InfoCons Consumer Protection informs you – Cenrifki – Package Leaflet

Before anything else

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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.

ℹ️ 1. What Cenrifki is and what it is used for

Cenrifki contains the active substance to lebrutinib. It is a protein kinase inhibitor , which is a type of substance that adjusts the immune system.

Cenrifki is used in adults to treat secondary progressive m ultiple s clerosis (SPMS) who have not experienced any relapses in the last 2 years.

Multiple s clerosis (MS) affects the central nervous system, especially the nerves in the brain and spinal cord. In MS, the immune system (the body’s defence system) works incorrectly and attacks a protective layer (called the myelin sheath) around nerve cells and causes inflammation which stops the nerves from working properly. Secondary progressive multiple sclerosis (SPMS) is described as a stage of the disease that follows an initial period of relapsing MS (RMS) and is marked by a gradual, steady worseni ng of neurological function and increasing disability.

Although the way t he active substance in Cenrifki, tolebrutinib, works is not clearly understood it is thought to target specific immune cells in the central nervous system, known as B cells and microglia.

This is expected to reduce activation of the immune system and prevent s inflammation caused by MS , which slows the progression of the disease.

⚠️ 2. What you need to know before you take Cenrifki

Do not take Cenrifki

• if you are allergic to tolebrutinib or any of the other ingredients of this medicine (listed in section 6).
• if you have moderate to severe liver problems.
• if you have a severely weakened immune system ( e.g., if you have acquired immunodeficiency syndrome ( AIDS ), bone marrow disease, or severe infections that are not under control).

If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cenrifki:

• if you suffer from liver disease
• if you are taking or plan to take other medicines that may affect your liver, especially during the first 12 weeks of Cenrifki treatment. Your doctor may need to consider alternative options for those medicines.
• if you are using or plan to use herbal or dietary supplements. Some of these may potentially affect your liver, and you should avoid using them while taking Cenrifki.
• if you have an infection, or you are unable to fight infections (see section 2 ‘Infections’).
• if you are going to have a vaccination (see section 2 ‘Vaccinations’).
• if you have a bleeding disorder, have recently undergone surgery or have one scheduled, or are taking medicines that may increase your risk of bleeding (see section 2 ‘Other medicines and Cenrifki’).
• if you have a history of irregular heartbeat particularly atrial fibrillation.
• if you have or have had thoughts of harming or killing yourself. You (or your caregiver) should contact your doctor immediately if any such thoughts occur.
• if you are taking medicines that can affect the levels of Cenrifki in your blood (see section 2 ‘Other medicines and Cenrifki’) This medicine may cause your liver to not work properly, particularly in the first 12 weeks. Inform your doctor immediately if you have signs that could indicate potential liver problems such as:
• tiredness
• nausea
• vomiting
• pain in the abdomen (belly)
• fever
• rash or itching of your skin
• loss of appetite or loss of interest in food
• dark urine
• yellowing of skin or eyes (jaundice) To help reduce your risk of liver problems, your healthcare provider will do a blood test to check your liver:
• before you start taking this medicine ,
• after you start taking this medicine,
• once every 7 days for the first 12 weeks,
• then once a month from months 4 to 12,
• then once every 6 months from months 12 till 2 4,
• thereafter, your healthcare provider will advise you on when to schedule future blood tests and how often they should be carried out.

If you had to stop taking Cenrifki because of abnormal liver test results, or if there has been a break in your treatment of one year or more, you should begin the blood test schedule outlined above from the start when you restart Cenrifki treatment.

If you miss a scheduled blood test, immediately inform your doctor and reschedule the blood test to be completed as soon as possible.

Infections

• Talk to your doctor before taking Cenrifki if you have an infection or are unable to fight infections. Cenrifki may make you more likely to get infections. If you have an active infection, you must not start taking Cenrifki until the infection has cleared up.
• Tell your doctor straight away if you develop any signs or symptoms of infection such as cough, fever, blocked or runny nose, sore throat, or headache, during treatment with Cenrifki. Your doctor will evaluate you and may need to stop your treatment temporarily if you develop a serious infection.

32 – Medicines that can weaken your immune system (such as immunosuppressants), may increase your risk of getting infections when used together with Cenrifki (see section 2 ‘Other medicines and Cenrifki’). Your doctor will advise you on the most appropriate course of action should you need to take such medicines while on Cenrifki treatment.

Vaccinations

• Tell your doctor if you have recently been given any vaccine or are going to get one in the near future.
• You must avoid vaccinations with live or live attenuated vaccines during treatment with Cenrifki, as it may make you more likely to get infections (see section 2 ‘Other medicines and Cenrifki’).
• If you need a live or live attenuated vaccine, it should be given at least 2 months before you start treatment with Cenrifki.
• Cenrifki may affect how well non -live vaccines work. Your doctor may advise you to complete all recommended non -live vaccinations before you start treatment with Cenrifki.

Patient guide Your doctor will give you a p atient guide which contains important safety information you need to be aware of when receiving treatment with Cenrifki . It is important that you read this guide.

Patient card A patient card is included in this pack. Read the card carefully, keep it with you at all times during treatment, and show it to any healthcare professional involved in your care.

Children and adolescents

Do not give this medicinal product to children and adolescents less than 18 years of age . The safety and efficacy of Cenrifki have not been established.

Other medicines and Cenrifki

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken or might take any other medicines. This includes prescription medicines, medicines obtained without a prescription, herbal medicines, and supplements. Cenrifki may affect the way some other medicines work and because some other medicines can affect the way this medicine works. Medicines, herbal or dietary supplements that could be harmful to the liver, may increase the chance of liver damage when taken with Cenrifki (see section 2 ‘Warnings and precautions’).

In particular, before taking this medicine , tell your doctor if you are taking or have recently taken any of the following medicines .

Medicines that can increase the levels of Cenrifki in your blood, which may increase your risk of side effects. Examples include:

• Gemfibrozil – a medicine used to lower cholesterol
• Deferasirox – a medicine used to treat iron overload
• Letermovir – a medicine used to prevent viral infections after bone marrow transplant
• Selpercatinib – a medicine used to treat certain types of cancer Medicines that can decrease the levels of Cenrifki in your blood, which may make Cenrifki less effective. Examples include:
• St John’s wort – a herbal product used to treat depression
• Rifampicin, Nafcillin – antibiotics used to treat bacterial infections
• Carbamazepine, Phenytoin – medicines used to treat epilepsy and nerve pain
• Efavirenz, Etravirine – medicines used to treat HIV infection
• Bosentan – a medicine used to treat high blood pressure in the lungs Medicines that can thin your blood, which may increase your risk of bleeding. Examples include :
• Warfarin, Heparin, Apixaban, Rivaroxaban, Edoxaban – medicines that prevent blood clots (anticoagulants) 33 – Clopidogrel, Ticagrelor, Prasugrel – medicines that prevent blood platelets from clumping together (antiplatelet agents) Medicines that may increase your risk of infections. Examples include:
• Medicines that can weaken your immune system – immunosuppressants like mycophenolate mofetil, cyclophosphamide, or azathioprine, as well as medicines used to treat inflammation such as Disease-Modifying Antirheumatic Drugs (DMARDs) or long-term corticosteroids (see section 2 ‘Infections’) .
• Live or live attenuated vaccines – such as chickenpox, oral polio, or nasal flu vaccines (see section 2 ‘Vaccinations’) .

Medicines whose levels in your blood may be increased when taken with Cenrifki, which may increase their risk of side effects. Caution should be taken when such medicines are taken with Cenrifki. Examples include:

• Cyclosporin and tacrolimus – medicines used to reduce immune reactions and prevent organ rejection
• Digoxin – a medicine used to treat abnormal heart rhythm or disorders Pregnancy and breast -feeding If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is limited information about using Cenrifki during pregnancy in humans. A risk to your unborn child cannot be completely ruled out. Therefore, Cenrifki is not recommended during pregnancy and in women who could become pregnant and are not using contr aception .

