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RILUZOLE 50MG FILM-COATED TABLETS

Active substance(s): RILUZOLE / RILUZOLE

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Package leaflet: Information for the user

Riluzole 50mg film-coated Tablets
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 any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4
- This medicine is known as the above but will be referred to as Riluzole
throughout this leaflet.
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

1. What Riluzole is and what it is used for
What Riluzole is
The active substance in Riluzole 50mg 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 in 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 contact 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.
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.
If you think you may be pregnant, or if you intend to breast-feed, ask your
doctor for advice before taking Riluzole.
Driving and using machines
You can drive or use any tools or machines, unless you feel dizzy or light
headed after taking this medicine.

3. How to take Riluzole
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.

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 a 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.

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.
If your medicine shows any signs of deterioration, seek the advice of your
pharmacist.
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 50mg
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 03B68903 white consisting of hypromellose
6CP, titanium dioxide (E171), talc, macrogol 400.
What Riluzole looks like and contents 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 tablets (4 blister cards of 14 tablets each) to
be taken orally.
PL holder: Manx Pharma Ltd, Taylor Group House, Wedgnock Lane,
Warwick, CV34 5YA
PL 15833/0083
Procured from within the EU

POM

Manufacturer: Sun Pharmaceutical Industries Europe BV, Polarisavenue 87,
2132 JH Hoofddorp, The Netherlands
To request a copy of this leaflet in large print, audio or Braille, please call
01926 482511
This leaflet was last revised in September 2016
WIP URN: 150916-XXXX-PIL-01

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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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