OLUMIANT 4 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Olumiant 1mgfilm-coated tablets

Olumiant 2mgfilm-coated tablets

Olumiant 4mgfilm-coated tablets

baricitinib

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

• 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.

Contents of the pack

1. What is Olumiant and what is it used for
2. What you need to know before you take Olumiant
3. How to take Olumiant
4. Possible side effects
5. Storage of Olumiant
6. Contents of the pack and other information

1. What is Olumiant and what is it used for

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

Rheumatoid Arthritis

Olumiant is used to treat adults with moderate to severe rheumatoid arthritis, an inflammatory disease of the joints, 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 works 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 to reduce pain, stiffness, and inflammation of your joints, fatigue, and helps to slow down the progression of damage to the bone and cartilage of the joints. These effects can help you to perform your daily activities and improve your health-related quality of life in patients with rheumatoid arthritis.

Atopic Dermatitis

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

Olumiant works 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 to improve the condition of the skin and reduce itching. Additionally, Olumiant helps to improve sleep disturbances (caused by itching) and overall quality of life. It has also been shown that Olumiant 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 inflammatory and non-scarring hair loss on the scalp, face, and sometimes on other areas of the body, which can be recurrent and progressive.

Olumiant works 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 hair to regrow on the scalp, face, and other areas of the body affected by the disease.

Juvenile Idiopathic Polyarticular Arthritis, Enthesitis-Related Arthritis, and Juvenile Psoriatic Arthritis

Olumiant is used to treat active polyarticular juvenile idiopathic arthritis, an inflammatory disease of the joints, in children from 2 years of age.

Olumiant is also used to treat active enthesitis-related arthritis, an inflammatory disease of the joints and the places where tendons join the bone, in children from 2 years of age.

Olumiant is also used to treat active juvenile psoriatic arthritis, an inflammatory disease of the joints that is often accompanied by psoriasis, in children from 2 years of age.

Olumiant can be used alone or in combination with methotrexate.

2. What you need to know before you take Olumiant

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

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

• are over 65 years of age. Patients over 65 years of age may have a higher risk of infections, heart problems, including heart attack, and some types of cancer. Your doctor will discuss with you whether Olumiant is suitable for you.
• have an infection, or if you get infections often. Tell your doctor if you experience symptoms such as fever, wounds, feel more tired than usual, or have dental problems, as these can 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 you getting a new infection. If you have diabetes or are over 65 years of age, you may have a higher chance of getting an infection.

• have or have had tuberculosis in the past. You may need tests to check for tuberculosis before starting Olumiant. Tell your doctor if you have a persistent cough, fever, night sweats, and weight loss during treatment with Olumiant, as these can be signs of tuberculosis.

• have had a herpes infection (herpes zoster), as Olumiant may cause it to come back. Tell your doctor if you have a painful rash with blisters during treatment with Olumiant, as these can be signs of herpes zoster.

• have or have had hepatitis B or C.

• need to be vaccinated. You should not be given certain types of vaccines (live) while taking Olumiant.

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

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

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

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

• wheezing.
• severe dizziness or feeling of spinning.
• swelling of the lips, tongue, or throat.

• hives (itching or rash).
• severe abdominal pain, especially accompanied by fever, nausea, and vomiting.
• severe chest pain or pressure (which may spread to the arms, jaw, neck, or back).
• difficulty breathing.

• cold sweats.
• weakness on one side of the arm and/or leg.
• slurred speech.

You may need to have blood tests before you start taking Olumiant or while you are taking it to check 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, to make sure that treatment with Olumiant is not causing problems.

Children and adolescents

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

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

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

Other medicines and Olumiant

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor or pharmacist before you start taking Olumiant if you are taking any other medicine such as:

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

• antirheumatic injectable medicine.
• injectable medicines that suppress the immune system, including targeted 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 disorders of the muscles or joints) or opioids (used to treat severe pain), or corticosteroids (usually used to treat inflammatory disorders) (see section 4).
• medicines to treat diabetes or if you have diabetes. Your doctor may decide if you need less antidiabetic medication during treatment with Olumiant.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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

Driving and using machines

Olumiant has no or negligible influence on the ability to drive and use machines.

Olumiant contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially 'sodium-free'.

3. How to take Olumiant

Treatment should be started by a doctor with experience in the diagnosis and treatment of your disease. Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

Adults with rheumatoid arthritis, atopic dermatitis, and alopecia areata

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

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

If you have reduced kidney function, the recommended dose of Olumiant is 2 mg once daily.

Use in children and adolescents

The recommended dose is 4 mg once daily for patients ≥ 30 kg. For patients from 10 kg to <30 kg, the recommended dose is 2 mg once daily.< p>

If you have reduced kidney 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 cloudy pale pink suspension. Some sediment may appear.
• After dispersing the tablet, gently shake again and then swallow the mixture immediately.
• Rinse the container with 5-10 ml of water at room temperature, shaking and swallow the mixture immediately to ensure 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 scheduled dose the following day.

Method of administration

Olumiant is for oral use. You should swallow the tablet with a little water.

You can take the tablets with or 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, talk to your doctor. You may experience some of the side 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 during the entire day, simply skip the missed dose and take a single dose the next day as you normally would.
• Do not take a double dose to make up for a missed tablet.

If you stop taking Olumiant

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Severe Adverse Effects

Infections such as herpes zoster and pneumonia, which can 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:

• herpes zoster: 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 severe herpes zoster were infrequent.

Other Adverse Effects

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

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

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

• fever (simple herpes)

• infection causing nausea or diarrhea (gastroenteritis)

• urinary tract infection

• high number of platelets (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 the hair follicles, especially in the scalp area, associated with hair growth (observed in alopecia areata)

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

• low number of white blood cells (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
• facial swelling

• hives

• 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 (painful inflammation of the small bags of the intestine lining)

Children and Adolescents

• Juvenile idiopathic polyarthritis, enthesitis-related arthritis, and juvenile psoriatic arthritis:In a study in children from 2 years of age with juvenile idiopathic polyarthritis, enthesitis-related arthritis, and juvenile psoriatic arthritis, headache was very frequent, low number of white blood cells was frequent, and blood clots in the lungs were frequent (1 in 82 children).
• Pediatric atopic dermatitis:In a study in children from 2 years of age with atopic dermatitis, adverse effects were consistent with those observed in adult patients, except for low number of white blood cells (neutrophils), which was more common compared to adults.

Reporting Adverse Effects

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

5. Storage of Olumiant

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Olumiant

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

• The othercomponents 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 Package Contents

Olumiant 1 mg film-coated tablets are very light pink, round tablets of 6.75 mm, with "Lilly" on one side and "1" on the other.

Olumiant 2 mg film-coated tablets are light pink, oblong tablets of 9 x 7.5 mm, with "Lilly" on one side and "2" on the other.

Olumiant 4 mg film-coated tablets are medium pink, round tablets of 8.5 mm, with "Lilly" on one side and "4" on the other.

The tablets are rounded and have a recessed area to help with handling.

Olumiant 1 mg is available in blister packs of 14 and 28 tablets in calendar blisters and 28 x 1 tablets in single-dose precut blisters. Olumiant 2 mg and 4 mg are available in blister packs of 14, 28, 35, 56, 84, and 98 tablets in calendar blisters and 28 x 1 and 84 x 1 tablets in single-dose precut blisters. Not all pack sizes may be marketed.

Marketing Authorization Holder

Marketing authorization holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, Netherlands.

Manufacturer

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Prospectus:month AAAA.

Other Sources of Information

Detailed information about this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

Include QR code + www.olumiant.eu

Please cut out this part of the prospectus and keep it.

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