Riluzole Teva 50 Mg Film-Coated Tablets
Illllllll
1005
PACKAGE LEAFLET INFORMATION FOR THE USER
Read all of this leaflet carefully before
you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Riluzole is and what it is used for
2. Before you take Riluzole
3. How to take Riluzole
4. Possible side effects
5. How to store Riluzole
6. Further 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.
\ 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 increased blood levels of some enzymes of the liver (transaminases)
• if you are pregnant or breast-feeding.
Take special care with Riluzole
Tell your doctor:
• 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 you are less than 18 years of age. The use of Riluzole is not recommended in children because there is no information available in this population
• if you experience coughs or difficulties in breathing, as this may be a sign of
If any of the above applies to you, or if you are not sure, tell your doctor who will decide what to do.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding You MUST NOT take Riluzole if you are pregnant or think you may be pregnant. You MUST NOT take Riluzole 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. 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
Always take Riluzole exactly as your doctor has told you. You should 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 by mouth 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 film-coated tablets than you should
If you have accidentally taken too many tablets, contact your doctor or nearest hospital emergency department immediately.
Symptoms of an overdose: neurological and psychiatric symptoms, acute toxic brain disease with stupor and coma has been observed in isolated cases.
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 product, ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Riluzole can cause side effects, although not everybody gets them.
Very common side effects (affects more than 1 user in 10):
• tiredness,
• feeling sick
• increased blood levels of some enzymes of the liver (transaminases). Could be associated with jaundice* (see BEFORE YOU TAKE RILUZOLE).
Common side effects (affects 1 to 10 users in 100):
• dizziness
• sleepiness
• headache
• tingling or burning sensation in the mouth
• increase in heart beat
• abdominal pain, vomiting, diarrhoea
• pain.
Uncommon side effects (affects 1 to 10 users in 1,000):
• allergic reactions, swelling of the face, lips, tongue or throat associated with difficulties in breathing and/or swallowing (angioedema)
• anaemia
• inflammation of the pancreas (pancreatitis)
• lung inflammation (interstitial lung disease).
Not known: frequency cannot be estimated from the available data:
• Decreases in the number of white blood cells (which are important in fighting infections)
• liver disease (hepatitis) (see BEFORE YOU TAKE RILUZOLE).
You should stop taking Riluzole and see your doctor immediately if you experience symptoms of angioedema, such as
• swollen face, tongue or pharynx
• difficulty to swallow
• hives and difficulties to breathe.
• study data indicate that Asian patients may be more susceptible to liver function test abnormalities than Caucasian patients.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5^ HOW TO STORE RILUZOLE
Keep out of the reach and sight of children.
Do not use Riluzole after the expiry date which is stated on the carton and the blister after EXP
Blisters (aluminium/aluminium): This medicinal product does not require any special storage conditions.
Blisters (aluminium/PVC): Keep the blister in the outer carton in order to protect from light. This medicinal
product does not require any special temperature storage conditions. 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.
^ FURTHER INFORMATION
What Riluzole contains
• The active substance is riluzole. Each film-coated tablet contains 50 mg of riluzole.
• The other ingredients are:
• Tablet core: calcium hydrogen phosphate, anhydrous; maize starch, pregelatinised; croscarmellose sodium; silica, colloidal anhydrous; magnesium stearate.
• Tablet coating: OPADRY AMB white 03F28689 consisting of: hypromellose; macrogol 6000; titanium dioxide (E171).
What Riluzole looks like and contents of the pack
Riluzole are white or off-white, oval and biconvex film-coated tablets marked RL 50 on one side.
Blister pack size of 50 x1, 56, 60 and 90 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne,
BN22 9AG, UNITED KINGDOM.
Manufacturer
Actavis hf, Reykjavfkurvegur 76-78, IS-220 HafnarfjorSur, ICELAND.
This leaflet was last revised in July 2011
TEUZD
TEVA UK LIMITED__ 170x320