RINVOQ 45 mg prolonged-release tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

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

Talk to your doctor or pharmacist before and during treatment with RINVOQ 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. RINVOQ 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 65 years of age or older you may have an increased chance of getting infections.
• you have had tuberculosis or have been in close contact with someone with tuberculosis. Your doctor will test you for tuberculosis before starting RINVOQ and may retest during treatment
• you have had a herpes zoster infection (shingles), because RINVOQ may allow it to come back. Tell your doctor if you get a painful skin rash with blisters as these can be signs of shingles
• you have ever had hepatitis B or C
• you have recently had or plan to have a vaccination (immunisation) - this is because live vaccines are not recommended while using RINVOQ
• you have or had in the past cancer, smoke or have smoked in the past, because your doctor will discuss with you if RINVOQ is appropriate for you
• Non-melanoma skin cancer has been observed in patients taking RINVOQ. Your doctor may recommend that you have regular skin examinations while taking RINVOQ. If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.
• have, or have had, heart problems, because your doctor will discuss with you if RINVOQ is appropriate for you
• your liver does not work as well as it should
• 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 recent major surgery, if you use hormonal contraceptives\hormonal replacement therapy, if a blood clotting disorder is identified in you or your close relatives). Your doctor will discuss with you if RINVOQ 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 discolouration in the leg or arm as these can be signs of blood clots in the veins
• you have kidney problems
• you have unexplained stomach (abdominal) pain, have or have had diverticulitis (painful inflammation of small pockets in the lining of your intestine) or ulcers in your stomach or intestines, or are taking non-steroidal anti-inflammatory medicines.

If you notice any of the following serious side effects, tell a doctor straight away:

• symptoms such as a rash (hives), trouble breathing, or swelling of your lips, tongue, or throat, you may be having an allergic reaction. Some people taking RINVOQ had serious allergic reactions. If you have any of these symptoms during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help straight away
• severe stomach pain especially accompanied by fever, nausea, and vomiting.

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:

• 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 fits (such as phenytoin)
• medicines that affect your immune system (such as azathioprine, 6-mercaptopurine, ciclosporin and tacrolimus)
• medicines that may increase your risk of gastrointestinal perforation or diverticulitis such as non-steroidal anti-inflammatory medicines (usually used to treat painful and/or inflammatory conditions of muscle or joints), and/or opioids (used to treat severe pain), and/or corticosteroids (usually used to treat inflammatory conditions).
• medicines to treat diabetes or if you have diabetes. Your doctor may decide if you need less anti-diabetic medicine while taking upadacitinib.

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.

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.

• Swallow the tablet whole with water. Do not split, crush, chew or break the tablet before swallowing as it may change how much medicine gets into 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.

If you take more RINVOQ than you should, contact your doctor. You may get some of the side effects listed in section 4.

• If you miss a dose, take it as soon as you remember.
• If you forget your dose for an entire day, just skip the missed dose and take only a single dose as usual the following day.
• Do not take a double dose to make up for a forgotten tablet.

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

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

• infection such as shingles or painful skin rash with blisters (herpes zoster) – common (may affect up to 1 in 10 people)
• infection of the lung (pneumonia), which may cause shortness of breath, fever, and a cough with mucus – common (may affect up to 1 in 10 people)
• infection in the blood (sepsis) – uncommon (may affect up to 1 in 100 people)
• allergic reaction (chest tightness, wheezing, swelling of the lips, tongue or throat, hives) – uncommon (may affect up to 1 in 100 people)

Talk to your doctor if you notice any of the following side effects:

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

• throat and nose infections
• acne

Common (may affect up to 1 in 10 people)

• non-melanoma skin cancer
• cough
• fever
• cold sores (herpes simplex)
• feeling sick in the stomach (nausea)
• increase in an enzyme called creatine kinase, shown by blood tests
• low white blood cell counts shown in blood tests
• increased levels of cholesterol (a type of fat in the blood) as shown in tests
• increased levels of liver enzymes, shown by blood tests (sign of liver problems)
• weight gain
• inflammation (swelling) of the hair follicles
• flu (influenza)
• anaemia
• pain in your belly (abdomen)
• fatigue (feeling unusually tired and weak)
• headache
• hives (urticaria)
• urinary tract infection
• rash
• a spinning sensation (vertigo)
• dizziness
• infection of the lungs (bronchitis)

Uncommon (may affect up to 1 in 100 people)

• thrush in the mouth (white patches in the mouth)
• increased levels of triglycerides (a type of fat) in the blood, as shown in tests
• diverticulitis (painful inflammation of small pockets in the lining of your intestine)
• gastrointestinal perforation (a hole in the bowel)

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.

The active substance is upadacitinib.

RINVOQ 15 mg prolonged-release tablets

• Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg upadacitinib.
• The other ingredients are:
  • Core tablet: microcrystalline cellulose, mannitol, tartaric acid, hypromellose, silica colloidal anhydrous, magnesium stearate.
  • Film coating: poly(vinyl alcohol), macrogol, talc, titanium dioxide (E171), iron oxide red (E172), iron oxide black (E172).

RINVOQ 30 mg prolonged-release tablets

• Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 30 mg upadacitinib.
• The other ingredients are:
  • Core tablet: microcrystalline cellulose, mannitol, tartaric acid, hypromellose, silica colloidal anhydrous, magnesium stearate.
  • Film coating: poly(vinyl alcohol), macrogol, talc, titanium dioxide (E171), iron oxide red (E172).

RINVOQ 45 mg prolonged-release tablets

• Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 45 mg upadacitinib.
• The other ingredients are:
  • Core tablet: microcrystalline cellulose, mannitol, tartaric acid, hypromellose, silica colloidal anhydrous, magnesium stearate.
  • Film coating: poly(vinyl alcohol), macrogol, talc, titanium dioxide (E171), iron oxide yellow (E172) and iron oxide red (E172).

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.