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The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 41042/0044.
RINVOQ 15 mg, 30 mg and 45 mg prolonged-release tablets
RINVOQ® 15 mg
prolonged-release tablets
upadacitinib
RINVOQ® 30 mg
prolonged-release tablets
upadacitinib
RINVOQ® 45 mg
prolonged-release tablets
upadacitinib
1. What RINVOQ is and what it is used for
2. What you need to know before you take RINVOQ
3. How to take RINVOQ
4. Possible side effects
5. How to store RINVOQ
6. Contents of the pack and other information
RINVOQ contains the active substance upadacitinib. It belongs to a group of medicines called Janus kinase inhibitors. By reducing the activity of an enzyme called ‘Janus kinase’ in the body, RINVOQ lowers inflammation in the following diseases:
Rheumatoid arthritis
RINVOQ is used to treat adults with rheumatoid arthritis. Rheumatoid arthritis is a disease that causes inflamed joints. If you have moderate to severe active rheumatoid arthritis, you may first be given other medicines, one of which will usually be methotrexate. If these medicines do not work well enough, you will be given RINVOQ either alone or in combination with methotrexate to treat your rheumatoid arthritis.
RINVOQ can help to reduce pain, stiffness and swelling in your joints, reduce tiredness and it can slow down damage to the bone and cartilage in your joints. These effects can ease your normal daily activities and so improve your quality of life.
Psoriatic arthritis
RINVOQ is used to treat adults with psoriatic arthritis. Psoriatic arthritis is a disease that causes inflamed joints and psoriasis. If you have active psoriatic arthritis, you may first be given other medicines. If these medicines do not work well enough, you will be given RINVOQ either alone or in combination with methotrexate to treat your psoriatic arthritis.
RINVOQ can help to reduce pain, stiffness, and swelling in and around your joints, pain and stiffness in your spine, psoriatic skin rash, and tiredness, and it can slow down damage to the bone and cartilage in your joints. These effects can ease your normal daily activities and so improve your quality of life.
Axial spondyloarthritis (non-radiographic axial spondyloarthritis and ankylosing spondylitis)
RINVOQ is used to treat adults with axial spondyloarthritis. Axial spondyloarthritis is a disease that primarily causes inflammation in the spine. If you have active axial spondyloarthritis, you may first be given other medicines. If these medicines do not work well enough, you will be given RINVOQ to treat your axial spondyloarthritis.
RINVOQ can help to reduce back pain, stiffness, and inflammation in your spine. These effects can ease your normal daily activities and so improve your quality of life.
Atopic dermatitis
RINVOQ is used to treat adults and adolescents 12 years and older with moderate to severe atopic dermatitis, also known as atopic eczema. RINVOQ may be used with eczema medicines that you apply to the skin or it may be used on its own.
Taking RINVOQ can improve the condition of your skin, and reduce itching and flares. RINVOQ can help improve symptoms of pain, anxiety and depression that people with atopic dermatitis may have. RINVOQ can also help improve your sleep disturbance and overall quality of life.
Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the large bowel. RINVOQ is used to treat adults with ulcerative colitis who did not respond well enough or did not tolerate previous therapy.
RINVOQ can help to reduce the signs and symptoms of the disease including bloody stools, abdominal pain and the need to rush to and the number of times you go to the toilet. These effects can enable your normal daily activities and reduce fatigue.
Crohn’s disease
Crohn’s disease is an inflammatory disease that may involve any part of the digestive tract, but most commonly affects the bowel. RINVOQ is used to treat adults with Crohn’s disease who did not respond well enough or did not tolerate previous therapy.
RINVOQ can help to reduce the signs and symptoms of the disease including the need to rush to and the number of times you go to the toilet, abdominal pain, and the inflammation of your intestinal lining. These effects can enable your normal daily activities and reduce fatigue.
Talk to your doctor or pharmacist before and during treatment with RINVOQ if:
If you notice any of the following serious side effects, tell a doctor straight away:
You will need blood tests before you start taking RINVOQ, or while you are taking it. This is to check for a low red blood cell count (anaemia), low white blood cell count (neutropenia or lymphopenia), high blood fat (cholesterol) or high levels of liver enzymes. The tests are to check that treatment with RINVOQ is not causing problems.
There is a higher rate of infection in patients aged 65 years of age and older. Tell your doctor as soon as you notice any signs or symptoms of an infection.
Patients 65 years of age and older may be at increased risk of infections, heart problems including heart attack, and some types of cancer. Your doctor will discuss with you if RINVOQ is appropriate for you.
RINVOQ is not recommended for use in children under 12 years of age or adolescents weighing less than 30 kg with atopic dermatitis. This is because it has not been studied in these patients.
RINVOQ is not recommended for use in children and adolescents under 18 years of age with rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (non-radiographic axial spondyloarthritis and ankylosing spondylitis), ulcerative colitis, or Crohn’s disease. This is 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. This is because some medicines may reduce how well RINVOQ works or may increase the risk of getting side effects. It is very important to talk to your doctor or pharmacist if you are taking any of the following:
If any of the above apply to you or you are not sure, talk to your doctor or pharmacist before taking RINVOQ.
