Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - olumiant

Document Subject

Generated Narrative: MedicinalProductDefinition mpe9af86ad22ac9c13e3208cd0b150b229

identifier: http://ema.europa.eu/identifier/EU/1/16/1170/017

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Olumiant 1 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-e9af86ad22ac9c13e3208cd0b150b229

identifier: http://ema.europa.eu/identifier/EU/1/16/1170/017

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - olumiant

Attesters

What is in 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

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 some 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 the activity of this enzyme, Olumiant helps to reduce pain, stiffness and swelling in your joints, tiredness, and helps to slow damage to the bone and cartilage in the joints. These effects can help you to do normal daily activities and so improve the health-related quality of life for patients with rheumatoid arthritis.

Atopic dermatitis Olumiant is used to treat children from the age of 2 years, adolescents and adults with moderate to severe atopic dermatitis, also known as atopic eczema. Olumiant may be used with eczema medicines that you apply to the skin or it may be used on its own.

Olumiant works by reducing the activity of an enzyme in the body called Janus kinase , which is involved in inflammation. By reducing the activity of this enzyme, Olumiant helps to improve the condition of your skin and reduce itching. In addition, Olumiant helps improve your sleep disturbance (due to itch) and overall quality of life. Olumiant has also been shown to improve symptoms of 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, nonscarring hair loss on the scalp, face and sometimes on other areas of the body that can be recurrent and progressive.

Olumiant works by reducing the activity of an enzyme in the body called Janus kinase , which is involved in inflammation. By reducing the activity of this enzyme, Olumiant helps hair to regrow on scalp, face and other areas of the body impacted by the disease.

Polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis and juvenile psoriatic arthritis Olumiant is used for the treatment of active polyarticular juvenile idiopathic arthritis, an inflammatory disease of the joints, in children 2 years of age and older.

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

Olumiant is also used for the treatment of active juvenile psoriatic arthritis, a condition that is an inflammatory disease of the joints often accompanied by psoriasis, in children 2 years of age and older.

Olumiant can be used alone or together 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
Talk to your doctor or pharmacist before and during treatment with Olumiant if you:

• are older than 65. Patients aged 65 years 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 Olumiant is appropriate for 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. Olumiant 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 older than 65 you may have an increased chance of getting infections
• have, or have previously had, tuberculosis. You may need tests to check for tuberculosis before you are given Olumiant. Tell your doctor if you get persistent cough, fever, night sweats and weight loss during Olumiant treatment as these can be signs of tuberculosis
• have had a herpes infection (shingles), because Olumiant may allow it to come back. Tell your doctor if you get painful skin rash with blisters during Olumiant treatment as these can be signs of shingles
• have, or have previously had, hepatitis B or C
• are due to have a vaccine. You should not be given certain (live) vaccines while using Olumiant
• have or have had cancer, smoke or have smoked in the past, because your doctor will discuss with you if Olumiant is appropriate for you
• have poor liver function
• have, or have had, heart problems, because your doctor will discuss with you if Olumiant is appropriate for 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, or if a coagulation defect is identified in you or your close relatives). Your doctor will discuss with you if Olumiant 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 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 ulcers in stomach or intestines (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 therapy or if existing lesions change appearance, tell your doctor.

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

• wheezing
• severe dizziness or light-headedness
• swelling of the lips, tongue or throat
• hives (itching or skin rash)
• severe abdominal pain especially accompanied with fever, nausea and vomiting.
• severe chest pain or tightness (that may spread to arms, jaw, neck, back)
• shortness of breath
• cold sweat
• one-sided weakness in arm and/or leg
• slurred speech

You may need blood tests before you start Olumiant, or while you are taking it, to check if you have a low red blood cell count (anaemia), low white blood cell count (neutropaenia or lymphopaenia), high blood fat (cholesterol) or high levels of liver enzymes, to ensure 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 younger than 2 years of age.

