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calendary January 23, 2024

Flemoxin solutab: safety updates for the consumers

The well-known antibiotic amoxicillin has been found to have new undesirable effects. An information letter was published on the Roszdravnadzor website about this.

Back in November 2022, it became known about a possible relationship between amoxicillin administration and the development of aseptic meningitis, Kounis syndrome (allergic acute coronary syndrome), crystalluria (including acute renal failure), drug-induced enterocolitis syndrome (DIES) and linear IgA-dependent bullous dermatosis.

According to the information letter, the Marketing Authorization Holder (MAH) should update the “Undesirable effects” section with the following information:

  1. Acute coronary syndrome (undesirable effect from the side of cardiovascular system, occurring with an unknown frequency).
  2. Drug-induced enterocolitis (undesirable effect from the side of the gastrointestinal tract, occurring with an unknown frequency).
  3. Linear IgA-dependent bullous dermatosis (undesirable effect from the side of the skin and subcutaneous tissues, occurring with an unknown frequency).
  4. Crystalluria, including acute renal failure (undesirable effect from the side of the urinary system, occurring with an unknown frequency).

In addition, updates will apply to the “Special warnings & precautions for use” section:

  1. The subsection “Hypersensitivity reactions” is recommended to be supplemented with the following information: “Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can lead to myocardial infarction (see section “Undesirable Effects”).
  2. It is recommended to add a subsection "Drug-induced enterocolitis syndrome (DIES)".
  3. It is recommended to add “crystalluria (including acute renal failure)” to the “Crystalluria” subsection.

Flemoxin Solutab is currently available as dispersible tablets in dosages of 125 mg, 250 mg, 500 mg, and 1000 mg. MAH - Cheplapharm Arzneimittel GmbH). The official representative of the MAH in the territory of the Russian Federation is Pharmagate LLC.

References:
  1. https://pharmvestnik.ru/content/news/V-instrukciu-preparata-Flemoksin-Solutab-vnesli-pobochnye-deistviya.html
  2. https://roszdravnadzor.gov.ru/i/upload/images/2023/8/22/1692716894.08366-1-3806408.pdf

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