In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.
The Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) has reported that blood pressure monitoring in patients prescribed bromocriptine is mandatory, especially during the first days of treatment.
Bromocriptine — a dopamine agonist used for the prevention or suppression of postpartum physiological lactation only when there are appropriate medical indications.
A report received through the Yellow Card system indicates the need for careful monitoring of blood pressure during bromocriptine therapy, particularly in the first days of treatment.
When bromocriptine is prescribed, health care professionals should carefully monitor for a possible increase in blood pressure, especially at the start of therapy and with each dose increase. If signs or symptoms of hypertension appear in a patient receiving bromocriptine, treatment should be discontinued immediately and a clinical assessment of the patient's condition should be carried out.
TO ANALYZE THE PUBLISHED INFORMATION, THE APPLICANT MUST USE THE ORIGINAL TEXT POSTED AT THE LINKS:
