Patient Information Leaflet

Olumiant 2 mg Film-Coated Tablets

Olumiant 4 mg Film-Coated Tablets

baricitinib

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, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as 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.

1. How to take Olumiant
2. Possible side effects

1. Storage of Olumiant
2. Contents of the pack and additional information

Olumiant contains the active ingredient baricitinib. It belongs to a group of medicines called Janus kinase inhibitors, which help reduce inflammation.

Rheumatoid Arthritis

Olumiant is used to treat adults with moderate to severe rheumatoid arthritis, an inflammatory joint disease, when previous treatments have not worked well or have not been tolerated. Olumiant can be used alone or in combination with other medicines such as methotrexate.

Olumiant acts by reducing the activity of an enzyme in the body called 'Janus kinase', which is involved in the inflammatory process. By reducing the activity of this enzyme, Olumiant helps reduce joint pain, stiffness, and inflammation, fatigue, and helps slow the progression of damage to the bone and cartilage in the joints. These effects can help you perform your daily activities and thus improve health-related quality of life in patients with rheumatoid arthritis.

Atopic Dermatitis

Olumiant is used to treat children aged 2 years and older, adolescents, and adults with moderate to severe atopic dermatitis, also known as eczema. Olumiant can be used with other eczema medicines applied to the skin or used alone.

Olumiant acts by reducing the activity of an enzyme in the body called 'Janus kinase', which is involved in the inflammatory process. By reducing the activity of this enzyme, Olumiant helps improve skin condition and reduce itching. Additionally, Olumiant helps improve sleep disturbances (caused by itching) and overall quality of life. It has also been shown thatOlumiant improves symptoms such as skin pain, anxiety, and depression associated with atopic dermatitis.

Alopecia Areata

Olumiant is used to treat adults with severe alopecia areata, an autoimmune disease characterized by non-scarring and inflammatory hair loss on the scalp, face, and sometimes other parts of the body, which can be recurrent and progressive.

Olumiant acts by reducing the activity of an enzyme in the body called "Janus kinase", whichis involved in the inflammatory process. By reducing the activity of this enzyme, Olumiant helps hair regrow on the scalp, face, and other affected areas of the body.

Juvenile Idiopathic Arthritis, Entesitis-Related Arthritis, and Juvenile Psoriatic Arthritis

Olumiant is used to treat active juvenile idiopathic arthritis, an inflammatory joint disease, in children aged 2 years and older.

Olumiant is also used to treat active entesitis-related arthritis, an inflammatory joint and tendon disease, in children aged 2 years and older.

Olumiant is also used to treat active juvenile psoriatic arthritis, an inflammatory joint disease that often accompanies psoriasis, in children aged 2 years and older.

Olumiant can be used alone or in combination with methotrexate.

Do not take Olumiant

• if you are allergic to baricitinib or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or think you may be pregnant.

Warnings and precautions

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

• are 65 years of age or older. Patients 65 years of age or older may have a higher risk of infections, heart problems, including myocardial infarction, and certain types of cancer. Your doctor will discuss with you whether Olumiant is appropriate for you.
• have an infection, or if you frequently get infections. Inform your doctor if you experience symptoms such as fever, wounds, feel more tired than usual, or have dental problems, as these may be signs of infection. Olumiant may reduce your body's ability to fight infections and may make an existing infection worse or increase the likelihood of acquiring a new infection. If you have diabetes or are 65 years of age or older, you may have a higher chance of getting an infection.

• have or have had previously tuberculosis. You may need tests to detect tuberculosis before starting to take Olumiant. Inform your doctor if you have persistent cough, fever, night sweats, and weight loss during treatment with Olumiant, as these may be signs of tuberculosis.

• have had a herpes (herpes zoster) infection, as Olumiant may cause its reactivation. Inform your doctor if you have a painful skin rash with blisters during treatment with Olumiant, as these may be signs of herpes zoster.

• have, or have had previously, hepatitis B or C.

• need to be vaccinated. Certain types of live vaccines should not be administered while taking Olumiant.

• have or have had cancer, smoke, or have smoked in the past, because your doctor will discuss with you whether Olumiant is appropriate for you.
• have decreased liver function.
• have, or have had, heart problems, because your doctor will discuss with you whether Olumiant is appropriate for you.

• have had previously deep vein thrombosis or pulmonary embolism, or have a higher risk of developing them (for example, if you recently underwent major surgery, if you use hormonal contraceptives/hormone replacement therapy, or if you have been identified with a coagulation disorder in you or your close relatives). Your doctor will discuss with you whether Olumiant is appropriate for you. Inform your doctor if you suddenly lack air or have difficulty breathing, chest pain or pain in the upper back, swelling of the leg or arm, pain or sensitivity in the leg, or redness or discoloration in the leg or arm, as these may be signs of blood clots in the veins.

• have had diverticulitis (a type of inflammation of the large intestine) or ulcers in the stomach or intestine (see section 4).
• Cancer of the skin (non-melanoma) has been observed in patients taking Olumiant. Your doctor may recommend that you undergo periodic skin examinations while taking Olumiant. If new skin lesions appear during or after treatment, or if existing lesions change in appearance, inform your doctor.

If you experience any of the following severe side effects, contact your doctor immediately:

• asthma
• severe dizziness or vertigo
• swelling of the lips, tongue, or throat

• urticaria (pruritus or hives)
• severe abdominal pain, especially accompanied by fever, nausea, and vomiting.
• intense or oppressive chest pain (which may extend to the arms, jaw, neck, or back)
• difficulty breathing

-chills

-weakness on one side of the arm and/or leg

-slurred speech

You may need blood tests before starting to take Olumiant or while taking it to determine if you have a low red blood cell count (anemia), low white blood cell count (neutropenia or lymphopenia), high levels of fat in the blood (cholesterol), or high levels of liver enzymes, in order to ensure that treatment with Olumiant is not causing problems.

Children and adolescents

If possible, children and adolescents should be up to date on all vaccinations before using Olumiant.

Do not administer this medicine to children under 2 years of age.

Do not administer this medicine to children and adolescents with alopecia areata under 18 years of age, as there is no information on use in this condition.

Other medicines and Olumiant

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

In particular, inform your doctor or pharmacist before starting to take Olumiant if you are taking any other medicine, such as:

• probencid (for gout), as this medicine may increase the levels of Olumiant in your blood. If you are taking probencid, the recommended dose of Olumiant in adults is 2 mg once a day, and in children and adolescents, the dose should be reduced to half.

• injectable anti-inflammatory medicine
• injectable medicines that suppress the immune system, including biologic treatments (antibodies)
• medicines used to control the immune response of the body, such as azathioprine, tacrolimus, or cyclosporine
• other medicines that belong to the group of Janus kinase inhibitors
• medicines that may increase the risk of diverticulitis, such as non-steroidal anti-inflammatory drugs (usually used to treat painful or inflammatory muscle or joint disorders) or opioids (used to treat intense pain), or corticosteroids (usually used to treat inflammatory disorders) (see section 4).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

You should use an effective contraceptive method to avoid becoming pregnant during treatment with Olumiant and for at least one week after completing treatment with Olumiant. Inform your doctor if you become pregnant, as Olumiant should not be used during pregnancy.

You should not use Olumiant during breastfeeding, as it is unknown whether this medicine passes into breast milk. You and your doctor should decide whether to breastfeed or take Olumiant. Do not do both.

Driving and operating machinery

The influence of Olumiant on the ability to drive and operate machinery is negligible or insignificant.

Olumiant contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, it is essentially "sodium-free".

The treatment should be started by a doctor with experience in diagnosing and treating your disease. Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults with rheumatoid arthritis, atopic dermatitis, and alopecia areata

The recommended dose is 4 mg once a day. Your doctor may give you a lower dose of 2 mg once a day, especially if you are over 65 years old or if you have an increased risk of infections, blood clots, severe cardiovascular events, or cancer.

If the medication is working well, your doctor may decide to reduce the dose.

