OTEZLA 20 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

APREMILAST

Available from:

AMGEN EUROPE B.V.

ATC code:

L04AA32

Pharmaceutical form:

FILM COATED TABLETS

Composition:

APREMILAST 20 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

AMGEN EUROPE B.V., NETHERLANDS

Therapeutic area:

APREMILAST

Therapeutic indications:

Otezla is indicated:- For treatment of adult patients with active psoriatic arthritis (PsA).- For adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy (PSOR).- For the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD).

Authorization date:

2020-05-31

Patient Information leaflet

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) 1986
This medicine is to be supplied by doctor’s prescription only
OTEZLA 10 MG
OTEZLA 20 MG
OTEZLA 30 MG
Film-coated tablets
ACTIVE INGREDIENT:
Each tablet of Otezla 10 mg contains 10 mg Apremilast
Each tablet of Otezla 20 mg contains 20 mg Apremilast
Each tablet of Otezla 30 mg contains 30 mg Apremilast
Inactive ingredients and allergens: see section 6 “Additional
information”.
READ ALL THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE.
This leaflet contains
essential information about this medicine. If you have any further
questions, refer to the
doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their medical condition is
similar.
Otezla is not intended for use in children and young people aged under
the age of 18.
1. WHAT IS OTEZLA USED FOR?
•
ACTIVE PSORIATIC ARTHRITIS - Otezla is intended to treat adults who
suffer from active
psoriatic arthritis.
•
MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS - Otezla is intended to
treat adult
patients who suffer from moderate to severe plaque psoriasis who are
candidates for a
phototherapy treatment (a treatment by which the infected areas are
exposed to light)
or to systemic therapy.
•
BEHÇET’S DISEASE (BD) - to treat the mouth ulcers which is a common
problem for
people with this illness.
THERAPEUTIC GROUP:
Otezla belongs to a group of medicines called phosphodiesterase 4
inhibitors (PDE4), which
help to reduce inflammation.
WHAT IS PSORIATIC ARTHRITIS
Psoriatic Arthritis is an inflammatory disease of the joints, usually
accompanied by an
inflammatory skin disease called psoriasis.
WHAT IS PLAQUE PSORIASIS
Plaque Psoriasis is an inflammatory disease of the skin, characterized
by red, scaly, itchy,
painful patches on the skin which can also appear in your scalp and
nails.
WHAT IS BEHÇET’S DISEASE
Behçet’s disease is a rare type of inflammatory disease which

Summary of Product characteristics

[לוגו מדינת ישראל] [http://www.gov.il/]
[http://www.gov.il/] [לוגו משרד הבריאות] [לוגו משרד
הבריאות] [*5400]
[http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx]
[http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx]
הציבור הרחב עסקים ומוסדות עובדים
בבריאות חפש מידע
תפריט *
[סגירה]
סגור *
דף הבית [http://www.health.gov.il/] *
אודות *
אודות המשרד
[http://www.health.gov.il/About/Pages/about_us.aspx] *
תוכנית עבודה
[http://www.health.gov.il/About/Pages/Agenda.aspx] *
תקציב המשרד
[http://www.health.gov.il/About/Pages/budget.aspx] *
תרשים מבנה ארגוני
[http://www.health.gov.il/About/Pages/OrganizationalStructureDiagram.aspx] *
בעלי תפקידים
[http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx] *
יחידות המשרד
[http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] *
לשכות הבריאות
[http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx?tab=3] *
אמנת שירות
[http://www.health.gov.il/About/sla/Pages/default.aspx] *
אותות ופרסים
[http://www.health.gov.il/About/Awards/Pages/mifal.aspx] *
פרוייקטים תשתיתיים
[http://www.health.gov.il/About/projects/shared_medical_info/Pages/default.aspx] *
דרושים
[http://www.health.gov.il/About/Careers/Pages/default.aspx] *
מנכ"לי משרד הבריאות לדורותיהם
[http://www.health.gov.il/About/Pages/GeneralManegerHistory.aspx] *
יחידות המשרד *
יחידות המשרד
[http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] *
לשכות הבריאות
[http://www.health.gov.il/UnitsOffice/LB/Pages/default.aspx] *
וועדות ומועצות
[http://www.health.gov.il/Services/Committee/Pages/CommitteeList.aspx] *
נושאים *
בריאות הנפש
[http://www.health.gov.il/Subjects/mental_health/Pages/default.aspx] *
בריאות הסביבה
[http://www.health.gov.il/Subjects/Environmental_Health/