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Riluzole Zentiva - patient leaflet, side effects, dosage

Contains active substance :

ATC code:

Dostupné balení:


Sources: Original PDF (ema.europa.eu)

Patient leaflet - Riluzole Zentiva

- 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 Zentiva is and what it is used for

  • 2. What you need to know before you take Riluzole Zentiva

  • 3. How to take Riluzole Zentiva

  • 4. Possible side effects

  • 5. How to store Riluzole Zentiva

  • 6. Contents of the pack and other information

1. What Riluzole Zentiva is and what it is used for

What Riluzole Zentiva is

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

What Riluzole Zentiva is used for

Riluzole Zentiva 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 Zentiva 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 Zentiva

Do not take Riluzole Zentiva

  • – 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 Zentiva:

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

Other medicines and Riluzole Zentiva

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 Zentiva 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 Riluzole Zentiva.

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 Zentiva

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 Zentiva 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 Zentiva

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 Zentiva 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 Riluzole Zentiva 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 Riluzole Zentiva 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 Riluzole Zentiva are:

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

  • – sleepiness – increase in heart beat – diarrhoea

  • – headache – abdominal pain – pain

Uncommon side effects (may affect up to 1 in 100 people) of Riluzole Zentiva 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 in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Riluzole Zentiva

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 Riluzole Zentiva contains

  • – The active substance is riluzole.

  • – The other ingredients are:

Sources: Original PDF (ema.europa.eu)

The drug is classified in the ATC tree:

N NERVOUS SYSTEM DRUGS

N07 OTHER NERVOUS SYSTEM DRUGS in ATC

N07X OTHER NERVOUS SYSTEM DRUGS in ATC

N07XX Other nervous system drugs in ATC

N07XX02 riluzole

Frequently Asked Questions

What is Riluzole Zentiva used for?

Riluzole Zentiva is primarily used to treat amyotrophic lateral sclerosis (ALS), a condition that affects nerve cells in the brain and spinal cord.

How does Riluzole Zentiva work in the body?

Riluzole Zentiva works by reducing the release of glutamate, a neurotransmitter that can damage nerve cells when levels are too high, thereby slowing the progression of ALS.

What should I do if I miss a dose of Riluzole Zentiva?

If you miss a dose of Riluzole Zentiva, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at once.

Can I drink alcohol while taking Riluzole Zentiva?

It is advisable to limit alcohol consumption while taking Riluzole Zentiva, as alcohol can increase the risk of side effects and may impact liver function.

Are there any dietary restrictions while on Riluzole Zentiva?

There are no specific dietary restrictions with Riluzole Zentiva, but maintaining a balanced diet can help support overall health.

What are common side effects of Riluzole Zentiva?

Common side effects include nausea, diarrhea, and fatigue. If you experience serious side effects like liver problems or allergic reactions, seek medical attention immediately.

Can Riluzole Zentiva interact with other medications?

Yes, Riluzole Zentiva can interact with certain medications such as antidepressants and anticoagulants. Always inform your doctor about all medications you are taking.

Is Riluzole Zentiva safe during pregnancy or breastfeeding?

Riluzole Zentiva should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Consult your doctor if you are pregnant or breastfeeding.

How should I store Riluzole Zentiva?

Store Riluzole Zentiva at room temperature away from moisture and heat. Keep it out of reach of children.

What happens if I overdose on Riluzole Zentiva?

An overdose may lead to symptoms such as nausea, vomiting, or liver complications. Seek immediate medical help if an overdose is suspected.

Can I stop taking Riluzole Zentiva suddenly?

Do not stop taking Riluzole Zentiva suddenly without consulting your doctor, as this may worsen your condition.

How long does it take for Riluzole Zentiva to work?

Some patients may notice an improvement in symptoms within a few weeks, but it may take several months to see full benefits.

Will I need regular blood tests while on Riluzole Zentiva?

Yes, regular blood tests may be required to monitor liver function and ensure safe use of the medication.

Is there a generic version of Riluzole available?

Yes, generic versions of Riluzole are available and they contain the same active ingredient as brand name versions like Rilutek.

Can children take Riluzole Zentiva?

Riluzole is generally not indicated for use in children; consult your healthcare provider for advice specific to pediatric use.

Can I take herbal supplements while on Riluzole Zentiva?

You should consult your healthcare provider before taking herbal supplements alongside Riluzole to avoid potential interactions.

Does Riluzole affect mood or emotional state?

Some patients report mood changes while taking Riluzole. If you experience significant mood swings or depression, contact your doctor.

How often do I need to take Riluzole Zentiva?

Riluzole is typically taken twice daily; however, follow your doctor's instructions regarding dosage and timing.