Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
Baricitinib
Eli Lilly Nederland B.V.
L04AA37
baricitinib
Immunosuppressants
Arthritis, Rheumatoid
Rheumatoid arthritisBaricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Olumiant may be used as monotherapy or in combination with methotrexate.Atopic DermatitisOlumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy.Alopecia areataBaricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5.1).Juvenile idiopathic arthritisBaricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs:- Polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular),- Enthesitis related arthritis, and- Juvenile psoriatic arthritis.Baricitinib may be used as monotherapy or in combination with methotrexate.
Revision: 17
Authorised
2017-02-13
53 B. PACKAGE LEAFLET 54 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, 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 children from the age of 2 years, adolescents and adults with mo Lire le document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Olumiant 1 mg film-coated tablets Olumiant 2 mg film-coated tablets Olumiant 4 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Olumiant 1 mg film-coated tablets Each film-coated tablet contains 1 mg baricitinib. Olumiant 2 mg film-coated tablets Each film-coated tablet contains 2 mg baricitinib. Olumiant 4 mg film-coated tablets Each film-coated tablet contains 4 mg baricitinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Olumiant 1 mg film-coated tablets Very light pink, 6.75 mm round tablets, debossed with “Lilly” on one side and “1” on the other. Olumiant 2 mg film-coated tablets Light pink, 9 x 7.5 mm oblong tablets, debossed with “Lilly” on one side and “2” on the other. Olumiant 4 mg film-coated tablets Medium pink, 8.5 mm round tablets, debossed with “Lilly” on one side and “4” on the other. The tablets contain a recessed area on each side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rheumatoid arthritis Baricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Baricitinib may be used as monotherapy or in combination with methotrexate (see sections 4.4, 4.5 and 5.1 for available data on different combinations). 3 Atopic dermatitis Baricitinib is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. Alopecia areata Baricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5.1). Juvenile idiopathic arthritis Baricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior con Lire le document complet