It is not known whether Cenrifki passes into breast milk. A risk to breast -fed babies cannot be ruled out. If you are breast -feeding or planning to breast -feed, talk to your doctor before using this medicine .

You and your doctor must decide if you should breast -feed while on this medicine , considering the benefits of breast -feeding for your baby and the benefits of this treatment for you .

Driving and using machines

Cenrifki is not expected to affect your ability to drive or to use machines.

Cenrifki contains lactose

Cenrifki contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

💊 3. How to take Cenrifki

Treatment with Cenrifki should be started and supervised by a doctor who is experienced in the treatment of multiple sclerosis.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Cenrifki is available as a tablet which is taken by mouth. The recommended dose is 60 mg taken once daily with a meal preferably at the same time each day. Your doctor will monitor your liver function before and during treatment with Cenrifki. Depending on the results of these liver function tests, your treatment may be temporarily stopped or permanently discontinued.

If you take more Cenrifki than you should

If you have taken too much Cenrifki , talk to a doctor or pharmacist.

If you forget to take Cenrifki

Take the dose as soon as possible on the same day. Do not take a double dose to make up for a missed dose.

If you stop taking Cenrifki

Do not stop taking Cenrifki or change your dose without talking to your doctor first. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

❗ 4. P ossible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Cenrifki may cause your liver not to work properly (may affect up to 1 in 10 people) .

Tell your doctor if you have symptoms such as tiredness, nausea, vomiting, pain in the abdomen, fever, rash or itching of your skin, loss of appetite or interest in food, dark urine, or yellowing of skin or eyes.

Cenrifki may increase your likelihood of developing infections (may affect more than 1 in 10 people) .

This medicine may cause infection of the chest (bronchitis) or lungs (pneumonia) . Tell your doctor if you have or develop symptoms of infection such as cough, fever, blocked or runny nose, sore throat, and headache. Other side effects:

Very Common (may affect more than 1 in 10 people)

• COVID-19

Common (may affect up to 1 in 10 people)

• Influenza
• Small red or purple spot s caused by bleeding into the skin (petechiae).
• Increased chance of bruising
• Belly (abdominal) pain
• Heavy menstrual bleeding
• Bruising (contusion)

Reporting of side effects

If you get any side effects, talk to your doctor or pharm acist. 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.

🌡️ 5. H ow to store Cenrifki

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, wallet card and the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30˚C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Cenrifki contains

The active substance is tolebrutinib. Each film -coated tablet contains 60 mg of tolebrutinib.

35 The other ingredients are lactose monohydrate, microcrystalline cellulose, hypromellose, crospovidone (Type A) , magnesium stearate, titanium dioxide, yellow iron oxide (E172), red iron oxide (E172), macrogol – polyethylene glycol (400) (see section 2 “Cenrifki contains lactose” ).

What Cenrifki looks like and contents of the pack

60 mg film -tablet: orange, drop shape, film -coated tablet of 12.7 mm in length, debossed with “60” on one side.

Your medicine is supplied in the following pack sizes:

Packs of 7 film -coated tablets in 1 alumin ium-alumin ium blister sealed inside a cardboard wallet.

Packs of 28 film -coated tablets in 2 alumin ium-alumin ium blisters (each with 14 tablets) sealed inside a cardboard wallet.

Packs of 98 film -coated tablets in 7 alumin ium-alumin ium blisters (each with 14 tablets) sealed inside a cardboard wallet.

Not all pack sizes may be marketed .

Marketing Authorisation Holder

Sanofi Winthrop Industrie 82 Avenue Raspail 94250, Gentilly France

Manufacturer

Sanofi S.r.l.

Strada Statale 17 Km 22 Scoppito 67019 Italy For any information about this medicine, 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 04 36 996 Tel. aus dem Ausland: +49 69 305 70 13 Nederland Sanofi B.V.

Tel: +31 20 245 4000 Eesti Norge 36 Swixx Biopharma OÜ Tel: +372 640 10 30 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: 800 536 389 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 This leaflet was last revised in .

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

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Cenrifki (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/25/2011).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.