Metamizole Kalceks
On the Bulgarian pack: Метамизол Калцекс 500 mg/ml инжекционен разтвор
500 mg/ml · solution for injection
- Prescription only
- Pain, sleep, mood, epilepsy and the brain
- Active substance
- Metamizole sodium
- Made by
- AS KALCEKS
- Source
- Official label
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
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
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
Spain2 matching products
Netherlands3 matching products
SwitzerlandNo exact match for this strength and form
Details
| Made by | AS KALCEKS · Czech Republic |
|---|---|
| Active substance | Metamizole sodium |
| Used in | Pain, sleep, mood, epilepsy and the brain |
| Strength | 500 mg/ml |
| Form | solution for injection |
| Pack sizes | 5 · 10 · 100 |
| Classification | N02BB02 · Pain, sleep, mood, epilepsy and the brain |
| Name in the register | Метамизол Калцекс 500 mg/ml инжекционен разтвор |
| Reg. no. | 20200069 |
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.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.