Package leaflet: Information for the user

Riluzole Zentiva 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 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

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

What Riluzole Zentiva is and what it is used for What Riluzole Zentiva is
The active substance in Riluzole Zentiva is riluzole which acts on the nervous system.

What Riluzole Zentiva is used for

Riluzole Zentiva 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 Zentiva 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.
What you need to know before you take Riluzole Zentiva Do not take Riluzole Zentiva
- 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 Zentiva:
- 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
  If you are less than 18 years of age, the use of Riluzole Zentiva is not recommended because there is no information available in this population.
  
  Other medicines and Riluzole Zentiva
  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 Zentiva 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 breast-feed, ask your doctor for advice before taking Riluzole Zentiva.
  
  Driving and using machines
  You can drive or use any tools or machines, unless you feel dizzy or light headed after taking this medicine.
How to take Riluzole Zentiva

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).

If you take more Riluzole Zentiva 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 Zentiva

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.

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 Zentiva 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 Zentiva 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).

Other side effects
Very common side effects (may affect more than 1 in 10 people) of Riluzole Zentiva 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 Zentiva are:

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

Uncommon side effects (may affect up to 1 in 100 people) of Riluzole Zentiva are:

anaemia
allergic reactions
inflammation of the pancreas (pancreatitis).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via thenationalreportingsystem listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

How to store Riluzole Zentiva

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 that month.

This medicine does not require any special storage conditions.
Contents of the pack and other information What Riluzole Zentiva contains