PHARMACOR DIMETHYL FUMARATE dimethyl fumarate 120 mg delayed release capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dimethyl fumarate, Quantity: 120 mg

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Capsule, enteric

Composition:

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

Administration route:

Oral

Units in package:

14's, 112's, 70's

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

It 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: 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

Authorization status:

Registered

Authorization date:

2021-07-14

Patient Information leaflet

Pharmacor Dimethyl Fumarate (Version-02)
Page 1
PHARMACOR DIMETHYL FUMARATE
_ DIMETHYL FUMARATE _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Pharmacor Dimethyl Fumarate.
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
Pharmacor Dimethyl fumarate
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 PHARMACOR
DIMETHYL FUMARATE IS
USED FOR
Pharmacor Dimethyl Fumarate
is used to treat relapsing
multiple sclerosis (MS).
Pharmacor 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 Pharmacor
Dimethyl Fumarate. However
Pharmacor Dimethyl Fumarate
cannot repair damage that has
already been caused by MS.
When you start Pharmacor
Dimethyl Fumarate you might
not notice an improvement, but
Pharmacor 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'.
Pharmacor Dimethyl Fumarate
contains the active ingredient
dimethyl fumarate

Summary of Product characteristics

Pharmacor Dimethyl Fumarate (Version-02)
Page 1
AUSTRALIAN PRODUCT INFORMATION
PHARMACOR DIMETHYL FUMARATE (DIMETHYL FUMARATE) DELAYED RELEASE
CAPSULES
1.
NAME OF THE MEDICINE
Dimethyl fumarate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pharmacor Dimethyl Fumarate 120 mg Delayed Release Capsules
Each capsule contains 120 mg of Dimethyl fumarate
Pharmacor Dimethyl Fumarate 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
Pharmacor Dimethyl Fumarate 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.
Pharmacor Dimethyl Fumarate 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
Pharmacor 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
The starting dose for Pharmacor Dimethyl Fumarate is 120 mg twice a
day orally. After 7 days,
increase to the recommended dose of 240 mg twice a day orally.
Pharmacor Dimethyl Fumarate (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.
Pharmacor Dimethyl Fumarate can be taken with or without food. For
those patients who may
experience gastrointestinal or flushing side eff