Dimethyl fumarate Teva

Pays: Union européenne

Langue: anglais

Source: EMA (European Medicines Agency)

Ingrédients actifs:

dimethyl fumarate

Disponible depuis:

Teva GmbH

Code ATC:

L04AX07

DCI (Dénomination commune internationale):

dimethyl fumarate

Groupe thérapeutique:

Immunosuppressants

Domaine thérapeutique:

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

indications thérapeutiques:

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

Statut de autorisation:

Authorised

Date de l'autorisation:

2022-12-12

Notice patient

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

Résumé des caractéristiques du produit

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Dimethyl fumarate Teva 120 mg gastro-resistant hard capsules
Dimethyl fumarate Teva 240 mg gastro-resistant hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dimethyl fumarate Teva 120 mg gastro-resistant hard capsules
Each gastro-resistant hard capsule contains 120
_ _
mg dimethyl fumarate.
Dimethyl fumarate Teva 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 Teva 120 mg gastro-resistant hard capsules
Capsules size 0, approximately 21.7 mm, with white opaque body and
blue opaque cap. Marking
'D120' printed in black ink on cap and body.
Dimethyl fumarate Teva 240 mg gastro-resistant hard capsules
Capsules size 0, approximately 21.7 mm, with blue opaque body and blue
opaque cap. Marking 'D240'
printed in black ink on cap and body.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dimethyl fumarate Teva 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
Medicinal product no longer authorised