The preparation is used to offset the effects of rhinosinusitis and has also been shown to alleviate the symptoms of chronic idiopathic urticaria in both adults and children.
The General Pharmaceutical Inspectorate received information - sent by the responsible entity, Synoptis Pharma Sp. z o.o. - about the decision to exclude from sale those batches of the medicine that did not meet the quality requirements. The medicine was examined with regard to the parameters: "active substance content" and "release". In both cases, the result was out of specification.
The GIF granted the request of the responsible entity, withdrawing a total of 6 batches of the medicine that could pose a potential risk to patients using it.
Here are the batches of the medicinal preparation (in the case of packs containing different quantities of tablets) for which the above-mentioned irregularities were found:

Cetirizine Genoptim SPH (Cetirizini dihydrochloridum), 10 mg, film-coated tablets, 10 tablets:

• batch number: E16326B, expiry date: 07.2019
• batch number: E16324D, expiry date: 07.2019
• batch number: E16325A, expiry date: 07.2019
• batch number: E17358C, expiry date: 04.2020

Cetirizine Genoptim SPH (Cetirizini dihydrochloridum), 10 mg, film-coated tablets, 7 tablets:

• batch number: E17358, expiry date: 04.2020
• batch number: E16326A, expiry date: 07.2019

More information can be found by looking at the indicated web address: https://www.gif.gov.pl/pl/decyzje-i-komunikaty/decyzje/decyzje/1324,Decyzja-Nr-108WC2018.html.