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BENLEK

On the Bulgarian pack: БЕНЛЕК 500 mg/38,75 mg/50 mg таблетки

500 mg/ 38,75 mg/ 50 mg · tablet

  • Available without prescription
  • Pain, sleep, mood, epilepsy and the brain
Made by
Adifarm EAD

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

Regulator safety notice · 2024-09-18

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

Measures to minimise serious outcomes of known side effect with painkiller metamizole

On 18 September 2024, the CMDh endorsed the measures recommended by EMA’s safety committee, PRAC, to minimise the serious outcomes of agranulocytosis, a known side effect caused by the painkiller metamizole.

Agranulocytosis involves a sudden and sharp decrease in granulocytes, a type of white blood cell, that can lead to serious or even fatal infections.

The committee recommended that healthcare professionals must inform patients to stop taking these medicines and seek immediate medical attention if they develop symptoms of agranulocytosis.

These include fever, chills, sore throat and painful sores on the moist, inner body surfaces (mucosa), especially in the mouth, nose and throat or in the genital or anal regions.

Patients must remain alert for these symptoms both during and shortly after stopping treatment.

The PRAC concluded that the benefits of metamizole medicines continue to outweigh the risks.

Quoted from: European Medicines Agency — Metamizole-containing medicinal products, referral · retrieved 2026-09-30

What it is for

Medicine groupPain, sleep, mood, epilepsy and the brainN02BB52

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

Details

Made byAdifarm EAD · Bulgaria
Active substanceMetamizole sodium, combinations excl. psycholeptics
Used inPain, sleep, mood, epilepsy and the brain
Strength500 mg/ 38,75 mg/ 50 mg
Formtablet
Pack sizes9 · 18 · 20 · 27
ClassificationN02BB52 · Pain, sleep, mood, epilepsy and the brain
Name in the registerБЕНЛЕК 500 mg/38,75 mg/50 mg таблетки
Reg. no.20130266

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.

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Same active substance

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

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