Jyseleca 100 mg film-coated tablets

• 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.

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

Jyseleca is used to treat adults with rheumatoid arthritis, an inflammatory disease of the joints. It can be used if previous therapy did not work well enough, or was not tolerated. Jyseleca can be used on its own, or together with another arthritis medicine, methotrexate.

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

Jyseleca is used to treat adults with ulcerative colitis, an inflammatory disease of the bowel. It can be used if you did not respond well enough or did not tolerate previous therapy. It helps to reduce the signs and symptoms of ulcerative colitis and to reduce your need for steroids.

• if you are allergic to filgotinib or 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 think you may be pregnant.

• If any of these apply to you, do not take Jyseleca and tell your doctor immediately.

Talk to your doctor or pharmacist before taking Jyseleca:

• if you have an infection, or if you often get infections. Tell your doctor if you get symptoms such as fever, wounds, feeling more tired than usual or dental problems as these can be signs of infection. Jyseleca can reduce your body’s ability to fight infections and may make an existing infection worse or increase the chance of you getting a new infection. If you have diabetes or are aged 65 years or older you may have an increased chance of getting infections.
• if you have ever had tuberculosis (TB), or have come into contact with somebody with TB. You may need tests to check for tuberculosis before and during treatment with Jyseleca.
• if you have had a herpes zoster infection (shingles) in the past, Jyseleca can allow it to come back. Tell your doctor if you get a painful skin rash with blisters during Jyseleca treatment as these can 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, because your doctor will discuss with you if Jyseleca is appropriate for you..
• non-melanoma skin cancer has been observed in patients taking Jyseleca. Your doctor may recommend that you have regular skin examinations while taking Jyseleca. If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.
• if you recently had a vaccine, or are due to have one. Certain types of vaccines (live vaccines) are not recommended while using Jyseleca. Talk to your doctor or pharmacist before you start Jyseleca. They may want to make sure that you are up to date with your vaccinations.
• if you have, or have had, heart problems, because your doctor will discuss with you if Jyseleca is appropriate for you.
• if you have previously had blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) or have an increased risk for developing this (for example: if you had a recent major surgery, if you use hormonal contraceptives\hormonal replacement therapy, if a coagulation defect is identified in you or your close relatives). Your doctor will discuss with you if Jyseleca is appropriate for you. Tell your doctor if you get sudden shortness of breath or difficulty breathing, chest pain or pain in upper back, swelling of the leg or arm, leg pain or tenderness, or redness or discoloration in the leg or arm as these can be signs of blood clots in the veins.

Patients aged 65 years and older may be at increased risk of infections, heart attack and some types of cancer. Your doctor may decide that Jyseleca is not suitable for you.

Do not give this medicine to children and adolescents under 18 years of age because it 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, especially if you use medicines that affect your immune system (such as ciclosporin or tacrolimus).

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

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

Pregnancy

Jyseleca must not be used in pregnancy. If you are pregnant, think you may be pregnant or if you are planning to have a baby, do not take this medicine. Talk to your doctor for advice.

Contraception

Be careful not to get pregnant while you are taking Jyseleca. You must use reliable contraception while you are taking Jyseleca, and for at least 1 week after you take your last dose of Jyseleca. If you do become pregnant while you are taking Jyseleca, stop taking the tablets and tell your doctor immediately.

Breast-feeding

Do not breast-feed while you are taking Jyseleca. It is not known whether the active substance passes into human breast milk.

Jyseleca can cause dizziness and vertigo. If you feel dizzy when taking Jyseleca, do not drive and do not use any tools or machines.

Each Jyseleca 100 mg film-coated tablet contains 76 mg of lactose, and each Jyseleca 200 mg film-coated tablet contains 152 mg of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

If you take more tablets than you should, tell your doctor straight away.

• If you miss a dose, take it as soon as you remember.
• If you have gone a whole day (24 hours) without taking a dose, just 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, tell your doctor straight away.

Talk to your doctor or get medical help straight away if you get any signs of serious infection such as:

• fever and symptoms of urinary tract infection (urinating more frequently than usual, pain or discomfort when urinating or back pain). Urinary tract infections are common (may affect up to 1 in 10 people), and some of these may be serious.
• lung infection (pneumonia): symptoms can include persistent cough, fever, shortness of breath, and tiredness. This is uncommon (may affect up to 1 in 100 people).
• shingles (herpes zoster): symptoms can include a painful skin 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).

Talk to 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
• feeling sick (nausea)

Blood tests may show:

• a low number of white blood cells (lymphocytes).

Uncommon

(may affect up to 1 in 100 people)

• a spinning sensation (vertigo)

Blood tests may show:

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

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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

• 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, pregelatinised starch, colloidal silicon dioxide, fumaric acid, magnesium stearate

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

Jyseleca 100 mg film-coated tablets are beige, 12 mm × 7 mm in size, capsule-shaped with “G” on one side and “100” on the other.

Jyseleca 200 mg film-coated tablets are beige, 17 mm × 8 mm in size, capsule-shaped with “G” on one side and “200” on the other.

Jyseleca 100 mg and 200 mg are available in bottles of 30 tablets. Each bottle contains a silica gel desiccant that must be kept in the bottle to help protect your tablets. The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.