RILUTEK 50 mg. 56 tablets

SANOFI AVENTIS
RILUTEK 50 mg. 56 tablets
€ 415.00
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WHAT RILUTEK IS AND WHAT IT IS USED FOR?
What is RILUTEK?
The active substance in RILUTEK is riluzole which acts on the nervous system.

What is RILUTEK?
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 controlling the muscles lead to weakness, muscle wasting and paralysis.
Dystrophic nerve cells in motor neurone disease may be caused by increased new glutamate (a chemical messenger) in the brain and spinal cord. RILUTEK stops the release of glutamate and this may help to protect the damaged neurons.
Please consult your doctor for more information about ALS and the reason you are prescribed this medicine.

2. BEFORE YOU TAKE RILUTEK
Do not take RILUTEK
- If you are allergic (hypersensitive) to riluzole or any of the other ingredients of RILUTEK,
- Have any liver disease or increased blood levels of certain liver enzymes (transaminases)
- If you are pregnant or breastfeeding.
Take special care with RILUTEK
Tell your doctor:
- If you have any liver problems: yellowing of your skin or the whites of the eyes (jaundice), itching, nausea, vomiting
- If your kidneys are not working very well
- If the fever: this may be due to a decrease in the number of white blood cells, which can cause an increased risk of infection
- If you are under 18 years of age. Not recommended for use RILUTEK in children due to lack of data in this population.
If any of the above applies to you or if you feel unsure, 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 lactation
Should NOT take RILUTEK if you are pregnant or think you are pregnant, or are breast-feeding,.
If you think you may be pregnant or if you intend to breast-feeding, talk to your doctor before you start taking RILUTEK.

Driving and using machines
Do not drive or use any tools or machines if you have vertigo or feel dizzy when taking this medicine.

3. HOW TO TAKE RILUTEK?
The recommended dose is one tablet twice daily.
The tablets should be taken orally, every 12 hours, at the same time of day each day (eg morning and evening).

If you take more RILUTEK than
If you take too many tablets, contact your doctor or nearest emergency center.

If you forget to take RILUTEK
If you forget to take your tablet, skip the missed dose completely and take the next dose at its regular 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, RILUTEK can cause side effects, although not everybody gets them.
IMPORTANT
Tell your doctor immediately
- If you have a fever (high temperature) because RILUTEK may cause a decrease in the number of white blood cells. Your doctor may conduct blood tests to check the number of white blood cells that are important in fighting infections.
- If you have any of the following symptoms: yellowing of your skin or the whites of the eyes (jaundice), itching, nausea, vomiting, as this may be signs of liver disease (hepatitis). Your doctor may do regular blood tests while you are taking RILUTEK, to prevent this.
- If you have a cough or difficulty in breathing, as this may be a sign of lung disease (called interstitial lung disease).

Very common side effects (affecting more than 1 in 10 patients) of RILUTEK are:
- Tiredness,
- Nausea,
- Increased blood levels of certain liver enzymes (transaminases).
Common side effects (between 1 in 10 and 1 in 100 patients) of RILUTEK are:
- dizziness
- Numbness or tingling around the mouth
- vomiting
- sleepiness
- Increase in heart rate
- diarrhea
- headache
- Abdominal pain
- pain
- Abdominal pain
- pain
Uncommon side effects (between 1 in 100 and 1 in 1000 patients) of RILUTEK are:
- Anemia
- Allergic reactions
- Inflammation of the pancreas (pancreatitis).
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE RILUTEK?
Keep out of reach of children.
Do not use RILUTEK after the expiry date stated on the carton and blister.

6. FURTHER INFORMATION
What RILUTEK?
- The active substance is riluzole.
- The other ingredients are:
Core: anhydrous dibasic calcium phosphate, microcrystalline cellulose, silica, colloidal anhydrous, magnesium stearate, croscarmellose sodium; Coating: hypromellose, macrogol 6000, titanium dioxide (E 171).
RILUTEK looks like and contents of the pack?
The tablets are film-coated, capsule-shaped and white. Each tablet contains 50 mg of riluzole and is engraved with "RPR 202" on one side.
RILUTEK is available in a pack of 56 tablets (4 blister cards of 14 tablets each) to be taken orally.
€ 415.00
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