Riluzole Sun

PACKAGE LEAFLET

Package leaflet: information for the user

Riluzole SUN 50 mg film-coated tablets

Riluzole
Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Riluzole SUN is and what it is used for
2. What you need to know before taking Riluzole SUN
3. How to take Riluzole SUN
4. Possible side effects
5. How to store Riluzole SUN
6. Contents of the pack and other information

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

What Riluzole SUN is
The active substance of Riluzole SUN 50 mg film-coated tablets is riluzole, which acts on the nervous system.
What Riluzole SUN is used for
Riluzole SUN is used for the treatment of patients with amyotrophic lateral sclerosis (ALS).
ALS is a form of motor neuron disease in which damage to nerve cells responsible for sending impulses to muscles causes weakness, muscle deterioration, and paralysis.
In motor neuron disease, destruction of nerve cells may be caused by excessively high levels of glutamate (a chemical messenger) in the brain and spinal cord. Riluzole SUN inhibits the release of glutamate, thereby helping to prevent damage to nerve cells.
Please consult your doctor for further information on ALS and the reason why this medicine has been prescribed for you.

2. What you need to know before taking Riluzole SUN

Do not take Riluzole SUN

• if you are allergic to riluzole or to any of the other ingredients of this medicine (listed in section 6)
• if you have any liver disease or increased blood levels of certain liver enzymes (transaminases)
• if you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Riluzole SUN

• if you have liver problems: yellowing of the skin or whites of the eyes (jaundice), widespread itching, feeling unwell, malaise
• if you have kidney dysfunction
• if you have fever (sometimes fever may be due to a low white blood cell count, which can increase the risk of infection).

If any of the conditions listed above apply to you or if you have any doubts, consult your doctor who will decide
what to do.
Children and adolescents
If you are under 18 years of age, the use of Riluzole SUN is not recommended due to lack of information in
this patient population.
Other medicines and Riluzole SUN
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
DO NOT TAKE Riluzole SUN if you are pregnant or think you might be, or if you are breastfeeding.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding,
please consult your doctor before taking this medicine.
Driving and using machines
You may drive vehicles or operate tools or machinery unless dizziness or lightheadedness occurs after taking the medicine.
Riluzole SUN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Riluzole SUN

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet twice daily.
The tablets should be taken orally every 12 hours, at the same time each day (for
example, in the morning and in the evening).
If you take more Riluzole SUN than you should
If you take more tablets than prescribed, go immediately to your doctor or to the
nearest hospital emergency department.
If you forget to take Riluzole SUN
If you forget to take a tablet, simply take the next one at the scheduled time.
Do not take a double dose to make up for the missed tablet.
If you have any doubts about how to use this medicine, consult 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 develop fever (raised temperature), as Riluzole SUN may cause a reduction in white blood cells. Your doctor may take a blood sample to check your white blood cell levels, which are important for fighting infections;
• if you develop any of the following symptoms: yellowing of the skin and whites of the eyes (jaundice), widespread itching, feeling unwell, malaise, as these may be signs of liver disease (hepatitis). Your doctor may carry out regular blood tests during treatment with Riluzole SUN to ensure these symptoms do not occur;
• if you develop cough or breathing difficulties, which may be signs of lung disease (called interstitial pneumonia).

Other side effects
Very common side effects (may affect more than 1 in 10 patients) of Riluzole SUN are:

• tiredness
• feeling unwell
• increased blood levels of certain liver enzymes (transaminases)

Common side effects (may affect up to 1 in 10 patients) of Riluzole SUN are:

• dizziness
• somnolence
• headache
• numbness or tingling of the mouth
• increased heart rate
• abdominal pain
• vomiting
• diarrhoea
• pain

Uncommon side effects (may affect up to 1 in 100 patients) of Riluzole SUN are:

• anaemia
• allergic reactions
• inflammation of the pancreas (pancreatitis)

Not known: frequency cannot be estimated from the available data

• skin rash

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Riluzole SUN

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister after Exp. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Riluzolo SUN contains

• The active substance is riluzole. Each coated tablet contains 50 mg of riluzole.
• The other components are:
  Tablet core: anhydrous calcium hydrogen phosphate (E341), microcrystalline cellulose (E460), povidone (K-30) (E1201), sodium croscarmellose (E468), colloidal anhydrous silica (E551), talc, magnesium stearate (E572).
  Tablet coating: Opadry White 03B68903 containing hypromellose 6CP, titanium dioxide (E171), talc, macrogol 400.

Description of the appearance of Riluzolo SUN and contents of the pack
White to off-white, round, biconvex, film-coated tablets, engraved with '538' on one side and plain on the other.
Riluzolo SUN is available in packs of 56 or 98 tablets (4 or 7 blisters containing 14 tablets each) for oral use.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sun Pharma France
31, Rue Des Poissonniers
92200 Neuilly sur Seine
France

Local representative:
Sun Pharma Italia Srl
Viale Giulio Richard, 3
20143 Milano
Italy

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Germany: Riluzol SUN 50 mg Filmtabletten
Italy: Riluzolo SUN 50 mg compresse rivestite con film
Spain: Riluzol SUN 50 mg comprimidos recubiertos con película EFG
United Kingdom: Riluzole 50 mg film-coated tablets