Olumiant 2 mg and 4 mg Film-Coated Tablets

XPIL (Text-only Patient Information Leaflet)

Source: Olumiant_PIL_OL052_July24_NI-IE-MT.pdf

Note: This XPIL text version is intended for accessibility (screen readers / large print).

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Package leaflet: Information for the patient

Olumiant® 1 mg film-coated tablets

Olumiant® 2 mg film-coated tablets

Olumiant® 4 mg film-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.

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Contents of this leaflet:

1. What Olumiant is and what it is used for

2. What you need to know before you take Olumiant

3. How to take Olumiant

4. Possible side effects

5. How to store Olumiant

6. Contents of the pack and other information

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1. What Olumiant is and what it is 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, if previous therapy did not work well enough or was not tolerated. Olumiant can be used alone or together 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 inflammation. By reducing this activity, Olumiant helps reduce pain, stiffness and swelling in your joints, tiredness, and helps slow damage to bone and cartilage. This can improve daily activity and quality of life.

Atopic dermatitis

Olumiant is used to treat children from 2 years of age, adolescents, and adults with moderate to severe atopic dermatitis (eczema). It may be used alone or with medicines applied to the skin.

By reducing Janus kinase activity, Olumiant improves the condition of your skin and reduces itching. It can improve sleep disturbance, quality of life, and symptoms of skin pain, anxiety, and depression.

Alopecia areata

Olumiant is used to treat adults with severe alopecia areata, an autoimmune disease causing recurrent, progressive, non-scarring hair loss on scalp, face, and sometimes other areas.

Olumiant helps hair regrow on affected areas by reducing Janus kinase activity.

Juvenile arthritis

Olumiant is used for children aged 2 years and older with:

- polyarticular juvenile idiopathic arthritis (inflammatory disease of the joints)

- enthesitis-related arthritis (inflammation where tendons join bone)

- juvenile psoriatic arthritis (arthritis often with psoriasis)

Olumiant can be used alone or together with methotrexate.

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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 (see 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 if you:

- are older than 65 (increased risk of infections, heart problems, cancer).

- have or often get infections. Olumiant can reduce your body’s ability to fight infections. Tell your doctor if you get fever, wounds, unusual tiredness, or dental problems.

- have or have had tuberculosis. Tests may be needed before treatment. Tell your doctor if you get cough, fever, night sweats, or weight loss.

- have had shingles. Olumiant may allow it to return.

- have or have had hepatitis B or C.

- are due to have a vaccine (avoid live vaccines).

- have or had cancer, or smoke(d).

- have poor liver function.

- have or had heart problems.

- have or had blood clots (DVT, pulmonary embolism) or risk factors (recent surgery, contraceptives, family history). Seek urgent help for chest pain, shortness of breath, leg pain/swelling, redness or discoloration.

- have had diverticulitis or stomach/intestinal ulcers.

- have non-melanoma skin cancer or new/changed skin lesions.

You may need blood tests before or during treatment to check red and white blood cell counts, cholesterol, and liver enzymes.

Children and adolescents

- Children should be up to date with vaccinations before treatment.

- Do not use in children <2 years old.

- Do not use in alopecia areata under 18 years old.

Other medicines

Tell your doctor if you are taking:

- probenecid (for gout) – dose may need reducing.

- injectable anti-rheumatics or immunosuppressants (e.g. azathioprine, tacrolimus, ciclosporin).

- biologic therapies (antibodies).

- other Janus kinase inhibitors.

- NSAIDs, opioids, corticosteroids (increased risk of diverticulitis).

- medicines for diabetes (dose may need adjusting).

Pregnancy and breast-feeding

- Do not take if pregnant. Use contraception during and for 1 week after treatment. Tell your doctor if pregnant.

- Do not use if breastfeeding. You and your doctor must decide between Olumiant or breastfeeding.

Driving and using machines

Olumiant has no effect on driving or machine use.

Olumiant contains sodium

Each tablet contains less than 1 mmol sodium (23 mg), essentially sodium-free.

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3. How to take Olumiant

Treatment should be started by a doctor experienced in your condition. Always take as prescribed.

Adults with rheumatoid arthritis, atopic dermatitis, or alopecia areata

- Recommended dose: 4 mg once daily.

