Dimethylfumaraat SDZ 120 mg, harde maagsapresistente capsules

Maa: Alankomaat

Kieli: hollanti

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

Aktiivinen ainesosa:

DIMETHYLFUMARAAT 120 mg/stuk

INN (Kansainvälinen yleisnimi):

DIMETHYLFUMARAAT 120 mg/stuk

Lääkemuoto:

Maagsapresistente capsule, hard

Koostumus:

AMMONIA (E 527) ; BRILJANTBLAUW FCF (E 133) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; CROSPOVIDON (E 1202) ; GELATINE (E 441) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505) ; ZWARTE INKT, AMMONIA (E 527) ; BRILJANTBLAUW FCF (E 133) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; CROSPOVIDON (E 1202) ; GELATINE (E 441) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505) ; ZWARTE INKT

Antoreitti:

Oraal gebruik

Valtuutus päivämäärä:

1900-01-01

Pakkausseloste

Sandoz B.V.
Dimethylfumaraat SDZ 120, 240 mg, harde maagsapresistente capsules
Page 1/10
RVG 129796; RVG 129797
1313-v1
1.3.1.3 Bijsluiter
September 2023
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIMETHYLFUMARAAT SDZ
® 120 MG, HARDE MAAGSAPRESISTENTE CAPSULES
DIMETHYLFUMARAAT SDZ
® 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
[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).
Sandoz B.V.
Dimethylfumaraat SDZ 120, 240 mg, harde maagsapresistente capsules
Page 2/10
RVG 129796; RVG 129797
1313-v1
1.3.

Valmisteyhteenveto

Sandoz B.V.
Dimethylfumaraat SDZ 120, 240 mg, harde maagsapresistente capsules
Page 1/25
RVG 129796; RVG 129797
1311-v1
1.3.1.1 SmPC
September 2023
SUMMARY OF PRODUCT CHARACTERISTICS_ _
1.
NAME OF THE MEDICINAL PRODUCT
Dimethylfumaraat SDZ 120 mg, harde maagsapresistente capsules
Dimethylfumaraat SDZ 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
{[Nationally completed name] 120 mg gastro-resistant hard capsules}
Green opaque cap and white opaque body, capsule shell size No. 0,
length 21.4 mm, imprinted in
black ink with “DMF 120” on the body containing white to off-white
minitablets.
{[Nationally completed name] 240 mg gastro-resistant hard capsules}
Green opaque cap and body, capsule shell size No. 00, length 23.2 mm,
imprinted in black ink with
“DMF 240” on the body containing white to off-white minitablets.
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).
Sandoz B.V.
Dimethylfumaraat SDZ 120, 240 mg, harde maagsapresistente capsules
Page 2/25
RVG 129796; RVG 129797
1311-v1
1.3.1.1 SmPC
September 2023
If a patient misses a dose, a double dose should not be taken. The
patient may take the missed dose only