Dimethylfumaraat 1A Pharma 120 mg, harde maagsapresistente capsules

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

DIMETHYLFUMARAAT 120 mg/stuk

INN (Algemene Internationale Benaming):

DIMETHYLFUMARAAT 120 mg/stuk

farmaceutische vorm:

Maagsapresistente capsule, hard

Samenstelling:

AMMONIA (E 527) ; BRILJANTBLAUW FCF (E 133) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; COPOLYMEER VAN METHACRYLZUUR-METHYLMETHACRYLAAT (1:1) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; GLYCEROLMONOSTEARAAT 40-55 (E 471) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; NATRIUMSTEARYLFUMARAAT ; POLYSORBAAT 80 (E 433) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505) ; ZWARTE INKT

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2022-10-25

Bijsluiter

1A Pharma
Dimethylfumaraat 1A Pharma 120, 240 mg, harde maagsapresistente
capsules
Page 1/7
RVG 128721-3
1313-v1
1.3.1.3 Package Leaflet
Oktober 2022
1
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIMETHYLFUMARAAT 1A PHARMA
® 120 MG, HARDE MAAGSAPRESISTENTE CAPSULES
DIMETHYLFUMARAAT 1A PHARMA
® 240 MG, HARDE MAAGSAPRESISTENTE 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 {[Nationally completed name]} is and what it is used for
2. What you need to know before you take {[Nationally completed name]}
3. How to take {[Nationally completed name]}
4. Possible side effects
5. How to store {[Nationally completed name]}
6. Contents of the pack and other information
1. WHAT {[NATIONALLY COMPLETED NAME]}
IS AND WHAT IT IS USED FOR
WHAT {[NATIONALLY COMPLETED NAME]} IS
{[Nationally completed name]} is a medicine that contains the active
substance
DIMETHYL FUMARATE
.
WHAT {[NATIONALLY COMPLETED NAME]} IS USED FOR
{[NATIONALLY COMPLETED NAME]} 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 rela

Productkenmerken

1A Pharma
Dimethylfumaraat 1A Pharma 120, 240 mg, harde maagsapresistente
capsules
Page 1/21
RVG 128721-3
1311-v1
1.3.1.1 SmPC
Oktober 2022
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dimethylfumaraat 1A Pharma 120 mg, harde maagsapresistente capsules
Dimethylfumaraat 1A Pharma 240 mg, harde maagsapresistente capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
{[Nationally completed name] 120 mg gastro-resistant hard capsules}
Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate.
{[Nationally completed name] 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).
{[Nationally completed name] 120 mg gastro-resistant hard capsules}
Hard gelatin capsules with white body and light-green cap, size 1,
approx. 19.4 mm length and 8.53
mm width, with “120 mg” imprinted on the body.
{[Nationally completed name] 240 mg gastro-resistant hard capsules}
Hard gelatin light-green capsules, size 00, approx. 23.3 mm length and
8.53 mm width, with “240 mg”
imprinted on the body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
{[Nationally completed name]} 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).
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 should
wait until the next scheduled
dose.
Temporary dose reduction to 120 mg twice a day may reduce the
occurrence of flushi