GIF: Powerful painkiller suspended from marketing

The Chief Sanitary Inspector halts nationwide marketing of the medicinal product named Benlek, Metamizolum natricum monohydricum + Thiamini hydrochloridum + Coffeinum, tablets, 500 mg + 38.75 mg + 50 mg, pack of 20 tablets, GTIN 05909991492977

The responsible entity is SOLINEA sp. z o.o. sp. k. based in Ciecierzyn.

The decision was given the order of immediate enforceability.

Pursuant to Article 119a (2) of the A.P.F., the Chief Pharmaceutical Inspector shall, by decision, order the transfer of a medicinal product that was first marketed in the territory of the Republic of Poland for quality testing by the units referred to in the regulations issued pursuant to Article 22 (2) of the Act.

The medicinal product Benlek, Metamizolum natricum monohydricum + Thiamini hydrochloridum + Coffeinum, tablets, 500 mg + 38.75 mg + 50 mg, pack of 20 tablets, GTIN 05909991492977, in connection with a decision issued by the Chief Pharmaceutical Inspector dated 06.03.2023, mark: IWJP.5451.115.2023.MST.2-, was transferred by the responsible entity Solinea sp. z o.o. sp.k. headquartered in Ciecierzyn, for quality testing performed by the National Institute of Medicines, i.e. an entity with the status of Official Medicines Control Laboratory (OMCL) certified by the European Directorate for the Quality of Medicinal Products at the Council of Europe (EDQM).

The test gave a negative result with regard to the parameter Chromatographic purity of thiamine hydrochloride, resulting in a ruling that the medicinal product in question did not meet the quality requirements stipulated for it. Pursuant to Article 121(1) of the PPF, in the event of a justified suspicion that a medicinal product does not meet the requirements established for it, or in the face of a suspicion that a medicinal product has been falsified, the provincial pharmaceutical inspector shall issue a decision to suspend the marketing of certain batches of the medicinal product within its territory. The second paragraph of the cited provision, on the other hand, stipulates that the decision to suspend marketing of the product throughout the country is made by the Chief Pharmaceutical Inspector. Page 3 of 6 The rationale for halting the marketing of a medicinal product is therefore a justified suspicion that the product does not meet the requirements established for it. On the other hand, there is no doubt that a negative result of a test conducted by OMCL on a sample of a medicinal product supplied by the responsible party justifies the suspicion of irregularities in the quality of the product. The explanations provided by the party in response to the Chief Pharmaceutical Inspector did not undermine the results of the tests conducted by the National Institute of Medicine in a way that would allow the authority to assume that the premise of a reasonable suspicion of non-compliance with quality requirements does not exist with respect to the tested product.

Benlek is used in pain of various origins of high intensity, fever, when the use of other drugs is contraindicated or ineffective. It contains three active substances: metamizole, vitamin B1 and caffeine.
Source: GIF