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RILUZOLE 50MG FILM-COATED TABLETS

Active substance(s): RILUZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Riluzole 50 mg film-coated tablets
Riluzole

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.

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.

IMPORTANT
Tell your doctor immediately
• If you experience serious allergic reaction which causes
difficulty in breathing, dizziness, swelling of the face or throat.



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.

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



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 these 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).

1. What Riluzole is and what it is used for

The most common side effects (may affect more than 1 in 10
people) of riluzole are tiredness, feeling sick and increased blood
levels of some enzymes of the liver (transaminases) (see What you
need to know before you take Riluzole).

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. 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 riluzole,
• if you have any liver disease or abnormal elevations of some
enzymes of the liver (transaminases),
• if you are pregnant or breast-feeding.
Warnings and precautions
• if you experience increased blood levels of some enzymes of
the liver (transaminases), your doctor will do regular blood
tests to follow this during treatment and will take the
necessary measures, because of the risk of hepatitis.
• if you experience any fever (increase in temperature), you must
call your doctor immediately. This may be a sign of decrease in
the number of white blood cells which are important in
fighting infections.
• if you develop cough or difficulties in breathing after taking
riluzole, you should tell your doctor.
• if you have any kidney disease, you should tell your doctor.

The following side effects are common (may affect up to 1 in 10
people): dizziness, sleepiness, headache, numbness or tingling of
the mouth, increase in heart beat, abdominal pain, vomiting,
diarrhoea, and pain.
The uncommon side effects (may affect up to 1 in 100 people) of
riluzole are: anaemia, allergic reactions, inflammation of the
pancreas (pancreatitis) and interstitial lung disease.
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.
This medicinal product does not require any special 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.

Children and adolescents
Riluzole Tablets is not recommended for use in children and
adolescents.

6. Contents of the pack and other information

Other medicines and Riluzole
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

- The active substance is riluzole 50 mg.
- The other ingredients are: calcium hydrogen phosphate
anhydrous, maize starch, croscarmellose sodium, silica
colloidal, anhydrous, magnesium stearate, hypromellose,
macrogol and titanium dioxide.

Pregnancy and breast-feeding
If you are pregnant or think you are, you must NOT take riluzole.
You must NOT breast-feed if you are taking riluzole.
If you think you may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this medicine.
Driving and using machines
Do not drive or use machines if you have vertigo or feel dizzy
when you take riluzole.

What Riluzole contains

What Riluzole looks like and contents of the pack
Riluzole are white or off-white, oval and biconvex film-coated
tablets with the dimensions of 5.2 x 10 mm and marked RL 50 on
one side.
Pack sizes:
Blisters:
1, 14, 28, 30, 56 and 60 tablets.

3. How to take Riluzole

Not all pack sizes may be marketed.

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

Marketing Authorisation Holder:
Aptil Pharma Limited
Unit 4, Charlwood Court
County Oak Way
Crawley
West Sussex

The recommended dose is one tablet twice a day.
You should take this medicine orally 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 than you should
If you have accidentally taken too many tablets, contact your doctor.
If you forget to take Riluzole
If you forget to take your tablet, take the next tablet as originally
planned.
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.

RH11 7XA
Manufacturer:
Actavis ehf.
Reykjavikurvegur 78,
IS-220 Hafnafjordur
ICELAND

This leaflet was last revised in .

APTIL Riluzole 50 mg PIL V2- Second Proof 22.11.12 (First Proof 23.10.12)
Size 200 x 432 (text area 170 x 320 mm)
Font size 8pt, Font used Myraid Pro Regular and Bold as placed
Minimum document line spacing 3.0 mm

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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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