Otezla

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

apremilast

Available from:

Amgen Europe BV

ATC code:

L04AA32

INN (International Name):

apremilast

Therapeutic group:

Immunosuppressants

Therapeutic area:

Arthritis, Psoriatic; Psoriasis

Therapeutic indications:

Psoriatic arthritisOtezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.PsoriasisOtezla is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).

Product summary:

Revision: 21

Authorization status:

Authorised

Authorization date:

2015-01-15

Patient Information leaflet

33
B. PACKAGE LEAFLET
34
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OTEZLA 10 MG FILM-COATED TABLETS
OTEZLA 20 MG FILM-COATED TABLETS
OTEZLA 30 MG FILM-COATED TABLETS
apremilast
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, 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Otezla is and what it is used for
2.
What you need to know before you take Otezla
3.
How to take Otezla
4.
Possible side effects
5.
How to store Otezla
6.
Contents of the pack and other information
1.
WHAT OTEZLA IS AND WHAT IT IS USED FOR
WHAT OTEZLA IS
Otezla contains the active substance ‘apremilast’. This belongs to
a group of medicines called
phosphodiesterase 4 inhibitors, which help to reduce inflammation.
WHAT OTEZLA IS USED FOR
Otezla is used to treat adults with the following conditions:
•
ACTIVE PSORIATIC ARTHRITIS -
if you cannot use another type of medicine called
‘Disease-Modifying Antirheumatic Drugs’ (DMARDs) or when you have
tried one of these
medicines and it did not work.
•
MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS
-
if you cannot use one of the following
treatments or when you have tried one of these treatments and it did
not work:
-
phototherapy - a treatment where certain areas of skin are exposed to
ultraviolet light
-
systemic therapy - a treatment that affects the entire body rather
than just one local area,
such as ‘ciclosporin’, ‘methotrexate’ or ‘psoralen ’.
•
BEHÇET’S DISEASE (BD)
- to treat the mouth ulcers which is a common problem for people with
this illness.
WHAT PSORIATIC ARTHRITIS IS
Psoriati

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Otezla 10 mg film-coated tablets
Otezla 20 mg film-coated tablets
Otezla 30 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Otezla 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of apremilast.
_Excipient(s) with known effect _
Each film-coated tablet contains 57 mg of lactose (as lactose
monohydrate).
Otezla 20 mg film-coated tablets
Each film-coated tablet contains 20 mg of apremilast.
_ _
_Excipient(s) with known effect _
Each film-coated tablet contains 114 mg of lactose (as lactose
monohydrate).
Otezla 30 mg film-coated tablets
Each film-coated tablet contains 30 mg of apremilast.
_ _
_Excipient(s) with known effect _
Each film-coated tablet contains 171 mg of lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Otezla 10 mg film-coated tablets
Pink, diamond shaped 10 mg film-coated tablet of 8 mm length with
“APR” engraved on one side and
“10” on the opposite side.
Otezla 20 mg film-coated tablets
Brown, diamond shaped 20 mg film-coated tablet of 10 mm length with
“APR” engraved on one side
and “20” on the opposite side.
Otezla 30 mg film-coated tablets
Beige, diamond shaped 30 mg film-coated tablet of 12 mm length with
“APR” engraved on one side
and “30” on the opposite side.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Psoriatic arthritis
Otezla, alone or in combination with Disease Modifying Antirheumatic
Drugs (DMARDs), is
indicated for the treatment of active psoriatic arthritis (PsA) in
adult patients who have had an
inadequate response or who have been intolerant to a prior DMARD
therapy (see section 5.1).
Psoriasis
Otezla is indicated for the treatment of moderate to severe chronic
plaque psoriasis in adult patients
who failed to respond to or who have a contraindication to, or are
intolerant to other systemic therapy
including cyclosporine, methotrexate or psoralen and u