Dimethyl fumarate Accord

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

dimethyl fumarate

Saadav alates:

Accord Healthcare S.L.U.

ATC kood:

L04AX07

INN (Rahvusvaheline Nimetus):

dimethyl fumarate

Terapeutiline rühm:

Immunosuppressants

Terapeutiline ala:

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Näidustused:

Dimethyl fumarate Accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Volitamisolek:

Authorised

Loa andmise kuupäev:

2023-02-15

Infovoldik

33
B. PACKAGE LEAFLET
Medicinal product no longer authorised
34
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIMETHYL FUMARATE ACCORD 120 MG GASTRO-RESISTANT HARD CAPSULES
DIMETHYL FUMARATE ACCORD 240 MG GASTRO-RESISTANT HARD CAPSULES
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 Dimethyl fumarate Accord is and what it is used for
2.
What you need to know before you take Dimethyl fumarate Accord
3.
How to take Dimethyl fumarate Accord
4.
Possible side effects
5.
How to store Dimethyl fumarate Accord
6.
Contents of the pack and other information
1.
WHAT DIMETHYL FUMARATE ACCORD IS AND WHAT IT IS USED FOR
WHAT DIMETHYL FUMARATE ACCORD IS
Dimethyl fumarate Accord
is a medicine that contains the active substance
DIMETHYL FUMARATE
.
WHAT DIMETHYL FUMARATE ACCORD IS USED FOR
DIMETHYL FUMARATE ACCORD IS USED TO TREAT RELAPSING-REMITTING MULTIPLE
SCLEROSIS (MS) IN PATIENTS
AGED 13 YEARS AND OLDER
.
MS is a long-term condition that affects the central nervous system
(CNS), including the brain and the
spinal cord. Relapsing-remitting MS is characterised by repeated
attacks (relapses) of nervous system
symptoms. Symptoms vary from patient to patient, but typically include
walking difficulties, feeling
off balance and visual difficulties (e.g. blurred or double vision).
These symptoms may disappear
completely when the relapse is over, but some problems may remain.
HOW DIMETHYL FUMARATE ACCORD WORKS
Dimethyl fumarate Accord seems to work by stopping the body’s
defence system from damagi

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Dimethyl fumarate Accord 120 mg gastro-resistant hard capsules
Dimethyl fumarate Accord 240 mg gastro-resistant hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dimethyl fumarate Accord 120 mg gastro-resistant hard capsules
Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate
Dimethyl fumarate Accord 240 mg gastro-resistant hard capsules
Each gastro-resistant hard capsule contains 240 mg dimethyl fumarate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant hard capsule (Gastro-resistant capsule)
Dimethyl fumarate Accord 120 mg gastro-resistant hard capsules
Size “0” (approximate 21.3 x 7.5 mm) hard gelatin capsules with
green cap and white body, printed
with “HR1” in black ink on capsule body containing white to
off-white, round, biconvex enteric
coated mini tablets plain on both the sides.
Dimethyl fumarate Accord 240 mg gastro-resistant hard capsules
Size “0” (approximate 21.3 x 7.5 mm) hard gelatin capsules with
green cap and body, printed with
“HR2” in black ink on capsule body containing white to off-white,
round, biconvex enteric coated
mini tablets plain on both the sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dimethyl fumarate Accord is indicated for the treatment of adult and
paediatric patients aged 13 years
and older with relapsing remitting multiple sclerosis (RRMS).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under supervision of a physician
experienced in the treatment of
multiple sclerosis.
Posology
The starting dose is 120 mg twice a day. After 7 days, the dose should
be increased to the
recommended maintenance dose of 240 mg twice a day (see section 4.4).
Medicinal product no longer authorised
3
If a patient misses a dose, a double dose should not be taken. The
patient may take the missed dose
only if they leave 4 hours between doses. Otherwise the patient shou