Dimethyl fumarate Clonmel 120 mg gastro-resistant hard capsules

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

थमां उपलब्ध:

Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary E91 D768, Ireland

ए.टी.सी कोड:

L04AX07

INN (इंटरनेशनल नाम):

DIMETHYL FUMARATE 120 mg

फार्मास्यूटिकल फॉर्म:

GASTRO-RESISTANT HARD CAPSULE

रचना:

DIMETHYL FUMARATE 120 mg

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

IMMUNOSUPPRESSANTS

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2023-08-23

सूचना पत्रक

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

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Dimethyl fumarate Clonmel 120 mg gastro-resistant hard capsules
Dimethyl fumarate Clonmel 240 mg gastro-resistant hard capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Dimethyl fumarate Clonmel 120 mg gastro-resistant hard capsules
Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate
Dimethyl fumarate Clonmel 240 mg gastro-resistant 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 Clonmel 120 mg gastro-resistant hard capsules
Gastro-resistant hard capsule (21 mm) with green cap and white body,
with “DMF 120” imprinted in
black on the body.
Dimethyl fumarate Clonmel 240 mg gastro-resistant hard capsules
Gastro-resistant hard capsule (23 mm) with green cap and body, with
“DMF 240” imprinted in black on
the body.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dimethyl fumarate Clonmel 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.
Dimethyl fumarate Clonmel should be taken with food (see section 5.2).
For those patients who may
experience flushi