In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.
Updating of the instructions for medical use to raise awareness of the known risk of agranulocytosis and to facilitate its early detection and diagnosis
These changes to the relevant sections of the package leaflet are the result of the referral procedure.
Changes to be made to the relevant sections of the package inserts (new text underlined and in bold).
[For all medicinal products, the existing instructions for medical use must be amended (inclusion, replacement or deletion of text, as appropriate) to reflect the agreed wording, as indicated below.
If the current package inserts contain the relevant information in any other sections, it should be removed to avoid duplication of information.]
- Section “Posology and method of administration” (and/or any other section if necessary)
[Delete any recommendation on regular monitoring of blood parameters in patients.]
[Delete any text indicating that the risk of agranulocytosis increases after one week or with long-term use].
- “Contraindications” section
[The following contraindications should be added]
– History of agranulocytosis caused by metamizole, other pyrazolones or pyrazolidines
– Impaired bone marrow function or diseases of the hematopoietic system
- Section “Special warnings and precautions for use”
[The following warning text should be added in a box at the top of the “Special warnings and precautions for use” section]
Agranulocytosis
Treatment with metamizole may cause agranulocytosis, which can be fatal (see the section “Adverse reactions”). It can occur even after previous use of metamizole without adverse consequences.
Metamizole-induced agranulocytosis is an idiosyncratic adverse reaction. Agranulocytosis is not dose-dependent and can occur at any time during treatment, even shortly after treatment has been discontinued.
Пацієнтів необхідно поінформувати про необхідність припинити лікування та негайно звернутися за медичною допомогою у разі появи будь-яких симптомів, що вказують на агранулоцитоз (наприклад, гарячка, озноб, біль у горлі та болючі зміни на слизовій оболонці, особливо у роті, носі та горлі, а також у ділянці статевих органів або анального отвору).
If metamizole is used for fever, some symptoms of a developing agranulocytosis may go unnoticed. Similarly, symptoms may be masked in patients receiving antibiotic therapy.
If signs and symptoms suggestive of agranulocytosis appear, a complete blood count (including a differential count) should be performed immediately and treatment should be discontinued while awaiting the results. If the diagnosis is confirmed, treatment must not be resumed (see the section "Contraindications").
List of medicinal products containing metamizole and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 24.12.2024).
TO ANALYZE THE PUBLISHED INFORMATION AND SUBMIT THE CORRESPONDING APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT POSTED AT THE LINKS:
