Dimethyl fumarate Sandoz
On the Bulgarian pack: Диметилфумарат Сандоз 240 mg капсула стомашно-устойчива, твърда
240 mg gastro-resistant capsule, hard Unit-dose 168 · gastro-resistant capsule, hard
- Prescription only
- Cancer treatments and immune-system medicines
- Active substance
- Dimethyl fumarate
- Made by
- Sandoz Pharmaceuticals d.d.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet read the official leaflet for this product. The exact uses and dose are in the leaflet inside the pack. Open the official leaflet
How it works
This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (dimethyl fumarate). It describes the substance, not this Bulgarian product — its uses and doses can differ.
The mechanism by which dimethyl fumarate (DMF) exerts its therapeutic effect in multiple sclerosis is unknown.
DMF and the metabolite, monomethyl fumarate (MMF), have been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans.
In humans, dimethyl fumarate is extensively metabolized by esterases, which are ubiquitous in the gastrointestinal tract, blood, and tissues, before it reaches the systemic circulation.
Following administration of dimethyl fumarate delayed-release capsules 240 mg twice a day with food, the mean C max of MMF was 1.87 mg/L and AUC was 8.21 mg.hr/L in MS patients.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-10-30
Safety of the active substance
This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (dimethyl fumarate). It describes the substance, not this Bulgarian product — its uses and doses can differ.
- Dimethyl fumarate delayed-release capsules are contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate delayed-release capsules.
- Reactions have included anaphylaxis and angioedema [see Warnings and Precautions ( 5.1 )].
- Known hypersensitivity to dimethyl fumarate or any of the excipients of dimethyl fumarate delayed-release capsules.
Most common adverse reactions (incidence ≥10% and ≥2% placebo) were flushing, abdominal pain, diarrhea, and nausea.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
European UnionNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Sandoz Pharmaceuticals d.d. · Slovenia |
|---|---|
| Active substance | Dimethyl fumarate |
| Used in | Cancer treatments and immune-system medicines |
| Strength | 240 mg gastro-resistant capsule, hard Unit-dose 168 |
| Form | gastro-resistant capsule, hard |
| Pack sizes | 168 |
| Classification | L04AX07 · Cancer treatments and immune-system medicines |
| Name in the register | Диметилфумарат Сандоз 240 mg капсула стомашно-устойчива, твърда |
| Reg. no. | 20240302 |
Source: Bulgarian Drug Agency register · 2026-08-01 · not reviewed by a clinician
Източник: Изпълнителна агенция по лекарствата (ИАЛ). The publisher’s terms do not grant reproduction, so text is shortened and linked. Publisher’s terms.
Other strengths and forms
5 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- gastro-resistant capsule, hard5 products
- 120 mg
- 120 mg gastro-resistant capsule, hard Unit-dose 14
- 240 mg gastro-resistant capsule, hard Unit-dose 168
- 240 mg
- 240 mg gastro-resistant capsule, hard Unit-dose 56
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.