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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.

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Package leaflet: Information for the user
3. How to take Riluzole

Riluzole 50 mg film-coated tablets

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).

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.

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.

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

If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects

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.

2. What you need to know before you take Riluzole
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.
Warnings and precautions
Tell your doctor:
- 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 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.
If any of the above applies to you, or if you are not sure, tell your doctor who will
decide what to do.

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).
Very common side effects (affecting 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 (affecting between 1 in 10 and 1 in 100 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 (affecting between 1 in 100 and 1 in 1000 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. By reporting side effects
you can help provide more information on the safety of this medicine.

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

5. How to store Riluzole

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

This medicinal product does not require any special storage conditions.

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

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.

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

375 mm

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

1. What Riluzole is and what it is used for

Keep out of the sight and reach of children.

Do not use Riluzole after the expiry date which is stated on the carton and the blister.

248 mm

Size: 248x375 mm

SUN EUROPE
EUUK - UNITED KINGDOM

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Riluzole 50 mg-PIL-248x375mm-EUUK-REV2-04-03-16-V2
Friday, March 04, 2016 11:55:39 AM

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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.
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
The Netherlands: Riluzol SUN 50 mg filmomhulde tabletten
United Kingdom: Riluzole 50 mg film-coated tablets.

Suppliers LOGO / ID here

044BP1676E

375 mm

This leaflet was last revised in 03/2016.

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

248 mm

Size: 248x375 mm

SUN EUROPE
EUUK - UNITED KINGDOM

100

95

75

25

5

0

Riluzole 50 mg-PIL-248x375mm-EUUK-REV2-04-03-16-V2
Friday, March 04, 2016 11:55:39 AM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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