Medicine guide

Teriflunomide Sandoz 14 mg

As listed in the register: Teriflunomide Sandoz 14 mg, filmomhulde tabletten

14 mg · filmomhulde tablet

  • Prescription only
  • Cancer treatments and immune-system medicines
Active substance
Teriflunomide
Made by
Sandoz B.V.

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

What it is for

Medicine groupCancer treatments and immune-system medicinesL04AK02

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 (Teriflunomide). It describes the substance, not this exact product.

Teriflunomide, an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis.

The exact mechanism by which teriflunomide exerts its therapeutic effect in multiple sclerosis is unknown but may involve a reduction in the number of activated lymphocytes in CNS.

Peak level after1–4 h
How the body breaks it down

Drug Interaction Studies Teriflunomide is not metabolized by Cytochrome P450 or flavin monoamine oxidase enzymes.

How it leaves the body

Teriflunomide is eliminated mainly through direct biliary excretion of unchanged drug as well as renal excretion of metabolites.

With food

Food does not have a clinically relevant effect on teriflunomide pharmacokinetics.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-26

Safety of the active substance

From the US prescribing label for the same active substance (Teriflunomide). It describes the substance, not this exact product.

Serious warning

WARNING: HEPATOTOXICITY and EMBRYOFETAL TOXICITY Hepatotoxicity Clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with teriflunomide in the postmarketing setting [see Warnings and Precautions ( 5.1 )].

Must not be used by
  • Teriflunomide is contraindicated in/with: Patients with severe hepatic impairment [see Warnings and Precautions ( 5.1 )].
  • Pregnant women and females of reproductive potential not using effective contraception.
  • Teriflunomide may cause fetal harm [see Warnings and Precautions ( 5.2, 5.3 ) and Use in Specific Populations ( 8.1 )].
  • Patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in teriflunomide tablets.
Most common side effects

The most common were headache, an increase in ALT, diarrhea, alopecia, 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

European UnionNo exact match for this strength and form

SwitzerlandNo exact match for this strength and form

Details

Made bySandoz B.V.
Active substanceTeriflunomide
Used inCancer treatments and immune-system medicines
Strength14 mg
Formfilmomhulde tablet
ClassificationL04AK02 · Cancer treatments and immune-system medicines
Routeoraal gebruik
Dispensing (as stated by the register)Uitsluitend recept
Name in the registerTeriflunomide Sandoz 14 mg, filmomhulde tabletten
RVG128862

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.