riluzole: package leaflet

What RILUTEK is

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

What RILUTEK is used for

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 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. RILUTEK 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.

Do not take RILUTEK
- 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 RILUTEK:
- 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 RILUTEK is not recommended because there is no information available in this population.

Other medicines and RILUTEK
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 RILUTEK 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 RILUTEK.

Driving and using machines
You can drive or use any tools or machines, unless you feel dizzy or lightheaded after taking this medicine.

RILUTEK contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium free”.

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 RILUTEK than you should

If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately.

If you forget to take RILUTEK

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.

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 RILUTEK 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 RILUTEK 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 RILUTEK 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 RILUTEK are:
- dizziness
- numbness or tingling of the mouth
- vomiting
- sleepiness
- increase in heartbeat
- diarrhoea
- headache
- abdominal pain
- pain

Uncommon side effects (may affect up to 1 in 100 people) of RILUTEK are:
- anaemia
- allergic reactions
- inflammation of the pancreas (pancreatitis).

Not known: frequency cannot be estimated from the available data
- rash

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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

What RILUTEK contains

- The active substance is riluzole.
- The other ingredients are:
Core: anhydrous dibasic calcium phosphate, micro crystalline cellulose, anhydrous colloidal silica, magnesium stearate, croscarmellose sodium;
Coating: hypromellose, macrogol 6000, titanium dioxide (E171).

What RILUTEK looks like and content 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 to be taken orally.

Marketing Authorisation Holder
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France

Manufacturer
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne
France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/ Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275
Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131

Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél : 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda.
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525

This leaflet was last approved in {MM/YYYY}.

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.

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.

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.

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).

Not known effects (frequency cannot be estimated from the available data) of Riluzole Zentiva are:
- rash

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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

What Riluzole Zentiva contains

- The active substance is riluzole.
- The other ingredients are:
Core: anhydrous dibasic calcium phosphate, micro crystalline cellulose, anhydrous colloidal silica, magnesium stearate, croscarmellose sodium;
Coating: hypromellose, macrogol 6000, titanium dioxide (E171).

What Riluzole Zentiva looks like and content 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.
Riluzole Zentiva is available in a pack of 28, 56, 98, 112 or 168 tablets to be taken orally.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturers
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne
France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 (78) 700 112
PV-Belgium@zentiva.com

Lietuva
Zentiva, k.s.
Tel: +370 52152025
PV-Lithuania@zentiva.com
България
Zentiva, k.s.
Тел: +35924417136
PV-Bulgaria@zentiva.com

Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
PV-Luxembourg@zentiva.com
Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
PV-Czech-Republic@zentiva.com
Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
PV-Hungary@zentiva.com
Danmark
Zentiva Denmark ApS
Tlf: +45 787 68 400
PV-Denmark@zentiva.com

Malta
Zentiva, k.s.
Tel: +356 2034 1796
PV-Malta@zentiva.com

Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
PV-Germany@zentiva.com

Nederland
Zentiva, k.s.
Tel: +31 202 253 638
PV-Netherlands@zentiva.com
Eesti
Zentiva, k.s.
Tel: +372 52 70308
PV-Estonia@zentiva.com

Norge
Zentiva Denmark ApS
Tlf: +45 787 68 400
PV-Norway@zentiva.com
Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
PV-Greece@zentiva.com

Österreich
Zentiva, k.s.
Tel: +43 720 778 877
PV-Austria@zentiva.com
España
Zentiva, k.s.
Tel: +34 671 365 828
PV-Spain@zentiva.com

Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
PV-Poland@zentiva.com
France
Zentiva France
Tél: +33 (0) 800 089 219
PV-France@zentiva.com

Portugal
Zentiva Portugal, Lda
Tel: +351210601360
PV-Portugal@zentiva.com
Hrvatska
Zentiva d. o. o.
Tel: +385 1 6641 830
PV-Croatia@zentiva.com

Ireland
Zentiva, k.s.
Tel: +353 818 882 243
PV-Ireland@zentiva.com

România
ZENTIVA S.A.
Tel: +4 021.304.7597
PV-Romania@zentiva.com

Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
PV-Slovenia@zentiva.com
Ísland
Zentiva Denmark ApS
Sími: +354 539 5025
PV-Iceland@zentiva.com

Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
PV-Slovakia@zentiva.com
Italia
Zentiva Italia S.r.l.
Tel:+39 800081631
PV-Italy@zentiva.com
Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
PV-Finland@zentiva.com

Κύπρος
Zentiva, k.s.
Τηλ: +30 211 198 7510
PV-Cyprus@zentiva.com

Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
PV-Sweden@zentiva.com
Latvija
Zentiva, k.s.
Tel: +371 67893939
PV-Latvia@zentiva.com

This leaflet was last revised in <Month YYYY>.

Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu.