Revise the instruction manual for quick-acting heart-saving pills to add adverse reactions

Medicine Network January 20th, January 19th, the State Drug Administration issued a notice on the revision of the quick-acting heart-saving pill instructions.
Based on the results of the evaluation of adverse drug reactions, and in order to further ensure the safety of public drug use, the State Drug Administration has decided to revise the warning words, "adverse reactions" (taboos) and "precautions" of the instruction manual for quick-acting heart-saving pills.
The relevant matters are heeded as follows: First, the licensed holders of this product shall, in accordance with the Measures for the Administration of Drug Registration and other relevant provisions, and in accordance with the revised requirements of the corresponding instructions (see annex), report the revised instructions to the provincial drug regulatory departments for the record by April 13, 2021.
of the amendment relates to the drug label, it shall be revised together, and the instructions and other contents of the label shall be consistent with the original approval content.
the original drug instructions for medicines produced on the date of filing.
drug market license holder shall replace the factory-issued drug instructions and labels within 9 months of filing.
. Drug market license holders shall conduct in-depth research on the mechanism for the occurrence of new adverse reactions, take effective measures to do a good job in publicity and training on drug use and safety issues, and guide physicians and patients to use drugs rationally.
, clinicians should carefully read the revision of this product description, in the choice of medication, should be in accordance with the new revision of the manual to carry out adequate benefit/ risk analysis.
, patients should carefully read the drug instructions before taking the drug, the use of prescription drugs, should strictly follow the doctor's instructions for medication.
. The provincial drug supervision and administration department shall urge the holders of drug listing licenses in the administrative area to do a good job in revising the corresponding instructions and replacing the labels and instructions as required, and severely investigate and punish violations of laws and regulations in accordance with the law.
this announcement. Annex
: The revision of the description of quick-acting heart-saving pills requires the State Drug Administration to revise the instructions for quick-acting heart-saving pills on January 14, 2021, and the warning words should include: pregnant women should be banned from two, "adverse reactions" items should be added: monitoring data show that the following adverse reactions can be seen: nausea, vomiting, dry mouth, headache, dizziness, rash, itching, redness, fatigue, allergic and allergic reactions.
, taboo items should be added: 1. Pregnant women are prohibited.
2. Banned for those who are allergic to this product and the ingredients contained therem.
, "Precautions" items should be increased: allergic physique carefully used.