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RILUZOLE ZENTIVA 50 MG FILM-COATED TABLETS

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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 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.
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 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 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 (hypersensitive) 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 you doctor or pharmacist before taking 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
The use of riluzole is not recommended in children and adolescents less than 18 years of age
because there is no information available in this population.
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 pregnant or breast-feeding or think you may be
pregnant.
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 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).

Very common side effects (may affect more than 1 in 10 people) of riluzole are:
tiredness
feeling sick
increased blood levels of some enzymes of the liver (transaminases).
Common side effects (may affect up to 1 in 10 people) of riluzole are:
dizziness
numbness or tingling of the
vomiting
mouth
sleepiness
increase in heart beat
diarrhoea
headache
abdominal pain
pain
-

Uncommon side effects (may affect up to 1 in 100 people) of riluzole are:
anaemia
allergic reactions
inflammation of the pancreas (pancreatitis).
-

If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet.
5.

HOW TO STORE RILUZOLE

Keep this medicine out of the sight and reach of children.
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.
This medicine does not require any special storage conditions.
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 50mg film-coated tablets contain
The active substance of Riluzole 50mg film-coated tablets is riluzole.

Each film-coated tablet contains 50 mg of riluzole.
The other ingredients are:
Core: anhydrous dibasic calcium phosphate, microcrystalline cellulose, anhydrous colloidal
silica, magnesium stearate, croscarmellose sodium;
Coating: hypromellose, macrogol 6000, titanium dioxide (E171).
What Riluzole 50mg film-coated tablets look like and contents of the pack
White, capsule-shaped film-coated tablet, engraved with “RPR 202” on one side.
Riluzole 50mg film-coated tablets are available in a pack of 56 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Manufacturer
Sanofi Winthrop Industrie, 56, Route de Choisy au Bac, F-60205 Compiègne, France.
This leaflet was last revised in October 2012.
’Zentiva’ is a registerd trademark © 2012 Zentiva

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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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