TECFIDERA GASTRO-RESISTANT HARD CAPSULES 240 MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Dimethyl fumarate

Available from:

EISAI (SINGAPORE) PTE. LTD.

ATC code:

N07XX09

Pharmaceutical form:

CAPSULE, ENTERIC COATED

Composition:

Dimethyl fumarate 240.0 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Corden Pharma Fribourg SA

Authorization status:

ACTIVE

Authorization date:

2016-07-26

Summary of Product characteristics

DIN Pro-Regular, DIN Pro-Bold, DIN Pro-Italic
8.0 pt
ART08490
01
English
FPO
STANDARD
MOCK UP PAT INF INSERT X-LARGE TECFIDERA SGP
N/A
PKG00069-01
N/A
XXXXXX
Schawk-108385734/403211424 0020
08 Mar 2023
Black
PMS 249 PMS 368 PMS 299
PHARMACODE
NUMBER:FPO
I_I_045_V2
W360 X H690, FOLDED: 100 X 45
TBC
TBC
TBC
PROFILE
PROFILE (NON PRINT)
TBC
ENGLISH
120 MG
GASTRO-RESISTANT HARD CAPSULES
240 MG
GASTRO-RESISTANT HARD CAPSULES
DIMETHYL FUMARATE
TECFIDERA GASTRO-RESISTANT HARD CAPSULES
1.
NAME OF THE MEDICINAL PRODUCT
Tecfidera 120 mg gastro-resistant hard capsules
Tecfidera 240 mg gastro-resistant hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tecfidera 120mg gastro-resistant hard capsules
Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate.
Tecfidera 240mg 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
Tecfidera 120 mg gastro-resistant hard capsules
Green and white gastro-resistant hard capsules, size 0, printed with
‘BG-12 120 mg’ containing
microtablets.
Tecfidera 240 mg gastro-resistant hard capsules
Green gastro-resistant hard capsules, size 0, printed with ‘BG-12
240 mg’ containing microtablets.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Tecfidera 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.
Tempora