Do not give this medicine to children and adolescents with alopecia areata under 18 years old, because there is no information on 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 taking Olumiant if you are taking any other medicine such as:

• probenecid (for gout), since this medicine may increase the levels of Olumiant in your blood. If you are taking probenecid, the recommended dose of Olumiant for adults is 2 mg once a day and for children and adolescents the dose should be reduced by half.
• injectable anti-rheumatic medicine
• injectable medicines that depress the immune system, including so called targeted biologic (antibody) therapies
• medicines which are used to control the body s immune response, such as azathioprine, tacrolimus or ciclosporin
• other medicines belonging to the group of Janus kinase inhibitors
• medicines that may increase your risk of diverticulitis such as a 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) (see section 4)

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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 the last Olumiant treatment. You must tell your doctor if you become pregnant as Olumiant should not be used during pregnancy.

You should not use Olumiant while breast-feeding as it is not known if this medicine passes into milk. You and your doctor should decide if you will breast-feed or use Olumiant. You should not do both.

Driving and using machines
Olumiant has no effect on the ability to drive and use machines.

Olumiant contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free .

Treatment should be started by a doctor experienced in the diagnosis and treatment of your condition. Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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, particularly if you are over 65 years old or if you have an increased risk of infections, of blood clots, major cardiovascular events or cancer.

If the medicine is working well, your doctor may decide the dose can be reduced.

If you have reduced kidney 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 30 kg. For patients 10 kg to < 30 kg the recommended dose is 2 mg once a day.

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

For paediatric patients who are unable to swallow whole tablets, the tablets may be dispersed in water:

• Place whole tablet in a container with 5-10 mL of water at room temperature and gently swirl to disperse (break apart) tablet. It may take up to 10 minutes for the tablet to disperse into a cloudy pale pink suspension. Some settling may occur.
• After the tablet is dispersed, gently swirl again and then swallow mixture immediately
• Rinse the container with 5-10 mL of water at room temperature by swirling, and swallow the mixture immediately to ensure full dose is delivered.

Only water should be used to disperse the tablet. After the tablet is dispersed in water it can be used for up to 4 hours if kept at room temperature. If a tablet is dispersed in water and only part of the dispersed dose is taken, wait until the next day to take the next scheduled dose.

Method of administration Olumiant is for oral use. You should swallow your tablet with a drink of water.

You can take the tablets either with or without food. To help you remember to take Olumiant, you may find it 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, contact your doctor. You may get some of the side effects described in section 4. If you forget to take Olumiant

• 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.

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

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

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

Serious side effects

Infection such as shingles and pneumonia, which may affect up to 1 in 10 people: Tell your doctor or seek medical help immediately if you get the following symptoms, which may be signs of:

• shingles (herpes zoster): painful skin rash with blisters and fever (this was very rare in atopic dermatitis and uncommon in alopecia areata)
• pneumonia: persistent cough, fever, shortness of breath, and tiredness (this was uncommon in atopic dermatitis and alopecia areata) Serious pneumonia and serious herpes zoster were uncommon.

Other side effects

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

• throat and nose infections
• high levels of blood fat (cholesterol) shown by blood test

Common (may affect up to 1 in 10 people)

• cold sores (herpes simplex)
• infection causing a sick stomach or diarrhoea (gastroenteritis)
• urinary infection
• high number of platelets (cells involved in blood clotting), shown by blood test (this was uncommon in atopic dermatitis and alopecia areata)
• headache
• feeling sick in the stomach (nausea; this was uncommon in atopic dermatitis)
• stomach pain (this was uncommon in alopecia areata)
• high levels of liver enzymes, shown by blood test (this was uncommon in atopic dermatitis)
• rash
• acne (this was uncommon in rheumatoid arthritis)
• increase in an enzyme called creatine kinase, shown by a blood test (this was uncommon in rheumatoid arthritis)
• inflammation (swelling) of the hair follicles particularly in the scalp region associated with hair regrowth (observed in alopecia areata)

