Rilutek 50 mg film-coated tablets

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

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

The active substance in RILUTEK is riluzole which acts on the nervous system.

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

ALS is a form of motor neurone disease where attacks of the nerve cells responsible for sending instructions to the muscles lead to weakness, muscle waste and paralysis.

The destruction of nerve cells in motor neurone disease may be caused by too much glutamate (a chemical messenger) in the brain and spinal cord. RILUTEK stops the release of glutamate and this may help in preventing the nerve cells being damaged.

Please consult your doctor for more information about ALS and the reason why this medicine has been prescribed for you.

• if you are allergic to riluzole or any of the other ingredients of this medicine (listed in section 6).
• if you have any liver disease or increased blood levels of some enzymes of the liver (transaminases).
• if you are pregnant or breast-feeding.

Talk to your doctor before taking RILUTEK:

• if you have any liver problems: yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick
• if your kidneys are not working very well
• if you have any fever: it may be due to a low number of white blood cells which can cause an increased risk of infection

If any of the above applies to you, or if you are not sure, tell your doctor who will decide what to do.

If you are less than 18 years of age, the use of RILUTEK is not recommended because there is no information available in this population.

Tell your doctor if you are taking, have recently taken or might take any other medicines.

You MUST NOT take RILUTEK if you are or think you may be pregnant, or if you are breast-feeding.

If you think you may be pregnant, or if you intend to breast-feed, ask your doctor for advice before taking RILUTEK.

You can drive or use any tools or machines, unless you feel dizzy or light-headed after taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium free”.

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

If you forget to take your tablet, leave out that dose completely and take the next tablet at the usual time. Do not take a double dose to make up for a forgotten tablet.

Tell your doctor immediately

• if you experience any fever (increase in temperature) because RILUTEK may cause a decrease in the number of white blood cells. Your doctor may want to take a blood sample to check the number of white blood cells, which are important in fighting infections.
• if you experience any of the following symptoms: yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick, as this may be signs of liver disease (hepatitis).Your doctor may do regular blood tests while you are taking RILUTEK to make sure that this does not occur.
• if you experience cough or difficulties in breathing, as this may be a sign of lung disease (called interstitial lung disease).

Very common side effects (may affect more than 1 in 10 people) of RILUTEK are:

• tiredness
• feeling sick
• increased blood levels of some enzymes of the liver (transaminases)

Common side effects (may affect up to 1 in 10 people) of RILUTEK are:

• dizziness
• sleepiness
• headache
• numbness or tingling of the mouth
• increase in heart beat
• abdominal pain
• vomiting
• diarrhoea
• pain

Uncommon side effects (may affect up to 1 in 100 people) of RILUTEK are:

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

Not known: frequency cannot be estimated from the available data

• rash

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

United Kingdom

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is riluzole.
• The other ingredients are:
  • Core: anhydrous dibasic calcium phosphate, micro crystalline cellulose, anhydrous colloidal silica, magnesium stearate, croscarmellose sodium
  • Coating: hypromellose, macrogol 6000, titanium dioxide (E171)

The tablets are film-coated, capsule-shaped and white. Each tablet contains 50 mg of riluzole and is engraved with “RPR 202” on one side.

RILUTEK is available in a pack of 56 tablets to be taken orally.

Market Authorisation Holder

Manufacturer