Package leaflet: Information for the user

Riluzole SUN, 50 mg, film-coated tablets
Riluzolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

What Riluzole SUN is and what it is used for
What you need to know before taking Riluzole SUN
How to take Riluzole SUN
Possible side effects
How to store Riluzole SUN
Contents of the pack and other information

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

What Riluzole SUN is
The active substance in Riluzole SUN is riluzole, which acts on the nervous system.
What Riluzole SUN is used for
Riluzole SUN is used in patients with amyotrophic lateral sclerosis (ALS).
Amyotrophic lateral sclerosis is a form of motor neuron disease in which the destruction of nerve cells responsible for transmitting signals to muscles leads to muscle weakness, atrophy, and paralysis.
In motor neuron disease, nerve cell damage may be caused by excessive amounts of glutamate (a neurotransmitter) in the brain and spinal cord. Riluzole SUN inhibits the release of glutamate and may help prevent nerve cell damage.
Please consult your doctor for further explanations regarding amyotrophic lateral sclerosis and why this medicine has been prescribed for the patient.

2. Important information before using Riluzole SUN

When not to use Riluzole SUN

if the patient is allergic to riluzole or any of the other ingredients of this medicine (listed in section 6),
if the patient has liver disease or increased activity of certain liver enzymes (aminotransferases) in the blood,
if the patient is pregnant or breastfeeding.

Warnings and precautions
Before starting treatment with Riluzole SUN, discuss the following with your doctor:

if the patient has any liver problems: yellowing of the skin or whites of the eyes (jaundice), itching, nausea, vomiting;
if the patient has impaired kidney function;
if the patient has fever (this may sometimes indicate low white blood cell count, which may increase the risk of infection).

If any of the above apply to the patient, or if the patient is unsure,
the patient should contact the doctor, who will decide what action should be taken.
Children and adolescents
If the patient is under 18 years of age, the use of Riluzole SUN is not recommended, as there is no
available information regarding this patient group.
Riluzole SUN and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as
any medicines the patient plans to take.
Pregnancy and breastfeeding
The patient MUST NOT take Riluzole SUN if she is pregnant or suspects she may be pregnant,
or if she is breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Driving and operating machinery
The patient may drive, use tools, or operate machinery if, after taking this medicine, there is no sensation of dizziness or feeling of emptiness in the head.
Riluzole SUN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Riluzole SUN

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, consult
your doctor or pharmacist.
The recommended dose is one tablet twice daily.
The tablets should be taken orally every 12 hours, at the same time each day (e.g. in the morning and
evening).
Taking more than the recommended dose of Riluzole SUN
If a patient takes more tablets than recommended, they should immediately contact their
doctor or the nearest hospital emergency department.
Missing a dose of Riluzole SUN
If a patient forgets to take a tablet, they should completely omit that dose and take the next
tablet at the usual scheduled time.
Do not take a double dose to make up for the missed tablet.
If there are any further doubts regarding 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.
IMPORTANT INFORMATION
You should contact your doctor immediately:

if you develop fever (raised temperature), because Riluzole SUN may reduce the number of white blood cells. Your doctor may order a blood test to check your white blood cell count, which is important in fighting infections.
if you experience any of the following symptoms: yellowing of the skin or whites of the eyes (jaundice), itching, nausea, vomiting, as these may be signs of liver disease (hepatitis). While taking Riluzole SUN, your doctor may order regular blood tests to ensure that liver disease is not occurring.
if you develop cough or difficulty breathing, as these may be symptoms of a lung disease (called interstitial lung disease)

Other side effects
Very common side effects (may affect more than 1 in 10 patients) of Riluzole SUN are:

feeling tired
nausea
increased activity of certain liver enzymes (aminotransferases) in the blood

Common side effects (may affect up to 1 in 10 patients) of Riluzole SUN are:

dizziness
drowsiness
headache
numbness or tingling of the lips
increased heart rate
abdominal pain
vomiting
diarrhoea
pain

Uncommon side effects (may affect up to 1 in 100 patients) of Riluzole SUN are:

anaemia
allergic reactions
pancreatitis

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Riluzole SUN

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the cardboard box and
blister pack following EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the pack and other information

What Riluzole SUN contains

The active substance is riluzole. Each film-coated tablet contains 50 mg of riluzole.
The other ingredients are:
Tablet core: anhydrous calcium hydrogen phosphate (E341), microcrystalline cellulose (E460), povidone K30 (E1201), sodium croscarmellose (E468), anhydrous colloidal silicon dioxide (E551), talc, magnesium stearate (E572).
Tablet coating: Opadry white 03B68903, which contains hypromellose 6 cP, titanium dioxide (E171), talc, polyethylene glycol 400.

What Riluzole SUN looks like and contents of the pack
White or almost white, round, biconvex film-coated tablets, embossed with "538" on one side and smooth on the other.
Riluzole SUN is available in packs containing 56 or 98 tablets (4 or 7 blisters with 14 tablets each) and is to be taken orally.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego 16
00-710 Warsaw
Tel. 22 642 07 75

This medicinal product is authorised in 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 con película EFG
United Kingdom – Northern Ireland: Riluzole SUN 50 mg film-coated tablets