Rilutek - patient leaflet, side effects, dosage

- 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 RILUTEK is and what it is used for

• 2. What you need to know before you take RILUTEK

• 3. How to take RILUTEK

• 4. Possible side effects

• 5. How to store RILUTEK

• 6. Contents of the pack and other information

1. What RILUTEK is and what it is used for

What RILUTEK is

The active substance in RILUTEK is riluzole which acts on the nervous system.

What RILUTEK is used for

RILUTEK 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. RILUTEK 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 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 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 RILUTEK:

• – 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 RILUTEK is not recommended because there is no information available in this population.

Other medicines and RILUTEK

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 RILUTEK 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 breast-feed, ask your doctor for advice before taking RILUTEK.

Driving and using machines

You can drive or use any tools or machines, unless you feel dizzy or lightheaded after taking this medicine.

RILUTEK 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 RILUTEK

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 RILUTEK than you should

If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately.

If you forget to take RILUTEK

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 RILUTEK 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 this may be signs of liver disease (hepatitis).Your doctor may do regular blood tests while you are taking RILUTEK 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 side effects (may affect more than 1 in 10 people) of RILUTEK are:

• – tiredness

• – feeling sick

• – increased blood levels of some enzymes of the liver (transaminases).

Common side effects (may affect up to 1 in 10 people) of RILUTEK are:

• – dizziness – numbness or tingling of the mouth – vomiting

• – sleepiness – increase in heartbeat – diarrhoea

• – headache – abdominal pain – pain

Uncommon side effects (may affect up to 1 in 100 people) of RILUTEK are:

• – anaemia

• – allergic reactions

• – inflammation of the pancreas (pancreatitis).

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 national reporting system listed inBy reporting side effects you can help provide more information on the safety of this medicine.

5. 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 the blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

6. Contents of the pack and other information

What RILUTEK contains

• – The active substance is riluzole.

• – The other ingredients are: