JYSELECA

Patient Information Leaflet

Jyseleca 100 mg film-coated tablets, 200 mg film-coated tablets

filgotinib
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Jyseleca is and what it is used for

Jyseleca contains the active substance filgotinib. It belongs to a group of medicines known as Janus kinase inhibitors, which help reduce inflammation.
Rheumatoid arthritis
Jyseleca is used to treat adults with rheumatoid arthritis, an inflammatory disease affecting the joints. It may be used if previous treatment has not been sufficiently effective or was not tolerated. Jyseleca can be used alone or together with another arthritis medicine, methotrexate.
Jyseleca reduces inflammation in the body. It helps reduce pain, fatigue, stiffness, and joint swelling, and reduces damage to bones and cartilage in the joints. These effects may help you carry out 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 may be used if you have not responded adequately or did not tolerate previous therapy. It helps reduce the signs and symptoms of ulcerative colitis and the need for steroids.

2. What you should know before taking Jyseleca

Do not take Jyseleca

• if you are allergic to filgotinib or to any of the other ingredients of this medicine (listed in section 6);
• if you have active tuberculosis (TB);
• if you have an active serious infection (see section “Warnings and precautions”);
• if you are pregnant or suspect 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 pharmacist before taking Jyseleca:

• if you have an infection or if you frequently get infections. Inform your doctor if you experience symptoms such as fever, sores, unusual tiredness, or 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 your risk of developing a new infection. If you have diabetes or are aged 65 years or older, you may have an increased risk of infections;
• if you have ever had tuberculosis (TB) or have been in contact with someone who has TB. You may need to undergo tests for tuberculosis before and during treatment with Jyseleca;
• if you have previously had herpes zoster infection (shingles), as Jyseleca may cause it to recur. Inform your doctor if you develop painful skin rashes with blisters during treatment with Jyseleca, as these may be signs of shingles;
• if you have or have had hepatitis B or C;
• if you have or have had cancer, or if you smoke or have smoked in the past, as your doctor will discuss whether Jyseleca is an appropriate treatment for you;
• cases of non-melanoma skin cancer have been observed in patients treated with Jyseleca. Your doctor may recommend regular skin examinations during treatment with 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 or plan to receive a vaccine. Some types of vaccines (live vaccines) are not recommended while taking Jyseleca. Talk to your doctor or pharmacist before starting Jyseleca. Your doctor or pharmacist will ensure that you have received all necessary vaccinations;
• if you have or have had heart problems, as your doctor will discuss whether Jyseleca is an appropriate treatment for you;
• if you have previously had blood clots in the veins of your legs (deep vein thrombosis) or in your lungs (pulmonary embolism), or if you have an increased risk of developing such clots (e.g.: if you have recently undergone major surgery, if you use hormonal contraceptives/hormone replacement therapy, or if you or your close relatives have been diagnosed with a clotting disorder). Your doctor will discuss whether Jyseleca is suitable for you. Inform your doctor if you experience sudden shortness of breath or difficulty breathing, chest or upper back pain, swelling of an arm or leg, pain or tenderness in the leg, or redness or discoloration of an arm or leg, as these may be signs of blood clots in the veins.

Elderly

Patients aged 65 years or older may have an increased risk of infections, heart attack, and certain 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

Inform 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 to consult your doctor or pharmacist if you are taking any of the following medicines:

• medicines for heart failure, coronary artery 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, suspect you may be pregnant, or are planning a pregnancy, do not take this medicine. Consult your doctor.

Contraception

Do not become pregnant while being treated with Jyseleca. You must use a reliable method of contraception during treatment with Jyseleca and for at least 1 week after the last dose of Jyseleca. If you become pregnant while taking Jyseleca, stop taking the tablets and inform your doctor immediately.

Breastfeeding

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

Driving and using machines

Jyseleca may cause dizziness and vertigo. If you experience dizziness while taking Jyseleca, do not drive or operate tools or machinery.

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 diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Jyseleca

Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is one 200 mg or 100 mg tablet once daily.
If you are 65 years of age or older and have rheumatoid arthritis, or if you have kidney problems, your doctor may
recommend a dose of one 100 mg tablet per 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 you.
Swallow the tablet with a glass of water. Do not divide, crush, or chew the tablet before swallowing, as this may alter the amount of medicine you receive. You may take Jyseleca with food or between meals. Do not ingest the desiccant.
Take Jyseleca every day at the same time. This will help you remember to take your tablets.
Your doctor may temporarily or permanently stop treatment if your blood tests show a low number of white or red blood cells.
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 full day (24 hours) has passed without you taking a dose, skip the missed dose and take a single dose at your usual time.
• Do not take a double dose to make up for a forgotten tablet.

If you stop taking Jyseleca
If you stop treatment with Jyseleca, inform your doctor immediately.
If you have any questions about how to use 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
Contact your doctor immediately or seek medical help if you develop signs of a serious infection, including:

• fever and symptoms of urinary tract infection (urinating more often than usual, pain or discomfort when urinating, or back pain). Urinary tract infections are common (may affect up to 1 in 10 people) and in some cases can be serious;
• lung infection (pneumonia): symptoms may include persistent cough, fever, shortness of breath, and fatigue. This side effect is not common (may affect up to 1 in 100 people);
• shingles (herpes zoster): symptoms may include a painful rash with blisters. This side effect is not common (may affect up to 1 in 100 people);
• blood infection (sepsis): not common (may affect up to 1 in 100 people).

Other side effects
Contact your doctor if you notice any of the following side effects:
Common

• nose and throat infections
• dizziness
• feeling unwell (nausea)

Blood tests may show:

• low number of white blood cells (lymphocytes)
• low level of phosphate in the blood

Uncommon

• feeling dizzy (vertigo)

Blood tests may show:

• low number of white blood cells (neutrophils)
• increased level of a muscle enzyme called creatine phosphokinase
• increased level of fats in the blood (cholesterol).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Jyseleca

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after Exp.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. Keep the bottle tightly closed.
Do not use this medicine if you notice that the seal on the bottle cap is broken or missing.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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 components 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)

Description of the appearance of Jyseleca and contents of the pack
The 100 mg film-coated tablets of Jyseleca are beige in colour, 12 mm × 7 mm in size, capsule-shaped, with “G” imprinted on one side and “100” on the other side.
The 200 mg film-coated tablets of Jyseleca are beige in colour, 17 mm × 8 mm in size, capsule-shaped, with “G” imprinted on one side and “200” on the other side.
Jyseleca 100 mg and 200 mg tablets are available in bottles containing 30 tablets and in packs containing 3 bottles, each bottle containing 30 tablets. Each bottle contains a silica desiccant, which must remain in the bottle to protect the tablets. The silica desiccant is contained in a sachet or a separate container and must not be ingested.
Not all pack sizes may be marketed.

Marketing Authorization 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

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