Land: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
dimethyl fumarate, Quantity: 240 mg
Accelagen Pty Ltd
Capsule, enteric
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
Oral
60 capsules
(S4) Prescription Only Medicine
DIMETHYL FUMARATE MSN is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.
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
Registered
2021-04-20
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 Lestu allt skjalið
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 Lestu allt skjalið