DIMETHYL FUMARATE SANDOZ dimethyl fumarate 240 mg modified release capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dimethyl fumarate, Quantity: 240 mg

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Capsule, modified release

Composition:

Excipient Ingredients: colloidal anhydrous silica; glyceryl monostearate 40-55 per cent; Gelatin; Shellac; isopropyl alcohol; purified talc; propylene glycol; triethyl citrate; titanium dioxide; methacrylic acid - ethyl acrylate copolymer (1:1); croscarmellose sodium; butan-1-ol; methacrylic acid copolymer; iron oxide black; ethanol; sodium stearylfumarate; purified water; iron oxide yellow; brilliant blue FCF; polysorbate 80; strong ammonia solution

Administration route:

Oral

Units in package:

56, 14

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

DIMETHYL FUMARATE SANDOZ 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: Hard gelatin light-green capsules with overprint on the body 240 mg; size of capsules No 00; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2021-11-17

Patient Information leaflet

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

Summary of Product characteristics

221114-DimethylFumarateSandoz-pi
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
DIMETHYL FUMARATE SANDOZ
® (DIMETHYL FUMARATE) MODIFIED
RELEASE CAPSULES
1.
NAME OF THE MEDICINE
Dimethyl fumarate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DIMETHYL FUMARATE SANDOZ (dimethyl fumarate [DMF]) is formulated as
enteric
coated granules enclosed within hard gelatin capsules, containing the
active ingredient
dimethyl fumarate.
Each DIMETHYL FUMARATE SANDOZ capsule contains 120 mg or 240 mg DMF.
The
inactive ingredients of DIMETHYL FUMARATE SANDOZ are: croscarmellose
sodium,
colloidal anhydrous silica, sodium stearylfumarate, methacryclic acid
copolymer, purified talc,
triethyl
citrate,
methacrylic
acid
–
ethyl
acrylate
copolymer
(1:1)
dispersion,
glyceryl
monostearate 40-55 per cent, polysorbate 80, gelatin, titanium
dioxide, iron oxide yellow,
brilliant blue FCF, printing ink (shellac glaze, iron oxide black,
propylene glycol).
3.
PHARMACEUTICAL FORM
Modified release capsules.
120 mg capsules:
DIMETHYL FUMARATE SANDOZ is supplied as white and light-green capsules
printed
with “120 mg” on the capsule body. Each capsule contains 120 mg
DMF.
240 mg capsules:
DIMETHYL FUMARATE SANDOZ is supplied as light-green capsules printed
with “240
mg” on the capsule body. Each capsule contains 240 mg DMF.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
DIMETHYL FUMARATE SANDOZ 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 DIMETHYL FUMARATE SANDOZ 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 granules prevents irritant effects on the gut.
221114-DimethylFumarateSandoz-pi
Page 2 of 17
Temporary dose reduction to 120 mg twice a day may reduce the
occurrence of flushing and
gastrointestinal (GI) side effects. Wit