Riluzole Sun 50 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Riluzol SUN 50 mg film-coated tablets EFG
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet Contents:
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What Riluzol SUN is and what it is used for
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What you need to know before taking Riluzol SUN
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How to take Riluzol SUN
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Possible side effects
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Storage of Riluzol SUN
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Package contents and additional information
1. What Riluzol SUN is and what it is used for
What Riluzol SUN is
The active substance of Riluzol SUN is riluzole, which acts on the nervous system.
What Riluzol SUN is 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 the muscles, causing weakness, loss of muscle mass, and paralysis.
The destruction of nerve cells in motor neuron disease may be caused by an excess of glutamate (a chemical messenger) in the brain and spinal cord. Riluzol SUN stops the release of glutamate, which may help prevent damage to nerve cells.
For further information, consult your doctor about ALS and the reason why this medicine has been prescribed for you.
2. What you need to know before starting to take Riluzol SUN
Do not take Riluzol SUN
- if you are allergic to riluzole or to any of the other ingredients of this medicine (listed in section 6).
- if you have any liver disease or elevated blood levels of certain liver enzymes (transaminases).
- if you are pregnant or breastfeeding.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Riluzol SUN:
- if you have liver problems: yellowing of the skin or whites of the eyes (jaundice), widespread itching, dizziness, nausea
- if your kidneys are not functioning properly
- if you have fever: this may be due to a reduced number of white blood cells, which could increase your risk of developing infections
If any of the above conditions affect you or if you have any doubts, inform your doctor so that they can advise you on what to do.
Children and adolescents
Riluzol SUN is not recommended for patients under 18 years of age, as there is no available information in this population.
Taking Riluzol SUN with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
DO NOT take Riluzol SUN if you are pregnant or suspect you may be pregnant, or if you are breastfeeding.
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
Driving and use of machines
You may drive or operate tools or machinery, unless you feel dizzy or confused after taking this medicine.
Riluzol SUN contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.
3. How to take Riluzol SUN
Follow exactly your doctor's instructions on how to take this medicine. If in doubt, consult your doctor or pharmacist again.
The recommended dose is one tablet twice a day.
The 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20.
If you forget to take Riluzol SUN
If you forget to take a tablet, skip this dose and take the next tablet at the usual time.
Do not take a double dose to make up for forgotten doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
IMPORTANT
Contact your doctor immediately
- if you have fever (raised temperature), because Riluzole SUN may cause a decrease in the number of white blood cells. Your doctor may advise you to have blood tests to monitor your white blood cell count, which is important in fighting infections.
- if you experience any of the following symptoms: yellowing of the skin or the whites of the eyes (jaundice), widespread itching, dizziness or nausea, as these may be signs of liver disease (hepatitis). Your doctor may carry out periodic blood tests while you are taking Riluzole SUN to ensure this does not occur.
- if you develop cough or difficulty breathing, as this could be a sign of lung disease (called interstitial lung disease).
Other adverse effects
The very common adverse effects (may affect more than 1 in 10 patients) of Riluzole SUN are:
- fatigue
- dizziness
- elevated levels in the blood of certain liver enzymes (transaminases)
The common adverse effects (may affect up to 1 in 10 people) of Riluzole SUN are:
- vertigo
- drowsiness
- headache
- numbness or tingling of the mouth
- increased heart rate
- abdominal pain
- vomiting
- diarrhoea
- pain
The uncommon adverse effects (may affect up to 1 in 100 people) of Riluzole SUN are:
- anaemia
- allergic reactions
- inflammation of the pancreas (pancreatitis)
Adverse effects with unknown frequency are:
- skin rash
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Riluzole SUN
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging and blister. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. ADDITIONAL INFORMATION
Composition of Riluzol SUN 50 mg film-coated tablets
- The active substance is riluzole. Each film-coated tablet contains 50 mg of riluzole.
- The other components are:
Core: calcium hydrogen phosphate anhydrous (E341), microcrystalline cellulose (E460), povidone (K-30) (E1201), sodium croscarmellose (E468), colloidal anhydrous silica (E551), talc, magnesium stearate (E572)
Coating: Opadry White 03B68903 composed of hypromellose 6 CP, titanium dioxide (E171), talc, macrogol 400.
Appearance of the product and contents of the pack
The tablets are white to off-white, round, biconvex, with the inscription “538” engraved on one side and plain on the other.
Riluzol SUN is available in packs of 56 or 98 tablets (4 or 7 blisters of 14 tablets each) for oral administration.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Local Representative
Sun Pharma Laboratorios, S.L.
Rambla de Catalunya 53-55
08007 Barcelona
Spain
Tel.: +34 93 342 78 90
This medicinal product is authorized in the European Economic Area countries 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 50 mg film-coated tablets.
This leaflet was approved in January 2023
Detailed and up-to-date 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/.