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RILUZOLE TEVA 50 MG FILM-COATED TABLETS

Active substance(s): RILUZOLE

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RILUZOLE TEVA 50 mg
FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION
FOR THE USER

Read all of this leaflet carefully before
you start taking this medicine.
• 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. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
• If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:

1. What Riluzole is and what it is used
for
2. Before you take Riluzole
3. How to take Riluzole
4. Possible side effects
5. How to store Riluzole
6. Further information

1 WHAT RILUZOLE IS AND WHAT
IT IS USED FOR
Riluzole is a nervous system medicine.
Riluzole has been prescribed by your
doctor for a disease of the nervous
system affecting your muscle strength
called amyotrophic lateral sclerosis.
Your doctor may give you further
information about why this medicine
has been prescribed for you.

2 BEFORE YOU TAKE RILUZOLE
Do not take Riluzole
• if you are allergic (hypersensitive) to
riluzole or any of the other ingredients
of Riluzole
• if you have any liver disease or
increased blood levels of some
enzymes of the liver (transaminases)
• if you are pregnant or breast-feeding.
Take special care with Riluzole
Tell your doctor:
• 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 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 you experience coughs or difficulties
in breathing, as this may be a sign of

a lung disease (called interstitial lung
disease).
If any of the above applies to you, or if
you are not sure, tell your doctor who
will decide what to do.
Taking other medicines
Please tell your doctor if you are taking
or have recently taken any other
medicines, including medicines
obtained without a prescription.
Pregnancy and breast-feeding
You MUST NOT take Riluzole if you are
pregnant or think you may be pregnant.
You MUST NOT take Riluzole 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
Always take Riluzole exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you
are not sure.
The recommended dose is one tablet
twice a day.
You should take this medicine by mouth
on a regular basis, every 12 hours, at
the same time of the day (e.g. in the
morning and evening) each day.
There is no benefit in increasing the
dose above 2 tablets per day. However,
you may encounter more side effects.
If you take more Riluzole film-coated
tablets than you should
If you have accidentally taken too many
tablets, contact your doctor or nearest
hospital emergency department
immediately.
Symptoms of an overdose: neurological
and psychiatric symptoms, acute toxic
brain disease with stupor and coma has
been observed in isolated cases.
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 product, ask your doctor or
pharmacist.

4 POSSIBLE SIDE EFFECTS
Like all medicines, Riluzole can cause
side effects, although not everybody
gets them.

Very common side effects (affects more
than 1 user in 10):
• tiredness,
• feeling sick
• increased blood levels of some
enzymes of the liver (transaminases).
Could be associated with jaundice*
(see BEFORE YOU TAKE RILUZOLE).

product does not require any special
temperature storage conditions.
Medicines should not be disposed of via
wastewater or household waste. Ask
your pharmacist how to dispose of
medicines no longer required. These
measures will help to protect the
environment.

Common side effects (affects 1 to 10 users
6 FURTHER INFORMATION
in 100):
• dizziness
What Riluzole contains
• sleepiness
• The active substance is riluzole. Each
• headache
film-coated tablet contains 50 mg of
• tingling or burning sensation in the
riluzole.
mouth
• The other ingredients are:
• increase in heart beat
• Tablet core: calcium hydrogen
• abdominal pain, vomiting, diarrhoea
phosphate, anhydrous; maize
• pain.
starch, pregelatinised;
croscarmellose sodium; silica,
Uncommon side effects (affects 1 to 10
colloidal anhydrous; magnesium
users in 1,000):
stearate.
• allergic reactions, swelling of the face,
• Tablet coating: OPADRY AMB white
lips, tongue or throat associated with
03F28689 consisting of:
difficulties in breathing and/or
hypromellose; macrogol 6000;
swallowing (angioedema)
titanium dioxide (E171).
• anaemia
• inflammation of the pancreas
What Riluzole looks like and contents of
(pancreatitis)
the pack
• lung inflammation (interstitial lung
Riluzole are white or off-white, oval and
disease).
biconvex film-coated tablets marked RL
50 on one side.
Not known: frequency cannot be
Blister pack size of 50 x1, 56, 60 and 90
estimated from the available data:
film-coated tablets.
• Decreases in the number of white
Not all pack sizes may be marketed.
blood cells (which are important in
fighting infections)
Marketing Authorisation Holder
• liver disease (hepatitis) (see BEFORE TEVA UK Limited, Eastbourne,
YOU TAKE RILUZOLE).
BN22 9AG, UNITED KINGDOM.
You should stop taking Riluzole and see
your doctor immediately if you
experience symptoms of angioedema,
such as
• swollen face, tongue or pharynx
• difficulty to swallow
• hives and difficulties to breathe.
* study data indicate that Asian patients
may be more susceptible to liver
function test abnormalities than
Caucasian patients.

Manufacturer
Actavis hf, Reykjavíkurvegur 76-78,
IS-220 Hafnarfjörður, ICELAND.
This leaflet was last revised in July 2011

If any of the side effects gets serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.

5 HOW TO STORE RILUZOLE
Keep out of the reach and sight of
children.
Do not use Riluzole after the expiry date
which is stated on the carton and the
blister after EXP.
Blisters (aluminium/aluminium): This
medicinal product does not require any
special storage conditions.
Blisters (aluminium/PVC): Keep the
blister in the outer carton in order to
protect from light. This medicinal

41201-A
170 x 320

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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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