Coronary heart Suhe pill and other preparations specification revision Yin false fire high patients taboo to take.

According to the results of the evaluation of adverse drug reactions, in order to further protect the safety of public drug use, the State Drug Administration decided to make a unified revision of the specifications of preparations such as coronary heart-su-pills, "adverse reactions", "taboos" and "precautions".
will now announce the relevant matters as follows: First, the production enterprises of the preparations such as Guanxin Suhe Pill shall, in accordance with the relevant provisions of the Measures for the Administration of Drug Registration and Administration, submit a supplementary application for the revision of the specification in accordance with the requirements of the Specification (see annex), and submit it to the provincial drug regulatory department for the record before June 5, 2020. Where the contents of the
revision involve drug labels, they shall be revised together; the specifications and other contents of the labels shall be consistent with the original approval content.
replace the factory's drug specifications and labels within 9 months of filing. The production enterprises of
,000, such as the preparation of the crown heart and suhe pill, shall conduct in-depth study on the mechanism of the occurrence of new adverse reactions, take effective measures to do a good job in publicity and training on the use of relevant drugs and safety issues, and guide physicians to use them rationally.
, clinicians shall carefully read the revised contents of the preparation instructions such as coronary su-hepills, and shall conduct full benefit/risk analysis in accordance with the new revised specification when selecting the drug.
three, coronary heart suhe pills and other preparations for prescription drugs, patients should strictly follow the doctor's instructions to use drugs, before taking the drug should carefully read the preparation instructions such as coronary suhe pills.
. The provincial drug regulatory departments shall urge the production enterprises of the preparations such as guanxin Suhe pill in the administrative area to do a good job of revising the corresponding specifications and changing the labels and instructions as required, and strictly investigate and punish the illegal and illegal acts in accordance with the law.
hereby make this announcement.
State Drug Administration March 10, 2020 Attached: Coronary Heart Suhe Pill and other preparations specification revision requirements 1, "Warning" item should be standardized as follows: Please read the instructions carefully and use under the guidance of a physician.
delete: "Please read the instructions carefully and use them or purchase and use them under the guidance of the pharmacist".
. 2, "Adverse Reactions" item should be increased: Adverse reaction monitoring data show that the following adverse reactions can be seen in the coronary heart and sioxin preparations: 1. Digestive system: nausea, vomiting, bloating, abdominal pain, diarrhea, abdominal discomfort, dry mouth, etc.
2. Nervous system: dizziness, headache, etc.
3. Skin: rash, itching, etc.
4. Other: Palpitations, etc.
. "Taboo" items should be increased: 1. Pregnant women are prohibited.
2. The shady fire is a bogey.
3. Is prohibited for anyone who is allergic to this product and the ingredients contained therein.
Four, "Precautions" items should be added: 1. This product is recommended to take after meals.
2. Patients with a tendency to bleed, menstruating women or patients treated with anticoagulant, antiplatelet treatment.
3. Patients with weak spleen and stomach, gastritis, esophagitis, and gastrointestinal ulcers are used with caution.
4. Use with caution in the chest paralysis caused by vulva blood clots.
5. Use with caution by lactating women.
6. Allergy is used with caution.
. Avoid raw cold, spicy, greasy food, avoid tobacco, alcohol, strong tea.
8. During treatment, angina continues to occur, it is advisable to add nitrate drugs.
if there is severe angina, myocardial infarction, should be treated in a timely manner.
9. This product lacks evidence of safety for long-term use and is not recommended for long-term use.
.