If you have reduced renal function, the recommended dose of Olumiant is 2 mg once a day.

Use in children and adolescents

The recommended dose is 4 mg once a day for patients over 30 kg. For patients 10 kg to < 30 kg, the recommended dose is 2 mg once a day.

If you have reduced renal function, the recommended dose of Olumiant should be reduced by half.

For pediatric patients who cannot swallow whole tablets, the tablets can be dispersed in water:

-Place the whole tablet in a container with 5-10 ml of water at room temperature and gently shake to disperse (dissolve) the tablet. The tablet may take up to 10 minutes to disperse into a pale pink turbid suspension. Some sediment may appear.

-After dispersing the tablet, gently shake again and then take the mixture immediately.

-Wash the container with 5-10 ml of water at room temperature, shaking and take the mixture immediately to ensure that the full dose is administered.

Only water should be used to disperse the tablet.

After dispersing the tablet in water, it can be used for a maximum of 4 hours if kept at room temperature.

If a tablet is dispersed in water and only part of the dose is taken, wait until the next day to take the next scheduled dose.

Administration form

Olumiant is for oral administration. Swallow the tablet with a little water.

You can take the tablets both with food and without food. To help you remember to take Olumiant, it may be easier to take it at the same time every day.

If you take more Olumiant than you should

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

If you forget to take Olumiant

• 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 you normally do.
• Do not take a double dose to compensate for a missed dose.

If you interrupt treatment with Olumiant

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

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

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

Severe side effects

Infections such as shingles and pneumonia, which may affect more than 1 in 10 people:Inform your doctor or seek medical help immediately if you experience any of the following symptoms, which may be signs of:

• shingles: painful skin rash with blisters and fever (was very rare in atopic dermatitis and infrequent in alopecia areata)

• pneumonia: persistent cough, fever, difficulty breathing, and fatigue (was infrequent in atopic dermatitis and alopecia areata)

Severe pneumonia and shingles were infrequent.

Other side effects

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

• throat and nose infections
• high levels of fat in the blood (cholesterol) observed in blood tests

Common(may affect up to 1 in 10 people):

• fevers (herpes simplex)

• infection that causes nausea or diarrhea (gastroenteritis)

• urinary tract infection

• high platelet count (cells involved in blood clotting), observed in blood tests (was infrequent in atopic dermatitis and alopecia areata)
• headache
• feeling of discomfort in the stomach (nausea; was infrequent in atopic dermatitis)
• stomach pain (was infrequent in alopecia areata)

• high levels of liver enzymes, observed in blood tests (was infrequent in atopic dermatitis)
• skin rash
• acne (was infrequent in rheumatoid arthritis)
• increase in an enzyme called creatine kinase, observed in blood tests (was infrequent in rheumatoid arthritis)
• inflammation (swelling) of hair follicles, especially on the scalp, associated with hair growth (observed in alopecia areata)

Infrequent(may affect up to 1 in 100 people):

• low white blood cell count (neutrophils), observed in blood tests
• high levels of fat in the blood (triglycerides), observed in blood tests
• high levels of liver enzymes, observed in blood tests (was frequent in alopecia areata)

• weight gain
• swelling of the face

• urticaria

• blood clots in the blood vessels of the lungs

• blood clot in the veins of the legs or pelvis, called deep vein thrombosis (DVT)
• diverticulitis (inflammatory and painful condition of the small pouches of the intestinal lining)

Children and adolescents

• Juvenile idiopathic polyarticular arthritis, enthesitis-related arthritis, and juvenile psoriatic arthritis:In a study in children aged 2years or older with juvenile idiopathic polyarticular arthritis, enthesitis-related arthritis, and juvenile psoriatic arthritis, headache was very common, low white blood cell count was common, and blood clots in the lungs were common (1 in 82children).
• Pediatric atopic dermatitis:In a study in children aged 2years or older with atopic dermatitis, side effects were consistent with those observed in adult patients, except for low white blood cell count (neutrophils), which was more common compared to adults.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

Medicines 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. By doing so, you will help protect the environment.

