Patient Information Leaflet

RINVOQ 15 mg prolonged-release tablets

RINVOQ 30 mg prolonged-release tablets

RINVOQ 45 mg prolonged-release tablets

upadacitinib

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you are unsure about anything, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

RINVOQ contains the active ingredient upadacitinib. It belongs to a group of medicines called Janus kinase inhibitors. By reducing the activity of an enzyme in the body called "Janus kinase", RINVOQ reduces inflammation in the following diseases:

• Rheumatoid Arthritis
• Psoriatic Arthritis
• Axial Spondyloarthritis,
• Non-radiographic Axial Spondyloarthritis
• Ankylosing Spondylitis (AS, Radiographic Axial Spondyloarthritis)
• Atopic Dermatitis
• Ulcerative Colitis
• Crohn's Disease

Rheumatoid Arthritis

RINVOQ is used to treat adults with rheumatoid arthritis. Rheumatoid arthritis is a disease that causes inflammation of the joints. If you have moderate to severe rheumatoid arthritis, you may first be prescribed other medications, one of which is usually methotrexate. If these medications do not work well enough, you will be administered RINVOQ alone or in combination with methotrexate to treat your rheumatoid arthritis.

RINVOQ may help reduce joint pain, stiffness, and inflammation, reduce fatigue, and slow the progression of damage to the bone and cartilage in the joints. These effects may make your daily activities easier and improve your quality of life.

Psoriatic Arthritis

RINVOQ is used to treat adults with psoriatic arthritis. Psoriatic arthritis is a disease that causes inflammation of the joints and psoriasis. If you have active psoriatic arthritis, you are likely to be administered other medications first. If these medications do not work well enough, you will be administered RINVOQ alone or in combination with methotrexate to treat psoriatic arthritis.

RINVOQ may help reduce pain, stiffness, and inflammation in and around the joints, back pain and stiffness, skin rash due to psoriasis, and fatigue, and may also slow the damage to the bones and cartilage in the joints. These effects may make your daily activities easier and 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 mainly causes inflammation in the spine. If you have active axial spondyloarthritis, you are likely to be administered other medications first. If these medications do not work well enough, you will be administered RINVOQ to treat axial spondyloarthritis.

RINVOQ may help reduce lower back pain, stiffness, and inflammation of the spine. These effects may make your daily activities easier and improve your quality of life.

Atopic Dermatitis

RINVOQ is used to treat adults and adolescents aged 12 years and older with moderate to severe atopic dermatitis, also known as eczema. RINVOQ can be used with topical eczema medications or alone.

Taking RINVOQ may improve skin condition and reduce itching and flare-ups. RINVOQ may help improve symptoms of pain, anxiety, and depression that people with atopic dermatitis may experience. RINVOQ may help improve sleep disorders and overall quality of life.

Ulcerative Colitis

Ulcerative colitis is an inflammatory bowel disease of the large intestine. RINVOQ is used for treatment in adults with ulcerative colitis who did not have a sufficient response or could not tolerate a previous treatment.

RINVOQ may help reduce signs and symptoms of the disease, including bloody stools, abdominal pain, and urgency and frequency of bowel movements. These effects may make your daily activities easier and reduce fatigue.

Crohn's Disease

Crohn's disease is an inflammatory bowel disease that can affect any part of the digestive tract, but most often affects the intestine. RINVOQ is used for treatment in adults with Crohn's disease who did not have a sufficient response or could not tolerate a previous treatment.

RINVOQ may help reduce signs and symptoms of the disease, including urgency and frequency of bowel movements, abdominal pain, and inflammation of the intestinal lining. These effects may make your daily activities easier and reduce fatigue.

Do not take RINVOQ

• if you are allergic to upadacitinib or any of the other ingredients in this medicine (listed in section 6)
• if you have a serious infection (such as pneumonia or skin infection caused by bacteria)
• if you have active tuberculosis (TB)
• if you have severe liver problems
• if you are pregnant (see the Pregnancy, breastfeeding and contraception section)

Warnings and precautions

Consult your doctor or pharmacist before and during treatment with RINVOQ if:

