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RILUZOLE MYLAN 50 MG FILM-COATED TABLETS

Active substance(s): RILUZOLE / RILUZOLE / RILUZOLE

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Package leaflet: Information for the patient

Riluzole 50 mg
Film-coated
Tablets
(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 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.
What is 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 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 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. 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
Talk to your doctor or pharmacist before
using Riluzole
• 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.
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 or pharmacist 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
pregnant or think you may be pregnant,
or if you are breast-feeding.
If you think you may be pregnant or are
planning to breast-feed, ask your doctor
or pharmacist for advice before taking
this medicine.
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
Always take this medicine exactly as your
doctor or pharmacist 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. Signs of
an overdose can include feeling dizzy
or drowsy, or reduced consciousness
including coma.
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 an allergic reaction.
Such reactions may appear in the form
of anaphylaxis (a severe form of allergic
reaction) with symptoms such as:
* rash
* swelling of the face, lips, mouth,
tongue or throat (angioedema)
* sudden wheezing, fainting or
difficulty swallowing
• 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
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 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).
• if you experience severe pain
spreading from the abdomen to the
back, as this may be signs of an
inflamed pancreas (pancreatitis).
Other possible side effects
Very common side effects (may affect
more than 1 in 10 people):
• feeling tired or weak
• feeling sick
• increased blood levels of some
enzymes of the liver (transaminases).
Common side effects (may affect up to
1 in 10 people):
• headache
• dizziness
• numbness or tingling of the mouth
• sleepiness
• increase in heart beat
• vomiting
• diarrhoea
• abdominal pain
• pain
Uncommon side effects (may affect up
to 1 in 100 people):
• anaemia
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 at:
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 this medicine out of the sight and
reach of children.
HDPE containers: Store in the original
package to protect from light. This
medicinal product does not require any
special temperature storage conditions.
Blisters: Store in the original package to
protect from light. This medicinal product
does not require any special temperature
storage conditions.
Do not use this medicine after the expiry
date, which is stated on the carton and
the blister. The expiry date refers to the
last day of that month.
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 Riluzole 50 mg Film-coated Tablet
contains 50 mg of riluzole.
The other tablet ingredients are
anhydrous calcium hydrogen phosphate,
microcrystalline cellulose, croscarmellose
sodium, colloidal anhydrous silica and
magnesium stearate.
The film-coat ingredients are
hypromellose, titanium dioxide (E171)
and macrogol 400.
What Riluzole looks like and contents of
the pack
Riluzole 50 mg Film-coated Tablets are
white, film-coated, capsule shaped,
biconvex tablets, debossed with ‘M’ on
one side and ‘RE 50’ on the other side.
Riluzole 50 mg Film-coated Tablets
come in blister packs of 14, 56, 60 and
112 tablets, perforated unit dose blisters
of 56 x 1 tablets and plastic bottles
containing 56, 112 and 250 tablets*.
*Not all pack sizes may be marketed
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer
Gerard Laboratories, 35/36 Baldoyle
Industrial Estate, Grange Road, Dublin 13,
Ireland
This leaflet was last revised in 01/2017.

987794

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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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