Dimethyl Fumarate Sandoz 120 mg gastro-resistant hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

ATC code:

L04AX07

INN (International Name):

DIMETHYL FUMARATE 120 mg

Pharmaceutical form:

GASTRO-RESISTANT HARD CAPSULE

Composition:

DIMETHYL FUMARATE 120 mg

Prescription type:

POM

Therapeutic area:

IMMUNOSUPPRESSANTS

Authorization status:

Authorised

Authorization date:

2023-12-12

Patient Information leaflet

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PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIMETHYL FUMARATE SANDOZ 120 MG GASTRO-RESISTANT HARD CAPSULES
DIMETHYL FUMARATE SANDOZ 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 Sandoz is and what it is used for
2.
What you need to know before you take Dimethyl Fumarate Sandoz
3.
How to take Dimethyl Fumarate Sandoz
4.
Possible side effects
5.
How to store Dimethyl Fumarate Sandoz
6.
Contents of the pack and other information
1.
WHAT DIMETHYL FUMARATE SANDOZ IS AND WHAT IT IS USED FOR
Dimethyl Fumarate Sandoz is a medicine that contains the active
substance
DIMETHYL
FUMARATE
.
WHAT DIMETHYL FUMARATE SANDOZ IS USED FOR
Dimethyl Fumarate Sandoz 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 SANDOZ WORKS
Dimethyl Fumarate Sandoz seems to work by stopping the body’s
defense system from
damaging your brain and spinal cord. This may also help to delay
future worseni

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dimethyl Fumarate Sandoz 120 mg gastro-resistant hard capsules
Dimethyl Fumarate Sandoz 240 mg gastro-resistant hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dimethyl Fumarate Sandoz 120 mg gastro-resistant hard capsules
Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate.
Dimethyl Fumarate Sandoz 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
Dimethyl Fumarate Sandoz 120 mg gastro-resistant hard capsules
Green opaque cap and white opaque body, capsule shell size No. 0,
length 21.4 mm, imprinted in
black ink with “DMF 120” on the body containing white to off-white
minitablets.
Dimethyl Fumarate Sandoz 240 mg gastro-resistant hard capsules
Green opaque cap and body, capsule shell size No. 00, length 23.2 mm,
imprinted in black ink with
“DMF 240” on the body containing white to off-white minitablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dimethyl Fumarate Sandoz 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.
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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