InfoCons Consumer Protection informs you – TAVLESSE – Package Leaflet

Before anything else

Read all of this leaflet carefully before you st art 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, pharmacist or nurse.  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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

What TAVLESSE is TAVLESSE contains the active substance fostamatinib. It specifically targets an enzyme called spleen tyrosine kinase, that plays an important part in the destruction of platelets. In this way TAVLESSE limits platelet destruction by the immune system and increases platelet count in the body. This helps reduce the risk of severe bleeding.

What TAVLESSE is used for

TAVLESSE is used to treat adults with low platel et counts due to chronic immune thrombocytopenia (ITP) when an earlier treatment for ITP has not wo rked well enough. ITP is an autoimmune disease, in which the body’s own immune system attacks and destr oys platelets in the blood. Platelets are needed to help create clots and stop bleeding.

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

Do not take TAVLESSE

 if you are allergic to fostamatinib or any of th e other ingredients of this medicine (listed in section 6).  if you are pregnant.

Warnings and precautions Talk to your doctor or pharmaci st before taking TAVLESSE, about all of your medical conditions, particularly if you:  have high blood pressure,  have liver problems,  become pregnant or plan to become pregnant,  are breastfeeding or plan to breastfeed.

33 Tell your doctor, pharmacist or nurse immediately if you get any of the following symptoms while you are taking this medicine:  if you have high blood pressure (hypertension). New or worsening high blood pressure is common in people treated with TAVLESSE and can be severe. Your doctor will check your blood pressure regularly during treatment with th is medicine. If needed, your doctor may start you on blood pressure medicine or change your cu rrent medicine to treat your blood pressure.

Tell your doctor or pharmacist if you get head aches, confusion, dizziness, chest pain or shortness of breath.  if your skin and eyes appear yellowish (jaundice) or if you get abdominal pain and swelling, swelling in your legs and ankles, itchy skin, abnorm al dark urine, pale stool colour or bloody or tar-coloured stool, chronic fatigue, feeling or be ing sick in the stomach, and loss of appetite.

Changes in liver function blood tests are comm on with this medicine. These may be symptoms of liver problems. Liver problems may occur and can be severe. Your doctor will regularly carry out blood tests to check how well your liver is working during treatment with this medicine.  if you get diarrhoea. This is common in people tr eated with this medicine and can be severe.

Tell your doctor or pharmacist if you get diarr hoea during treatment with this medicine. Your doctor may recommend changes in your diet, drinki ng more water, or give an antidiarrhoeal medicine to limit your symptoms.  if you get a high fever (a sign of serious infection) , chills, feel sick, or have a general feeling of being unwell. Your doctor will regularly do blood tests to check your white blood cell counts, and you may be told about a decrease in your white blood cell counts (neutropenia). Decreases in your white blood cell count are common with this medicine and can be severe. This may increase your risk of infection, including serious infections.

Children and adolescents TAVLESSE should not be used in patients less than 18 years of age. This medicine has not been studied in this age group.

Other medicines and TAVLESSE

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Taking TAVLESSE with certain other medicines may a ffect how the other medicines work and other medicines may affect how TAVLESSE works.

In particular, tell your doctor if yo u are taking anything in this list:  Ketoconazole, this medicine is typica lly used to treat fungal infections.  Rifampicin, this medicine is typically used to treated bacterial infections.  Simvastatin and rosuvastatin, these medicines are typically used to treat high cholesterol.  Digoxin, this medicine is typically used to treat various heart conditions such as atrial fibrillation, atrial flutter and heart failure.  Midazolam, this medicine is typically used for sedation or to treat anxiety.  Anticoagulants, this medicine is typica lly used to prevent blood clotting.  Nelfinavir, this medicine is typica lly used to treat HIV infection.  Verapamil, this medicine it typically used to treat various heart conditions such as high blood pressure.  Ranitidine, this medicine is typically used to treat heart burn.  Ethinylestradiol, this medicine is typically used for birth control.  Pioglitazone, this medicine is typically used to treat type 2 diabetes.

Pregnancy, breast-feeding and fertility Pregnancy TAVLESSE should not be used during pregnancy. It can cause harm or birth defects to your unborn baby.

34 If you are pregnant, if think you may be pregnant or if you are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are a woman who could become pregna nt, you must use reliable contraception while you are taking TAVLESSE, and you must continue to use re liable contraception for at least 1 month after taking your last dose. Contact your doctor straight away if you beco me pregnant while taking this medicine.

Breast-feeding

TAVLESSE is not recommended while breast-feeding. You should not breastfeed during treatment with TAVLESSE and for at least 1 month after your last dose.

If you are breast-feeding, or are planning to breast-feed, ask your doctor or pharmacist for advice before taking this medicine. Fertility TAVLESSE may affect the ability of a woman to get pre gnant and have a child. Talk to your doctor if this is a concern for you. There is no impact on males.

TAVLESSE contains sodium

[TAVLESSE 100 mg film-coated tablets] This medicine contains 23 mg sodium (main component of cooking/table salt) in each tablet. This is equiva lent to 1.2% of the recommended maximum daily dietary intake of sodium for an adult. [TAVLESSE 150 mg film-coated tablets] This medicine contains 34 mg sodium (main component of cooking/table salt) in each tablet. This is equiva lent to 1.7% of the recommended maximum daily dietary intake of sodium for an adult.

💊 3. How to take TAVLESSE How much to take

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

Before starting treatment, your doctor will measure your platelet count. The recommended dose of TAVLESSE is 100 mg tw ice daily (one tablet of 100 mg).

