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

Rhapsido contain s the active substance remibrutinib, which belongs to a group of medicines called Bruton’s tyrosine kinase (BTK) inhibitors.

Rhapsido is used to treat adults with chronic (long -term) spontaneous urticaria (CSU) when treatment with antihistamines does not work well enough .

In people with CSU, symptoms can happen when the immune system (the body’s natural defences) becomes overactive. Certain immune cells switch on a protein called Bruton ’s tyrosine kinase, which causes hives, itching and/or swelling . Remibrutinib works by blocking BTK which helps stop the immune cells from becoming overactive and reduces inflammation, making CSU symptoms less frequent and less severe .

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

Do not take Rhapsido

• if you are allergic to remibrutinib or any of the other ingredients of this medicine (listed in section 6).

24 Warnings and precautions Talk to your doctor or pharmacist before taking Rhapsido :

• if you have or have ever had unusual bru ising or bleeding, or are taking any medic ines that could increase your risk of bleeding. See section “Other medicines and Rhapsido ” below.
• if you have recently had any surgery or are planning to have surgery. Your doctor may ask you to stop taking Rhapsido for a short time before (3 to 7 days) and after (3 to 7 days) your surgery.
• if you have recently had a vaccination or are planning to have a vaccination . Certain types of vaccines ( known as live or live -attenuated vaccine s) are not recommended to be used during treatment with Rhapsido . If you have had, or are planning to have another type of vaccine (known as a non-live vaccine ), your doctor may ask you to stop taking Rhapsido for 1 week before and 2 weeks after the vaccination.
• if you are taking any other medic ines as these could interact with Rhapsido. See section “Other medicines and Rhapsido” below.

Children and adolescents

Do not give this medicine to children or adolescents below 18 years of age . It has not been studied in this age group.

Other medicines and Rhapsido

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines , including medicines obtained without a prescription.

Rhapsido may make you bleed more easily. This means you should tell your doctor if you take any other medicines or supplements that increase your risk of bleeding (see “Warnings and precautions” above). This includes any of the following:

• medicines used to relieve pain , reduce fever or prevent blood clots , such as acetylsalicylic acid.
• medicines used to treat blood clots , such as clopidogrel.
• medicines used to thin the blood , such as warfarin.

Tell your doctor or pharmacist if you are taking any of the following medicines as they may increase the risk of side effects of Rhapsido , or Rhapsido may increase the risk of side effects of them:

• medicines used to treat HIV infection, such as ritonavir.
• medicines used to treat heart problems , such as digoxin.
• medicines used to treat high cholesterol , such as rosuvastatin.
• medicines used for sedation or sleep disturbances , such as mid azolam.

Tell your doctor or pharmacist if you are taking any of the following medicines as they may decrease the effectiveness of Rhapsido :

• medicines used to treat certain types of seizures , such as carbamazepine .

Tell your doctor or pharmacist i f you have recently had a vaccination or plan to have a vaccination (see “Warnings and precautions” above) .

Pregnancy, breast -feeding and fertility If you are pregnant or breast -feeding , think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Treatment with Rhapsido is not recommended during pregnancy or in women who can become pregnant who are not using effective contraception (birth control). This is because studies in animals have shown that Rhapsido may cause harm to the unborn baby.

Do not breast -feed during treatment with Rhapsido and for one week after stopping treatment , as it is not known if Rhapsido passes into breast milk.

If you are a woman who could become pregnant, you must use a n effective method of contraception (birth control) during treatment with Rhapsido and for at least one week after stopping treatment. Ask your doctor about effective method s of contraception .

25 Driving and using machines Rhapsido has no or negligible influence on the ability to drive and use machines.

Rhapsido contains sodium

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

💊 3. How to take Rhapsido

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

The recommended dose is one 25 mg tablet twice a day , once in the morning and once in the evening .

• Swallow the tablet whole with water.
• Do not split, crush or chew the tablet before swallowing as this may change how much medicine gets into your body.
• To help you remember to take Rhapsido , take it at the same time every day.
• Rhapsido can be taken with or without food .

Rhapsido and surgery Tell your doctor if you have recently had surgery or plan to have surgery. Your doctor may ask you to stop taking Rhapsido for 3 to 7 days before and 3 to 7 days after any planned medical or surgical procedures.

