Dimethyl fumarate Mylan

Kraj: Unia Europejska

Język: angielski

Źródło: EMA (European Medicines Agency)

Składnik aktywny:

dimethyl fumarate

Dostępny od:

Mylan Ireland Limited

Kod ATC:

L04AX07

INN (International Nazwa):

dimethyl fumarate

Grupa terapeutyczna:

Immunosuppressants

Dziedzina terapeutyczna:

Multiple Sclerosis, Relapsing-Remitting

Wskazania:

Dimethyl fumarate Mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Podsumowanie produktu:

Revision: 4

Status autoryzacji:

Authorised

Data autoryzacji:

2022-05-13

Ulotka dla pacjenta

37
B. PACKAGE LEAFLET
Medicinal product no longer authorised
38
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIMETHYL FUMARATE MYLAN 120 MG GASTRO-RESISTANT HARD CAPSULES
DIMETHYL FUMARATE MYLAN 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 Mylan is and what it is used for
2.
What you need to know before you take Dimethyl fumarate Mylan
3.
How to take Dimethyl fumarate Mylan
4.
Possible side effects
5.
How to store Dimethyl fumarate Mylan
6.
Contents of the pack and other information
1.
WHAT DIMETHYL FUMARATE MYLAN IS AND WHAT IT IS USED FOR
WHAT DIMETHYL FUMARATE MYLAN IS
DIMETHYL FUMARATE MYLAN
is a medicine that contains the active substance
DIMETHYL FUMARATE
WHAT DIMETHYL FUMARATE MYLAN IS USED FOR
Dimethyl fumarate Mylan 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 MYLAN WORKS
Dimethyl fumarate Mylan seems to work by stopping the body’s defence
system from damaging your
brain an

Charakterystyka produktu

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Dimethyl fumarate Mylan 120 mg gastro-resistant hard capsules
Dimethyl fumarate Mylan 240 mg gastro-resistant hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dimethyl fumarate Mylan 120 mg gastro-resistant hard capsules
Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate
Dimethyl fumarate Mylan 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 Mylan 120 mg gastro-resistant hard capsules
Blue-green and white gastro-resistant hard capsules, 21.7 mm in
length, printed with ‘MYLAN’ over
‘DF 120’ containing white to off-white enteric coated pellets.
Dimethyl fumarate Mylan 240 mg gastro-resistant hard capsules
Blue-green gastro-resistant hard capsules, 21.7 mm in length, printed
with ‘MYLAN’ over ‘DF 240’
containing white to off-white enteric coated pellets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dimethyl fumarate Mylan 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.
Medicinal product no longer authorised
3
Temporary dose reduction to 120 mg twice a day may reduce the
occurrence of flushing and
gastrointestinal adverse reactions. W