Skilarence
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
27-09-2022
Fachinformation
(SPC)
27-09-2022
Öffentlichen Beurteilungsberichts
(PAR)
27-09-2017
Wirkstoff:
dimethyl fumarate
Verfügbar ab:
Almirall S.A
ATC-Code:
L04AX07
INN (Internationale Bezeichnung):
dimethyl fumarate
Therapiegruppe:
Immunosuppressants
Therapiebereich:
Psoriasis
Anwendungsgebiete:
Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.
Produktbesonderheiten:
Revision: 11
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2017-06-23
Gebrauchsinformation
27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SKILARENCE 30 MG GASTRO-RESISTANT TABLETS
dimethyl fumarate
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.
-
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. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Skilarence is and what it is used for
2.
What you need to know before you take Skilarence
3.
How to take Skilarence
4.
Possible side effects
5.
How to store Skilarence
6.
Contents of the pack and other information
1.
WHAT SKILARENCE IS AND WHAT IT IS USED FOR
WHAT SKILARENCE IS
Skilarence is a medicine that contains the active substance dimethyl
fumarate. Dimethyl fumarate
works on cells of the immune system (the body's natural defences). It
changes the activity of the
immune system by reducing the production of certain substances
involved in causing psoriasis.
WHAT SKILARENCE IS USED FOR
Skilarence tablets are used to treat moderate to severe plaque
psoriasis in adults. Psoriasis is a disease
causing thickened, inflamed, red areas on the skin, often covered by
silvery scales.
Response to Skilarence can be generally seen as early as week 3 and
improves over time. Experience
with related products containing dimethyl fumarate shows treatment
benefit for at least up to
24 months.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SKILARENCE
DO NOT TAKE SKILARENCE
-
if you are allergic to dimethyl fumarate or any of the other
ingredients of this medicine (listed in
section 6)
-
if you have severe problems with your stomach or intestines
-
if you have severe liver or kidney problems
-
if you are pregnant or breast-feeding
WARNINGS AND
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Skilarence 30 mg gastro-resistant tablets
Skilarence 120 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Skilarence 30 mg gastro-resistant tablets
Each gastro-resistant tablet contains 30 mg dimethyl fumarate.
_Excipient with known effect _
Each gastro-resistant tablet contains 34.2 mg lactose (as
monohydrate).
Skilarence 120 mg gastro-resistant tablets
Each gastro-resistant tablet contains 120 mg dimethyl fumarate.
_Excipient with known effect _
Each gastro-resistant tablet contains 136.8 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet
Skilarence 30 mg gastro-resistant tablets
White, film-coated, round, biconvex tablet with a diameter of
approximately 6.8 mm.
Skilarence 120 mg gastro-resistant tablets
Blue, film-coated, round, biconvex tablet with a diameter of
approximately 11.6 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Skilarence is indicated for the treatment of moderate to severe plaque
psoriasis in adults in need of
systemic medicinal therapy.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Skilarence is intended for use under the guidance and supervision of a
physician experienced in the
diagnosis and treatment of psoriasis.
Posology
To improve tolerability of Skilarence, it is recommended to begin
treatment with a low initial dose
with subsequent gradual increases. In the first week, a 30 mg dose is
taken once daily (1 tablet in the
evening). In the second week, a 30 mg dose is taken twice daily (1
tablet in the morning and 1 in the
evening). In the third week, a 30 mg dose is taken three times daily
(1 tablet in the morning, 1 at
midday, and 1 in the evening). From the fourth week, treatment is
switched to only 1 tablet of
3
a 120 mg dose in the evening. This dose is then increased by one 120
mg tablet per week at different
times of day for the subsequent 5 weeks, as shown in the table below.
The maximum daily dos
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