Leflunomide medac 15 mg
As listed in the register: Leflunomide medac 15 mg, filmomhulde tabletten
15 mg · filmomhulde tablet
- Prescription only
- Cancer treatments and immune-system medicines
- Active substance
- Leflunomide
- Made by
- Medac Gesellschaft für klinische Spezialpräparate mbH
- 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 retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (Leflunomide). It describes the substance, not this exact product.
Leflunomide is an isoxazole immunomodulatory agent that inhibits dihydroorotate dehydrogenase (a mitochondrial enzyme involved in de novo pyrimidine synthesis) and has antiproliferative activity.
Several in vivo and in vitro experimental models have demonstrated an anti-inflammatory effect.
Following oral administration, leflunomide is metabolized to an active metabolite, teriflunomide, which is responsible for essentially all of leflunomide's in vivo activity.
Teriflunomide, the active metabolite of leflunomide, is eliminated by direct biliary excretion of unchanged drug as well as renal excretion of metabolites.
Effect of food Coadministration of leflunomide tablets with a high fat meal did not have a significant impact on teriflunomide plasma concentrations.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-05-01
Safety of the active substance
From the US prescribing label for the same active substance (Leflunomide). It describes the substance, not this exact product.
WARNING: EMBRYO-FETAL TOXICITY and HEPATOTOXICITY WARNING: EMBRYO-FETAL TOXICITY and HEPATOTOXICITY See full prescribing information for complete boxed warning.
- Leflunomide is contraindicated in: Pregnant women.
- Leflunomide may cause fetal harm.
- If a woman becomes pregnant while taking this drug, stop leflunomide, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see Warnings and Precautions (5.1, 5.3) and Use in Specific Populations (8.1) ].
- Patients with severe hepatic impairment [see Warnings and Precautions (5.2) ].
Most Common Adverse Reactions The most common adverse reactions in leflunomide-treated patients with RA include diarrhea, elevated liver enzymes (ALT and AST), alopecia, and rash.
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
Spain1 matching products
CanadaNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Medac Gesellschaft für klinische Spezialpräparate mbH |
|---|---|
| Active substance | Leflunomide |
| Used in | Cancer treatments and immune-system medicines |
| Strength | 15 mg |
| Form | filmomhulde tablet |
| Classification | L04AK01 · Cancer treatments and immune-system medicines |
| Route | oraal gebruik |
| Dispensing (as stated by the register) | Uitsluitend recept |
| Name in the register | Leflunomide medac 15 mg, filmomhulde tabletten |
| RVG | EU/1/10/637 |
Source: Geneesmiddeleninformatiebank · 2026-09-30 · not reviewed by a clinician
Bron: College ter Beoordeling van Geneesmiddelen (CBG). De Rijksoverheid is het niet automatisch eens met de inhoud van deze site. Reuse terms: CC0 1.0 (CBG website).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.