FURATEC dimethyl fumarate 120 mg delayed release capsule blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

dimethyl fumarate, Quantity: 120 mg

Dostopno od:

Pharmacor Pty Ltd

Farmacevtska oblika:

Capsule, enteric

Sestava:

Excipient Ingredients: magnesium stearate; methacrylic acid copolymer; silicified microcrystalline cellulose; purified talc; croscarmellose sodium; colloidal anhydrous silica; triethyl citrate; titanium dioxide; indigo carmine; purified water; iron oxide yellow; Gelatin; polysorbate 80; sodium lauryl sulfate

Pot uporabe:

Oral

Enote v paketu:

14's, 70's, 112's

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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

Povzetek izdelek:

Visual Identification: White to off white, enteric coated round shaped mini tablets filled in size "1" hard gelatin capsule, opaque green cap printed with "DMF" and opaque white body printed with "120" in black ink.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius

Status dovoljenje:

Registered

Datum dovoljenje:

2021-07-14

Navodilo za uporabo

Furatec (Version-01)
Page 1
FURATEC
_ DIMETHYL FUMARATE _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Furatec. 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
Furatec 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 FURATEC IS USED
FOR
Furatec is used to treat
relapsing multiple sclerosis
(MS).
Furatec 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 Furatec.
However Furatec cannot repair
damage that has already been
caused by MS. When you start
Furatec you might not notice
an improvement, but
Furatec 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'.
Furatec contains the active
ingredient dimethyl fumarate.
Dimethyl fumarate decreases
the inflammation in your brain
that is caused by MS and
thereby reduces nerve damage.
Furatec works by reducing
inflammatory responses in
cells and helps to protect the
central nervous system cells
against attac

Lastnosti izdelka

Furatec (Version-02)
Page 1
AUSTRALIAN PRODUCT INFORMATION
FURATEC (DIMETHYL FUMARATE) DELAYED RELEASE CAPSULES
1.
NAME OF THE MEDICINE
Dimethyl fumarate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Furatec 120 mg Delayed Release Capsules
Each capsule contains 120 mg of Dimethyl fumarate
Furatec 240 mg Delayed Release Capsules
Each capsule contains 240 mg of Dimethyl fumarate
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Capsule, Delayed release
Furatec 120 mg Delayed Release Capsules-
White to off white, enteric coated round shaped mini tablets filled in
size "1" hard gelatin
capsules, Opaque Green cap printed with "DMF" and Opaque white body
printed with" 120" in
black ink.
Furatec 240 mg Delayed Release Capsules-
White to off white, enteric coated round shaped mini tablets filled in
size "0" hard gelatin
capsules, Opaque Green cap printed with "DMF" and Opaque green body
printed with "240" in
black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Furatec 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
The starting dose for Furatec is 120 mg twice a day orally. After 7
days, increase to the
recommended dose of 240 mg twice a day orally.
Furatec (Version-02)
Page 2
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.
Furatec
can
be
taken
with
or
without
food.
For
those
patients
who
may
experience
gastrointestinal or flushing side effects, taking Furatec 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 heal