Skip to Content

RILUZOLE ACTAVIS 50 MG FILM-COATED TABLETS

Active substance(s): RILUZOLE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Riluzole 50mg
film-coated tablets
Read all of this leaflet carefully before
2 Before you take
Do not take Riluzole if you
you start taking this medicine.
• are allergic (hypersensitive) to riluzole or
• Keep this leaflet. You may need to read it
any of the other ingredients of Riluzole
again.
tablets.
• If you have any further questions, ask your
• have any liver disease or increased blood
levels of some enzymes of the liver
doctor or pharmacist.
(transaminases).
• This medicine has been prescribed for you.
• are pregnant or breast-feeding.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
Take special care with Riluzole
Tell your doctor
as yours.
• if you have any liver problems: yellowing
• If any of the side effects gets serious, or
of your skin or the white of your eyes
if you notice any side effects not listed
(jaundice), itching all over, feeling sick,
being sick
in this leaflet, please tell your doctor or

if your kidneys are not working very well
pharmacist.

In this leaflet:
1 What Riluzole is and what it is used
for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

• if you have any fever: it may be due to a
low number of white blood cells which can
cause an in creased 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

1 What Riluzole is and what it is used
for

You must not take Riluzole if you are or think
you may be pregnant, or if you are breast
feeding.

What Riluzole is
The active substance in Riluzole is riluzole
which acts on the nervous system.

If you think you may be pregnant, or if you
intend to breast-feed, ask your doctor for
advice before taking Riluzole.

What Riluzole is used for
Riluzole is used in patients with amyotrophic
lateral sclerosis (ALS).

Driving and using machines

ALS is a form of motor nervous disease
where attacks of the nerve cells responsible
for sending instructions to the muscles lead
to weakness, muscle waste and paralysis.

You can drive or use any tools or machines,
unless you feel dizzy or light headed after
taking this medicine.

The distruction 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.

Continued over page
17980
PC 830

Continued top of next column
AAAI7517

Riluzole 50 mg Tablets PIL UK

1. black

item no:

AAAI7517

dimensions: 170 x 320

print proof no:

4

pharmacode: 830 / 17980

origination date: 5.2.16
approved for print/date

colours/plates:

min pt size:

10.5 pt

originated by:

db

revision date:

19.2.15

Technical Approval

revised by:

db

date sent:

supplier:

Specifar

approved:

2.
3.
4.
5.
6.

5.2.16

Non Printing Colours
1. profile
2.
3.

* Please note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

3 How to take

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.

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 tablets than
you should
If you have taken too many tablets,
contact your doctor or the nearest hospital
emergency department immediately.

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).

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.

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.

4 Possible side effects

Like all medicines, Riluzole can cause side
effects, although not everybody gets them.

5 How to store

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.
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.

Important
You should stop taking Riluzole and
see your doctor immediately if you
experience symptoms of angiodema, such
as
• s wollen face, tongue or pharynx
•d
 ifficulty 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.
• 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.
• cough or difficulties in breathing, as this
may be a sign of lung disease (called
interstitial lung disease).

6 Further information

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, study data
indicates that Asian patients may be
more susceptible to liver function test
abnormalities than Caucasian patients (see
before you take).

What Riluzole contains

• The active substance is riluzole. Each filmcoated tablet contains 50mg 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 tablets are white to off white, oval
and biconvex film-coated tablets marked
RL 50.
Pack sizes of 56 film-coated tablets
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegur 76-78,
220 Hafnarfjordur,
Iceland
Manufacturer
Specifar S.A.,
1, 28 Octovriou str.,
Agia Varvara Attiki, 12351,
Greece
This leaflet was last revised in February
2016

Actavis, Barnstaple, EX32 8NS, UK
17980
PC 830

Continued top of next column
AAAI7517

Riluzole 50 mg Tablets PIL UK

1. black

item no:

AAAI7517

dimensions: 170 x 320

print proof no:

4

pharmacode: 830 / 17980

origination date: 5.2.16
approved for print/date

colours/plates:

min pt size:

10.5 pt

originated by:

db

revision date:

19.2.15

Technical Approval

revised by:

db

date sent:

supplier:

Specifar

approved:

2.
3.
4.
5.
6.

5.2.16

Non Printing Colours
1. profile
2.
3.

* Please note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

Expand view ⇕

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