Dimethyl Fumarate Te Arai

Land: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Dimethyl fumarate 240mg

Fáanlegur frá:

Te Arai BioFarma Limited

Skammtar:

240 mg

Lyfjaform:

Modified release capsule

Samsetning:

Active: Dimethyl fumarate 240mg Excipient: Colloidal silicon dioxide Crospovidone SheffCoat Clear ASA 5X00294 SheffCoat White ENT TEC 5X00273 Capsugel green OP. C162 Magnesium stearate Microcrystalline cellulose Povidone

Gerð lyfseðils:

Prescription

Ábendingar:

Indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

Vörulýsing:

Package - Contents - Shelf Life: Blister pack, Al/Al in outer cardboard carton - 14 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, Al/Al in outer cardboard carton - 56 capsules - 36 months from date of manufacture stored at or below 30°C

Leyfisdagur:

2020-10-02

Upplýsingar fylgiseðill

Dimethyl Fumarate Te Arai
1
DIMETHYL FUMARATE TE ARAI
_Dimethyl fumarate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dimethyl Fumarate Te
Arai. It does not contain all the
available information. It does not take
the place of talking to your doctor or
pharmacist.
This leaflet was last updated on the
date at the end of this leaflet.
SPEAK TO YOUR PHARMACIST OR DOCTOR
TO OBTAIN THE MOST UP TO DATE
INFORMATION ON THIS MEDICINE.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking Dimethyl Fumarate Te Arai
against the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT
DIMETHYL
FUMARATE IS USED FOR
Dimethyl Fumarate is used to treat
relapsing multiple sclerosis
(MS).
Dimethyl Fumarate slows
down the progression of physical
disability in people with relapsing
forms of MS and decreases the
number of flare ups (relapses).
Some people feel better when they
start to take Dimethyl Fumarate.
However Dimethyl Fumarate cannot
repair damage that has already been
caused by MS. When you start
Dimethyl Fumarate you might not
notice an improvement,
but Dimethyl Fumarate may
still be working to help prevent your
MS from becoming worse.
The cause of MS is not yet known,
MS affects the brain and spinal cord.
In MS, the body’s immune system
reacts against its own myelin (the
‘insulation’ surrounding nerve fibres).
In relapsing forms of MS, people
have ‘exacerbations’ from time to
time (e.g. blurred vision, weakness in
the legs or arms, or loss of control of
bowel or bladder function). They are
followed by periods of recovery.
Recovery may be complete or
incomplete. If it is incomplete there is
‘progression of disability’.
Dimethyl Fumarate contains
the active ingredient dimethyl
fumarate. Dimethyl fumarate
decreases the inflammation in your
brain that is caused by MS and
thereby redu

Vara einkenni

Dimethyl Fumarate Te Arai Data Sheet January 2023
Page 1 of 17
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Dimethyl Fumarate Te Arai 120 mg modified release capsules
Dimethyl Fumarate Te Arai 240 mg modified release capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dimethyl Fumarate Te Arai 120 mg capsule
Each capsule contains 120 mg Dimethyl Fumarate.
Dimethyl Fumarate Te Arai 240 mg capsule
Each capsule contains 240 mg Dimethyl Fumarate.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dimethyl Fumarate Te Arai 120 mg capsule
Green and white capsules printed with “DMF 120” in black ink on
the capsule body.
Dimethyl Fumarate Te Arai 240 mg capsule
Green capsules printed with “DMF 240” in black ink on the capsule
body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dimethyl Fumarate is indicated in patients with relapsing multiple
sclerosis to reduce the frequency
of relapses and to delay the progression of disability.
4.2
DOSE AND METHOD OF ADMINISTRATION
Posology
The starting dose for Dimethyl Fumarate is 120 mg twice a day orally.
After 7 days, increase to the
recommended dose of 240 mg twice a day orally.
Temporary dose reduction to 120 mg twice a day may reduce the
occurrence of flushing and
gastrointestinal (GI) side effects. Within 1 month, the recommended
dose of 240 mg twice a day
orally should be resumed.
Dimethyl Fumarate can be taken with or without food. For those
patients who may experience
gastrointestinal or flushing side effects, taking Dimethyl Fumarate
with food may improve tolerability.
Administration of 325 mg non‐enteric coated aspirin prior to
Dimethyl Fumarate dosing reduced the
occurrence and severity of flushing in a healthy volunteer study (see
section 4.5)_._
_ _
_Paediatric population_
_ _
The safety and effectiveness of Dimethyl Fumarate in paediatric
patients with multiple sclerosis
below
the age of 18 have not been established.
Dimethyl Fumarate Te Arai Data Sheet January 2023
Page 2 of 17
_Elderly_
_ _
There are limited data available for the use o