Riluzole 50mg Film-Coated Tablets
4. Possible side effects
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 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.
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
Riluzole is a nervous system medicine.
Riluzole has been prescribed by your doctor for a disease of the nervous system affecting your muscle strength called amyotrophic lateral sclerosis. Your doctor may give you further information about 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 (hypersensitive) to riluzole or any of the other ingredients of riluzole,
• if you have any liver disease or abnormal elevations of some enzymes of the liver (transaminases),
• if you are pregnant or breast-feeding.
Warnings and precautions
• if you experience increased blood levels of some enzymes of the liver (transaminases), your doctor will do regular blood tests to follow this during treatment and will take the necessary measures, because of the risk of hepatitis.
• if you experience any fever (increase in temperature), you must call your doctor immediately. This may be a sign of decrease in the number of white blood cells which are important in fighting infections.
• if you develop cough or difficulties in breathing after taking riluzole, you should tell your doctor.
• if you have any kidney disease, you should tell your doctor.
Children and adolescents
Riluzole Tablets is not recommended for use in children and adolescents.
Other medicines and Riluzole
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
if you are pregnant or think you are, you must NOT take riluzole. You must NOT breast-feed if you are taking riluzole.
if you 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
Do not drive or use machines if you have vertigo or feel dizzy when you take riluzole.
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.
You should take this medicine orally on a regular basis, every 12 hours, at the same time of the day (e.g. in the morning and evening) each day.
There is no benefit in increasing the dose above 2 tablets per day. However, you may encounter more side effects.
If you take more Riluzole than you should
if you have accidentally taken too many tablets, contact your doctor.
If you forget to take Riluzole
if you forget to take your tablet, take the next tablet as originally planned.
Do not take a double dose to make up for a forgotten tablet.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
IMPORTANT
Tell your doctor immediately
• if you experience serious allergic reaction which causes difficulty in breathing, dizziness, swelling of the face or throat.
• 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.
• 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 these 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).
The most common side effects (may affect more than 1 in 10 people) of riluzole are tiredness, feeling sick and increased blood levels of some enzymes of the liver (transaminases) (see What you need to know before you take Riluzole).
The following side effects are common (may affect up to 1 in 10 people): dizziness, sleepiness, headache, numbness or tingling of the mouth, increase in heart beat, abdominal pain, vomiting, diarrhoea, and pain.
The uncommon side effects (may affect up to 1 in 100 people) of riluzole are: anaemia, allergic reactions, inflammation of the pancreas (pancreatitis) and interstitial lung disease.
if you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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. 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
- The active substance is riluzole 50 mg.
- The other ingredients are: calcium hydrogen phosphate anhydrous, maize starch, croscarmellose sodium, silica colloidal, anhydrous, magnesium stearate, hypromellose, macrogol and titanium dioxide.
What Riluzole looks like and contents of the pack
Riluzole are white or off-white, oval and biconvex film-coated
tablets with the dimensions of 5.2 x 10 mm and marked RL 50 on
one side.
Pack sizes:
Blisters:
1, 14, 28, 30, 56 and 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Aptil Pharma Limited Unit 4, Charlwood Court County Oak Way Crawley West Sussex
RH11 7XA
Manufacturer:
Actavis ehf.
Reykjavikurvegur 78, iS-220 Hafnafjordur
Iceland
if you have any further questions on the use of this medicine, ask your doctor or pharmacist.
This leaflet was last revised in
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APTIL Riluzole 50 mg PIL V2- Second Proof 22.11.12 (First Proof 23.10.12) | |
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