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RILUZOLE 50 MG FILM-COATED TABLETS

Active substance(s): RILUZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Riluzole 50 mg film-coated tablets
Riluzole
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

Pharmacode

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. 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 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 or think you may
be pregnant, or if you are breast feeding
If you think you may be pregnant, or if you intend to breastfeed, 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 film-coated tablets than you
should
If you have 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 product,
ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Riluzole can cause side effects, although
not everybody gets them.
IMPORTANT
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 breath.
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 (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
- numbness or tingling of the mouth
- increase in heart beat
- abdominal pain
- vomiting
- diarrhoea
- pain.
Uncommon side effects (affects 1 to 10 users in 1,000):
- allergic reactions, swelling of the face, lips, tongue or
throat associated with difficulties in breathing and/or
swallowing (angioedema)
- anaemia
- inflammation of the pancreas (pancreatitis).
* study data indicate that Asian patients may be more
susceptible to liver function test abnormalities than
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.
Do not use Riluzole after the expiry date which is stated on
the carton and the blister.
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; crosscarmellose sodium;
silica, colloidal anhydrous; magnesium stearate.
- Tablet coating: OPADRY AMB white 03F28689
consisting of: hypromellose; macrogol 6000; titanium
dioxide (E171).
What Riluzole looks like and contents of the pack
Riluzole are white to off-white, oval and biconvex filmcoated tablets marked RL 50.
Blister pack sizes of 28, 30, 56 and 60 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Limited
Victoria Court, Bexton Road, Knutsford, Cheshire, WA16
0PF
United Kingdom
Tel: +44 1565 751378
Fax: +44 1565 751379
Manufacturer:
Actavis Hf.
Reykjavikurvegi 78, P.O.Box 420,
IS-222 Hafnafjordur
ICELAND
This medicinal product is authorised in the Member
States of the EEA under the following names:
United Kingdom Riluzole 50 mg film-coated tablets
This leaflet was last approved in 06/2013.

ID#: xxxxxx

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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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