Femsira 240 mg hard gastro-resistant capsules

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Adalvo Limited Malta Life Sciences Park, Building 1, Level 4 Sir Temi Zammit San Gwann Industrial Est, SGN 3000 San Gwann, Malta

ATC code:

L04AX07

INN (International Name):

DIMETHYL FUMARATE 240 mg

Pharmaceutical form:

GASTRO-RESISTANT HARD CAPSULE

Composition:

DIMETHYL FUMARATE 240 mg

Prescription type:

POM

Therapeutic area:

IMMUNOSUPPRESSANTS

Authorization status:

Authorised

Authorization date:

2023-08-24

Patient Information leaflet

1
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FEMSIRA 120 MG HARD GASTRO-RESISTANT CAPSULES
FEMSIRA 240 MG HARD GASTRO-RESISTANT 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 Femsira is and what it is used for
2.
What you need to know before you take Femsira
3.
How to take Femsira
4.
Possible side effects
5.
How to store Femsira
6.
Contents of the pack and other information
1.
WHAT FEMSIRA IS AND WHAT IT IS USED FOR
WHAT FEMSIRA IS
Femsira is a medicine that contains the active substance
DIMETHYL FUMARATE
.
WHAT FEMSIRA IS USED FOR
FEMSIRA 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 FEMSIRA WORKS
Femsira 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 FEMSIRA
DO NOT TAKE FEMSIRA
-
IF YOU ARE ALLERGIC TO DIMETHYL FUMARATE
or any of the other ingredients of this medicine (listed
in section

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Femsira 120 mg hard gastro-resistant capsules
Femsira 240 mg hard gastro-resistant capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Femsira 120 mg hard gastro-resistant capsules
Each hard gastro-resistant capsule contains 120 mg dimethyl fumarate
Femsira 240 mg hard gastro-resistant capsules
Each hard gastro-resistant capsule contains 240 mg dimethyl fumarate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule (gastro-resistant capsule)
Femsira 120 mg hard gastro-resistant capsules
Green cap and white body, capsule shell of 21.4 mm, imprinted in black
ink with “DMF 120” on the
body containing white to off-white minitablets.
Femsira 240 mg hard gastro-resistant capsules
Green cap and body, capsule shell of 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
Femsira 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.
Femsira should be taken with food (see section 5.2). For those
patients who may experience flushing
or gastrointestinal adverse reactions, taking this