Patient Leaflet Updated 20-Feb-2018 | Ranbaxy (UK) Limited a Sun Pharmaceutical Company
Riluzole 50 mg film-coated tablets
Package leaflet: Information for the user
Riluzole 50 mg film-coated tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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
1. What Riluzole is and what it is used for
What Riluzole is
The active substance in Riluzole 50 mg film-coated tablets is riluzole which acts on the nervous system.
What Riluzole is used for
Riluzole is used in patients with amyotrophic lateral sclerosis (ALS).
ALS is a form of motor neurone disease where damage to the nerve cells responsible for sending instructions to the muscles lead to weakness, muscle wastage 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
Warnings and precautions
Talk to your doctor or pharmacist before taking Riluzole:
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 and breast-feeding
You MUST NOT take Riluzole if you are or think you may be pregnant, or if you are breast-feeding.
If you are pregnant or breast-feeding, 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
You can drive or use any tools or machines, unless you feel dizzy or light headed after taking this medicine.
Riluzole contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.
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).
If you take more Riluzole 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
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
IMPORTANT
Tell your doctor immediately
Other side effects
Very common side effects (may affect more than 1 in 10 patients) of Riluzole are:
Common side effects (may affect up to 1 in 10 patients) of Riluzole are:
Uncommon side effects (may affect up to 1 in 100 patients) of Riluzole are:
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 the Yellow Card Scheme, www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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.
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 after EXP. 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.
6. Contents of the pack and other information
What Riluzole contains
What Riluzole looks like and content of the pack
The tablets are white to off white coloured, round shape, biconvex, film coated tablets debossed with ‘538’ on one side and plain on the other side.
Riluzole is available in a pack of 56 or 98 tablets (4 or 7 blister cards of 14 tablets each) to be taken orally.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany: Riluzol SUN 50 mg Filmtabletten
Italy: Riluzolo SUN 50 mg compresse rivestite con film
Spain: Riluzol SUN 50 mg comprimidos recubiertos con película EFG
United Kingdom: Riluzole 50 mg film-coated tablets
This leaflet was last revised in 02/2018.
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