Tecfidera

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

dimethyl fumarate

Available from:

Biogen Netherlands B.V.

ATC code:

L04AX07

INN (International Name):

dimethyl fumarate

Therapeutic group:

Immunosuppressants

Therapeutic area:

Multiple Sclerosis

Therapeutic indications:

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

Product summary:

Revision: 28

Authorization status:

Authorised

Authorization date:

2014-01-30

Patient Information leaflet

43
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TECFIDERA 120 MG GASTRO-RESISTANT HARD CAPSULES
TECFIDERA 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 Tecfidera is and what it is used for
2.
What you need to know before you take Tecfidera
3.
How to take Tecfidera
4.
Possible side effects
5.
How to store Tecfidera
6.
Contents of the pack and other information
1.
WHAT TECFIDERA IS AND WHAT IT IS USED FOR
WHAT TECFIDERA IS
Tecfidera is a medicine that contains the active substance
DIMETHYL FUMARATE
.
WHAT TECFIDERA IS USED FOR
TECFIDERA 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 TECFIDERA WORKS
Tecfidera seems to work by stopping the body’s defence system from
damaging your brain and spinal
cord. This may also help to delay future worsening of your MS.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TECFIDERA
DO NOT TAKE TECFIDERA
-
IF YOU ARE ALLERGIC TO DIMETHYL FUMARATE
or any of the other ingredient

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
43
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 120 mg gastro-resistant hard capsules
Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate.
Tecfidera 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
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.
Temporary dose reduction to 120 mg twice a day may reduce the
occurrence of flushing and
gastrointestinal adverse reactions. Within 1 month, the recommended
maintenance dose of 240 mg
twice a day should be resumed.
43
Tecfidera should be taken with food (see section 5.2). For those
patients who may experience flushing
or gastrointestinal adverse reactions, taking Tecfidera with food may
improve tolerability (see
sections 4.4, 4.5 and 4.