Composition of Olumiant

• The active principle is baricitinib. Each tablet contains 2 or 4 milligrams of baricitinib.

• The other components are: microcrystalline cellulose, sodium croscarmellose (see section 2 “Olumiant contains sodium”), magnesium stearate, mannitol, red iron oxide (E172), soy lecithin (E322), macrogol, polyvinyl alcohol, talc, and titanium dioxide (E171).

Appearance of the product and contents of the pack

Olumiant 2 mg film-coated tablets are pinkish-white, oblong-shaped tablets measuring 9 x 7.5 mm, with “Lilly” on one face and “2” on the other.

Olumiant 4 mg film-coated tablets are medium-pink, round tablets measuring 8.5 mm, with “Lilly” on one face and “4” on the other.

The tablets are rounded and have a concave area to help them be grasped.

Olumiant 2 mg and 4 mg are available in calendar blister packs of 14, 28, 35, 56, 84, and 98 tablets, and in pre-cut single-dose blister packs of 28 x 1 and 84 x 1 tablets. Only some pack sizes may be marketed.

Marketing Authorisation Holder

Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, Netherlands.

Responsible Person

Responsible Person: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgium/België/BelgienLietuva

Eli Lilly Benelux S.A./N.V.Eli Lilly Lietuva

Tel: + 32-(0)2 548 84 84Tel. +370 (5) 2649600

Luxembourg/Luxemburg

?? "??? ???? ?????????" ?.?. - ????????Eli Lilly Benelux S.A./N.V.

???. + 359 2 491 41 40Tél/Tel: + 32-(0)2 548 84 84

Czech RepublicHungary

ELI LILLY CR, s.r.o.Lilly Hungária Kft.

Tel: + 420 234 664 111Tel: + 36 1 328 5100

DenmarkMalta

Eli Lilly Danmark A/SCharles de Giorgio Ltd.

Tlf: +45 45 26 60 00Tel: + 356 25600 500

GermanyNetherlands

Lilly Deutschland GmbHEli Lilly Nederland B.V.

Tel. + 49-(0) 6172 273 2222Tel: + 31-(0) 30 60 25 800

EstoniaNorway

Eli Lilly Nederland B.V.Eli Lilly Norge A.S.

Tel: +372 6 817 280Tlf: + 47 22 88 18 00

GreeceAustria

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.EliLilly Ges.m.b.H.

Τηλ: +30 210 629 4600Tel: + 43-(0) 1 711 780

SpainPoland

Lilly S.A.Eli Lilly Polska Sp. z o.o.

Tel: + 34-91 663 50 00Tel: +48 22 440 33 00

FrancePortugal

Lilly FranceLilly Portugal Produtos Farmacêuticos, Lda

Tél: +33-(0) 1 5549 34 34Tel: + 351-21-4126600

CroatiaRomania

Eli Lilly Hrvatska d.o.o.Eli Lilly România S.R.L.

Tel: +385 1 2350 999Tel: + 40 21 4023000

IrelandSlovenia

Eli Lilly and Company (Ireland) LimitedEli Lilly farmacevtska družba, d.o.o.

Tel: + 353-(0) 1 661 4377Tel: +386 (0)1 580 00 10

IcelandSlovakia

Icepharma hf.Eli Lilly Slovakia s.r.o.

Sími + 354 540 8000Tel: + 421 220 663 111

ItalyFinland

Eli Lilly Italia S.p.A.Oy Eli Lilly Finland Ab

Tel: + 39- 055 42571Puh/Tel: + 358-(0) 9 85 45 250

CyprusSweden

Phadisco LtdEli Lilly Sweden AB

Τηλ: +357 22 715000Tel: + 46-(0) 8 7378800

LatviaUnited Kingdom

Eli Lilly (Suisse) S.A Parstavnieciba LatvijaEli Lilly and Company Limited

Tel:+371 67364000Tel: + 44-(0) 1256 315000

Last update of this leaflet:month YYYY.

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.

Incluir código QR+www.olumiant.eu

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