RILUZOLE AUROBINDO

PACKAGE LEAFLET: INFORMATION FOR THE USER

Riluzole Aurobindo 50 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

What Riluzole Aurobindo is
The active substance in Riluzole Aurobindo is riluzole, which acts on the nervous system.
What Riluzole Aurobindo is used for
Riluzole Aurobindo is used in patients with amyotrophic lateral sclerosis (ALS).
ALS is a form of motor neuron disease in which damage to nerve cells responsible for sending
instructions to muscles leads to muscle weakness, loss of muscle function, and paralysis.
The destruction of nerve cells in motor neuron disease may be caused by excessive glutamate (a
chemical messenger) in the brain and spinal cord. Riluzole Aurobindo interrupts the release of glutamate and
this may help prevent damage to nerve cells.
Please consult your doctor for further information about ALS and why this medicine has been prescribed for you.

2. What you should know before taking Riluzole Aurobindo

Do not take Riluzole Aurobindo

• If you are allergic to riluzole or to any of the ingredients of Riluzole Aurobindo,
• if you have liver disease or have 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 Aurobindo:

• if you have liver problems: yellowing of the skin or the white part of the eye (jaundice), itching all over the body, feeling unwell, or being unwell
• if your kidneys do not function properly
• if you develop fever: this may be due to a decrease in white blood cells; such a decrease may increase the risk of infections

If any of the above situations occur, or if you are unsure, consult your doctor,
who will decide on the appropriate course of action.
Children and adolescents
If you are under 18 years of age. The use of Riluzole Aurobindo is not recommended in children, as there is no available information in this population.
Taking with other medicines
Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those without a prescription.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
DO NOT take Riluzole Aurobindo if you are pregnant or think you might be pregnant, or if you are breastfeeding.
Driving and using machines
You may drive or operate tools or machinery unless, after taking this medicine, you experience dizziness or a sensation of light-headedness.

3. How to take Riluzole Aurobindo

Take this medicine exactly as directed 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 (e.g. in the morning and evening).
If you take more Riluzole Aurobindo 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 Aurobindo
Do not take a double dose to make up for the forgotten tablet.
If you forget to take your tablet, skip the missed dose and take the next tablet at your usual time.
If you stop taking Riluzole Aurobindo
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Riluzole Aurobindo can cause side effects, although not everyone experiences them.
IMPORTANT
Stop taking Riluzole Aurobindo and contact your doctor immediately if you experience symptoms of
angioedema such as

• swelling of the face, tongue or throat

• difficulty swallowing

• hives and breathing difficulties Contact your doctor immediately

• if you develop fever (raised temperature), as Riluzole Aurobindo may reduce the number of white blood cells. Your doctor may ask you to have a blood test to monitor your white blood cell count, which is important in fighting infections

• if you experience any of the following symptoms: yellowing of the skin or the whites of the eyes (jaundice), itching all over the body, feeling unwell or nausea, as these may indicate liver disease (hepatitis). Your doctor may carry out regular blood tests while you are taking Riluzole Aurobindo to ensure this does not occur

• if you develop cough or breathing difficulties, as these may be signs of a lung disorder (called interstitial lung disease).

Very common (may affect more than 1 in 10 people):

• Tiredness
• Feeling unwell
• Increased blood levels of certain liver enzymes (transaminases). This may be associated with jaundice* (see section 2 “BEFORE TAKING Riluzole Aurobindo”).

Common (may affect up to 1 in 10 people):

• Dizziness
• Drowsiness
• Headache
• Numbness or tingling of the mouth
• Increased heart rate
• Abdominal pain
• Vomiting
• Diarrhoea
• Pain

Uncommon (may affect up to 1 in 100 people):

• Allergic reactions, swelling of the face, lips, tongue or throat associated with breathing and/or swallowing difficulties (angioedema)
• Anaemia
• Inflammation of the pancreas (pancreatitis)

* Data from studies indicate that Asian patients may be more prone to changes in liver function parameters compared to Caucasian patients.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Riluzole Aurobindo

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging and blister.
Blister (Aluminum/Aluminum): This medicine does not require any special storage conditions.
Blister (Aluminum/PVC): Store the blister in the outer packaging to protect it from light.
This medicine does not require any special storage conditions.
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. Package contents and other information

What Riluzolo Aurobindo contains

• The active substance is riluzole. Each film-coated tablet contains 50 mg of riluzole.
• The excipients are:
  • Tablet core: Calcium hydrogen phosphate, anhydrous; pregelatinized maize starch; sodium croscarmellose, colloidal anhydrous silica; magnesium stearate.
  • Tablet coating: OPADRY AMB white 03F28689 consisting of: Hypromellose, Macrogol 6000, titanium dioxide (E171).

Description of the appearance of Riluzolo Aurobindo and the contents of the pack
Riluzolo Aurobindo film-coated tablets are white to cream-coloured, oval, biconvex tablets marked with "RL50".
Blister packs containing 28, 30, 56 and 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe 102, 21047 Saronno (VA)

Manufacturer responsible for batch release
Actavis ehf – Reykjavikurvegur 76-78 – IS-220 Hafnarfjördur (Iceland)
Specifar SA 1, 28 Octovriou str. Agia Varvara, 12351 Athens (Greece)

This medicinal product is authorized in the EEA Member States under the following names:
Belgium: Riluzol AB 50 mg filmomhulde tabletten
Germany: Riluzol-PUREN 50 mg Filmtabletten
Denmark: Riluzol Actavis
Spain: Riluzol Aurovitas 50 mg comprimidos recubiertos con película EFG
France: Riluzole Arrow 50mg, comprimé pelliculé
Iceland: Riluzol Actavis
Italy: Riluzolo Aurobindo
Netherlands: Riluzol Aurobindo 50 mg, filmomhulde tabletten
Norway: Riluzol Actavis
Portugal: Riluzol Aurovitas
Sweden: Riluzol Actavis
United Kingdom: Riluzole Actavis 50 mg Film-Coated Tablets

This summary of product characteristics was last approved in