Prospect: Patient Information

Jyseleca 100Film-coated Tablets

Jyseleca 200Film-coated Tablets

filgotinib

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Jyseleca contains the active ingredient filgotinib. It belongs to a group of medicines called Janus kinase inhibitors, which help to reduce inflammation.

Rheumatoid Arthritis

Jyseleca is used to treat adults with rheumatoid arthritis,a type of inflammatory joint disease. It can be used when previous treatment has not worked well enough or has not been tolerated. Jyseleca can be used alone or in combination with another arthritis medicine, methotrexate.

Jyseleca reduces inflammation in the body.It helps to reduce pain, fatigue, stiffness, and inflammation of the joints and decreases the progression of damage to the bone and cartilage of the joints. These effects can help you perform your daily activities normally and improve your quality of life.

Ulcerative Colitis

Jyseleca is used to treat adults with ulcerative colitis, a type of inflammatory bowel disease. It can be used when previous treatment has not worked well enough or has not been tolerated. It helps to reduce the symptoms and signs of ulcerative colitis and reduce the need for steroids.

Do not take Jyseleca

• if you are allergicto filgotinib or any of the other ingredients of this medicine (listed in section 6).
• if you have active tuberculosis (TB).
• if you have a severe active infection(see the section «Advertencias y precauciones»).
• if you are pregnantor think you may be pregnant.

→If any of these situations apply to you,do not take Jyseleca and inform your doctor immediately.

Advertencias y precauciones

Consult your doctor or pharmacistbefore starting to take Jyseleca:

• if you have an infectionor are prone to infections. Inform your doctor if you experience symptoms such as fever, wounds, feel more tired than usual, or have dental problems, as they may be signs of infection. Jyseleca may reduce your body's ability to fight infections and may worsen an existing infection or increase the likelihood of you contracting a new infection. If you have diabetes or are 65 years of age or older, you may be more likely to contract infections.
• if you have ever had tuberculosis (TB)or have been in contact with someone with TB. You may need to undergo tuberculosis detection tests before and during treatment with Jyseleca.
• if you have had a herpes zoster (shingles) infection in the pastJyseleca may cause a recurrence of the infection. Inform your doctor if you have a painful skin rash with blisters during treatment with Jyseleca, as these may be signs of shingles.
• if you have ever had hepatitis B or C.
• if you have or have had cancer, smoke or have smoked in the past, as your doctor will discuss with you whether Jyseleca is suitable for you.
• cases of skin cancer (non-melanoma) have been observed in patients receiving Jyseleca treatment. Your doctor may recommend that you undergo regular skin examinations while taking Jyseleca. If new skin lesions appear during or after treatment or if existing lesions change in appearance, inform your doctor.
• if you have recently received a vaccineor are due to receive one. Certain types of vaccines (live vaccines) are not recommended during Jyseleca use. Consult your doctor or pharmacist before starting Jyseleca treatment. They may want to check that your vaccinations are up to date.
• if you have or have had heart problems, as your doctor will discuss with you whether Jyseleca is suitable for you.
• if you have previously had blood clotsin the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) or have a higher risk of developing them (for example: if you have recently undergone major surgery, if you use hormonal contraceptives or hormone replacement therapy, if a blood clotting defect has been identified in you or your close relatives). Your doctor will discuss with you whether Jyseleca is suitable for you. Inform your doctor if you experience sudden shortness of breath or difficulty breathing, chest pain or upper back pain, leg or arm swelling, pain or tenderness in the leg, or redness or change in color in the leg or arm, as these may be signs of blood clots in the veins.

Pacientes de edad avanzada

Patients aged 65 and older may be at a higher risk of developing infections, heart attacks, and certain types of cancer. Your doctor may decide that Jyseleca is not suitable for you.

Niños y adolescentes

Do not administer this medicine to children and adolescents under 18 years of age, as it has not been studied in this age group.

Otros medicamentos y Jyseleca

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, especially if you use medications that affect the immune system (such as ciclosporina or tacrolimus).

It is also very important to consult your doctor or pharmacist if you are taking any of the following:

• medicines for the treatment of heart failure, coronary disease, or high blood pressure (such as diltiazem or carvedilol)
• the medicine fenofibrate (used to treat high cholesterol)

Embarazo, anticoncepción y lactancia

Pregnancy

Jyseleca should not be used during pregnancy.If you are pregnant, think you may be pregnant, or intend to become pregnant, do not take this medicine. Consult your doctor for advice.

Contraception

You should take precautions to avoid becoming pregnant during Jyseleca treatment.You should use an effective contraceptive method during Jyseleca treatment and for at least 1 week after taking the last dose of Jyseleca. If you become pregnant during Jyseleca treatment, stop taking the tablets and inform your doctor immediately.

