Riluzole Alkem 50 Mg Film-Coated Tablets
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 foryou.
- 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
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
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;
- 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 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).
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
- 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).
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.
6. Contents of the pack and other information What Riluzole contains
- 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 GutenbergstraBe 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.