However, your doctor will check your platelet c ounts during your treatment with TAVLESSE and may change your dose as needed. After starting treatment with TAVLESSE, the dose can be increased to 150 mg twice daily (one tablet of 150 mg) based on platelet count and tolerability . A daily dose of 300 mg (two tablets of 150 mg) daily must not be exceeded.

If you do not respond to treatment with fostam atinib, your doctor will stop treatment If you have liver problems or high blood pressu re, your doctor may start you on a lower dose.

If you get serious side effects (such as high blood pressu re, liver problems, diarrhoea or a decrease in white blood cell counts), your doctor may lower your dose or stop your treatment temporarily or permanently. How to take TAVLESSE Swallow the tablets whole with water.

TAVLESSE can be taken with food or between meals.

In case of stomach upset, take the tablets with food. If you are sick If you are sick at any time after taking TAVLESSE, do not take an additional tablet. Take your next dose at its regularly scheduled time.

If you take more TAVLESSE than you should If you take too much TAVLESSE, call your doctor or pharmacist right away or go to the nearest hospital emergency room.

If you forget to take TAVLESSE

Do not take a double dose to make up for a forgotte n tablet. Take your next dose at its regularly scheduled time. If you stop taking TAVLESSE It is important to take TAVLESSE for as long as y our doctor prescribes it. Do not stop taking this medicine unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

❗ 4. Possible side effects

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

Serious side effects

TAVLESSE may cause serious side effects. Tell your doctor immediately if you have any of the following serious side effects, either for the firs t time or if they get worse (see also section 2):  high fever. Fever has been associated with low le vels of white blood cells (febrile neutropenia) or infection  diarrhoea  infection and inflammation of th e lungs (pneumonia). Symptoms include feeling short of breath, chest pain and producing discoloured mucus  jaundice, abdominal pain and swelling, swelling in your legs and ankles, itchy skin, abnormal dark urine, pale stool colour or bloody or ta r-coloured stool, chronic fatigue, feeling or being sick in the stomach, loss of appetite. These may be symptoms of liver problems.  severe increase of blood pressure that can lead to a stroke (hypertensive crisis). Symptoms are headache, confusion, dizziness.

Other side effects Besides the serious side effects mentioned a bove, you may also get other side effects.

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

 gastrointestinal disorders such as diarrhoea, feeling or being sick in the stomach, and frequent bowel movement  high blood pressure  abnormal blood test results showing how your liver is working  dizziness

Common (may affect up to 1 in 10 people)

 low white blood cell count or neutropenia  stomach pain  chest pain 36  tiredness (fatigue)  flu-like symptoms  infections of the nose and throat, such as sore throat and the common cold  infection of the windpipe, such as bronchitis  taste changes  rash  headache

Reporting of side effects

If any of the side effects gets serious, or if you noti ce any side effects not listed in this leaflet, please tell your doctor or your pharmacist. You can also re port 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 TAVLESSE Keep this medicine out of the sight and reach of children.

This medicine does not require any special temper ature storage conditions. Store in the original package to protect from moisture. Keep the bottle tightly closed.

Do not use this medicine after the expiry date wh ich is stated on the carton and the 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 me asures will help protect the environment.

📦 6. Contents of the pack and other information

What TAVLESSE contains – The active substance is fostam atinib disodium hexahydrate.

TAVLESSE 100 mg film-coated tablets TAVLESSE 150 mg film-coated tablets

• The other ingredients are:

 Mannitol, sodium hydrogen carbonate, sodium starch glycolate (type A), povidone (K30), magnesium stearate. See section 2.  Film-coating: poly(vinyl alcohol), titanium dioxide, macrogol (3350), talc, iron oxide yellow, iron oxide red

What TAVLESSE looks like and contents of the pack

TAVLESSE 100 mg film-coated tablets The film-coated tablet is round, curved on both sid es with a dark orange film coat. The tablets are debossed with “R” on one side and “100” on the reverse side.

Available in bottle of 30 and 60 film-coa ted tablets. Each bottle has 2 desiccants.

Not all pack sizes may be marketed.

TAVLESSE 150 mg film-coated tablets The film-coated tablet is oval, curved on both sides, with a light orange film coat. The tablets are debossed with “R” on one side and “150” on the reverse side.

Available in bottle of 30 and 60 film-coa ted tablets. Each bottle has 2 desiccants.

Not all pack sizes may be marketed.

37 Marketing Authorisation Holder and Manufacturer Instituto Grifols, S.A.

Can Guasc, 2 – Parets del Vallès 08150 Barcelona – Spain For any information about this medicine, please c ontact the local representative of the Marketing Authorisation Holder:

AT/BE/BG/CY/EE/EL/ES/HR/HU/IE/LV/ LT/LU/MT/NL/RO/SI/SK Instituto Grifols, S.A.

Tel: +34 93 571 01 00 CZ Grifols S.R.O. Tel: +4202 2223 1415 DE Grifols Deutschland GmbH Tel: +49 69 660 593 100 DK/FI/IS/NO/SE Grifols Nordic AB Tel: +46 8 441 89 50 FR Grifols France Tél: +33 (0)1 53 53 08 70 IT Grifols Italia S.p.A. Tel: +39 050 8755 113 PL Grifols Polska Sp. z o. o.

Tel: +48 22 378 85 60 PT Grifols Portugal, Lda.

Tel: +351 219 255 200 This leaflet was last revised in .

Detailed information on this medici ne is available on the European Medicines Agency web site: https://www.ema.europa.eu/en

📄 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 TAVLESSE (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/19/1405).

⚠️ 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.