• 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.

1. What TAVLESSE is and what it is used for
2. What you need to know before you take TAVLESSE
3. How to take TAVLESSE
4. Possible side effects
5. How to store TAVLESSE
6. Contents of the pack and other information

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.

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

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

Talk to your doctor or pharmacist before taking TAVLESSE, about all of your medical conditions, particularly if you:

• have high blood pressure,
• have liver problems,
• are pregnant or plan to become pregnant,
• are breastfeeding or plan to breastfeed.

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 this medicine. If needed, your doctor may start you on blood pressure medicine or change your current medicine to treat your blood pressure. Tell your doctor or pharmacist if you get headaches, 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, abnormal dark urine, pale stool colour or bloody or tar-coloured stool, chronic fatigue, feeling or being sick in the stomach, and loss of appetite. Changes in liver function blood tests are common 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 treated with this medicine and can be severe. Tell your doctor or pharmacist if you get diarrhoea during treatment with this medicine. Your doctor may recommend changes in your diet, drinking 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.

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

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 affect how the other medicines work and other medicines may affect how TAVLESSE works.

In particular, tell your doctor if you are taking anything in this list:

• Ketoconazole, this medicine is typically 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 typically used to prevent blood clotting.
• Nelfinavir, this medicine is typically 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

TAVLESSE should not be used during pregnancy. It can cause harm or birth defects to your unborn baby.

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 pregnant, you must use reliable contraception while you are taking TAVLESSE, and you must continue to use reliable contraception for at least 1 month after taking your last dose.

Contact your doctor straight away if you become 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 pregnant and have a child. Talk to your doctor if this is a concern for you. There is no impact on males.

TAVLESSE 100 mg film-coated tablets contains 23 mg sodium (main component of cooking/table salt) per tablet. This is equivalent to 1.2% of the recommended maximum daily dietary intake of sodium for an adult.

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 twice daily (one tablet of 100 mg).

However, your doctor will check your platelet counts 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 fostamatinib, your doctor will stop treatment.

If you have liver problems or high blood pressure, your doctor may start you on a lower dose.

If you get serious side effects (such as high blood pressure, liver problems, diarrhoea or a decrease in white blood cell counts), your doctor may lower your dose or stop your treatment temporarily or permanently.

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 at any time after taking TAVLESSE, do not take an additional tablet. Take your next dose at its regularly scheduled time.

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

Do not take a double dose to make up for a forgotten tablet. Take your next dose at its regularly scheduled time.

It is important to take TAVLESSE for as long as your doctor prescribes it. Do not stop taking this medicine unless your doctor tells you to.

TAVLESSE may cause serious side effects. Tell your doctor immediately if you have any of the following serious side effects, either for the first time or if they get worse (see also section 2):

• high fever. Fever has been associated with low levels of white blood cells (febrile neutropenia) or infection
• diarrhoea
• infection and inflammation of the 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 tar-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.

Besides the serious side effects mentioned above, 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
• 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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist. You can also report side effects directly via:

Ireland:

United Kingdom:

or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

• The active substance is fostamatinib disodium hexahydrate. TAVLESSE 100 mg film-coated tablets
• The other ingredients are:
  • Mannitol, sodium hydrogen carbonate, sodium starch glycolate (type A), povidone (K30), magnesium stearate
  • Film-coating: poly(vinyl alcohol), titanium dioxide, macrogol(3350), talc, iron oxide yellow, iron oxide red

TAVLESSE 100 mg film-coated tablets

The tablet is round, curved on both sides with a dark orange film coat.

The commercial tablets are debossed with “R” on one side and “100” on the reverse side.

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

Not all pack sizes may be marketed.

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

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