• you have an infection or have frequent infections. Inform your doctor if you have symptoms such as fever, wounds, feeling more tired than usual, or dental problems, as these may be signs of infection. RINVOQ may reduce your body's ability to fight infections and may worsen an existing infection or increase the risk of a new infection. If you have diabetes or are 65 years of age or older, you may be more likely to get infections
• you have had tuberculosis or have been in close contact with someone with tuberculosis. Your doctor will make you take a test for tuberculosis before starting RINVOQ and may repeat the test during treatment
• you have had herpes (shingles), as RINVOQ may cause it to reappear. Inform your doctor if you have a painful skin rash with blisters, as this may be a sign of herpes zoster
• you have had hepatitis B or C at any time
• you have recently been vaccinated or plan to be vaccinated (immunized) – this is because live vaccines should not be administered while taking RINVOQ

• you have or have had cancer in the past, smoke or have smoked in the past, as your doctor will assess whether RINVOQ is suitable for you

• you have been observed to have non-melanoma skin cancer in patients taking RINVOQ. Your doctor may recommend that you undergo regular skin examinations while taking RINVOQ. Inform your doctor if you develop new skin lesions during or after treatment or if you notice a change in the appearance of existing lesions

• you have or have had heart problems, as your doctor will assess whether RINVOQ is suitable for you
• your liver is not functioning as well as it should

• you have had blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) or are at increased risk of developing them (for example, if you have recently had major surgery, use hormonal contraceptives/hormone replacement therapy, or have been identified with any coagulation disorder in yourself or your close relatives). Your doctor will assess whether RINVOQ is suitable for you. Inform your doctor if you experience sudden shortness of breath or difficulty breathing, chest pain or upper back pain, swelling in your leg or arm, pain or tenderness in your leg or arm, or redness or change in color in your leg or arm, as these may be signs of blood clots in the veins
• you have kidney problems
• you have unknown abdominal pain, have or have had diverticulitis (inflammation of small pouches in the lining of the intestine) or ulcers in the stomach or intestine, or are taking non-steroidal anti-inflammatory drugs (usually used to treat painful and/or inflammatory muscle or joint diseases), and/or opioids (used to treat intense pain), and/or corticosteroids (usually used to treat inflammatory diseases)
• you frequently see tablets or parts of tablets in your stool

If you notice any of the following serious side effects, inform your doctor immediately:

• symptoms such as a rash, difficulty breathing, or swelling of your lips, tongue, or throat, which may be a sign of an allergic reaction. Some people taking RINVOQ have had severe allergic reactions. If during treatment with RINVOQ you experience any of these symptoms, stop taking RINVOQ and seek urgent medical assistance
• severe stomach pain, especially accompanied by fever, nausea, and vomiting

Blood tests

You will need to have a blood test before starting RINVOQ, or while taking it. This is to check if you have a low red blood cell count (anemia), a low white blood cell count (neutropenia or lymphopenia), high levels of fat in your blood (cholesterol), or high levels of liver enzymes. The tests are to check that treatment with RINVOQ is not causing any problems

Older patients

There is a higher rate of infections in patients aged 65 years and older. Inform your doctor immediately if you notice any signs or symptoms of infection

Patients aged 65 years and older may be at increased risk of infections, heart problems, including heart attack, and certain types of cancer. Your doctor will assess whether RINVOQ is suitable for you

Children and adolescents

RINVOQ is not recommended for children with atopic dermatitis under 12 years of age or adolescents with a body weight under 30 kg. It has not been studied in these patients

RINVOQ is not recommended for 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. It has not been studied in this age group

Other medicines and RINVOQ

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. Some medicines may reduce the effectiveness of RINVOQ or increase the risk of side effects. It is very important that you inform your doctor or pharmacist if you are taking any of the following:

• medicines to treat fungal infections (such as itraconazole, posaconazole, or voriconazole)
• medicines to treat bacterial infections (such as clarithromycin)
• medicines to treat Cushing's syndrome (such as ketoconazole)
• medicines to treat tuberculosis (such as rifampicin)
• medicines to treat seizures or epilepsy (such as phenytoin)
• medicines that affect your immune system (such as azathioprine, 6-mercaptopurine, cyclosporine, and tacrolimus)
• medicines that may increase the risk of gastrointestinal perforation or diverticulitis, such as non-steroidal anti-inflammatory drugs (usually used to treat painful and/or inflammatory muscle or joint diseases), and/or opioids (used to treat intense pain), and/or corticosteroids (usually used to treat inflammatory diseases)
• medicines to treat diabetes or if you have diabetes. Your doctor may decide if you need less diabetes medicine while taking upadacitinib

If you have any of these cases or are unsure, consult your doctor or pharmacist before taking RINVOQ

