JYSELECA 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Jyseleca 100mg film-coated tablets

Jyseleca 200mg film-coated tablets

filgotinib

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.

Contents of the pack

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

1. What is Jyseleca and what is it used for

Jyseleca contains the active substance 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, an inflammatory disease of the joints. 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 medicine for arthritis, methotrexate.

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

Ulcerative Colitis

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

2. What you need to know before you take Jyseleca

Do not take Jyseleca

• to filgotinib or any of the other ingredients of this medicine (listed in section 6).
• (see section "Warnings and precautions").
• or think you may be pregnant.

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

Warnings and precautions

Talk to your doctor or pharmacistbefore you start taking Jyseleca:

• or are prone to infections. Inform your doctor if you have symptoms such as fever, wounds, feel more tired than usual, or have dental problems, as these may be signs of infection. Jyseleca may reduce your body's ability to fight infections and may worsen an existing infection or increase the chance of you getting a new infection. If you have diabetes or are 65 years of age or older, you may be more likely to get infections.
• or have been in contact with someone with TB. You may need to have tuberculosis screening tests before and during treatment with Jyseleca.
• in the past, Jyseleca may cause the infection to come back. Inform your doctor if you have a painful rash with blisters during treatment with Jyseleca, as these may be signs of shingles.
• because your doctor will discuss with you whether Jyseleca is suitable for you.
• Non-melanoma skin cancer has been observed in patients receiving Jyseleca. Your doctor may recommend that you have 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.
• or are scheduled to receive one. The use of certain types of vaccines (live vaccines) is not recommended during Jyseleca treatment. Talk to your doctor or pharmacist before you start taking Jyseleca. They may want to check that your vaccinations are up to date.
• because your doctor will discuss with you whether Jyseleca is suitable for you.
• in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) or are at increased risk of getting them (for example, if you have had recent major surgery, use hormonal contraceptives or hormone replacement therapy, have a coagulation defect identified in you or your close relatives). Your doctor will discuss with you whether Jyseleca is suitable for you. Inform your doctor if you have sudden shortness of breath or difficulty breathing, chest pain or pain in the upper back, swelling of the leg or arm, pain or tenderness in the leg, or redness or change in color of the leg or arm, as these may be signs of blood clots in the veins.

Elderly patients

Patient aged 65 and over may have a higher risk of getting infections, heart attacks, and some types of cancer. Your doctor may decide that Jyseleca is not suitable for you.

Children and adolescents

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

Other medicines and Jyseleca

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially if you are using medicines that affect the immune system (such as cyclosporine or tacrolimus).

It is also very important that you talk to 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)

Pregnancy, contraception, and breastfeeding

Pregnancy

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

Contraception

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

Breastfeeding

Do not breastfeed your child while taking Jyseleca.It is not known whether the active substance passes into breast milk.

Driving and using machines

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 an intolerance to some sugars, talk to them before taking this medicine.

3. How to take Jyseleca

Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

Recommended dose

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

If you are 65 years of age or older and have rheumatoid arthritis or have 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 of age and have ulcerative colitis. Inform your doctor if you have severe liver problems, as Jyseleca is not recommended for you.

Swallow the tablet with a glass of water. The tablet must not be split, crushed, or chewed before swallowing, as this may affect the amount of medicine absorbed by your body. You can take Jyseleca with or without food. Do not swallow the desiccant.

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

Your doctor may temporarily or permanently stop treatment if blood tests show a low count of white or red blood cells.

If you take more Jyseleca than you should

If you take more tablets than you should, talk to 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 has passed (24 hours) 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 a forgotten dose.

If you stop taking Jyseleca

If you stop taking Jyseleca, inform your doctor immediately.

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.

Serious side effects

Tell your doctor or seek medical attention immediately if you have any signs of a serious infection such as:

• fever and symptoms of urinary tract infection (need to urinate more often than usual, pain or discomfort while urinating, or back pain). Urinary tract infections are common (may affect up to 1 in 10 people) and some can be serious.
• lung infection (pneumonia): symptoms may include persistent cough, fever, difficulty breathing, and tiredness. This is uncommon (may affect up to 1 in 100 people).
• shingles (herpes zoster): symptoms may include a painful rash with blisters. This is uncommon (may affect up to 1 in 100 people).
• Blood infection (sepsis): uncommon (may affect up to 1 in 100 people).

Other side effects

Tell your doctor if you notice any of the following side effects:

Common

(may affect up to 1 in 10 people)

• throat and nose infections
• dizziness
• nausea

Blood tests may show:

• a low count of white blood cells (lymphocytes).
• a decrease in phosphate levels in the blood

Uncommon

(may affect up to 1 in 100 people)

• spinning sensation (vertigo)

Blood tests may show:

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

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. Storage of Jyseleca

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 is the last day of the month shown.

Store in the original package to protect from moisture. Keep the bottle tightly closed. Do not use this medicine if you notice that the security seal on the bottle is missing or broken.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Jyseleca contains

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

• The other ingredients are:

Tablet core:microcrystalline cellulose, lactose monohydrate, pregelatinized starch, colloidal silicon dioxide, fumaric acid, magnesium stearate

Film coating:polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), red iron oxide (E172)

Appearance of Jyseleca and pack contents

Jyseleca 100 mg film-coated tablets are beige, 12 x 7 mm, capsule-shaped, and engraved with "G" on one side and "100" on the other side of the tablet.

Jyseleca 200 mg film-coated tablets are beige, 17 x 8 mm, capsule-shaped, and engraved with "G" on one side and "200" on the other side of the tablet.

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

Not all pack sizes may be marketed.

Marketing authorisation holder

Alfasigma S.p.A.

Via Ragazzi del '99, n. 5

40133 Bologna

Italy

Manufacturer

Alfasigma S.p.A.

Via Enrico Fermi, 1

65020 Alanno (PE)

Italy

Date of last revision of this leaflet:June 2025

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

QR code to be included

www.jyseleca.eu