50 mg film-coated tablets
riluzole
What RILUTEK is and what it is used for
What R ILUTEK is
The active substance in R ILUTEK is riluzole, which acts on the nervous system.
What R ILUTEK is used for
R ILUTEK is used in patients with amyotrophic lateral sclerosis ( ALS ).
ALS is a type of motor neuron disease that attacks the nerve cells, which are responsible for sending instructions to the muscles, leading to weakness, muscle waste, ing, and paralysis.
The breakdown of nerve cells in a motor neuron disease can be due to too much glutamate (a chemical messenger) in the brain and spinal cord. R ILUTEK stops the release of glutamate and this can help prevent nerve cells from being destroyed.
Ask your doctor for more information about ALS and why you have been prescribed this medicine.
What you need to know before taking RILUTEK
Do not take RILUTEK
- 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 high blood levels of certain liver enzymes ( transaminases )
- if you are pregnant or breastfeeding
Warnings and cautions
Talk to a doctor before taking R ILUTEK :
- if you have liver problems: skin or whites of the eyes have turned yellow (jaundice), itching all over your body, you feel nauseous, suffer from vomiting
- if your kidneys are not working so well
- if you have a fever: it may be due to a low number of white blood cells, which may cause an increased risk of infection
If any of the above applies to you or if you are not sure, talk to your doctor, who will decide what to do next.
Children and young people
If you are under 18 years of age, the use of R ILUTEK is not recommended as data are not available for this patient group.
Other medicines and RILUTEK
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
You should NOT take R ILUTEK if you are pregnant or think you may be pregnant, or if you are breastfeeding.
If you think you may be pregnant or are planning to breastfeed, talk to your doctor before taking R ILUTEK.
Driving and using machines
You can drive and use tools or machines unless you feel dizzy or dizzy after taking this medicine.
RILUTEK contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet.
ie is almost “sodium-free”.
How to take RILUTEK
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one tablet twice daily.
The tablets should be taken by mouth every 12 hours at the same time each day (eg morning and evening).
If you take more RILUTEK than you should
If you have taken too many tablets, contact your doctor or the nearest emergency department immediately.
If you forget to take RILUTEK
If you forget to take one tablet, skip the dose and take the next tablet as usual. 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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
IMPORTANT
Tell your doctor immediately
- if you get a fever (elevated temperature) R ILUTEK may reduce the number of white blood cells. Your doctor may want to take a blood test to check the number of white blood cells, which are important in fighting infection.
- if you experience any of the following symptoms: skin or whites of the eyes turn yellow (jaundice), itching all over your body, nausea or vomiting, as these may be signs of liver disease ( hepatitis ). Your doctor may need to perform regular blood tests while you are taking R ILUTEK, to check that this is not happening.
- if you have a cough or difficulty breathing, as this may be a sign of a lung disease (called interstitial lung disease).
Other side effects ar
Very common side effects (which may affect more than 1 in 10 people), when treated with R ILUTEK, are:
- fatigue
- nausea
- elevated blood levels of certain liver enzymes ( transaminases )
Common side effects (which may affect up to 1 in 10 people), when treated with R ILUTEK, are:
| dizzinesssomnolenceheadache | tingling in the mouth increase in heart rate one abdominal pain | vomitingdiarrheapain |
Uncommon side effects ( may affect up to 1 in 100 people), when treated with R ILUTEK, are:
- anemia
- allergic reactions
- inflammation of the pancreas ( pancreatitis )
How to store RILUTEK
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 blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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.
Contents of the package and other information
Content declaration
- The active substance is riluzole.
- Other ingredients are:
Tablet core: calcium hydrogen phosphate (anhydrous), microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, croscarmellose sodium;
Coating: hypromellose, Macrogol 6000, titanium dioxide (E171).
What the medicine looks like and the contents of the pack
The tablets are film-coated, capsule-shaped, and white. Each tablet contains 50 mg of riluzole and is marked with “RPR 202” on one side.
R ILUTEK is supplied in a pack of 56 tablets to be taken by mouth.
Marketing Authorisation Holder
Sanofi Mature IP
54 Rue de la Boétie
75008 Paris
France
Manufacturer
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne
France
Contact the representative of the marketing authorization holder to find out more about this medicine:
Sanofi AB
Tel: +46 (0) 8 634 50 00