- May be reduced to 2 mg daily if over 65 or at increased risk (infection, clots, cardiovascular disease, cancer).

- Dose may be reduced if effective.

Reduced kidney function

- Dose: 2 mg once daily.

Children and adolescents

- ≥30 kg: 4 mg once daily.

- 10–<30 kg: 2 mg once daily.

- Reduced kidney function: dose halved.

Dispersing tablets for children unable to swallow:

- Place whole tablet in 5–10 ml water at room temperature. Swirl gently. It may take up to 10 min to disperse into a cloudy pale pink suspension. Some settling may occur.

- Swirl again and swallow immediately.

- Rinse container with 5–10 ml water, swirl, and swallow immediately.

- Only water should be used.

- Suspension may be used for up to 4 hours if kept at room temperature.

- If only part of a dispersed dose is taken, wait until the next day for the next dose.

Method of administration

- Oral use. Swallow with water, with or without food. Take at the same time daily.

If you take more Olumiant than you should

Contact your doctor. You may experience side effects (see section 4).

If you forget to take Olumiant

- Take as soon as you remember.

- If missed for a whole day, skip it and take the next dose as usual.

- Do not double the dose.

If you stop taking Olumiant

Only stop if your doctor tells you to.

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4. Possible side effects

Like all medicines, this can cause side effects, although not everyone gets them.

Serious side effects

- Infections such as shingles (herpes zoster) and pneumonia (up to 1 in 10 people). Symptoms: rash with blisters and fever, cough, shortness of breath, tiredness.

- Blood clots in veins or lungs.

- Severe abdominal pain with fever, nausea, vomiting.

- Heart attack, stroke, chest pain, shortness of breath, cold sweat, one-sided weakness, slurred speech.

- Severe allergy: wheezing, dizziness, swelling of lips/tongue/throat, hives.

Other side effects

- Very common: throat/nose infections, high cholesterol.

- Common: cold sores, gastroenteritis, urinary infection, high platelets, headache, nausea, stomach pain, high liver enzymes, rash, acne, raised creatine kinase, inflamed hair follicles.

- Uncommon: low white cells, high triglycerides, high liver enzymes, weight gain, facial swelling, urticaria, blood clots (DVT, pulmonary embolism), diverticulitis.

Children/adolescents

- Juvenile arthritis: headache (very common), low white cells and lung clots (common).

- Paediatric atopic dermatitis: low white cells more common than in adults.

Reporting of side effects

Report to your doctor or via:

- Ireland: HPRA Pharmacovigilance (www.hpra.ie)

- Malta: ADR Reporting (www.medicinesauthority.gov.mt/adrportal)

- UK (NI): Yellow Card Scheme (www.mhra.gov.uk/yellowcard)

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5. How to store Olumiant

- Keep out of sight and reach of children.

- No special storage conditions.

- Do not use after expiry date (last day of month shown on carton/blister).

- Do not dispose of via wastewater or household waste. Ask pharmacist for safe disposal.

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6. Contents of the pack and other information

What Olumiant contains

- Active substance: baricitinib (1, 2 or 4 mg per tablet).

- Other ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, mannitol, iron oxide red (E172), lecithin (soya, E322), macrogol, poly(vinyl alcohol), talc, titanium dioxide (E171).

What Olumiant looks like

- 1 mg: very light pink, round, with “Lilly” on one side, “1” on the other.

- 2 mg: light pink, oblong, with “Lilly” on one side, “2” on the other.

- 4 mg: medium pink, round, with “Lilly” on one side, “4” on the other.

- Tablets have hollow sides for easier handling.

Packs

- 1 mg: blister packs of 14 or 28 tablets, calendar blisters, or perforated unit dose blisters (28x1).

- 2 mg and 4 mg: blister packs of 14, 28, 35, 56, 84 or 98 tablets; calendar blisters; perforated unit dose blisters (28x1, 84x1). Not all pack sizes marketed.

Marketing Authorisation Holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Manufacturer

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

Local representatives

- Ireland & UK (NI): Eli Lilly and Company (Ireland) Limited, Tel: +353-(0)1-661-4377

- Malta: Charles de Giorgio Ltd., Tel: +356-25600-500

This leaflet was last revised in July 2024.

Further information: www.ema.europa.eu | www.olumiant.eu

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Reference code: OL052