InfoCons Consumer Protection informs you – REZUROCK – 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 Rezurock is and what it is used for

Rezurock contains the active substance belumosudil which belongs to a group of medicines called immunosuppress ants.

Rezurock is used to treat adults and paediatric patients (12 years and older with a body weight of at least 40 kg) with chronic graft- versus -host disease (G VHD) when other treatment options provide limited clinical benefit, are not suitable, or have been exhausted .

Chronic GV HD can happen weeks to months after you have undergone a bone marrow or stem cell (blood-forming cells ) transplant ation ., the cells transplanted from the donor (the graft) attack the body (the host) caus ing inflammation and damage to many organs like the skin, liver or digestive system.

The active substance in Rezurock, belumosudil, works by blocking an enzyme (protein) called ROCK2 that is involved in how your immune system (the body’s natural defences) works. This reduces inflammation and further damage to organs.

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

Do not take Rezurock

• if you are allergic to belumosudil or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breast -feeding
• if you have severe liver problems without liver G VHD If you are uncertain whether the conditions above apply to you, talk to your doctor or pharmacist before taking Rezurock .

28 Warnings and precautions Talk to your doctor or pharmacist before taking Rezurock if you:

• are pregnant or plan to become pregnant, since Rezurock can harm your unborn baby (see section “Pregnancy, breast -feeding , fertility and contraception”).
• are breast -feeding or plan to breast -feed, since Rezurock may potentially cause serious side effects in a breast -fed child (see section “Pregnancy, breast -feeding , fertility and contraception”).
• have any liver problems. You must have blood tests before and during treatment with Rezurock including tests to monitor how well your liver is working.
• are taking other medicines (see section “Other medicines and Rezurock ”).

Children

Do not give Rezurock to children under 12 years ol d or with a bodyweight of less than 40 kg, because Rezurock has not been studied in this age group .

Other medicines and Rezurock

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Rezurock may a ffect the way other medicines work, and other medicines may a ffect the way Rezurock works.

Especially tell your doctor if you are taking any of the following medicines , as your doctor may need to change the dose of these medicines or the dose of Rezurock .

The following medicines might decrease the effectiveness of Rezurock by decreasing the amount of Rezurock in the blood:

• Rifamp in (used for tuberculosis ).
• Proton pump inhibitors like omeprazole or rabeprazole (used to lower acid production in the stomach ).
• Other gastric acid reducing age nts (used to lower acid production in the stomach).

Rezurock might increase the risk of side effects with these medicines by increasing the amounts of these medicines in the blood :

• Statins like rosuvastatin ( used to lower cholesterol ).
• Dabigatran ( used to prevent blood clots from forming in the body) .
• Raltegravir ( for HIV ).
• Sirolimus or tacrolimus (used to prevent graft -versus -host disease ).

If you are not sure if any of the above apply to you, talk to your doctor before taking Rezurock .

While you are taking Rezurock , you should never start a new medicine without checking fi rst with your doctor. This includes prescription medicines, non -prescription medicines (over -the-counter medicines) and herbal or alternative medicines.

Keep a list of all the medicines you take to show your doctor and pharmacist when you get a new medicine.

Rezurock with food

Rezurock must be taken with food. See section 3.

Pregnancy, breast -feeding , fertility and contraception Tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are breast – feeding. If you are planning to have a baby, ask your doctor for advice before taking this medicine.

29 Pregnancy Do not take Rezurock during pregnancy because Rezurock can harm your unborn baby. Your doctor will check if you are pregnant before starting the treatment. If you become pregnant while taking Rezurock , speak to your doctor immediately.

Contraception If you are a woman who is able to become pregnant, your doctor will check if you are pregnant before starting treatment with Rezurock . This is because Rezurock can harm an unborn baby. You must use a reliable and highly effective method of contraception (birth control) during your treatment with Rezurock and for at least one week after the last dose.

If you are a man with a partner who is able to become pregnant, your partner should avoid pregnancy while you are taking Rezurock. You must use a n effective method of contraception during your treatment with Rezurock and for at least one week after the last dose.

Talk to your doctor about which methods of contraception are appropriate for you during your treatment with Rezurock .

Breast -feeding Do not b reast -feed during treatment with Rezurock and for at least one week after the last dose.

Rezurock may be harmful to a breast -fed child.

Fertility

Based on animal studies, Rezurock may cause temporary infertility.

Driving and using machines

If you experience tiredness or dizziness after taking Rezurock, do not drive or use machines.

Rezurock contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say it is essentially ‘sodium -free’.

💊 3. How to take Rezurock

Always take Rezurock exactly as your doctor has told you. Check with your doctor if you are not sure.

The recommended dose for adults and adolescents (12 years of age or over and weighing at least 40 kg) is one tablet (containing 200 mg of belumosudil) taken once daily orally (by mouth) the same time each day.

Swallow the tablet whole with a glass of water and with a meal.

Your doctor may increase your dose of Rezurock if you are also taking certain other medicines that can affect how belumosudil works.

Your doctor may tell you to stop taking Rezurock for a while or permanently , depending on how well you tolerate the treatment.

Duration of treatment You should continue treatment until your doctor tells you to stop.

30 If you take more Rezurock than you should If you take too much Rezurock , tell your doctor or go to the nearest hospital right away. Take the medicine pack with you.