Avoid food or drink containing grapefruit during treatment with RINVOQ as these may increase the risk of side effects by increasing the amount of upadacitinib in your body.
Pregnancy
RINVOQ must not be used during pregnancy.
Breast-feeding
If you are breast-feeding or are planning to breast-feed, talk to your doctor before taking this medicine. You should not use RINVOQ while breast-feeding as it is not known if this medicine passes into breast milk. You and your doctor should decide if you will breast-feed or use RINVOQ. You should not do both.
Contraception
If you are a woman of child-bearing potential, you must use effective contraception to avoid becoming pregnant while taking RINVOQ and for at least 4 weeks after your last dose of RINVOQ. If you become pregnant during this time, you must talk to your doctor straight away.
If your child has her first menstrual period while taking RINVOQ, you should inform the doctor.
Do not drive or use machines if you experience dizziness or a spinning sensation (vertigo) when taking RINVOQ until they resolve.
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
If you have rheumatoid arthritis, psoriatic arthritis or axial spondyloarthritis (non-radiographic axial spondyloarthritis and ankylosing spondylitis)
The recommended dose is one 15 mg tablet once a day.
If you have atopic dermatitis
Adults:
The recommended dose is 15 mg or 30 mg as prescribed by your doctor, as one tablet once a day.
Your doctor may increase or decrease your dose depending on how well the medicine is working.
Elderly:
If you are 65 years of age or older, the recommended dose is 15 mg once a day.
Adolescents (from 12 to 17 years of age) weighing at least 30 kg:
The recommended dose is one 15 mg tablet once a day.
If you have ulcerative colitis
The recommended dose is one 45 mg tablet once a day for 8 weeks. Your doctor may decide to extend the initial 45 mg dose for another 8 weeks (for 16 weeks total). This will be followed by one 15 mg or one 30 mg tablet once a day for your long-term treatment. Your doctor may increase or decrease your dose depending on how you respond to the medicine.
Elderly:
If you are 65 years of age or older, the recommended dose is 15 mg once a day for your long-term treatment.
Your doctor may reduce your dose if you have kidney problems, or you are prescribed certain other medicines.
If you have Crohn’s disease
The recommended dose is one 45 mg tablet once a day for 12 weeks. This will be followed by one 15 mg or one 30 mg tablet once a day for your long-term treatment. Your doctor may increase or decrease your dose depending on how you respond to the medicine.
Elderly:
If you are 65 years of age or older, the recommended dose is 15 mg once a day for your long-term treatment.
Your doctor may reduce your dose if you have kidney problems, or you are prescribed certain other medicines.
If you take more RINVOQ than you should, contact your doctor. You may get some of the side effects listed in section 4.
Do not stop taking RINVOQ unless your doctor tells you to stop taking it.
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:
Talk to your doctor if you notice any of the following side effects:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects you can help provide more information on the safety of this medicine.
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 blister and carton after ‘EXP’.
This medicine does not require any special temperature storage conditions.
Store in the original blister in order to protect from moisture.
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.
The active substance is upadacitinib.
RINVOQ 15 mg prolonged-release tablets
RINVOQ 30 mg prolonged-release tablets
RINVOQ 45 mg prolonged-release tablets
RINVOQ 15 mg prolonged-release tablets
RINVOQ 15 mg prolonged-release tablets are purple, oblong, biconvex tablets imprinted on one side with ‘a15’.
The tablets are provided in blisters or bottles.
RINVOQ is available in packs containing 28 or 98 prolonged-release tablets and in multipacks of 84 comprising 3 cartons, each containing 28 prolonged-release tablets.
Each calendar blister contains 7 tablets.
RINVOQ is available in bottles with desiccant containing 30 prolonged-release tablets, each pack contains 1 bottle (30 tablet pack) or 3 bottles (90 tablet pack).
RINVOQ 30 mg prolonged-release tablets
RINVOQ 30 mg prolonged-release tablets are red, oblong, biconvex tablets imprinted on one side with ‘a30’.
The tablets are provided in blisters or bottles.
RINVOQ is available in packs containing 28 or 98 prolonged-release tablets.
Each calendar blister contains 7 tablets.
RINVOQ is available in bottles with desiccant containing 30 prolonged-release tablets, each pack contains 1 bottle (30 tablet pack) or 3 bottles (90 tablet pack).
RINVOQ 45 mg prolonged-release tablets
RINVOQ 45 mg prolonged-release tablets are yellow to mottled yellow, oblong, biconvex tablets imprinted on one side with ‘a45’.
The tablets are provided in blisters or bottles.
RINVOQ is available in packs containing 28 prolonged-release tablets.
Each calendar blister contains 7 tablets.
RINVOQ is available in bottles with desiccant containing 28 prolonged-release tablets, each pack contains 1 bottle.
Not all pack sizes may be marketed.
This leaflet was last revised in 10/2024
To listen to or request a copy of this leaflet in Braille, large print or audio, please contact the Marketing Authorisation Holder.
20087485