Announcement of the General Administration on the revision of the instructions for the preparation of renal decay

According to the results of the evaluation of adverse drug reactions, and in order to further ensure the safety of public drug use, the State Food and Drug Administration has decided to revise the warning words, "adverse reactions", "taboos" and "precautions" of the instructions for renal decay preparations. The relevant matters are heeded as follows:
First, all manufacturers of renal decay preparations shall, in accordance with the relevant provisions of the Measures for the Administration of Drug Registration and other relevant provisions, in accordance with the revised requirements of the renal decay preparation instructions (see annex), put forward supplementary applications for revision of the instructions, and report them to the provincial food and drug regulatory authorities for the record by October 28, 2016.
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 factory-issued drug instructions and labels shall be replaced within 6 months after the filing of the supplementary application.
the production enterprises of renal decay preparations should conduct in-depth research on the mechanism of new adverse reactions, take effective measures to do a good job in the publicity and training of the use and safety of renal decay preparations, and guide doctors to use drugs rationally.
. Clinicians should carefully read the revised contents of the renal decay preparation instruction manual, and when selecting the drug, they should carry out a full benefit/risk analysis in accordance with the newly revised instruction manual.
, renal decay preparations as prescription drugs, patients should strictly follow the doctor's instructions for medication, before taking drugs should carefully read the new revision of the renal decay preparation instructions.
this announcement.The revised requirements of the renal decay preparation
First, the warning words should include:
this product contains half-summer (made) / french half-summer (should be filled in according to the actual prescription)

Cases of dizziness, fatigue, palpitations, etc. have been reported.
, taboo items should include:
pregnant women disabled;
thursday, "Precautions" should include:
1. If the number of stools exceeds 4 times after taking the medicine, the amount should be reduced, and consult a doctor/pharmacist.
2. Children must be taken under adult supervision or as directed by a doctor.
. Patients with the following conditions with caution: spleen and stomach cold, stools more than 4 times before taking the drug, high potassiumemia, lactation and menstrual women.
4. Because the prescription contains half a summer, according to Chinese medicine 19 fear 18 back, carefully with the utopian class of drugs or follow the doctor's instructions.
5. It is not recommended to use with other preparations containing large yellow.
6. The drug should be kept in high temperature, direct sunlight. (State Administration of Food and Drug Administration)