If you take more Rhapsido than you should

If you take more Rhapsido than you should, talk to a doctor straight away. If you are told to go to the hospital, t ake the tablet pack and this leaflet with you.

If you forget to take Rhapsido

If you miss a dose then you should take the next dose at your usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Rhapsido

Stopping your treatment with Rhapsido may cause your CSU symptoms to return . Do not stop taking Rhapsido unless your doctor tells you to.

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.

All of the following side effects are mild to moderate.

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

• Nose and throat infections (upper respiratory tract infections )

Common (may affect up to 1 in 10 people)

• Herpes virus infection
• Headache
• Bruising
• Tiny red spots under the skin (petechiae)
• Bruising under the skin (contusion)
• A bleeding spot under the skin with blue or purplish patch (ecchymosis) 26 – Pink or brown urine /blood in the urine (haematuria)
• Feeling sick (nausea)
• Abdominal pain
• Back pain
• Fever (pyrexia)

Uncommon (may affect up to 1 in 100 people)

• Nosebleed (epistaxis)
• Purple or red -brown spots on the skin (purpura)
• A flat, bright red patch in the white of the eye (conjunctival bleeding)
• Bleeding gums (gingival bleeding)

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 Rhapsido

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 foil after “EXP”. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

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 Rhapsido contains

• The active substance is remibrutinib. Each film -coated tablet contains 25 mg of remibrutinib.
• The other ingredients are mannitol, microcrystalline cellulose, copovidone, croscarmellose sodium, sodium stearyl fumarate, sodium lauryl sulfate. The tablet coating is composed of polyvinyl alcohol, macrogol 4000 , talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) .

What Rhapsido looks like and contents of the pack

Rhapsido is supplied as 25 mg film -coated tablets. The tablets are light yellow , round and curved .

They have “LV” on one side and the company logo on the other side. The tablet diameter is approximately 7 mm.

Rhapsido is supplied in blisters and is available in packs containing 30, 60 or 180 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland 27 Manufacturer Novartis Pharmaceutical Manufacturing LLC Verov škova ulica 57 1000 Ljubljana Slovenia Novartis Farmaceutica S.A.

Gran Via de les Corts Catalanes, 764 08013 Barcelona Spain Novartis Pharma GmbH Sophie -Germain -Strasse 10 90443 Nuremberg Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50 България Novartis Bulgaria EOOD Тел.: +359 2 489 98 28 Luxembourg/Luxemburg Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11 Česká republika Novartis s.r.o.

Tel: +420 225 775 111 Magyarország Novartis Hungária Kft.

Tel.: +36 1 457 65 00 Danmark Novartis Healthcare A/S Tlf.: +45 39 16 84 00 Malta Novartis Pharma Services Inc.

Tel: +356 2122 2872 Deutschland Novartis Pharma GmbH Tel: +49 911 273 0 Nederland Novartis Pharma B.V.

Tel: +31 88 04 52 111 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810 Norge Novartis Norge AS Tlf: +47 23 05 20 00 Ελλάδα Novartis (Hellas) A.E.B.E.

Τηλ: +30 210 281 17 12 Österreich Novartis Pharma GmbH Tel: +43 1 86 6570 España Novartis Farmacéutica, S.A.

Tel: +34 93 306 42 00 Polska Novartis Poland Sp. z o.o.

Tel.: +48 22 375 4888 France Novartis Pharma S.A.S.

Tél: +33 1 55 47 66 00 Portugal Novartis Farma – Produtos Farmacêuticos, S.A.

Tel: +351 21 000 8600 28 Hrvatska Novartis Hrvatska d.o.o.

Tel. +385 1 6274 220 România Novartis Pharma Services Romania SRL Tel: +40 21 31299 01 Ireland Novartis Ireland Limited Tel: +353 1 260 12 55 Slovenija Novartis Pharma Services Inc.

Tel: +386 1 300 75 50 Ísland Vistor ehf.

Sími: +354 535 7000 Slovenská republika Novartis Slovakia s.r.o.

Tel: +421 2 5542 5439 Italia Novartis Farma S.p.A.

Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200 Κύπρος Novartis Pharma Services Inc.

Τηλ: +357 22 690 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 00 Latvija SIA Novartis Baltics Tel: +371 67 887 070

This leaflet was last revised i n

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 Rhapsido (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/26/2024).

⚠️ 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.