Skilarence 30mg gastro-resistant tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Dimethyl fumarate

Disponibil de la:

Almirall Ltd

Codul ATC:

N07XX09

INN (nume internaţional):

Dimethyl fumarate

Dozare:

30mg

Forma farmaceutică:

Gastro-resistant tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: ; GTIN: 8430308130413

Prospect

1
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 and reduces the production of 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 PRECAUTIONS
Talk to your doctor

Caracteristicilor produsului

OBJECT 1
SKILARENCE 30 MG GASTRO-RESISTANT TABLETS
Summary of Product Characteristics Updated 22-Jun-2018 | Almirall
Limited
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
Each gastro-resistant tablet contains 30 mg dimethyl fumarate.
Skilarence 120 mg
Each gastro-resistant tablet contains 120 mg dimethyl fumarate.
Excipient with known effect
Skilarence 30 mg
Each gastro-resistant tablet contains 34.2 mg lactose (as
monohydrate).
Skilarence 120 mg
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
White, film-coated, round, biconvex tablet with a diameter of
approximately 6.8 mm.
Skilarence 120 mg
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, it is recommended to begin treatment with a
low initial dose with subsequent
gradual increases. In the first week, Skilarence 30 mg is taken once
daily (1 tablet in the evening). In the
second week, Skilarence 30 mg is taken twice daily (1 tablet in the
morning and 1 in the evening). In the
third week, Skilarence 30 mg 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 Skilarence 120 mg in the
evening. This dose is then increased by 1 Skilarence 120 mg tablet per
week at different times of day for
the subsequent 5 weeks, as shown in the table below. The maximum daily
dose allowed is 72