Riluzole Sandoz

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Riluzole Sandoz 50 mg film-coated tablets

riluzole
Generic medicine
Please read this leaflet carefully before taking this medicine, as it may contain
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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you notice any adverse reaction, inform your doctor or pharmacist. This includes any adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Riluzolo Sandoz is and what it is used for

What Riluzolo Sandoz is
The active substance in Riluzolo Sandoz is riluzole, which acts on the nervous system.
What Riluzolo Sandoz is used for
Riluzolo Sandoz 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 signals 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. Riluzolo Sandoz interrupts the release of glutamate, which may help prevent nerve cell damage.
Please consult your doctor for further information about ALS and the reason why this medicine has been prescribed for you.

2. What you need to know before taking Riluzole Sandoz

Do not take Riluzole Sandoz:

• if you are allergic (hypersensitive) to riluzole or to any of the excipients of this medicine (listed in section 6)
• if you have liver disease or elevated 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 Sandoz:

• if you have liver problems: yellowing of the skin or whites of the eyes (jaundice), itching all over the body, feeling unwell, or nausea
• if your kidneys are not working properly
• if you develop fever: this could be due to a decrease in white blood cells, which may increase the risk of infections
• if you are under 18 years of age. The use of Riluzole Sandoz is not recommended in children, as there is no available information in this population.

If any of the above conditions occur, or if you are unsure, consult your doctor,
who will decide on the appropriate course of action.
Other medicines and Riluzole Sandoz:
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding:
DO NOT take RILUZOLE SANDOZ if you are pregnant or think you might be pregnant, or if you are breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, plan to become pregnant, or intend to breastfeed, consult your doctor before taking this medicine.
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.
Riluzole Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) per film-coated tablet, i.e. essentially "sodium-free".

3. How to take Riluzole Sandoz

Take this medicine exactly as your doctor or pharmacist has told you. If you are in doubt, 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 Sandoz 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 Sandoz
If you have forgotten to take your tablet, skip the missed dose and take the next tablet at your usual time.
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Riluzole Sandoz may cause side effects, although not everybody gets them.
IMPORTANT
Contact your doctor immediately

• if you develop fever (increased body temperature), as Riluzole Sandoz may cause a decrease in the number of white blood cells. Your doctor may ask you to have a blood test to check 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 becoming unwell, as these may indicate liver disease (hepatitis). Your doctor may carry out regular blood tests while you are taking Riluzole Sandoz to ensure this does not occur.
• if you develop cough or breathing difficulties, as these may be signs of a lung disease (called interstitial lung disease).

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

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

Common side effects (may affect more than 1 in 100 people):

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

Uncommon side effects (may affect more than 1 in 1,000 people):

• 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Riluzole Sandoz

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 which is stated on the carton, blister pack, and bottle after the wording “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. Package contents and other information

What Riluzole Sandoz contains
The active substance is riluzole.
Each film-coated tablet contains 50 mg of riluzole.
The excipients are: calcium hydrogen phosphate anhydrous, microcrystalline cellulose,
sodium croscarmellose, magnesium stearate, colloidal anhydrous silica, hypromellose, macrogol, titanium
dioxide.

Description of the appearance of Riluzole Sandoz and package contents
The tablet is white to almost white, film-coated, capsule-shaped, with "RLZ" engraved on one side and smooth on the other.
The tablets are packaged in PVC/Alu blisters placed in cardboard boxes or in HDPE bottles with child-resistant closures.

Pack sizes:
Blister packs: 14, 28, 56, 60, 98 film-coated tablets.
Bottle: 60 film-coated tablets.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
S.C. Sandoz, S.R.L., Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania
LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland
Lek Pharmaceuticals, d.d, Trimlini 2 D, 9220 Lendava, Slovenia

This summary of product characteristics has been approved