Skip to Content

RILUZOLE ALKEM 50 MG FILM COATED TABLETS

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

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 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

4.

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 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).

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. See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Riluzole is and what it is used for
What you need to know before you take Riluzole
How to take Riluzole
Possible side effects
How to store Riluzole
Contents of the pack and other information

1.

What Riluzole is and what it is used for

The active substance in this medicine is riluzole which acts
on the nervous system.
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 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 your doctor 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;

Possible side effects

Other side effects
Very common (may affect more than 1 in 10 people):
– tiredness
– feeling sick
– increased blood levels of some enzymes of the liver
(transaminases).
Common (may affect up to 1 in 10 people):










dizziness
sleepiness
headache
numbness or tingling of the mouth
increased in heart beat
abdominal pain
vomiting
diarrhoea
pain

Uncommon (may affect up to 1 in 100 people):
– anaemia
– allergic reactions
– inflammation of the pancreas (pancreatitis).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the
Yellow Card Scheme at : www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.
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 after EXP.
The expiry date refers to the last day of the 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.



if your kidneys are not working very well;



if you have any fever: it may be due to a low number of

6. Contents of the pack and other information
What Riluzole contains

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
If you are less than 18 years of age, the use of Riluzole is not
recommended 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, breast-feeding and fertility
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 this medicine.
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 this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
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).

The active substance is riluzole. Each tablet contains
50 mg of riluzole.
– The other ingredients are:
Core: dibasic calcium phosphate dihydrate, croscarmellose
sodium, hypromellose, microcrystalline cellulose, colloidal
silicon dioxide, magnesium stearate.
Coating: hypromellose 2910 (E464), polyethylene glycol
400 (E1521) and titanium dioxide (E171)
What Riluzole looks like and content of the pack
The tablets are film-coated, capsule-shaped and white to
off –white. Each tablet is debossed with “RIL” on one side
and “50”on other side.
Riluzole 50 mg film-coated tablet is available in a pack of 56
and 98 tablets to be taken orally.
Marketing Authorisation Holder:
ALKEM PHARMA GmbH
Gutenbergstraße 13,
24941 Flensburg
Germany
Manufacturer
Wave Pharma Limited
4th floor, Cavendish House,
369 Burnt Oak Broadway, Edgware,
Middlesex HA8 5AW, United Kingdom
Marketed by :
Ascend Laboratories (UK) Limited.
5th Floor, 89, New Bond Street,
London, W1S1DA
United Kingdom.
This leaflet was last revised in 11/2015

If you take more Riluzole than you should
If you take too many tablets, contact your doctor or the
nearest hospital emergency department immediately.

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.

PT 2359-01

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.

Expand Transcript

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.

Hide