Pregnancy, breastfeeding, and fertility

Pregnancy

RINVOQ should not be used during pregnancy

Breastfeeding

If you are breastfeeding or plan to breastfeed, consult your doctor before taking this medicine. You should not use RINVOQ while breastfeeding, as it is unknown whether this medicine passes into breast milk. You and your doctor should decide whether to breastfeed or take RINVOQ. Do not do both

Fertility

If you are a woman of childbearing age, you should use an effective contraceptive method to avoid becoming pregnant while taking RINVOQ and for at least 4 weeks after the last dose of RINVOQ. If you become pregnant during this time, inform your doctor immediately

Inform your doctor if your daughter has her first menstrual period while taking RINVOQ

Driving and operating machinery

Do not drive or operate machinery if you feel dizzy or have a sensation of spinning (vertigo) while taking RINVOQ until these symptoms have disappeared

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

Amount to take

If you have rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis (non-radiographic axial spondyloarthritis and ankylosing spondylitis)

The recommended dose is a 15 mg tablet once a day.

If you have atopic dermatitis

Adults (18 to 64 years of age):

The recommended dose is 15 mg or 30 mg, as prescribed by your doctor, as a tablet once a day.

Your doctor may increase or decrease your dose depending on how you respond to treatment.

Adolescents (12 to 17 years of age) weighing at least 30 kg:

The recommended dose is a 15 mg tablet once a day. Your doctor may increase your dose to a 30 mg tablet once a day depending on how you respond to treatment.

Older patients:

If you are 65 years of age or older, the recommended dose is 15 mg once a day.

If you have ulcerative colitis

The recommended dose is a 45 mg tablet once a day for 8 weeks. Your doctor will decide to prolong the initial dose of 45 mg for another 8 weeks (a total of 16 weeks), followed by a 15 mg or 30 mg tablet once a day for long-term treatment. Your doctor may increase or decrease your dose depending on how you respond to the medication.

Older patients:

If you are 65 years of age or older, the recommended dose is 15 mg once a day for long-term treatment.

Your doctor may reduce your dose if you have kidney problems or if you have been prescribed other medications.

If you have Crohn's disease

The recommended dose is a 45 mg tablet once a day for 12 weeks. This will be followed by a 15 mg or 30 mg tablet once a day for long-term treatment. Your doctor may increase or decrease your dose depending on how you respond to the medication.

Older patients:

If you are 65 years of age or older, the recommended dose is 15 mg once a day for long-term treatment.

Your doctor may reduce your dose if you have kidney problems or if you have been prescribed other medications.

How to take the medication

• Swallow the tablet whole with water. Do not break, crush, chew, or split the tablet before swallowing, as this may alter the amount of medication that enters your body.
• To help you remember to take RINVOQ, take it at the same time every day.

• The tablets can be taken with or without food.

• Do not ingest the desiccant.
• Avoid foods or beverages that contain grapefruit while taking (or being treated with) RINVOQ, as they may increase the risk of adverse effects by increasing the amount of medication in your body.

If you take more RINVOQ than you should

If you take more RINVOQ than you should, consult your doctor. You may experience some of the adverse effects described in section 4.

If you forget to take RINVOQ

• If you forget to take a dose, take it as soon as you remember.
• If you forget to take your dose for an entire day, simply skip the missed dose and take a single dose the next day as usual.
• Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with RINVOQ

Do not stop taking RINVOQ unless your doctor tells you to.

How to open the bottle

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects

Inform your doctor or seek immediate medical help if you experience any of the following symptoms:

• infection, such as shingles or painful skin rash with blisters (shingles) – frequent (may affect up to 1 in 10 people).
• lung infection (pneumonia), which may cause difficulty breathing, fever, and cough with mucus – frequent (may affect up to 1 in 10 people).
• blood infection (sepsis) – infrequent (may affect up to 1 in 100 people).
• allergic reaction (chest tightness, palpitations, swelling of the lips, tongue, or throat, hives) – infrequent (may affect up to 1 in 100 people).