Uncommon (may affect up to 1 in 100 people)

• low number of white bloods cells (neutrophils), shown by blood test
• high levels of blood fat (triglycerides), shown by blood test
• high levels of liver enzymes, shown by blood test (this was common 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 a deep vein thrombosis (DVT)
• diverticulitis (painful inflammation of small pockets in the lining of your intestine)

Children and adolescents

Polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis and juvenile psoriatic arthritis: In a study of children 2 years of age and older with polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis and juvenile psoriatic arthritis, headache was very common, low number of white blood cells and blood clots in the lungs were common (1 out of 82 children each).

Paediatric atopic dermatitis: In a study of children 2 years of age and older with atopic dermatitis, side effects were consistent with those seen in adult patients with the exception of low number of white bloods cells (neutrophils), which was more common compared to adults.

Reporting of side effects
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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP . The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Olumiant contains

• The active substance is baricitinib. Each tablet contains 1, 2 or 4 milligrams of baricitinib.

• The other ingredients are: microcrystalline cellulose, croscarmellose sodium (see section 2 Olumiant contains sodium ), magnesium stearate, mannitol, iron oxide red (E172), lecithin (soya) (E322), macrogol, poly (vinyl alcohol), talc and titanium dioxide (E171).

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

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

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

The tablets are rounded and have hollow sides to help you pick them up.

Olumiant 1 mg is available in blister packs of 14 and 28 tablets in calendar blisters and 28 x 1 tablets in perforated unit dose 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 perforated unit dose blisters. Not all the pack sizes may be marketed.

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

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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/Belgi /Belgien Eli Lilly Benelux S.A./N.V. T l/Tel: + 32-(0)2 548 84 Lietuva Eli Lilly Lietuva Tel. +370 (5) 2649
" " . . -
. + 359 2 491 41 Luxembourg/Luxemburg Eli Lilly Benelux S.A./N.V. T l/Tel: + 32-(0)2 548 84 esk republika ELI LILLY R, s.r.o. Tel: + 420 234 664 Magyarorsz g Lilly Hung ria Kft. Tel: + 36 1 328 5Danmark Eli Lilly Danmark A/S
Tlf: +45 45 26 60 Malta Charles de Giorgio Ltd. Tel: + 356 25600 Deutschland Lilly Deutschland GmbH Tel. + 49-(0) 6172 273 2Nederland Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 Eesti Eli Lilly Nederland B.V.
Tel: +372 6 817 Norge Eli Lilly Norge A.S.
Tlf: + 47 22 88 18

• . . . .
  : +30 210 629 4 sterreich Eli Lilly Ges.m.b.H.
  Tel: + 43-(0) 1 711 Espa a Lilly S.A. Tel: + 34-91 663 50 Polska
  Eli Lilly Polska Sp. z o.o. Tel: +48 22 440 33 France Lilly France T l: +33-(0) 1 55 49 34 Portugal Lilly Portugal Produtos Farmac uticos, Lda Tel: + 351-21-4126Hrvatska Eli Lilly Hrvatska d.o.o. Tel: +385 1 2350 Rom nia Eli Lilly Rom nia S.R.L. Tel: + 40 21 4023Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4Slovenija
  Eli Lilly farmacevtska dru ba, d.o.o. Tel: +386 (0)1 580 00 sland Icepharma hf. S mi + 354 540 8Slovensk republika Eli Lilly Slovakia s.r.o. Tel: + 421 220 663 Italia Eli Lilly Italia S.p.A. Tel: + 39- 055 42Suomi/Finland Oy Eli Lilly Finland Ab
  Puh/Tel: + 358-(0) 9 85 45
  Phadisco Ltd
  : +357 22 715Sverige Eli Lilly Sweden AB Tel: + 46-(0) 8 7378Latvija Eli Lilly (Suisse) S.A P rst vniec ba Latvij
  Tel: +371 67364United Kingdom (Northern Ireland) Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: