APO-DIMETHYL FUMARATE dimethyl fumarate 240 mg enteric coated capsule blister pack

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

dimethyl fumarate, Quantity: 240 mg

Disponible depuis:

Arrotex Pharmaceuticals Pty Ltd

forme pharmaceutique:

Capsule, enteric

Composition:

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

Mode d'administration:

Oral

Unités en paquet:

56 capsules, 7 capsules, 14 capsules

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

Dimethyl fumarate enteric coated capsules are indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

Descriptif du produit:

Visual Identification: Size 0 hard gelatin capsules with green cap and body, printed with HR2 in black ink on capsule body containing white to off-white, round, biconvex enteric coated mini tablets plain on both the sides.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Statut de autorisation:

Registered

Date de l'autorisation:

2022-06-28

Notice patient

APO-DIMETHYL FUMARATE
1
APO-DIMETHYL FUMARATE
_Dimethyl fumarate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APO-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 APO-
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 APO-DIMETHYL
FUMARATE IS USED
FOR
APO-DIMETHYL FUMARATE is
used to treat relapsing multiple
sclerosis (MS).
APO-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 APO-DIMETHYL
FUMARATE. However APO-
DIMETHYL FUMARATE cannot
repair damage that has already been
caused by MS. When you start APO-
DIMETHYL FUMARATE you
might not notice an improvement, but
APO-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'.
APO-DIMETHYL FUMARATE
contains the active ingredient
dimethyl fumarate. Dimethyl
fumarate decreases the inflammation
in your brain that is caused by MS
and there

Résumé des caractéristiques du produit

1
AUSTRALIAN PRODUCT INFORMATION – APO-DIMETHYL FUMARATE
(DIMETHYL FUMARATE) ENTERIC COATED CAPSULES
1
NAME OF THE MEDICINE
Dimethyl fumarate (DMF).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APO-DIMETHYL FUMARATE (dimethyl fumarate) is formulated as enteric
coated mini tablets enclosed
within hard gelatin capsules, containing the active ingredient
dimethyl fumarate.
Each APO-DIMETHYL FUMARATE capsule contains 120 mg or 240 mg dimethyl
fumarate.
Excipient with known effect: sulfites.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Modified release capsules.
120 mg hard gelatin capsules:
Size “0” hard gelatin capsules with green cap and white body,
printed with “HR1” in black ink on
capsule body containing white to off-white, round, biconvex enteric
coated mini tablets plain on
both the sides.
240 mg hard gelatin capsules:
Size “0” hard gelatin capsules with green cap and body, printed
with “HR2” in black ink on capsule
body containing white to off-white, round, biconvex enteric coated
mini tablets plain on both the
sides.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
APO-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
D
OSE AND METHOD OF ADMINISTRATION
The starting dose for APO-DIMETHYL FUMARATE 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
mini tablets prevents irritant effects on the gut.
2
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.
APO-DIMETHYL FUMARATE can
be
taken
with
or
without food.
For those
patients
who
may
experience gastrointestinal or flushing side effects, taking
APO-DIMETHYL FUMARATE with food may