DIMETHYL FUMARATE MSN dimethyl fumarate 240 mg enteric capsule bottle

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

dimethyl fumarate, Quantity: 240 mg

Tilgjengelig fra:

Accelagen Pty Ltd

Legemiddelform:

Capsule, enteric

Sammensetning:

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

Administreringsrute:

Oral

Enheter i pakken:

60 capsules

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

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

Produkt oppsummering:

Visual Identification: Size "0" hard gelatin capsule shell with a white opaque cap and white opaque body imprinted with "240 mg" with black ink, containing white to off white coloured enteric coated mini-tablets; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Autorisasjon status:

Registered

Autorisasjon dato:

2021-04-20

Informasjon til brukeren

Dimethyl Fumarate MSN v2.0
1 DIMETHYL FUMARATE MSN
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING DIMETHYL FUMARATE MSN?
Dimethyl Fumarate MSN contains the active ingredient dimethyl
fumarate. Dimethyl Fumarate MSN is used to treat relapsing
multiple sclerosis (MS).
For more information, see Section 1. Why am I taking Dimethyl Fumarate
MSN? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE DIMETHYL FUMARATE MSN?
Do not use if you have ever had an allergic reaction to dimethyl
fumarate or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I take
Dimethyl Fumarate MSN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Dimethyl Fumarate MSN and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE DIMETHYL FUMARATE MSN?
•
The recommended starting dose of Dimethyl Fumarate MSN is 120 mg taken
twice daily. After 7 days the recommended
dose is 240 mg twice daily.
More instructions can be found in Section 4. How do I take Dimethyl
Fumarate MSN? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING DIMETHYL FUMARATE MSN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Dimethyl Fumarate MSN.
•
If you are about to have any blood or urine tests, tell your doctor
that you are taking Dimethyl
Fumarate MSN. Blood and urine test results may be affected by
treatment with Dimethyl Fumarate
MSN.
•
Tell your doctor if you are going to be vaccinated.
•
Call your doctor right away if you think you have an infection, have
fever, or feel like you have the flu.
•
Call your doctor right away if you think

Preparatomtale

Dimethyl Fumarate MSN PI Ver 1.0
1
AUSTRALIAN PRODUCT INFORMATION
DIMETHYL FUMARATE MSN (DIMETHYL FUMARATE) ENTERIC CAPSULES
1.
NAME OF THE MEDICINE
Dimethyl fumarate
2.
QUALITIATIVE AND QUANTITATIVE COMPOSITION
Dimethyl Fumarate MSN (dimethyl fumarate) is formulated as enteric
coated microtablets
enclosed within hard gelatin capsules, containing the active
ingredient dimethyl fumarate.
Each Dimethyl Fumarate MSN capsule contains 120 mg or 240 mg dimethyl
fumarate. For
the full list of excipients, see Section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Enteric capsules.
120 mg capsules:
Dimethyl Fumarate MSN capsules are supplied as white to off white
coloured enteric coated
mini tablets filled in size "0" hard gelatin capsule shell with white
opaque cap and white
opaque body imprinted with "120 mg" with black ink.
240 mg capsules:
Dimethyl Fumarate MSN capsules are supplied as white to off white
coloured enteric coated
mini tablets filled in size "0" hard gelatin capsule shell with white
opaque cap and white
opaque body imprinted with "240 mg" with black ink
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dimethyl Fumarate MSN 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 Dimethyl Fumarate MSN 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.
Dimethyl Fumarate MSN PI Ver 1.0
2
Dimethyl Fumarate MSN can be taken with or without food. For those
patients who may
experience gastrointestinal or flushing side effects, taking Dimethyl
Fumarate MSN wi