If you forget to take Rezurock

If you miss a dose of Rezurock you should take it as soon as you remember on the same day , only if:

• you take Rezurock once a day and it has been less than 12 hours since your dose was due
• you take Rezurock twice a day and it has been less than 6 hours since your dose was due After taking the missed dose, t ake your next dose of Rezurock at your usual time.

If you miss a dose of Rezurock you should not take it if:

• you take Rezurock once a day and it has been more than 12 hours since your dose was due
• you take Rezurock twice a day and it has been more than 6 hours since your dose was due In these cases, skip the missed dose, and t ake your next dose of Rezurock at the usual time.

Do not take a double dose to make up for a forgotten dose.

If you are sick after taking Rezurock If you are sick (vomit) after taking Rezurock , do not take another dose of Rezurock . Take your next dose of Rezurock at the usual time .

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

❗ 4. Possible side effects

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

Serious side effects

Tell your doctor straight away if you experience any of the following common serious side effects (may affect up to 1 in 10 people) :

• Cough, chest pain, shortness of breath, fever. These could be symptoms of pneumonia.
• Feeling of not being able to breath or think properly. These could be symptoms of hypoxia (low oxygen).
• Inflammation of the deep skin tissue . These could be symptoms of cellulitis .
• Belly pain, diarrhoea, fever. These could be symptoms of a large intestine infection.
• Inflammation that affects the eyelids and surrounding skin. These could be symptoms of periorbital cellulitis.
• Fever, chills and low blood pressure. These could be symptoms of staphylococcal bacteraemia (infection in your bloodstream).
• Common cold, nose or throat ( upper respiratory tract ) infection .
• Feeling shortness of breath and chest pain. These could be symptoms of a pulmonary embolism (clot in a blood vessel in the lung s).
• Diarrhoea
• Feeling si ck (n ausea )
• Sores in your tongue that do not heal could be a sign of a presence of abnormal cells (which may become cancerous). These could be symptoms of tongue dysplasia.
• Vomiting
• Feeling very weak, vomiting, fever, chills, confusion, fast heartbeat. These could be symptoms of two to more of your organ systems that are failing to support your body’s needs (multiple organ dysfunction syndrome).

Other side effects

Other possible side effects include the following listed below. If these side effects become severe, tell your doctor.

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

• Headache
• Extreme tiredness

Common (may affect up to 1 in 10 people)

• Low red blood cell count (anaemia)
• An underactive thyroid gland (hypothyroidism)
• Decreased appetite
• High blood sugar levels (hyperglycaemia)
• Low blood phosphate levels (hypophosphataemia)
• High levels of fat in the blood (hyperlipidaemia)
• Nerve damage in the arms and legs (peripheral neuropathy)
• Dizziness
• Sensations like numbness, tingling, pins and needles (paraesthesia)
• High blood pressure (hypertension)
• Sudden shortness of breath or difficulty breathing (dyspnoea)
• Cough
• Constipation
• Belly (a bdominal) pain
• Abdominal swelling
• Abdominal discomfort
• Back pain
• Muscle spasm s
• Joint pain (arthralgia)
• Swelling especially of the ankles and feet (oedema peripheral)
• Fever
• Abnormal liver function test
• Weight loss
• Increase of levels of creatine phosphokinase, an enzyme (protein) that is released into the blood when muscle is damaged
• Decrease blood levels of platelets, components that help the blood to clot
• Increased levels of creatinine, a sign of worsening kidney problems
• Decreased blood count of lymphocytes, a type of white blood cell
• White blood cell count decreased
• Belly pain, diarrhoea, fever. These could be symptoms of gastroenteritis.
• Inflammation of the nose and throat
• Sinus infection
• Headache (migraine)
• Low blood pressure
• Itching
• Rash
• Inflammation o f the skin with large blisters (dermatitis bullous)
• Feeling generally unwell ( malaise)
• Local swelling
• Yellowing of the skin and eyes (bilirubin conjugated increased)
• Increased levels of procalcitonin, a protein in the blood that is a marker for infection Your doctor may change your dose of Rezurock , temporarily stop, or permanently stop treatment with Rezurock if you have certain side eff ects.

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.

🌡️ 5. How to store Rezurock

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 bottle after “EXP” .

The expiry date refers to the last day of that month.

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 Rezurock contains

The active substance is belumosudil (as mesy late). Each tablet contains 200 mg belumosudil.

The other ingredients are:

Tablet core: cellulose microcrystalline , hypromellose, croscarmellose sodium , magnesium stearate, silica colloidal anhydrous .

Tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E 171), macrogol (E1521), talc (E553b), iron oxide yellow (E172).

What Rezurock looks like and contents of the pack

Rezurock film -coated tablets are pale yellow to yellow , oval shaped tablets with “KDM” on one side and “200” on the other side.

Rezurock is available in a plastic bottle with a child -resistant closure in a pack -size of 28 or 30 film -coated tablets. The bottle contains a desiccant packet.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sanofi Winthrop Industrie, 82 Avenue Raspail, 94250 Gentilly, France

Manufacturer

Sanofi Winthrop Industrie, 30- 36 Avenue Gustave Eiffel, 37100 Tours, France 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., Magyarország Tel.: +36 1 505 0050 33 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 ΑΕΒΕ 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

This leaflet was last revised i n

This medicine has been given ‘ conditional approval ’. This means that there is more evidence to come about this medicine.

The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.

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 REZUROCK (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/26/2015).

⚠️ 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.