Medicine guide

Duloxetine Viatris (previously Duloxetine Mylan)

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  • Prescription status not stated
  • Pain, sleep, mood, epilepsy and the brain
Active substance
Duloxetine
Made by
Viatris Limited

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

What it is for

  • Treatment of major depressive disorder Treatment of diabetic peripheral neuropathic pain Treatment of generalised anxiety disorder Duloxetine Viatris is indicated in adults

From the official label · 2026-09-30 · European Medicines Agency

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 (duloxetine hydrochloride). It describes the substance, not this Bulgarian product — its uses and doses can differ.

Although the exact mechanisms of the antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.

Peak level after6–10 h
Half-life12 h
Mostly cleared after≈ 3 daysfive half-lives — our arithmetic
PeakHalf gone3 days0
The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.
How the body breaks it down

Elimination of duloxetine is mainly through hepatic metabolism involving two P450 isozymes, CYP1A2 and CYP2D6.

How it leaves the body

Most (about 70%) of the duloxetine dose appears in the urine as metabolites of duloxetine; about 20% is excreted in the feces.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-20

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

BulgariaNo 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 byViatris Limited
Active substanceDuloxetine
Used inPain, sleep, mood, epilepsy and the brain
ClassificationN06AX21 · Pain, sleep, mood, epilepsy and the brain
GenericYes — a generic medicine, according to the register
Authorised on2015-06-19
Last updated by the regulator2026-05-07
EMA product numberEMEA/H/C/003981

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.