Agency for Medicines Calms Citizens: You Can Freely Use Paracetamol

A kind of panic has spread among the population in BiH after it was announced that certain medicines have had their marketing authorization temporarily suspended in BiH, writes the news agency Patria.

The ban was issued for ESCONTRAL direkt (desloratadine), orally disintegrating tablets, 30x5 mg, manufactured by Jadran Galenski laboratorij, Croatia, ESCITALOPRAM PharmaS (escitalopram), film-coated tablets, 28x10 mg, manufactured by PharmaS d.o.o., Croatia, and TRAMADOL/PARACETAMOL PharmaS (tramadol, paracetamol), film-coated tablets, (37.5 mg + 325 mg), 10 and 30 film-coated tablets, manufactured by PharmaS d.o.o., Croatia.

Particular panic arose due to the third medicine, and we learned from pharmacies that people are buying less Paracetamol. However, as explained to us at the Agency for Medicines and Medical Devices, there is no reason for concern among BiH citizens, given that these are precautionary measures, meaning there have been no reports of adverse effects or quality defects for the three mentioned medicines, nor has the quality, safety, and efficacy of these medicines been compromised.

- To avoid confusion among patients, regarding the withdrawal of the medicine TRAMADOL/PARACETAMOL PharmaS, no paracetamol of any manufacturer will be withdrawn, as it is not covered by these measures. Citizens can obtain medicines containing paracetamol as an active substance in pharmacies without any fear. The withdrawal here applies only to the medicine containing the combination of tramadol and paracetamol, and only from the manufacturer PharmaS. Medicines containing this combination from other manufacturers can be freely obtained by patients in pharmacies – stated the Agency for Medicines and Medical Devices.

The Agency has issued temporary decisions to revoke, and has ordered the representatives of the manufacturers of these medicines to take all measures for their withdrawal from the BiH market. The revocation, and consequently the withdrawal, applies only to these three medicines from the specified manufacturers from Croatia.

- Patients who have used these three medicines have no reason for concern, given that there is a large number of parallel products on the market, i.e., the same medicines from other manufacturers, which specifically means that in no case is there any reason for concern regarding the market supply of medicines containing these active substances – the Agency added.