Dimethyl fumarate Polpharma

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

dimethyl fumarate

Dostupné z:

Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.

ATC kód:

L04AX07

INN (Medzinárodný Name):

dimethyl fumarate

Terapeutické skupiny:

Immunosuppressants

Terapeutické oblasti:

Multiple Sclerosis, Relapsing-Remitting

Terapeutické indikácie:

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

Prehľad produktov:

Revision: 4

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2022-05-13

Príbalový leták

30
B.
PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIMETHYL FUMARATE POLPHARMA 120 MG GASTRO-RESISTANT CAPSULES, HARD
DIMETHYL FUMARATE POLPHARMA 240 MG GASTRO-RESISTANT CAPSULES, HARD
_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 Polpharma is and what it is used for
2.
What you need to know before you take Dimethyl fumarate Polpharma
3.
How to take Dimethyl fumarate Polpharma
4.
Possible side effects
5.
How to store Dimethyl fumarate Polpharma
6.
Contents of the pack and other information
1.
WHAT DIMETHYL FUMARATE POLPHARMA IS AND WHAT IT IS USED FOR
WHAT DIMETHYL FUMARATE POLPHARMA IS
Dimethyl fumarate Polpharma is a medicine that contains the active
substance
DIMETHYL FUMARATE
.
WHAT DIMETHYL FUMARATE POLPHARMA IS USED FOR
DIMETHYL FUMARATE POLPHARMA 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 POLPHARMA WORKS
Dimethyl fum

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Dimethyl fumarate Polpharma 120 mg gastro-resistant capsules, hard
Dimethyl fumarate Polpharma 240 mg gastro-resistant capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dimethyl fumarate Polpharma 120 mg:
Each capsule contains 120 mg dimethyl fumarate.
Dimethyl fumarate Polpharma 240 mg:
Each capsule contains 240 mg dimethyl fumarate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant hard capsule
Dimethyl fumarate Polpharma 120 mg: hard gelatin capsules, length: 19
mm, with white body and
light-green cap, with overprint on the body 120 mg.
Dimethyl fumarate Polpharma 240 mg: hard gelatin capsules, length: 23
mm, light-green, with
overprint on the body 240 mg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dimethyl fumarate Polpharma 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.
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Dimethyl fumarate Polpharma should be taken with food (see section
5.2). For those patients who may
experience flushing or gastrointestinal adve