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RILUZOLE TEVA 50 MG FILM-COATED TABLETS

Active substance(s): RILUZOLE

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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

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;

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.

270mm

PACKAGE LEAFLET: INFORMATION
FOR THE USER

- 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.

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.

50mm

Riluzole Teva 50 mg
film-coated tablets

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.

50mm

270mm

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).
Common side effects (affects 1 to 10
users in 100):
- dizziness
- sleepiness
- headache
- tingling or burning sensation in the
mouth
- increase in heart beat
- abdominal pain, vomiting, diarrhea
- pain

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
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.

6

FURTHER INFORMATION

What Riluzole contains

- The active substance is riluzole.
Each film-coated tablet contains
50 mg of riluzole.
- The other ingredients are:
- Tablet core: calcium hydrogen
phosphate, anhydrous; maize
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
- Tablet coating: OPADRY AMB white
face, lips, tongue or throat
03F28689 consisting of:
associated with difficulties in
hypromellose; macrogol 6000;
breathing and/or swallowing
titanium dioxide (E171).
(angioedema)
- anaemia
What
Riluzole looks like and contents
- inflammation of the pancreas
of the pack
(pancreatitis)
- lung inflammation (interstitial lung
Riluzole are white
disease).
or off-white, oval
and biconvex
Not known: frequency cannot be
film-coated
estimated from the available data:
tablets marked
- Decreases in the number of white
RL 50 on one side.
blood cells (which are important in
fighting infections)
Blister pack size of 50 x 1, 56, 60 and
- liver disease (hepatitis) (see
90 film-coated tablets
BEFORE YOU TAKE RILUZOLE).
Not all pack sizes may be marketed.
You should stop taking Riluzole and
Marketing Authorisation Holder
see your doctor immediately if you
experience symptoms of angioedema,
TEVA UK Limited, Eastbourne
such as
BN22 9AG, UNITED KINGDOM
- swollen face, tongue or pharynx
- difficulty to swallow
Manufacturer
- hives and difficulties to breath.
Actavis ehf, Reykjavíkurvegur 78,
* study data indicate that Asian
IS-220 Hafnarfjörður, ICELAND
patients may be more susceptible to
This leaflet was last approved in
liver function test abnormalities than
July 2016.
Caucasian patients.
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.

41201-D
18325
PC 1133

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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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