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

The active substance in Riluzole 50 mg film-coated tablets is riluzole which acts on the nervous system.

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

ALS is a form of motor neurone disease where damage to the nerve cells responsible for sending instructions to the muscles lead to weakness, muscle wasting 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. Riluzole 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 or pharmacist before taking Riluzole:

• if you have any liver problems: yellowing of your skin or the whites of your eyes (jaundice), itching all over, feeling sick, being sick
• if your kidneys are not working very well
• if you have any fever (sometimes this can be due to a low number of white blood cells which can lead to 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 Riluzole 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 Riluzole if you are or think you may be pregnant, or if you are breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You can drive or use any tools or machines, unless you feel dizzy or lightheaded 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 Riluzole 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 whites 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 Riluzole 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 patients) of Riluzole are:

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

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

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

Uncommon side effects (may affect up to 1 in 100 patients) of Riluzole 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. You can also report side effects directly via the Yellow Card Scheme, 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. Each film-coated tablet contains 50 mg riluzole.
• The other ingredients are:
  Tablet core: calcium hydrogen phosphate anhydrous (E341), microcrystalline cellulose (E460), povidone (K-30) (E1201), croscarmellose sodium (E468), colloidal anhydrous silica (E551), talc, magnesium stearate (E572).
  Tablet coating: opadry white 03B68903 consisting of hypromellose 6CP, titanium dioxide (E171), talc, macrogol 400.

The tablets are white to off white coloured, round shape, biconvex, film coated tablets debossed with ‘538’ on one side and plain on the other side.

Riluzole is available in a pack of 56 or 98 tablets (4 or 7 blister cards of 14 tablets each) to be taken orally.

Not all pack sizes may be marketed.

This medicinal product is authorised 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 con película EFG

United Kingdom (NI): Riluzole 50 mg film-coated tablets