience any of the following symptoms: yellowing of the skin or the white of the eyes (jaundice), generalized itching, feeling of dizziness or nausea, as they may be a sign of liver disease (hepatitis).Your doctor may perform periodic blood tests while you are taking Riluzol SUN to ensure this does not occur.
• if you experience cough or difficulty breathing, as this could be a sign of lung disease (called interstitial lung disease).

Other side effects

Thevery common side effects(can affectmore than 1 in 10 patients) ofRiluzol SUNare:

• fatigue
• feeling of dizziness
• elevated levels in the blood of some liver enzymes (transaminases)

Thecommon side effects(can affect up to1 in 10 people) ofRiluzol SUNare:

• dizziness
• drowsiness
• headache
• numbness or tingling of the mouth
• increased heart rate
• abdominal pain
• vomiting
• diarrhea
• pain

Theuncommon side effects(can affect up to 1 in 100 people) ofRiluzol SUNare:

• anemia
• allergic reactions
• inflammation of the pancreas (pancreatitis)

The side effects withunknown frequencyare:

• skin rash

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging and in the blister pack. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Riluzol SUN 50 mg Film-coated Tablets Composition

• The active ingredient is riluzol. Each film-coated tablet contains 50 mg of riluzol.
• The other components are:

Core: anhydrous calcium hydrogen phosphate (E341), microcrystalline cellulose (E460), povidone (K-30) (E1201), sodium croscarmellose (E468), anhydrous colloidal silica (E551), talc, magnesium stearate (E572)

Coating: Opadry white 03B68903 formed by hypromellose 6 CP, titanium dioxide (E171), talc, macrogol 400.

Product Appearance and Packaging Contents

The tablets are white to off-white, round, biconvex, with the inscription “538” engraved on one face and smooth on the other face.

Riluzol SUNis available in a pack of 56 or 98 tablets (4 or 7 blisters of 14 tablets each) for oral administration.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de catalunya 53-55

08007 Barcelona

Spain

Phone: +34 93 342 78 90

This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany:Riluzol SUN 50 mg Filmtabletten

Italy:Riluzolo SUN 50 mg compresse rivestite con film

Spain:Riluzol SUN 50 mg comprimidos recubiertos conpelícula EFG

United Kingdom (Northern Ireland):Riluzole 50 mg film-coated tablets.

This leaflet was approved inJanuary 2023

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.