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RILUZOLE SUN 50 MG FILM-COATED TABLETS

Active substance(s): RILUZOLE

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Driving and using machines
You can drive or use any tools or machines, unless you feel dizzy or light headed after
taking this medicine.
Package leaflet: Information for the user

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

Riluzole 50 mg film-coated tablets

3. How to take Riluzole
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
- 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 symptoms are the same as yours.
- If you get and side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.

In this leaflet
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

Always take this medicine exactly as your doctor has told you. Check with your doctor
or pharmacist if you are not sure.
The recommended dose is one tablet, twice a day.
The tablets should be taken by mouth, every 12 hours, at the same time of the day
each day (e.g. in the morning and evening).
If you take more Riluzole than you should
If you take too many tablets, contact your doctor or the nearest hospital emergency
department immediately.
If you forget to take Riluzole
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.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

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

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
IMPORTANT
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).

2. What you need to know before you take Riluzole

Other side effects

Do not take Riluzole
- 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.

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)

Warnings and precautions
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.
Children and adolescents
If you are less than 18 years of age. The use of Riluzole is not recommended in
children because there is no information available in this population.
Other medicines and Riluzole
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Pregnancy and breast-feeding
You MUST NOT take Riluzole if you are or think you may be pregnant, or if you are
breast-feeding.

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 heart beat
- 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).
Reporting of side effects
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.

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.

Folding
375--9 zigzag--40 mm
248--2 --62 mm

248 mm

Size: 248x375 mm

375 mm

1. What Riluzole is and what it is used for

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(do not print here)

5. How to store Riluzole
Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use Riluzole after the expiry date which is stated on the carton and the blister.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other information
What Riluzole contains
- 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.
What Riluzole looks like and content of the pack
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.

375 mm

Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
This medicinal product is authorised in the Member States of the EEA 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: Riluzole 50 mg film-coated tablets.
This leaflet was last revised in 02/2018.

Folding
375--9 zigzag--40 mm
248--2 --62 mm

248 mm

Size: 248x375 mm

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