The Medicines and Medical Products Agency (HALMED) reported on Wednesday that it has withdrawn from the market due to established quality defects, the 140802 series of Ramipril H Farmal 2,5 mg / 12,5 mg pills, pharmaceutical companies Farmal dd
The withdrawal is carried out to the level of the pharmacy, ie to the point of delivery of the drug to the patients.
Patients already taking this drug series may continue to be administered as it is assessed that this discrepancy has no effect on the safety of drug administration and withdrawal is carried out for preventive reasons, HALMED points out.
The Department of the Official Drug Check Laboratory - OMCL HALMED has carried out a quality check of the quality of the medicines from the market as part of a regular check of the quality of this drug, and the result of the analysis established a deviation from the quality requirement that was approved for this drug in the dosing procedure marketing authorizations.
The drug manufacturer reiterated the analysis, confirming the relevant discrepancy, and a decision was therefore made to withdraw the said drug line from the HALMED.
The second drug series of Ramipril H Farmal 2,5 mg / 12,5 mg tablets is available in Croatia, which is not affected by the quality misstatement mentioned, the statement adds.
HALMEDs remind that healthcare professionals are obliged to report to HALMED any side effects of the drug as well as the quality defect in the drug. Patients who have developed a drug side effect may also report side effects directly to HALMED, with the recommendation that you should contact your doctor or pharmacist for any side effects that you may be advising on how to continue treatment.