Breastfeeding

Do not breastfeed your child during Jyseleca treatment.The active ingredient is unknown to pass into breast milk.

Conducción y uso de máquinas

Jyseleca may cause dizziness and vertigo. Do not drive or use tools or machines if you feel dizzy after taking Jyseleca.

Jyseleca contains lactose

Each 100 mg film-coated tablet of Jyseleca contains 76 mg of lactose, and each 200 mg film-coated tablet of Jyseleca contains 152 mg of lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended doseis one 200 mg or 100mg tablet once a day.

If you are 65 years of age or older and have rheumatoid arthritis or kidney problems, your doctor may recommend a dose of one 100 mg tablet once a day. Jyseleca is not recommended for you if you are over 75 years old and have ulcerative colitis. Inform your doctor if you have severe liver problems, as Jyseleca is not recommended for use in this case.

Swallow the tablet with a glass of water. The tablet should not be split, crushed, or chewed before swallowing, as this could affect the amount of medication your body absorbs. You can take Jyseleca with food or between meals. Do not swallow the desiccant.

Take Jyseleca at the same time every day. This will help you remember when to take the tablets.

Your doctor may temporarily or permanently discontinue treatment if blood tests show a low white or red blood cell count.

If you take more Jyseleca than you should

If you take more tablets than you should, inform your doctor immediately.

If you forget to take Jyseleca

• If you forget to take a dose, take it as soon as you remember.
• If a whole day (24 hours) has passed without taking a dose, skip the missed dose and take a single dose at the usual time.
• Do not take a double dose to make up for the missed doses.

If you discontinue treatment with Jyseleca

If you discontinue treatment with Jyseleca, inform your doctor immediately.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Severe Adverse Effects

Inform your doctor or seek immediate medical attention if you experience any signs of severe infection, such as:

• fever and urinary tract infection symptoms (frequent urination, pain or discomfort while urinating, or back pain). Urinary tract infections are common (can affect up to 1 in 10 people) and some can be severe.
• lung infection (pneumonia): symptoms may include persistent cough, fever, difficulty breathing, and fatigue. This is rare (can affect up to 1 in 100 people).
• shingles (herpes zoster): symptoms may include a painful skin rash with blisters. This is rare (can affect up to 1 in 100 people).
• blood infection (sepsis): rare (can affect up to 1 in 100 people).

Other Adverse Effects

Inform your doctor if you notice any of the following adverse effects:

Frequent

(can affect up to 1 in 10 people)

• throat and nasal infections
• dizziness
• nausea (gag reflex)

Blood tests may show:

• a low white blood cell count (lymphocytes).

Rare

(can affect up to 1 in 100 people)

• vertigo (dizziness)

Blood tests may show:

• a low white blood cell count (neutrophils)
• an increase in a muscle enzyme called creatine kinase.
• an increase in blood fat levels (cholesterol).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus.

You can also report them directly through the national notification system included in Appendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the bottle after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture. Keep the bottle perfectly closed. Do not use this medication if you observe that the safety seal of the bottle is missing or broken.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Jyseleca

• The active ingredient is filgotinib. Each film-coated tablet contains 100 or 200mg of filgotinib (as filgotinib maleate).

• The other components are:

Core of the tablet:microcrystalline cellulose, lactose monohydrate, pregelatinized starch, colloidal silicon dioxide, fumaric acid, magnesium stearate

Coating with film:polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), red iron oxide (E172)

Appearance of Jyseleca and contents of the packaging

Jyseleca 100 mg film-coated tablets are beige-colored tablets, 12 x 7 mm in size, capsule-shaped, engraved on one face with «G» and «100» on the other face of the tablet.

Jyseleca 200 mg film-coated tablets are beige-colored tablets, 17 x 8 mm in size, capsule-shaped, engraved on one face with «G» and «200» on the other face of the tablet.

Jyseleca 100mg and 200mg are available in bottles of 30tablets and in packs consisting of 3 bottles of 30tablets each. Each bottle contains a silica gel desiccant that should be kept inside the bottle to help protect the tablets. The silica gel desiccant is contained in a separate sachet or container and should not be taken.

Only some sizes of packaging may be commercially available.

Marketing Authorization Holder

Alfasigma S.p.A.

Via Ragazzi del '99, n. 5

40133 Bologna

Italy

Responsible for manufacturing

Alfasigma S.p.A.

Via Enrico Fermi, 1

65020 Alanno (PE)

Italy

Last revision date of this leaflet:

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

QR code that will be included

www.jyseleca.eu