Olumiant - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

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, or 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, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

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 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 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.

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:

• – 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

• – 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 cancer, because your doctor will have to decide if you can still be given Olumiant

• – have poor liver function

• – have previously had blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism). Tell your doctor if you get a painful swollen leg, chest pain, or shortness of breath 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)

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

• – chest tightness

• – 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.

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

Do not give this medicine to children and adolescents under 18 years old because there is no information on use in this age group.

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 is 2 mg once a day

• – 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”.

3. How to take Olumiant

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.

Rheumatoid arthritis and atopic dermatitis

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 75 years old or if you have an increased risk of infections. 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.

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.

4. Possible side effects

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)

• – pneumonia: persistent cough, fever, shortness of breath, and tiredness (this was uncommon in atopic dermatitis)

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)

• – headache

• – feeling sick in the stomach (nausea; this was uncommon in atopic dermatitis)

• – stomach pain

• – 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)

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

• – 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)

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 inBy reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Olumiant

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.

6. Contents of the pack and other information

What Olumiant contains

• – The active substance is baricitinib. Each tablet contains 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 2 mg film-coated tablets are light pink, 9 × 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 2 mg and 4 mg are available in blister packs of 14, 28, 35, 56, 84 and 98 tablets in calendar blisters and 28 × 1 and 84 × 1 tablets in perforated unit dose blisters. Not all the pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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:

Efcnrapua Luxembourg/Lu­xemburg

Tn „Enu ^unu HegepnaHg“ E.B. – Etnrapun Eli Lilly Benelux S.A./N.V.

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

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Please remove this portion of the package leaflet and keep it with you.

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