State Food and Drug Administration: there is another revision of the manual of traditional Chinese Medicine

According to the evaluation results of adverse drug reactions, in order to further ensure the safety of drug use by the public, the State Drug Administration decided to add warning words to the prescription drug instructions of zhufengtougu preparation (capsule, tablet, pill) and Pudilan anti-inflammatory preparation (tablet, capsule, oral liquid), and revise the items of [adverse drug reactions], [contraindications] and [precautions] The relevant matters are hereby announced as follows: 1 All prescription drug manufacturers of houfengtougu preparation and Pudilan antiphlogistic preparation shall, in accordance with the measures for the administration of drug registration and other relevant regulations, put forward the supplementary application for the revision of the specification in accordance with the revision requirements of the corresponding specification (see Annex 1-3), and report to the provincial drug regulatory authority for the record before December 31, 2018 If the revised contents involve drug labels, they shall be revised together; the instructions and other contents of the labels shall be consistent with the original approved contents Within 6 months after the supplementary application is filed, the ex factory drug instructions and labels shall be replaced The above drug manufacturers shall 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 relevant drug use and safety issues, and guide doctors to use drugs reasonably 2、 Clinicians should carefully read the revised contents of the above drug instructions, and make full benefit / risk analysis according to the newly revised instructions when selecting drugs 3、 The above-mentioned drugs are prescription drugs, and patients should strictly follow the doctor's instructions, and carefully read the above-mentioned drug instructions before use 4、 Each provincial drug regulatory department shall urge the above-mentioned drug manufacturing enterprises in the administrative region to do a good job in the revision of corresponding instructions and the replacement of labels and instructions as required It is hereby announced Appendix: 1 Revision requirements for the instruction manual of houfengtougu capsule (tablet) 2 Revision requirements for the instruction manual of houfengtougu pill 3 Revision requirements for the instruction manual of prescription drugs of Pudilan anti-inflammatory preparation of State Food and Drug Administration on October 22, 2018 Appendix 1: revision requirements for the instruction manual of houfengtougu capsule (tablet) 1 Warning words should be added: This product includes Chuanwu, Caowu and tiannanxing 2、 [adverse reactions] items should be added: digestive system: nausea, vomiting, hiccup, heartburn, abdominal distention, abdominal pain, diarrhea, etc Nervous system: dizziness, headache, numbness of mouth and tongue, numbness of limbs, etc Skin: rash, pruritus, flush, etc Respiratory system: chest tightness, dyspnea, etc., with laryngeal edema case report Cardiovascular system: palpitation, arrhythmia and hypertension Systemic reactions: anaphylaxis, asthenia, edema, etc 3、 [contraindications] items should be added: 1 It is forbidden to use this product and its ingredients 2 It is forbidden for pregnant women and those with liver and kidney dysfunction 4、 [precautions] items should be added: 1 This product contains Radix Aconiti, Radix Aconiti, and Rhizoma Arisaema It should be taken under the guidance of doctors in strict accordance with the instructions It is not allowed to increase the dosage and taking time arbitrarily This product is not suitable for long-term use In case of headache, dizziness, numbness of mouth and tongue, nausea, palpitation, dyspnea and allergic reaction after taking the medicine, stop taking the medicine immediately and go to the hospital for treatment 2 Athletes should be careful Appendix 2: requirements for revision of the manual of zhuiftougu pill 1 [adverse reactions] should be added: digestive system: nausea, vomiting, hiccup, heartburn, abdominal distention, abdominal pain, diarrhea, etc Skin: rash, pruritus, flush, etc Nervous system: dizziness, headache, numbness of mouth and tongue, numbness of limbs, etc Cardiovascular system: palpitation, chest distress, hypertension and arrhythmia Systemic reaction: allergic reaction, edema, etc 2、 [contraindications] items should be added: it is forbidden to use this product and those who are allergic to its ingredients 3、 [precautions] items should be added: 1 This product contains Radix Aconiti, Radix Aconiti, and Rhizoma Arisaema It should be taken under the guidance of doctors in strict accordance with the instructions It is not allowed to increase the dosage and taking time arbitrarily This product is not suitable for long-term use In case of headache, dizziness, numbness of mouth and tongue, nausea, palpitation, dyspnea and allergic reaction after taking the medicine, stop taking the medicine immediately and go to the hospital for treatment 2 Use with caution in patients with liver and kidney dysfunction Annex 3: requirements for revision of prescription drug Manual of Pudilan antiphlogistic preparation 1 [adverse reactions] shall include: the preparation has the following adverse reactions reports: nausea, vomiting, abdominal distention, abdominal pain, diarrhea, fatigue, dizziness, etc.; rash, pruritus and other allergic reactions 2、 [taboo] items should include: it is forbidden to use this product and the allergy to its ingredients 3、 [precautions] should include: 1 Pregnant women should use it with caution 2 Use with caution if you are allergic 3 Patients with abdominal pain, fever, diarrhea and other spleen and stomach deficiency cold should be used with caution.