Olumiant 2mg Film-Coated Tablets

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Baricitinib

Boleh didapati daripada:

ZUELLIG PHARMA SDN BHD

INN (Nama Antarabangsa):

Baricitinib

Unit dalam pakej:

4 x 7 Tablets; 7 Tablets

Dikeluarkan oleh:

LILLY DEL CARIBE INC

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
OLUMIANT FILM-COATED TABLETS
Baricitinib (2 mg, 4 mg)
1
What is in this leaflet
1.
What Olumiant is used for
2.
How Olumiant works
3.
Before you use Olumiant
4.
How to use Olumiant
5.
While you are using Olumiant
6.
Side effects
7.
Storage and Disposal of Olumiant
8.
Product Description
9.
Manufacturer
and
Product
Registration
Holder
10. Date of Revision
11. Serial Number
What Olumiant is used for
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.
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.
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.
How Olumiant works
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 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 works by reducing the activity
of an enzyme in the body called ‘Janus
kinase’,
which
is
involved
in
inflammation. By reducing the activity of
t

Ciri produk

Olumiant 2mg_4mg PI_EUSPC_20June2022_31Mar2023
1.
NAME OF THE MEDICINAL PRODUCT
Olumiant 2 mg film-coated tablets
Olumiant 4 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 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. 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).
Atopic Dermatitis
Baricitinib is indicated for the treatment of moderate to severe
atopic dermatitis in adult patients 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).
Olumiant 2mg_4mg PI_EUSPC_20June2022_31Mar2023
4.2
Posology and method of administration
Treatment should be initiated by physicians experienced in the
diagnosis and treatment of
the conditions for which this medicinal product is indicated.
Posology
Rheumatoid arthritis
The recommended dose of baricitinib is 4 mg once daily. A dose of 2 mg
once daily is appropriate for
patients such as those aged ≥ 75 years and may be appropriate for
patients with a history of chronic or
recurrent infections. A dose of 2 mg once daily may al