Patient Leaflet Updated 30-Sep-2024 | Alfasigma UK Limited (formerly Galapagos Biotech Limited)
Jyseleca 100 mg and 200 mg film-coated tablets
Jyseleca 100 mg film-coated tablets
Jyseleca 200 mg film-coated tablets
filgotinib
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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 contains the active substance filgotinib. It belongs to a group of medicines called Janus kinase inhibitors, which help reduce inflammation.
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.
Talk to your doctor or pharmacist before taking Jyseleca:
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:
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.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one 200 mg or 100 mg tablet once a day.
If you are aged 65 years of age or older with rheumatoid arthritis or if you 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 old with ulcerative colitis. Talk to your doctor if you have severe liver problems, as Jyseleca is not recommended for you.
Swallow your tablet with a glass of water. Do not split, crush, or chew the tablet before swallowing as it may change how much medicine gets into your body. 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 to remember to take the tablets.
Your doctor may stop treatment temporarily or permanently if blood tests show a low white or red blood cell count.
If you take more tablets than you should, tell your doctor straight away.
If you stop taking Jyseleca, tell your doctor straight away.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Talk to your doctor or get medical help straight away if you get any signs of serious infection such as:
Talk to your doctor if you notice any of the following side effects:
Common
(may affect up to 1 in 10 people)
Blood tests may show:
Uncommon
(may affect up to 1 in 100 people)
Blood tests may show:
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
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 refers to the last day of that month.
Store in the original package in order to protect from moisture. Keep the bottle tightly closed. Do not use this medicine if you notice that the seal over the bottle opening is broken or missing.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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.
For any information about this medicine, please contact the local representative:
Tel: 0800 072 7878
This leaflet was last revised in 09/2024
QR code to be included
www.jyseleca.eu
Salisbury House, Station Road, Cambridge, Cambridgeshire, CB1 2LA, UK
https://www.alfasigma.com/
0800 7878 1345
0800 072 7878
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