TECFIDERA dimethyl fumarate 240 mg modified release capsules blister packs

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dimethyl fumarate, Quantity: 240 mg

Available from:

Biogen Australia Pty Ltd

INN (International Name):

dimethyl fumarate

Pharmaceutical form:

Capsule, modified release

Composition:

Excipient Ingredients: brilliant blue FCF; croscarmellose sodium; methacrylic acid copolymer; polysorbate 80; purified talc; triethyl citrate; Gelatin; colloidal anhydrous silica; simethicone; magnesium stearate; sodium lauryl sulfate; titanium dioxide; microcrystalline cellulose; iron oxide yellow; methacrylic acid - ethyl acrylate copolymer (1:1); propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

56

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

TECFIDERA is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability

Product summary:

Visual Identification: Size 0 hard-gelatin capsules, green body with green cap imprinted with "BG-12 240 mg" on body containing white to off-white enteric-coated microtablets.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2013-07-11

Patient Information leaflet

TECFIDERA
®
_Dimethyl fumarate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TECFIDERA. 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.
You can also download the most up
to date leaflet from:
www.biogen.com.au/products/
tecfidera-CMI.pdf
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking TECFIDERA
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 TECFIDERA IS
USED FOR
TECFIDERA is used to treat
relapsing multiple sclerosis (MS).
TECFIDERA 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 TECFIDERA. However
TECFIDERA cannot repair damage
that has already been caused by MS.
When you start TECFIDERA you
might not notice an improvement, but
TECFIDERA 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'.
TECFIDERA contains the active
ingredient dimethyl fumarate.
Dimethyl fumarate decreases the
inflammation in your brain that is
caused by MS and thereby reduces
nerve damage.
TECFIDERA works by reducing
infl

Summary of Product characteristics

TECFIDERA PI (version 10621)
1
AUSTRALIAN PRODUCT INFORMATION
TECFIDERA
® (DIMETHYL FUMARATE) MODIFIED RELEASE CAPSULES
1
NAME OF THE MEDICINE
Dimethyl fumarate (DMF).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TECFIDERA (dimethyl fumarate [DMF]) is formulated as enteric coated
microtablets enclosed
within hard gelatin capsules, containing the active ingredient
dimethyl fumarate.
Each TECFIDERA capsule contains 120 mg or 240 mg DMF. The inactive
ingredients of
TECFIDERA are: microcrystalline cellulose, croscarmellose sodium,
purified talc, colloidal
anhydrous silica, magnesium stearate, triethyl citrate,
methylacrylate-methyl methacrylate
copolymer, methacrylic acid – ethyl acrylate copolymer (1:1),
simethicone, sodium lauryl
sulfate, polysorbate 80, gelatin, titanium dioxide, brilliant blue FCF
(CI42090), iron oxide yellow
(CI77492), iron oxide black (CI77499).
3
PHARMACEUTICAL FORM
Modified release capsules.
120 mg capsules:
TECFIDERA is supplied as green and white capsules printed with
“BG-12 120 mg” in black
ink on the capsule body. Each capsule contains 120 mg DMF.
240 mg capsules:
TECFIDERA is supplied as green capsules printed with “BG-12 240
mg” in black ink on the
capsule body. Each capsule contains 240 mg DMF.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
TECFIDERA is indicated in patients with relapsing multiple sclerosis
to reduce the frequency
of relapses and to delay the progression of disability.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The starting dose for TECFIDERA is 120 mg twice a day orally. After 7
days, increase to the
recommended dose of 240 mg twice a day orally.
The capsule or its contents should not be crushed, divided or
dissolved as the enteric coating
of the microtablets prevents irritant effects on the gut.
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.
TECFIDERA PI (version 10621)
2
TECFIDERA can be taken w