Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
dimethyl fumarate, Quantity: 120 mg
Arrotex Pharmaceuticals Pty Ltd
Capsule, enteric
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
Oral
7 capsules, 112 capsules, 14 capsules
(S4) Prescription Only Medicine
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.
Visual Identification: 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.; 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
Registered
2022-06-28
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 Прочетете целия документ
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 Прочетете целия документ