Announcement of the General Administration on the revision of the instruction manual for the oral solution of compound licorice

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 instructions for the oral solution of compound licorice, the "adverse reactions", "taboos" and "precautions". The relevant matters are heeded as follows:
First, all pharmaceutical production enterprises of compound licorice oral solution shall, in accordance with the relevant provisions of the Measures for the Administration of Drug Registration, and in accordance with the revised requirements of the description of the oral solution of compound licorice (see annex), file a supplementary application for revision of the instruction manual, which shall be submitted to the provincial food and drug regulatory department for the record by July 31, 2017.
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 pharmaceutical production enterprises of compound licorice oral solutions shall conduct in-depth research on the mechanism for the occurrence of new adverse reactions, take effective measures to do a good job in the publicity and training of use and safety issues, and guide physicians to use drugs rationally.
. Clinicians shall carefully read the revised contents of the oral solution instructions for compound licorice, and shall conduct a full benefit/risk analysis in accordance with the newly revised instructions when selecting medication.
, patients should strictly follow the doctor's instructions to use drugs, before taking drugs should carefully read the instructions.
this announcement.
The revision requirements of the oral solution of compound licorice
1, "The content" item
in addition after the "ml compound camphor" (camphor, opiate, ml, octagonal fennel oil, benzoic acid, mg) " specific identification. The specific content shall be revised by the enterprise according to the situation of their respective products.
II, "Adverse reactions" item is revised as:
gastrointestinal system: dry mouth, nausea, vomiting, bloating, abdominal pain, diarrhea, etc.;
skin and its accessories: sweating, itching, rash, etc.;
Cardiovascular system: redness, palpitations, elevated blood pressure, etc.;
respiratory system: chest tightness, shortness of breath, difficulty breathing, etc.;
central and peripheral nervous systems: dizziness, headache, drowsiness, convulsions, tremors, insomnia, mental abnormalities, etc.;
urinary system: urinary retention, facial edema, etc.;
systemic damage: allergic reactions, allergic shock, hysteria, etc.
, taboo items should contain:
1. It is prohibited for pregnant and lactating women.
2. Banned for those who are allergic to this product and its ingredients.
3. Those who are allergic to ethanol (alcohol) are prohibited.
, "Notes" should include the following:
1. Use with caution in bronchial asthma, chronic obstructive pulmonary disease (COPD), and respiratory suppressors.
. Patients with gastritis and peptic ulcers should use it with caution.
. Seek medical attention immediately if you overdos or have a serious adverse reaction.
4. Athletes use it with caution.
5. Because this product contains ethanol (alcohol), do not operate machinery and drive a vehicle after taking this product, and avoid the simultaneous application of cephalosporine or drugs prone to double sulfur reaction.
. People with high blood pressure should pay attention to monitoring blood pressure during taking this product.
15th, "Medication for pregnant and lactating women" was amended to read:
prohibited.
6th, the "old age medication" item is revised as follows:
elderly organ metabolism is slow, poor tolerance to such drugs, the use of this product must strictly follow the doctor's instructions.
, drug interaction, is revised to read:
1. When taking this product, take care to avoid taking strong cough medicine at the same time.
. Consult a physician or pharmacist before using this product if you are taking other medications.
3. This product contains ethanol, and cephalosporine drugs or drugs prone to double sulfur reaction can increase the concentration of acetylide in the blood, double thiolyde reaction (facial redness, headache, dizziness, abdominal pain, stomach pain, nausea, vomiting, shortness of breath, rapid heart rate, lower blood pressure and drowsiness, hallucinations, etc.).
(Note: If other contents of the manual are inconsistent with the above-mentioned amendment requirements, they shall be revised in une.) (State Food and Drug Administration)