Other side effects

Inform your doctor if you experience any of the following side effects:

Very frequent(may affect more than 1 in 10 people)

• throat and nasal infections
• acne

Frequent(may affect up to 1 in 10 people)

• non-melanoma skin cancer
• cough

• fever
• chills (herpes simplex)
• nausea (sensation of stomach discomfort)
• increased levels of a certain enzyme called creatine kinase, observed in blood tests
• low white blood cell count in blood tests
• high cholesterol levels (a type of blood fat), observed in blood tests
• high liver enzyme levels, observed in blood tests (sign of liver problems)
• weight gain
• inflammation (swelling) of hair follicles
• influenza (flu)
• anemia
• abdominal pain
• fatigue (unusual feeling of tiredness and weakness)
• headache
• hives (urticaria)
• urinary tract infection
• skin rash
• dizziness (feeling of spinning)
• vertigo
• bronchitis (lung infection)

Infrequent(may affect up to 1 in 100 people)

• oral candidiasis (white patches in the mouth)
• high triglyceride levels (a type of blood fat) in the blood, observed in blood tests
• diverticulitis (inflammation of small pouches in the intestinal lining)
• gastrointestinal perforation (a hole in the intestine)

Additional side effects in adolescents with atopic dermatitis

Frequent:

• warts (cutaneous papilloma)

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears onthe blister pack and on the box after “EXP”.

This medication does not require any special storage temperature.

Store in the original blister packor bottlewith the cap tightly closedto protect it from moisture.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of RINVOQ

The active ingredient is upadacitinib.

RINVOQ 15mg prolonged-release tablets

• Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15mg of upadacitinib.
• The other components are:

• Tablet core: microcrystalline cellulose, mannitol, tartaric acid, hypromellose, anhydrous colloidal silica, magnesium stearate.
• Coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), iron oxide red (E172), iron oxide black (E172).

RINVOQ 30mg prolonged-release tablets

• Each prolonged-release tablet containsupadacitinib hemihydrate, equivalent to30mg of upadacitinib.
• The other components are:

• Tablet core: microcrystalline cellulose, mannitol, tartaric acid, hypromellose, anhydrous colloidal silica, magnesium stearate.
• Coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), iron oxide red (E172).

RINVOQ 45mg prolonged-release tablets

• Each prolonged-release tablet containsupadacitinib hemihydrate, equivalent to45mg of upadacitinib.
• The other components are:

• Tablet core: microcrystalline cellulose, mannitol, tartaric acid, hypromellose, anhydrous colloidal silica, magnesium stearate.
• Coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), iron oxide yellow (E172) and iron oxide red (E172).

Appearance of the product and contents of the pack

RINVOQ 15mg prolonged-release tablets

RINVOQ 15mg prolonged-release tablets are purple, oblong and biconvex tablets, engraved with “a15” on one face.

The tablets are available in blisters or bottles.

RINVOQ is available in packs of 28 or 98prolonged-release tablets and in multiple packs of 84prolonged-release tablets with 3packs, each containing 28prolonged-release tablets.

Each calendar blister pack contains 7tablets.

RINVOQ is available in bottles with desiccant that contain 30prolonged-release tablets, each pack contains 1bottle (pack of 30tablets) or 3bottles (pack of 90tablets).

RINVOQ 30mg prolonged-release tablets

RINVOQ 30mg prolonged-release tablets are red, oblong and biconvex tablets, engraved with “a30” on one face.

The tablets are available in blisters or bottles.

RINVOQ is available in packs of 28 or 98 prolonged-release tablets.

Each calendar blister pack contains 7tablets.

RINVOQ is available in bottles with desiccant that contain 30 prolonged-release tablets, each pack contains 1 bottle (pack of 30 tablets) or 3 bottles (pack of 90 tablets).

RINVOQ 45mg prolonged-release tablets

RINVOQ 45mg prolonged-release tablets are yellow to yellow speckled, oblong and biconvex tablets, engraved with “a45” on one face.

The tablets are available in blisters or bottles.

RINVOQ is available in packs of 28 prolonged-release tablets.

Each calendar blister pack contains 7tablets.

RINVOQ is available in bottles with desiccant that contain 28 prolonged-release tablets, each pack contains 1 bottle.

Only some pack sizes may be marketed.

Marketing Authorization Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Responsible for manufacturing

AbbVie S.r.l.

S.R. 148 Pontina, km 52 SNC

04011 Campoverde di Aprilia (Latina)

Italy

AbbVie Logistics B.V.

Zuiderzeelaan 53

Zwolle, 8017 JV,

Netherlands

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

You can also consult detailed and updated information on this product by scanning the QR code below or on the outer carton with a smartphone. The same information is also available on the following URL:www.rinvoq.eu.

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To listen to or request a copy of this leaflet in , or to listen to it in ,please contact the local representative of the marketing authorization holder.